OUTER HOUSE, COURT OF SESSION
[2008] CSOH 128
|
|
OPINION OF
LORD UIST
in the cause
JUNE GREENHORN (AP)
Pursuer
against
SOUTH
GLASGOW UNIVERSITY
HOSPITALS NHS TRUST
Defender
ญญญญญญญญญญญญญญญญญ________________
|
Pursuer: MacAulay QC, Miss
Sutherland; A & W M Urquhart
Defenders: Stephenson; R F Macdonald
5 September 2008
Introduction
[1] The pursuer, who was born
on 1 June 1964, is
the mother of three children. She underwent a hysterectomy in
December 1994. She thereafter
developed symptoms of incontinence, for which she attended four sessions of
physiotherapy at Law Hospital,
Carluke. In about March 1999 she
was referred by her gynaecologist there to Dr Ian Ramsay, Consultant
Obstetrician and Gynaecologist at the Southern General Hospital in Glasgow. He performed urodynamic studies which showed
that she suffered from genuine stress incontinence (GSI) and detrusor
instability. GSI is caused by prolapse
of the urethra below the pelvic floor.
Detrusor instability is over-activity of the bladder muscle. As the pursuer's GSI did not respond to
physiotherapy Dr Ramsay offered her a colposuspension operation. She underwent a colposuspension at the
Southern General Hospital on 26 August 1999. In the course of the operation she suffered
serious blood loss, which ceased only after pelvic vessel embolisation had been
carried out following an emergency angiography which had revealed leakage of
blood from a branch of the right iliac artery.
She avers that her blood loss was caused by uncontrollable haemorrhage
from the branch of the right iliac artery due to one of the doctors who
performed the operation having damaged the right ileopectineal vessels as a
result of having negligently inserted sutures near those vessels (and not into
the ileopectinael ligament closer to the symphysis pubis) and too laterally
deep in the right pelvis. The blood loss
resulted in a neurological injury.
Colposuspension
[2] Colposuspension is an
operation which is designed to cure urinary leakage arising from GSI. It is designed to restore the normal position
of the bladder, which may have undergone some degree of prolapse and involves
drawing the bladder neck up through the pelvic floor muscles so that they can
work effectively to stop incontinence. The tissues at the neck of the bladder which
lie at the top of the vagina are hitched up by means of stitches to a ligament
on the front of the bony pelvis called the ileopectineal ligament. When the stitches are tightened the urethra is
restored to its normal position and incontinence should resolve. In about 2003 colposuspension was
effectively superseded by tension free vaginal tape procedure through keyhole
surgery whereby needles are placed through the tissues attached to a tape which
provides the hammock which the vagina did with the colposuspension. That procedure has itself been significantly
modified to the obturator tape procedure and has become the new gold standard
in the treatment of GSI.
Arteries and veins
[3] An
artery is a blood vessel which carries blood away from the heart. All arteries,
except the pulmonary artery, carry oxygenated blood. The walls of arteries
contain smooth muscle fibres which contract or relax under control of the
sympathetic nervous system. A vein is a blood vessel which conveys blood
towards the heart after it has circulated through the tissues off the body. All
veins, except the pulmonary vein, carry deoxygenated blood from the tissues.
The pursuer's operation
[4] The pursuer's
colposuspension was carried out by Dr Kalaivani Lingam, then a
Specialist Registrar in Obstetrics and Gynaecology, under the supervision of Dr Hassan Omar Mohammed Ali
(Dr Hassan), then an Associate Specialist in Obstetrics and
Gynaecology. They were the only doctors
who gave evidence about events at the gynaecological operation. Dr Grant Urquhart, Consultant
Radiologist at the Southern General Hospital with a special interest in
intervention radiology, gave evidence about his involvement in carrying out the
embolisation procedure which stopped the pursuer's bleeding. Expert evidence about how a colposuspension
should be carried out came from Dr Alan Brown, formerly Senior
Consultant in Obstetrics and Gynaecology at the Royal Infirmary of Edinburgh,
and Mr Gerald Jarvis, Consultant Obstetrician and Gynaecologist at
the BUPA Hospital
in Leeds with a special interest in urogynaecology.
[5] The
evidence led established that in the course of the operation there were two
separate sources of blood loss, the second more significant than the first. The first occurred in the area of the right
ileopectineal ligament. The pursuer
avers (at p 8D), in accordance with the operation note, that "right
ileopectineal vessel bleeding was noted and sutures were applied to this area"
and (at p 13C-D) the defenders admit that. It is not suggested that this first source of
blood loss was causally related to the pursuer's injury. The second and significant source of blood
loss was from a branch of the right internal iliac artery. There were two views from the expert witnesses
about how this damage occurred. According
to Dr Brown it occurred when Dr Lingam moved out of the operating
field to some extent while applying sutures to the vaginal wall. The final position adopted by Mr Jarvis
was that it occurred when a suture was being applied to the ileopectineal
ligament and the needle penetrated into a muscle in the pelvic floor, causing
damage to the artery. Such an
explanation was not pleaded by the defenders on record. Mr Jarvis accepted in evidence that Dr Lingam
was negligent if she moved outwith the operating field to cause damage to the
artery while applying sutures to the vaginal wall. It is the pursuer's case that the second
source of blood loss occurred because Dr Lingam moved outwith the operating
field when she applied the second vaginal suture and thus caused damage to a
branch of the internal iliac artery. She
avers, not only that Dr Lingam was negligent in carrying out the
operation, but also that she lacked the necessary experience to carry it out
and that Dr Hassan failed to supervise her properly when she was carrying
out the operation.
Dr Lingam's qualifications and experience
[6] Dr Lingam's curriculum vitae is 7/4 of process. She graduated MB ChB from the University
of Glasgow in 1987. She subsequently acquired the qualifications
of Fellow of the Royal College of Surgeons of Edinburgh (1992),
Member of the Royal College of Obstetricians and Gynaecologists (1996) and
Diploma of the Faculty of Family Planning (1999). At the time of giving evidence she was a
consultant obstetrician and gynaecologist at Queen's Hospital, Burton,
Derbyshire, having previously held a similar post in Rotherham
from 2001 to 2004. Before that she was a
specialist registrar in Glasgow. So far as her training was concerned, she
first worked from August 1987 to January 1988 as a Medical Junior
House Officer at the Victoria Infirmary in Glasgow, and then for the following
six months as a Surgical Junior House Officer at Glasgow Royal Infirmary. She was a Senior House Officer in Obstetrics
and Gynaecology at Stobhill Hospital,
Glasgow from August 1988 to
January 1989, at the Southern General Hospital from February to July 1989,
and at the Glasgow Royal
Maternity Hospital
from August 1989 to July 1990. From August 1990 to July 1991 she
was a Senior House Officer in Urology at Glasgow Royal Infirmary, during which
period she learned the procedure for carrying out a colposuspension. She carried out on average two
colposuspensions each week because at that time in Glasgow
all incontinence work was done by a urologist. For the first six months she assisted in the
procedure but towards the end of that period she undertook the procedure. Over the latter six months she was lead
surgeon in six procedures and assistant in another six. From August 1991 to July 1992 she
was a Surgical Senior House Officer at the Glasgow Victoria Infirmary. From August 1992 to July 1993 she
was a Senior House Officer in Urology at Glasgow Royal Infirmary, during which
time she was involved in about 20 colposuspensions, in about half of which
she was lead surgeon. From August 1993
to November 1993 she was a Senior House Office in Obstetrics and
Gynaecology at the Royal Alexandra Infirmary, Paisley, but did not undertake
any colposuspensions during that time. From December 1994 until April 1996
she was a Senior House Officer in Obstetrics and Gynaecology and from May to
July 1996 undertook research in urology at Glasgow Royal Infirmary and had
no involvement in colposuspensions during that time. From August 1996 to October 1996 she
was a Senior House Officer in Obstetrics and Gynaecology at Stobhill
Hospital, during which time she was
involved in about two colposuspensions, in neither of which she was the lead
surgeon. From November 1996 until
July 1997 she was a Specialist Registrar at Stobhill
Hospital, during which time she had
no involvement in colposuspensions. From
August 1997 until July 1998 she was a Specialist Registrar in
Obstetrics and Gynaecology at Falkirk and District Royal
Infirmary, during which time she was an assistant surgeon in one
colposuspension. She then moved to the
Queen Mother's Hospital in Glasgow
as a Specialist Registrar in Obstetrics and Gynaecology from August 1998
until July 1999 and during her year there performed one colposuspension as
a lead surgeon. She began working as a
Specialist Registrar at the Southern General Hospital on 1 August 1999 and left there on 29 September 1999. On 26 August 1999
she performed a colposuspension on another patient before she carried out the
operation on the pursuer. She performed
both these operations as lead surgeon. She
had no recollection whether she had done any colposuspensions between 1 and 26 August,
but thought that if she had done so she would probably have remembered. Nor had she any recollection whether she had
assisted in any colposuspensions between 1 and 26 August 1999. She accepted that it was probable that between
1 and 26 August 1999
she had neither assisted nor acted as lead surgeon in a colposuspension. Accordingly, in the period from July 1993
up to 26 August 1999
she had acted as lead surgeon in only one colposuspension and had been involved
in four altogether (including the one in which she acted as lead surgeon). In August 1999 the consultant in charge
of the Department at the Southern General Hospital was Dr Ramsay, who was
the lead clinician for Urogynaecology. Dr Hassan assisted him and there was a
sister who did all the conservative treatment. As Dr Lingam had an interest in
urogynaecology and was in her final year in training towards a consultant post
she requested that she be attached to Dr Ramsay. From January to October 2000 as
Specialist Registrar at Derby City
General Hospital
she carried out three colposuspensions as lead surgeon. Between 2001 and 2004 she performed two
colposuspensions in Rotherham as lead surgeon. She had not had to do any colposuspensions
thereafter.
Dr Hassan's qualifications and experience
[7] Dr Hassan was born on 1 January 1953. His curriculum
vitae is 7/1 of process. He
graduated MB, BS from the University of Khartoum, Sudan in 1976 and
obtained the qualification of Member of the Royal College of Obstetricians and
Gynaecologists in May 1991. He
worked as an intern in the Sudan
between October 1976 and October 1977. From November 1977 to September 1978 he worked
as a Senior House Officer in Obstetrics and Gynaecology in Sudan.
From October 1979 until December 1984
he worked at hospitals in Libya
- as Senior House Officer in casualty (January to October 1979), General
Medicine (October 1979 to October 1981) and Obstetrics and
Gynaecology (October 1981 to December 1982) and as Registrar in
Obstetrics and Gynaecology from October 1981 to December 1982. He moved from there to work in Cork
in Ireland where
he was a Supernumerary Registrar from March to August 1985 and Registrar
in Obstetrics and Gynaecology from September 1985 to June 1990. In July 1990 he took up a post as
Registrar in Obstetrics and Gynaecology at the Southern General Hospital. In October 1994 he became a Staff Grade
Registrar, a post which he held until October 1998. He was a Locum Senior Registrar from August 1998
until July 1999 and from July 1999 he was a Staff Grade/Acting Senior
Registrar. He became an Associate
Specialist in August 2004. Although
he had extensive training and experience in all aspects of obstetric and
gynaecological management his area of interest was urogynaecology, colposcopy
and oncology. He first saw a
colposuspension done in Libya
and assisted in two cases there in 1983. For five years in Cork
he was Registrar to Professor Jenkins and assisted in and performed
colposuspensions. Up to the end of 1999
he performed a total of 84 colposuspensions as lead surgeon at the
Southern General Hospital.
Evidence about the pursuer's operation
(i) Dr Lingam
[8] Dr Lingam explained
that at the time a colposuspension was the gold standard treatment for GSI. On being referred to Digest of Operative Procedures by W B Clark FRCS (Ed)
(Section on Burch Colposuspension by Alan D G Brown FRCOG, FRCS
Ed) (6/11 of process) she said that she had never seen the section and
explained that the colposuspension she had carried out was not that described
by Burch but was a modified Tanagho procedure, involving a different number of
sutures in a different position. She had
understood that other methods of treating the pursuer's GSI had been
unsuccessfully tried.
[9] Under
the heading "Preparation" in the above text it is stated in section 1 as
follows:
"The lower limbs
are placed in Lloyd-Davies supports, which allows good access to the abdomen
and vagina. A Foley catheter is inserted
to drain the bladder. It is then
attached to 500 ml of normal saline and 100 ml is instilled to define
the lower bladder edge."
She confirmed that the pursuer was
put in the Lloyd-Davies position and a Foley catheter was inserted to drain her
bladder. The reason why the patient was
put in the Lloyd-Davies position was so that the surgeon could get access to
the vagina and the abdomen simultaneously. The purpose of inserting the Foley catheter
was to identify the bladder neck, which helped the surgeon in dissecting and in
finding where to put sutures later on. She did not attach 500 ml or instil 100 ml
of saline in the pursuer's case: she
introduced the catheter into the pursuer's urethra, the catheter then went into
her bladder and she inflated the balloon on the end of the catheter with 10 ml
of saline or water and gently retracted the catheter so that it obstructed the
bladder neck. The 500 ml of saline
was inserted through the catheter at the end of the procedure in order to
distend the empty bladder and aid suprapubic catheterisation. She was assisted in knowing where the bladder
was from the balloon in the catheter.
[10] Section 2 under "Preparation" states:
"A Pfannenstiel
incision 2-3 cm above the symphysis pubis provides a good approach to the
retropubic space and ileopectineal ligaments."
She explained that that was the
incision which she used to open the abdomen to get to the bladder and the cave
of Retzius to perform the
procedure. The symphysis pubis was the
bony part to which ran the ileopectineal ligament to which she would attach the
sutures in order to perform a Burch colposuspension. She had been taught that you should have one
finger breadth above the symphisis pubis so that you could get as close as
possible to the ileopectineal ligament.
[11] Section 3 states:
"A swab on
sponge-holding forceps acts as a retractor, and long curved scissors are used
to displace fat and divide any scar tissue from previous surgery to define the
urethra and lower bladder edge. Blood
vessels are diathermied."
That generally explained what she
did when dealing with the pursuer. The
purpose of the swab on sponge-holding forceps to act as a retractor was to
displace the perivesical fat in order to try to get to the anterior vaginal
wall to place the sutures - really clearing a path. The long curved scissors helped to reflect the
tissues to clear the path towards the anterior vaginal wall, but sometimes they
were not needed as the tissues could be gently teased away by just using swab
dissection and "peanuts", which were little swabs. She could not remember whether she used
scissors on the pursuer when displacing the fat. "Diathermied" meant coagulated with heat: that
procedure was carried out to stop the blood vessels bleeding. The retractor was held by the assistant
surgeon.
[12] Section 4 states:
"The
right-handed surgeon applies a second, left glove and inserts the index and
middle fingers into the vagina. A finger
locates the paraurethral tissue lateral to the urethra and below the bladder
edge at the junction of the middle and distal vaginal thirds. The assistant retracts the bladder upwards."
If she were to go by any of the
last procedures she had done then she put her left hand into the vagina, which
would be good standard practice. It was
an operation which involved feel as well as dissection so that the surgeon knew
exactly to which part of the vagina he wished to put his stitches. If the surgeon had two fingers in, that was
the sort of breadth and dimension of the vagina that he wanted to clear out to
put his stitches in. The paraurethral
tissue required to be located so that the surgeon did not damage the bladder. The aim was to put the stitches through the
vagina and anchor it to the ileopectineal ligament as the surgeon did not want
any sutures going into the bladder he reflected it away from the vagina and the
paraurethral tissue. In the pursuer's
case she reflected the anterior vaginal wall, put her sutures through it and
then anchored them through the ileopectineal ligament. The pursuer's bladder was retracted by the
assistant surgeon, Dr Hassan. Retraction
meant pushing tissue away and reflection meant physically reflecting it with a
swab or scissors or the like.
[13] Section 5 states:
"Three gauge 1
Coated VICRYL (Polyglactin 910) sutures on a 30 mm needle (W9213 or
W9335, which is J-shaped) are inserted through the right paraurethral tissue
(including the vagina) then into the ileopectineal ligament (Figure 6),
starting with the lowest. The third
suture on each side must be as near as possible to the bladder neck. On the left side the procedure is repeated,
starting with the ileopectineal ligament or the paraurethral tissue."
In the pursuer's case she used only
two sutures. She used a J-shaped needle
and ethibond non-absorbable sutures. She
did not put the sutures through the paraurethral tissue. The first stitch was inserted just slightly
lateral to the urethra in order to support the bladder neck and the second
stitch had to be as lateral as possible to support the proximal urethra without
obstructing it. She explained the
procedure she adopted when dealing with the pursuer as follows:
"the first
stitch goes through the anterior vaginal wall, then you put a clip in it to
keep that needle still there because the needle is needed to anchor it to the
ileopectineal ligament. Then you put
another stitch laterally, so if I remember rightly, usually I start with the
right, then move to my left, so the first stitch goes, once I've reflected the
anterior vaginal wall, the first stitch goes through the anterior vaginal wall.
A clip is put ... the needle is put aside
and a fresh needle in the suture goes through the anterior vaginal wall, this
time lateral, more towards the pelvic side wall, and the aim of the second
stitch is to really support the proximal urethra. The first stitch .. two stitches, then once
that's done, it's clipped again. Then I
go on to my left side, do the same thing on the left and, once I'm happy that
the sutures are anchored in the right position then really the procedure is
more or less complete, and the next step being going back again to the right
or, if you're already on your left, then I just take one needle, put it through
the first ... into the ileopectineal ligament directly above where the suture is
being inserted, both those sutures, and then move back to my right and do the
same on my right, and then tie it, not obviously as tight as possible. There's some laxity because you don't want to
tie it too tightly because then you obstruct the urethra and the patient can't
void."
When asked whether she started on
the left or the right she replied:
"I always start
on my right, go to my left, then once I've put the four stitches, as I'm
already on my left, I start putting the needle through the ileopectineal
ligament on the left and then go back to my right."
[14] Section 7 reads:
"The extra glove
is removed and the sutures on the left side are tied, starting with the lowest.
The paraurethral tissue is elevated only
as high as it comfortably goes without tension, so that it lies adjacent to the
obturator fascia."
She explained that "once the four
stitches have been put, you take your hand out, you change your glove and then
you put your sutures through the ileopectineal ligament and tie it as outlined
in 7." It was not the paraurethral
tissue, it was the vaginal wall, which she elevated. If you examined a patient at the end of the
procedure you would see a shelf: the aim of the colposuspension was to create a
shelf on which the bladder neck and posterior urethra would lie unobstructed. As was stated below the diagram at the end of
section 7:
"Thus the
proximal urethra is elevated by about 2 cm and lies close to the symphysis
pubis."
That was the purpose behind the
operation.
[15] Section 8 reads:
"Once
haemostasis has been checked, a suction drain and suprapubic catheter are
inserted and the wound is closed."
That was the general procedure. With colposuspension there was always a little
venous ooze or bleeding and the purpose of the suction drain was to drain it to
avoid a collection of blood in the pelvis. The suprapubic catheter was inserted to drain
the bladder. She explained the procedure she used for reflection of the bladder
as follows:
"It's finger in
the vagina and using what we call a Peanuts, which is really a small artery
forceps with a little swab. It's
purpose-designed for it, and you gently tease your (sic) bladder away from bladder (sic)
and paraurethral tissue away from the vagina."
The operation which she performed
was closer to that described in the text of Surgery
of Female Incontinence (1986) by Stuart Stanton and Emil Tanagho (6/19 of
process) than in the text of 6/11 of process. The difference lay in the use of the vaginal
wall rather than the paraurethral tissue as the point of contact. The ileopectineal ligaments, which were just
ligaments of the pelvic floor that supported the bony pelvis, were used as anchor
points for the sutures because they were recognised to be a vascular, although
they had a blood supply. The vaginal
wall was vascular and you had to be very careful when you did the dissection,
but you identified the vessels and dealt with them.
[16] In the records of the Southern General Hospital for the pursuer
(6/7 of process) the pre-operative notes at p 33 detailed the surgeons as
"Dr Hassan et al" and at p 35 described the pursuer as "34 year old
obese ++". Dr Lingam stated that "obese ++" was the opinion of the person
assessing the patient. On p 38 the
time of arrival in the anaesthetic room was given as 11.35, the time of arrival
in theatre as 12.00, the surgeon as Dr Hassan and the first assistant as
Dr Seawald. She could not explain
why it had been recorded that Dr Seawald was the first assistant. It was Dr Ramsay's operating list, but as
he was on holiday Dr Hassan was in charge of the list. As far as she was aware she was doing the list
with Dr Hassan assisting her and the record should have shown her as the
surgeon and Dr Hassan as the first assistant. The operation note which she completed in
handwriting at the end of the procedure was to be found on pp 45-6. According to that note (p 46) the
procedure started at 12.10 and finished at 14.10. The purpose of the operation note was to
document clearly what was done. It reads
as follows:
"Low transverse
incision. Routine entry. Bladder reflected off vagina after cave
of Retzius opened. 2 sutures ethibond to (R) and (L) side
and anchored to ileopectineal ligament. Suprapubic catheter inserted but at that point
bleeding noted from (R) side. Dr Hassan
took over and took down sutures on (R) side. (R) ileopectineal vessel bleeding
and sutures applied. Haemostasis obtain (sic) but bleeding from deep pelvis and
lateral vaginal fornix. Several sutures
applied to control bleeding unsuccessfully. Dr Carty, Senior Consultant,
called in. At this point blood loss
about 2 litres. Dr Carty
applied sutures to base of bladder and vagina, initially some control but
bleeding welling up in pelvis side wall. CRI obturator vessel ligated but bleeding not
controlled. Further sutures to deep
pelvis but no effect. Blood loss 5 litres.
Decision for pelvic vessel embolization.
Abdomen packed with two large pack (sic). Bladder integrity checked with Methlyene blue and
confirmed. Suprapubic and urethral
catheter left. Drain also left. Embolization radiologist arrived and balloon
inserted to control bleeding before transfer to ITU and Radiology. Abdomen closed with vicryl and staples to
skin. Bleeding appeared to be settling. EBL - 6-7 litres. Radiologist carried out catheterization."
[17] If she remembered correctly she spotted the bleeding first. She could see active bleeding, which was not
normal. Before proceeding with the
operation she had satisfied herself that there was no bleeding. The bleeding she noted on the right side would
have occurred very shortly, five or ten minutes, after she had completed
the tying up of the sutures. Dr Hassan
took over when she noted the bleeding because she was not sure where it was
coming from. As he had more experience
in these procedures he said "I'll have a look at it" and took over. He took down the sutures that she had inserted
in the anterior vaginal wall attaching it to the ileopectineal ligament. That meant that he cut the knot which she had
tied. That then released the
ileopectineal ligament from the vaginal wall to allow a better view. The bleeding was coming from a blood vessel,
not from the ligament itself. She could
not say how it came to be that blood was coming from a blood vessel. It was coming from an area where she had been
working with her needle and it was possible and likely that in the course of
working there she had penetrated a blood vessel with the needle. She agreed that the reason why blood was seen
coming from that area was because she had penetrated a blood vessel in that
area with her needle. When it was
suggested to her that that should not have happened, she referred to Negura's
paper in the International Journal of Urogynaecology, which stated that there
was a 25% chance of going through blood vessels when you run through the
ileopectineal ligament because of aberrant blood vessels, and often why you tie
off the suture the bleeding stops. She
then conceded that that was not what happened in this case as there was active
blood loss following upon this part of the operation. When Dr Hassan applied ligatures to the
ileopectineal vessels he was doing a sort of repair job to either an artery or
a vein. It was likely that the bleeding
was arterial, but it was just as likely that it was venous. It was probable that it was an artery that was
damaged by her needle. Dr Hassan
was able to staunch the flow of blood in that area. She could not remember how many sutures he
applied. It took him about five to ten minutes
to sort out this particular problem. During
that period there was blood coming out from that particular vessel, which would
have made visibility in the area he was working in difficult, but suction was
used to remove the blood to keep the area as dry as possible. After Dr Hassan staunched the blood
bleeding was seen coming from another source in the deep pelvis and lateral
vaginal fornix on the right side, by which she meant the general area of the
vaginal arteries. This was something
quite different from what Dr Hassan had repaired. It was very difficult to say whether that
bleeding consisted of arterial or venous blood. When she first looked at it she thought it was
venous, but that view changed when the embolisation was done. The estimated blood loss was noted as 6 to 7 litres
but when looked at later (when the haemoglobin was done and the before and
after blood count checked) it was actually less. Dr Hassan applied several sutures in this
area but was not successful and he called for Dr Carty, the consultant on
call that day. Dr Carty applied
sutures in the same area and ligated the obturator vessel (another branch of
the internal iliac artery), but that did not work and he then applied further
sutures to the deep pelvis in the same area but that did not work. Dr Carty then decided that he wanted to
consider pelvic vessel embolisation because the blood loss was not being
controlled. An angiogram could identify
the vessel that was bleeding and it could be selectively embolised, which mean
that the blood vessel in question is stopped from functioning. It was similar to ligating the blood vessel,
but it was done radiologically under x-ray control. The abdomen was packed with two large packs to
put pressure into the pelvis to stop the bleeding. She gathered that the radiologist put balloons
up the femoral artery and then stopped the vessel bleeding until the pursuer
was taken to the x-ray department. The
abdomen was closed as a temporary measure. The blood loss was more like three or three
and a half litres than the six or seven litres which she had
estimated. The haemoglobin levels
disclosed what the blood levels were before surgery and after transfusion, and
if you subtracted one from the other it enabled you to estimate the blood loss.
She alone had made the noted estimate of
6-7 litres blood loss. Whichever
was the correct estimate, it was a massive blood loss. She had written below the above operation note
that the plan was to remove the pack 48 hours later.
[18] The note made by Dr Urquhart, the interventional
radiologist, below the above operation note reads as follows:
"Extravasation
noted from branch of rt int iliac which was selectively catheterised and
embolisation done using gel foam and metallic coil. Good post-procedure result."
Dr Lingam explained that she
followed the pursuer to the x-ray department and she remembered Dr Urquhart
injecting dye and showing on the x-ray image intensifier the small branch that
was bleeding off the internal iliac artery. He showed the dye extravasating out of the
vessel, then he embolised it and repeated the test and there was no leakage,
suggesting that the vessel was sealed. The radiology report from Dr Urquhart on
pp 79-80 reads as follows:
"Embolisation
In the gynaecology theatre 7F sheaths were placed in both common femoral
arteries and 10 mm balloons introduced bilaterally. A portable film was taken to confirm positions
of the balloons and the left one advanced so that both common iliac arteries
were occluded. Patient was then
transferred to angiography where selective right internal iliac injection
demonstrated marked spasm in a medial branch of the anterior division. This was then cannulated superselectively and
contrast extravasation confirmed. Embolisation
was performed initially with gelfoam pledgets followed by a 3 cm by 4 mm MR
compatible steel coil and this resulted in satisfactory occlusion of flow. Left common iliac injection showed no abnormality
so the catheters and sheaths were withdrawn and both ateriotomies closed with
perclose."
[19] Dr Lingam explained that the introduction of the balloons
was the first step to stop the upstream movement of blood. Sometimes when there was bleeding in an artery
it went into spasm and it just kept opening and closing. She was in the angiography suite when Dr Urquhart
showed on the x-ray where the bleeding was coming from. She received photographs of the x-rays and
subsequently published an article entitled "Angiographic embolisation in the
management of pelvic haemorrhage" (7/9 of process), which dealt with the case
of the pursuer. In her article she
wrote:
"Selective
bilateral internal iliac arteriography showed there was extravasation of dye
from the anterior division of the right internal iliac artery."
It would be more precise to say
that it was the medial branch as that was what Dr Urquhart said in his
report. In figure 1 in her article
she showed dye coming from what was more accurately a branch of the internal
iliac artery.
[20] When Dr Lingam was asked what caused the damage to the
branch of the internal iliac artery she replied that she did not really know. She accepted that it was probable that the
most likely cause of the bleeding from this branch of the internal iliac artery
was her needle. She accepted that a
surgeon should not be working in the area of the internal iliac artery and its
branches at all when putting sutures into the vaginal wall. She did not accept that if her needle caused
the damage she had moved out of position and was careless in carrying out the
procedure because sometimes when the surgeon went laterally there were hidden
arteries and "it is very possible and very probable that you do pick up an
artery." There was a risk that a patient
had an aberrant blood or nerve supply and the surgeon did his best to avoid
them, but sometimes he could not see them if they were hidden underneath
tissue. If they were hidden underneath a
bit of fatty tissue you could easily miss them. When the surgeon was clearing a path and
reflecting the fatty tissue that could damage an aberrant vessel. On being pressed about this suggestion on her
part she replied that she was "happy to say that probably it's not the blunt
dissection". As she had said earlier in
her evidence, after she carried out the blunt dissection she checked for blood
loss and satisfied herself that there was none before proceeding with the rest
of the operation.
[21] The note "obese ++" made by the anaesthetist was his opinion of
the pursuer, whose weight was 90 kilograms. She was probably not saying that her view was
different from that of the anaesthetist. The fact that the pursuer was classified as
obese when considering the colposuspension procedure was relevant, but she
might have been overweight and not obese. Obesity was defined as twice your expected
body weight to your given height. The
term "obese ++" was really not scientific at all unless a proper body mass
index was used. The strict definition of
obesity was twice body mass index. Obesity
was associated with complications. The
majority of patients who underwent colposuspension were overweight as they
could not exercise due to their incontinence. She had operated on both overweight and obese
women since she had started doing colposuspensions. The patient whom she operated on that morning
immediately before the pursuer was obese. That was the only occasion that Dr Hassan
had to assess her competence in carrying out this procedure. Visibility was more difficult when operating
on an obese patient because of the fat. The surgeon had to make greater efforts to
clear the routes which he needed to clear in order to see what he was doing. There was no specific mention in the pursuer's
operation note of fat being cleared away. It would not have been her practice to have
recorded that (or the use of the fingers in the vagina). She accepted that she should have indicated
with a little more precision where the sutures were placed. A suture put too far laterally and into the
pelvic side wall could possibly pick up any of the branches of the internal
iliac artery. She disagreed that she had
clearly put her needle into a vessel or damaged a vessel in a way she should
not have done if she had been exercising reasonable care.
[22] In cross-examination Dr Lingam explained that there were
other surgical procedures for dealing with female urinary incontinence but that
the only one she had undertaken before August 1999 was the modified Burch colposuspension.
Apart from that she had surgical
experience of operating within the pelvis by doing hysterectomies and anything
related to the female genital tract. The
only time that she went into the cave
of Retzius was when she was doing a
Burch colposuspension. The variant
of doing a colposuspension which she had described had no particular name. She had received her training in incontinence
surgery at the Glasgow Royal Infirmary under the tutelage of the urologists who
did a modified Burch colposuspension, and the closest to that was the Tanagho
modification to the Burch colposuspension. The procedure she was taught was the one she
used on the pursuer and the one she still used. She was referred to an American text dealing
with the historical evolution of colposuspension surgery, Urogynecologic Surgery (2nd Ed, 2000) by W Glenn Hurt (6/17 of
process), which states at p 82:
"Retropubic
urethropexy or colposuspension procedures are recommended for the treatment of
SUI and are most successful in patients who have SUI with hypermobility of the
urethrovesical junction."
SUI stood for stress urinary
incontinence, the American term for genuine stress incontinence. At p 82, under the heading "Burch
Modification" there was set out some of the history of the modification of the procedure
by Mr Burch himself. The variation on
the procedure that she undertook was to be found on p 84 under the heading
"Tanagho Modification". Tanagho believed
that the reason why you needed to put a suture quite laterally was to support
the proximal urethra, because initially Burch colposuspension was thought to be
too obstructive in that it cured the incontinence but the patient was unable to
void, so by moving it laterally you were creating a very gentle shelf on which
the urethrovesical angle was maintained so that the patient could void normally
but still remain continent. The text
states:
"In 1976 Tanagho
recommended that the suspending sutures in the anterior wall of the vagina be
placed as far lateral from the urethra as possible and that they pass through
the full thickness of the vaginal wall, sparing the mucosa."
That was with a view to creating
the shelf. In inserting the sutures in
the vaginal wall when performing a Tanagho modification the surgeon was trying
to go as lateral as he could. "Sparing
the mucosa" meant the surgeon went just short of the vagina, not through the
full thickness of the vagina. Tanagho
also recommended the removal of retropubic fat (the fat around that area as
well as in the cave of Retzius),
but she did not remove any fat. The text
goes on:
"The suspending
sutures were attached to Cooper's ligaments, not toward the midline, but
straight above their location within the vaginal wall."
[23] Cooper's ligaments were the ileopectineal ligaments and that
was the procedure which she had described earlier. Having put the sutures as far lateral as she
could into the vaginal wall, she then looked for an anchoring point in the
ileopectineal ligament directly above the vaginal sutures. The point of doing that was to create a shelf,
a bit like s suspension bridge, to suspend the vagina. When examining the patient after the procedure
the surgeon could run his hand in the vagina and feel the shelf that the
bladder sits on without obstructing the outlet. Where to place the stitches in the
ileopectineal ligament was determined in large part by where the stitches had
already been placed in the wall of the vagina with a view to the best
functional result for the patient. The
positioning of the sutures in the ileopectineal ligament was not just a free
choice as one was looking at a fairly determined area of the ligament when
deciding where precisely to place the sutures. If one went too laterally on the ileopectineal
ligament one could damage one of the blood vessels running down the side of the
pelvic wall. That was something which
she, as a surgeon performing this procedure, would be aware of. Steps were taken to avoid that by
visualisation of the ileopectineal ligament and the pelvic side wall and making
sure that there were no vessels in that ligament when putting the needle
through it. There was some risk of
bleeding when the needle was inserted into the ieopectineal ligaments and it
was probable that the risk would normally be associated with a heavy and
sustained bleed, such as occurred in the case of the pursuer. Such a bleed would be caused because of the
aberrant arteries and veins, including obturator veins and arteries. The risk of aberrant blood vessels was
increased by previous surgery or infection and there was the fact that no two
people have the same anatomy. The
pursuer had had a hysterectomy in 1994, during which the uterine artery, the
major blood supply to the uterus and vagina, would have been isolated by
ligation to reduce the risk of haemorrhage. It would then have shrivelled up and ceased to
exist, resulting in a process called angiogenesis, in which collateral
circulation could develop to keep the other organs functioning. If that happened, an aberrant blood supply had
developed.
[24] In the course of the pursuer's operation no difficulties were
encountered until the end of the procedure , when the bleeding was noticed. There had been no difficulty in obtaining
visibility of the structures in order to place the initial sutures in the
vaginal wall. There were no surgical
adhesions from the previous pelvic surgery that the pursuer had undergone. The procedure had been straightforward until
the bleeding occurred. When the bleeding
was first noticed it appeared to be coming from the right side of the pelvis. It was not apparent from where within the
pelvis it was coming. At that point in
the procedure it was still possible to visualise the ileopectineal ligament,
but only partially. According to her
case notes that was where the blood was seen to be coming from. It was possible that the bleeding from the
ileopectineal ligament was apparent only when the sutures were cut. The bleed from the ileopectineal ligament was
relatively easily dealt with, but the bleeding continued and it was then
obvious that the major source of the bleeding was not from the ileopectineal
ligament. She could not see where the
bleeding was coming from: it was just welling up, which was what happened with
bleeding in the pelvis. It was known
from the subsequent investigation that the bleed was from an artery. The blood within the arteries was under
pressure, so that if a needle were put into an artery it would result in a
pulsatile bleed - you see the blood coming out in spurts. With a vein there was hardly any pressure and
the blood came out like an ooze. Quite
often the pelvis just filled up and you did not know if the bleed was venous or
arterial: it could be quite difficult to distinguish between them. Once a significant amount of arterial blood
was lost you got a drop in blood pressure. In any event blood pressure might drop under
anaesthesia. If she had damaged an
artery with her needle it is possible that bleeding would have been delayed due
to the artery going into spasm. When the
initial stitches were placed into the vaginal wall there was a white background
and there was no evident bleeding until 20 minutes or so after these
stitches were placed. As she was placing
the stitches Dr Hassan was watching and seeing that she was doing the
procedure correctly. At no time did he
suggest to her that perhaps she was not putting the stitches in the right place
or that she was about to put them in the wrong place. If she had damaged a blood vessel with her
needle and it ought to have been apparent to her what she was about to do, then
it ought also to have been apparent to Dr Hassan. Dr Seawald was a junior registrar and she
was just assisting in the operation. This was a procedure done by doctors who had
not yet reached consultant grade. At the
time she herself was a specialist registrar in the final year of her training
and she became a consultant over a year afterwards. She received her Certificate of Specialist
Training in July 2000 and was entered into the Specialist Register (which
meant she was declared fit to be appointed a consultant) on 20 December 2000, after she had
obtained a consultant in September 2000. She started her consultant post in January 2001.
[25] Going back to the damage to the internal iliac artery or a
branch of it, she did not really know what caused it. It was a very straightforward procedure and it
was not until the end that the bleeding was noted. She thought that if she had caught a blood
vessel with her needle she would have known about it. Similarly, she did not really know what was
the cause of the bleed from the ileopectineal ligament. She did not know how the haemorrhage from the
blood vessel occurred. Unfortunately
colposuspension was one of these procedures which was complicated with
haemorrhage. Eventually she conceded, in
answer to a question from me, that bleeding from the right internal iliac
artery could not have been caused by anything other than a sharp instrument
penetrating that artery. In the course
of blunt dissection blood vessels could be damaged by being torn. Although something was being bluntly dissected
it did not mean that the tissues underneath it were not being damaged. Potentially you could injure an artery or tear
a bit of an artery and the artery could go into spasm, and initially there may
not be any bleeding but later on, once the artery was no longer in spasm, you
could have bleeding. That did not
require a sharp instrument coming into contact with the artery itself. If a vessel had a friable wall, just touching
it would make it break down. In blunt
dissection the tissues were exposed to forces during which they were stretched,
and that could cause damage to them. Tissues
were also exposed to pressure as they were being pushed during blunt dissection
and even indirect pressure could cause damage to a blood vessel. Two things could cause damage to a blood
vessel - putting a needle through it or blunt dissection. All that was meant by blunt dissection was
that an implement was not being used to dissect the tissue - a swab or a sponge
on a stick was being used - but that did not mean it was atraumatic and tissues
were not being damaged: as soon as you mobilised tissues you were damaging
them. She could not remember where in
the pursuer's pelvis the ruptured vessel was located. The internal iliac artery was a fairly large
vessel which branched into a large number of branches as it entered the pelvis
and it supplied the greater part of the pelvis with blood. A branch of the internal iliac artery could be
located virtually anywhere within the pelvis. As far as she could remember there was not,
during the attempts to staunch the bleeding, any point at which the actual
bleeding point was visually identified. She was unable to assist with where precisely
within the pelvis the bleeding was coming from. The fact that the bleeding was welling up at
the right side of the pelvis did not narrow down the possible points of
bleeding as the bleeding could have come from any number of branches of the
internal iliac artery and vein.
[26] In re-examination Dr Lingam accepted that according to the
radiology report the second blood loss was coming from a medial branch of the
internal iliac artery, but pointed out that when they were looking down the
pelvis there was bleeding on the right side and there was no way of telling
where it was coming from: if they had known where the bleeding was coming from
they would have attempted to secure haemostasis. The use of the word "blunt" in describing
dissection gave the impression that the surgeon was being very delicate with
any dissection, but blunt dissection was still dissection and could still cause
trauma to tissue. She considered either
a sharp instrument or blunt dissection to be possible causes of the second or
major bleed. She did not know whether,
looking to the timescales and the nature of the dissection involved, that a
sharp instrument was more likely than blunt dissection to have caused the major
bleed. She was not aware that the
medical literature helped because a lot of the papers published on haemorrhage
did not go on to say what the problem was. At the time she thought she saw blood coming
from the ileopectineal ligament on the right side. According to the operation note she saw blood
coming from a blood vessel. It was
possible that the blunt dissection which had taken place sometime before that
might have been the cause of the bleed: she did not know. She would not have seen it if the artery had
gone into spasm and was hidden in a bit of fatty tissue: the bleeding would occur only when the artery
was no longer in spasm. The notion of
collateral blood supply was not pure speculation on her part. Notwithstanding the fact that the vagina had
its own blood supply, a collateral blood supply could be set up for the vagina
in the event of the uterine artery being ligated.
(ii)
Dr Hassan
[27] Dr Hassan stated that
he first worked with Dr Lingam when she took up her appointment at the
Southern General Hospital. He had
previously known her only from Royal College
meetings. The following passage of
evidence indicates his understanding of her experience in colposuspension:
"Now, what was
your understanding as to her experience in the colposuspension procedure when
she first came to the Southern General? - Yeah, I thought she was interested in
urogynaecology, and she was already working with the urologist who's interested
in urogynaecology in the Royal Infirmary, and she did colposuspension
operations down there when I asked her.
Where? In the Royal Infirmary? - Yes.
So are you
telling the court that at a point in time you asked her about what
colposuspension operations she had done? - Asked, yes.
And what did she
say to you? - she said she was interested in urogynaecology and she worked in
the Urology Department and she did colposuspension operations.
Did she give you
any indication as to how many she had done prior to her appointment to the
Southern General? - I can't remember, so I don't think so.
Would it be of
relevance to know how many? - No.
Why not? -
Because once she said she had done and she's competent, I just take her word.
...
The Royal
Infirmary, and did you know when that was? - Before coming to us.
Were you given
any greater clarification than that? - No.
Would it be
relevant to know when Dr Lingam had been attached to the Royal Infirmary
to see how recent her experience was? - I think if we have got somebody who's a
senior registrar who's interested in urogynaecology and doing a urogynaecology
job in a Urology Department, I'd be satisfied with that if she told me that.
Well, did you
know when she had been attached? - No. I know she's coming from there, but I
don't know how long she worked down there.
Did you know
when she was working at the Glasgow Royal Infirmary? - No.
Well, did you
form any view when considering her experience as to when it might have been,
and, in particular, to see how recent her experience in this procedure might
have been? - Yes, I asked her just before coming to us, so she came straight
from the Royal to us, so these are recent experience. (sic)
Well, were you
proceeding on the basis that she had recent experience? - Absolutely.
And when you
talk about recent experience, is there any number that you'd have in mind of
colposuspension operations that would justify saying someone had appropriate
recent experience of the procedure? - I think if she have got about ten cases
before coming to us, I'll be satisfied with that.
In recent times?
- Absolutely.
And when you say
"absolutely" to that, why is it important to have recent experience? - You know
that she's doing them and she's acquainted herself with that area since she had
been interested in it, so she'll be more or in a better position being a senior
registrar. Her experience surgical-wise is more than a normal registrar who
would be attached to us.
If I can perhaps
put it in a colloquial way, if you're told someone has had recent experience of
the number you've mentioned, then you come to the view that she's up to speed,
as it were, and able to do the operation competently? Yes.
And when we're
talking about doing the operation, do I understand you to be saying that you
mean doing the operation as the lead surgeon? - As a separate person taking
care of the patient herself or the lead surgeon."
[28] He accepted that if Dr Lingam had done only one
colposuspension as lead surgeon in the previous five or six years it might
suggest that she lacked recent experience in that procedure, but added that it
didn't mean she wouldn't be able to do it. She could be the lead surgeon but her
assistant should be more experienced than herself. He would expect that, being a senior
registrar, she would be a skilled surgeon, otherwise she wouldn't be a senior
registrar. She need not have done ten
recent colposuspensions if there was an experienced person with her as her
assistant. He had asked her only if she
was experienced or not and she said yes: you only asked a very junior doctor
how many operations he had done. Recent
experience was obviously important. He
was confident that before 26 August 1999
she would have assisted at a colposuspension on a number of occasions.
[29] Over 50% of patients undergoing a colposuspension were regarded
as obese. You had to take account of a
previous hysterectomy when opening at the beginning of the operation. If the patient were obese and had had a
previous hysterectomy it might make the procedure slightly difficult for a
doctor in training. On the day of the
pursuer's operation he was supervising Dr Lingam. The pursuer was 90 kilograms and
therefore borderline obesity: if her
body mass index was 34 that classified her as obese. They started on the right side. He put the retractor in and retracted it to
expose the area: it then self-retained. It
was his job to hold the bladder away from the path of the stitch. There was no concern at all about blood loss
at that stage. The sutures had been tied
and the suprapubic catheter inserted when he noticed the bleeding "because we
always look before we go out in any surgery". He was asked in the following passage of
evidence about putting the sutures in the ileopectineal ligament:
"So far as the
connection from the vaginal wall to the ileopectineal ligament is concerned,
where do you put the sutures in the ileopectineal ligament? - Usually put it
most medially to the ileopectineal ligament rather than laterally.
Why do you do
that? - the medial part of it.
Why? - It's so
easy.
And you're
further away from the blood vessels? - There is not much ... the ligament itself
has not blood vessels, but if you're looking to put it very lateral you have to
lift ... you know, you have to lift the abdominal wall a bit more, and you can do
it, but you usually put it more medially than far lateral.
Well, what did
Dr Lingam do, so far as the ligament was concerned? - Yes, she use the same
way I do it because I exposed the ligament for her, so I know exactly where
she's going to put it and I knew where she had put it.
So you're saying
she put the sutures into the ligament in a medial .. - Yes.
... position, not
a lateral position? - No.
Did this form of
colposuspension that was being done by Dr Lingam, does it have a
particular name? - It's a Burch colposuspension, yes.
We've heard a
reference to a Tanagho type. Does that
mean anything to you? - No.
"through the
full thickness of the vaginal wall, sparing the mucosa", ... and then if you move to the next paragraph "The suspending sutures were attached to
Cooper's ligaments, not toward the midline, but straight above their location
within the vaginal wall". Now, do I
understand that that's putting them into a lateral position? - Yes.
Are you saying
Dr Lingam didn't follow this procedure? - I don't think we did that
procedure, no.
Well, I'm just
asking you about what Dr Lingam did on the day. You're telling the court that she didn't do
this procedure? - Not this procedure you're reading now. What we did, we did a Burch colposuspension
and we put two stitches at the bladder neck and we attached these to the
ileopectineal ligament, not in the lateral part of it - the medial part of it -
so that's a different description.
Well, I'm merely
asking you as to what Dr Lingam did, and you're saying she did not follow
this general procedure with regard to, in particular, placing sutures in a
lateral plane? - Yes."
[30] He confirmed, under reference to the operation note, that the
bleeding was spotted after the sutures had been tied and the suprapubic
catheter inserted. It was very difficult
to give an exact time as to how long had elapsed between the tying of the
sutures and his spotting the bleeding, but he thought about five to ten
minutes. He took over from Dr Lingam
when the bleeding was noticed because the most senior surgeon always took over
when a complication occurred. There was
quite a lot of blood and that affected visibility. It was very difficult at that time to say
whether the blood was arterial or venous. He dealt with the problem by taking down the
sutures on the right side and applying a stitch to the bleeding right
ileopectineal vessel. They then did
suction to see where the bleeding was coming from and it was coming from deep
in the pelvis. There was bleeding from
two separate sources, the first bleeding from the area of the ileopectineal
ligament and the second bleeding from an area deep in the pelvis. He thought that most probably the bleeding
from the ileopectineal vessel had been caused by the needle going through the
ligament and piercing the vessel. It was
not the position that Dr Lingam went too far laterally. He would not criticise her if she went too far
laterally. He did not accept that the
initial bleeding was caused by the suture having been put in a place where it
should not have been put. So far as the
second bleeding was concerned, an estimated blood loss of six to seven litres
suggested that it was more likely that it was arterial bleeding. The bleeding was coming from an area sort of
two or three centimetres laterally from where the stitch was put in the
vaginal wall. It was coming from the
urethra. He tried unsuccessfully to
control the bleeding by applying several sutures. Dr Carty's efforts to control the
bleeding by applying sutures to the base of the bladder and the vagina were
unsuccessful. He thought it was very
difficult for him to say why the second bleed had happened. He accepted that Dr Lingam had put
sutures into an area proximate to where the bleeding was coming from. It was very difficult to say the stitch caused
the bleeding. The commonest reason for
injury to a blood vessel was from separation of the bladder itself, by which he
meant the reflection of the bladder at the early part of the procedure. An injured blood vessel could retract by
moving from its regular position. He was
postulating that a vessel had been damaged when the blunt dissection was
carried out and that quite some time later blood appeared. It was very difficult to ascertain whether the
cause of the second bleed was "contact of the needle or the separation or the
lifting of the vagina after we tied it at the end". In order to control the bleeding they had the
choice of opening the pursuer's abdomen and ligating the internal iliac vessel
surgically or calling the radiologist to embolise the area: they chose the
latter option. He understood from the
subsequent radiological work that the bleeding had been coming from a medial
branch of the right internal iliac artery. The real answer was that they did not know
what caused the bleeding. He thought the
earlier bleed from the ileopectineal ligament was coincidental and that there
was not a significant amount of bleeding from that area. The significant bleeding that caused the
problem was from deep in the pelvis, not from the ileopectineal ligament. The fact that there were two sources of blood
loss did not tend to suggest that Dr Lingam was not doing the operation
properly because he was there and looked at every stitch before she placed it. He asserted that massive haemorrhaging was a
rare but recognised problem. He did not
agree that if the damage to the medial branch of the ileopectineal ligament was
caused by Dr Lingam's needle that showed that she was not doing the
operation properly. Stretching the
vessel could open and break it, but the lifting of the vagina was not
recognised in the medical literature as a complication of this procedure.
[31] He agreed that if Dr Lingam were to do something which was
incorrect he had a duty to stop her, but he did not think she had done anything
wrong or carried out the operation in any way different from the way it was
done in the unit. He totally disagreed
that on two occasions she put stitches in locations where she should not have
put them and thus caused the two bleeds.
[32] He had no input into the estimate of six to seven litres
blood loss on the operation note: it was
not discussed with him. Normally the
operation would have lasted a maximum of between 45 minutes and an hour. The following day he, assisted by Dr Seawald,
removed the packs from the pursuer. When
they were removed there was no active bleeding.
[33] In cross-examination Dr Hassan explained that at the time
of the pursuer's operation the unit, headed by Dr Ramsay, was a teaching
unit for urogynaecology, which included colposuspension. Since the unit was set up he had been involved
in the teaching of junior doctors, including teaching the surgical techniques
involved in colposuspension. A
specialist registrar had to train for five years before becoming a consultant. In the case of Dr Lingam her speciality
was obstetrics and gynaecology. It would
be normal for a specialist registrar in urogynaecology to undertake
colposuspensions. Dr Lingam left
the unit after only two months to move south with her family. By 1999 he was experienced in supervising
junior doctors who were carrying out colposuspensions. He had no reservations about Dr Lingam
being the lead surgeon for the pursuer's operation. He did not recollect Dr Lingam operating
that day as the lead surgeon on the patient before the pursuer, but as the list
began at 9 am there must have been at least one other patient before the
pursuer. He thought that maybe three quarters
of all patients who underwent a colposuspension were overweight. A previous hysterectomy could present a
problem of access to the abdomen because of adhesions. It was very unreal to think (as the pursuer
pleaded) that before Dr Lingam could properly be allowed to do a
colposuspension on an obese patient she would first have to have done at least
30 to 40 colposuspensions on non-obese patients: it was not what happened
in life. It would take about two years
working full time in the unit to do 40 colposuspensions on non-obese
patients. As far as he was aware there
was no urogynaecological unit in the country that applied such an approach to
the training of registrars. The point of
his being there when a junior doctor was operating was so that he could take
over in the event of any difficulty or complication occurring.
[34] Dr Hassan was able to recollect the surgery on the
pursuer. He had only had one other
patient in which there had been such a major blood loss intraoperatively. He saw Dr Lingam insert two sutures
in the wall of the pursuer's vagina. At
the time he had no concern whatsoever that the placement of these sutures was
in any way inappropriate. When she
placed those sutures there was no immediate bleeding or any other sign that any
damage might have been caused by the sutures. He also saw her insert the sutures in the
ileopectineal ligament and had no concern that the placement of those sutures
was in any way inappropriate. After
those sutures were placed there was no immediate bleeding or sign of any other
damage. His own preference was that the
sutures be placed in a medial position in the ileopectineal ligament. Some surgeons put in more than two sutures,
and the more sutures you put in the more lateral you had to go into the
ileopectineal ligament. Once the sutures
had gone in both sides of the vagina and both sides of the ileopectineal
ligament they had to be tied to bring the neck of the bladder and the vagina
upwards so that the vagina ended suspended from the ligament by the sutures. The Foley catheter was then taken out and a
special metal catheter put in the bladder until its tip came outside the
bladder altogether. That took about 10
to 15 minutes and during that time no bleeding was noted. Once the suprapubic catheter was in, the
surgeon had to look around to see that it was safe to close the abdomen. It was at that point that the bleeding was
noticed. Before the drain was put in he
thought there was "a little" bleeding, more significant than the amount of
blood that was normally seen, coming from the right side. There was always a degree of bleeding which
could be drained through the suprapubic drain. The bleeding had overflown the pelvis. He then took over the procedure and took down
the stitches. After he cut the sutures
the blood was still welling up out of the pelvis into the abdominal wound. The blood was sucked out by suction and swabs
were used to make the area dry. The only
bleeding he saw was a slight stream of blood coming from the ileopectineal
ligament and he put a stitch on it and stopped it altogether. The slight stream of blood was not enough to
account for the extent of bleeding seen. The point of bleeding was at the medial area
of the ileopectineal ligament, in the same sort of area where the sutures had
been placed by Dr Lingam. The
bleeding was still coming from the pelvis while it was being sucked out. He could not see exactly where it was coming
from. His response was to lift the
vagina up and place blind stitches in the deep pelvis in the hope that he would
catch the bleed. When he saw that that
was not going to work he called Dr Carty, the senior consultant on call
that day, who came into theatre and unsuccessfully tried to staunch the
bleeding by the same method. Dr Urquhart,
the interventional radiologist, then became involved, put balloons in to slow
the bleeding, removed the pursuer to the angioplasty room, identified the
bleeding vessel under x-ray and embolised it. Dr Hassan saw the x-ray view of the
bleeding vessel but at that point it was very difficult to tell where the
bleeding was coming from relative to the sutures. There was always some degree of bleeding in
colposuspension (indeed, in most operations) and that was why a drain was
inserted, but the amount of blood loss that was sustained in this case was not
normally expected. The amount of blood
loss from a damaged vessel was determined by the size of the vessel, whether it
was a vein or an artery, the pressure going through the vessel, the proximity
of that vessel to the main vessels and the duration of the bleed. The fact that the pursuer was bleeding in an
uncontrolled fashion for perhaps about an hour would be a substantial
contributory factor to her overall blood loss. If he had been able to identify the source of
the bleed, it was likely that he would have been able to stop it with a suture.
The principal difficulty was that he
could not find the source of the bleed to try to put a stitch in it. Usually in a colposuspension the source of the
bleeding was found and the bleeding stopped. There were three possible causes of the damage
to the vessel in this case in chronological order: trauma during blunt dissection of the bladder
from the vagina, direct damage by a suture needle and trauma to the vessel
during elevation of the vagina for the tying of the sutures. Each of these possible causes also required an
explanation for the delay in bleeding for a further period of at least 15 minutes.
That could be explained by the blood vessel
going into spasm. None of these three
explanations was more likely than the others. The mere fact that damage was caused by a
needle did not in his view mean that the surgeon had not taken enough care: you could always catch a blood vessel with a
needle, despite your diligence in avoiding it. It was not always possible to see the blood
vessels when you were operating as they might not be seen because they were
encased in tissue. In this case he saw
and was 100% content with the insertion of each stitch by Dr Lingam. He would not have put the stitches in any
different place had he been doing the operation. It was very unlikely that the outcome would
have been any different if the surgery had been done by another consultant
experienced in this operation.
[35] In re-examination Dr Hassan disputed that it would be
highly unlikely that the surgeon would catch a branch of an artery during this
particular procedure: as there were three arteries in that area, it was not
unlikely to catch one. You did not know
where they were. You could see many of
the veins because they were bigger than the arteries, but the arteries were
sometimes difficult to see. Before you
put your needle into the vaginal wall or ileopectineal ligament you would be
sure that there were no vessels there by clearing away anything that would
cause you concern. Dr Carty was
called after there had been a bleed of about a litre, in time say 50 minutes.
According to the operation note there
had been a blood loss of two litres before he arrived. Any control of the bleeding at that stage was
apparent rather than real. He had never,
when acting as lead surgeon, had haemorrhaging of this sort: it had always been controllable. It would be fair to describe the initial
bleeding as an active blood loss and not realistic to describe it as a minor
bleed. He applied only one suture to
stop it, contrary to what was noted in the operation note. He had not looked at the operation note
shortly after the event. He thought
about 10 or 15 minutes had elapsed between the pulling up of the sutures
and the appearance of blood. He had
witnessed Dr Lingam carrying out a Burch colposuspension.
(iii)
Dr Urquhart
[36] Dr Urquhart held the post
of Consultant Radiologist at the Southern General Hospital and had a special
interest in interventional radiology. He
had been a consultant radiologist at Law
Hospital from 1990 to 1995, when he
moved to the Southern General Hospital.
[37] Dr Urquhart became involved in treating the Pursuer on 26 August 1999 when complications
arose in the course of her operation. He
was the person referred to in Dr Lingam's note "Embolisation radiologist
arrived and balloon inserted to control bleeding". He had been phoned in his department and told
there was a problem with some bleeding which was proving difficult to control
and asked to attend to help stabilise the patient. When he arrived at the theatre there were
packs in place which were controlling the bleeding temporarily and a pack was
removed and he was shown that the bleeding was coming from deep in the right
side of the pelvis. The packs were
replaced to help reduce the blood loss. He had no formal record of when he arrived in
theatre, but it was probably about 1.30 pm. He scrubbed up and introduced needles into
both common femoral arteries and groins and introduced guide wires into both
iliac arteries. He then placed vascular
sheaths, through which he put angioplasty balloons, which were inflated by
pressure devices to the appropriate pressure.
That immediately caused a reduction in blood loss. He then took a portable x-ray, which showed
where the balloons were relative to the bony structures and moved one of the
balloons, which was a bit lower than the optimal, up a few centimetres. The balloons dramatically reduced the pressure
of blood flowing into the pelvis by blocking off the two main arteries. As soon as the balloons were blown up the
packs were removed and the pursuer was transferred in an ambulance to the x-ray
department to have the definitive procedure carried out. The note on p 46 of the hospital records
had been written by his registrar Dr Jay.
[38] Once the pursuer was in the radiology suite he removed the
balloon from the left side as he knew the bleeding was coming from the right
side. He passed a catheter over the
aortic bifurcation from the left iliac artery into the right and did an
injection of x-ray contrast, an angiogram of the internal iliac artery to see
if he could identify where the bleeding was coming from. The injection did not show any extravasation
of contrast but it showed an artery which was in spasm, which is a
physiological reaction to bleeding where the artery tries to clamp down and
reduce the blood loss. He then used a
special guide wire catheter to cannulate that artery directly and took a
picture, a further angiographic image, which showed both some spasm in the
artery and contrast extravasating from the damaged branch of the internal
iliac. The x-ray report at p 79 of
the hospital records described the procedure carried out. The embolisation was performed initially with
gelfoam pledgets, gelfoam being a sterile gelatine sponge specially designed
for that purpose. It was soaked up into small
pieces a few millimetres across, soaked in contrast medium which made it soft
and injected through the catheter into the affected artery. It was very effective in blocking medium-sized
arteries. It was absorbable and would be
absorbed after a few days, so because of that, and also because it was a single
small branch vessel that was involved, he put in a small metallic coil
specially made for the purpose of blocking arteries. Further images were taken which showed that
the artery was completely blocked and that there was no contrast extravasating
from it. He also took further pictures
of the internal iliac artery to check that there were no other branches which
appeared to be causing the bleeding and a picture on the left side just to be
sure that there were no other arteries involved. He was then sufficiently confident that the bleeding
source had been completely dealt with and he removed access to the arteries and
closed them. 7/8 of process consisted of
subtracted images (that is, minus the bones) which showed the x-ray contrast
inside the arteries. He thought it was not really possible to say which
anatomically named artery was involved: even if he had had the original x-rays
he thought he would have found it difficult to do that. It was a branch of the internal iliac artery
which came off medially from about the point where the internal iliac artery
divided into its branches. In the image
it was coming of a kind of dark spot and heading almost vertically downwards. In Figures 1 and 2 of Dr Lingam's
article 7/9 of process showed a dark splodge right in the centre which was
the contrast spilling out of the artery into the pelvic cavity: that indicated
where the damage, or hole, was in the artery. In his report he stated that the artery
involved was a medial branch of the internal iliac artery. The lateral branches could be seen to the left
of the image. If there had been no
damage to the artery involved you would see it coming further down and, like
the other ones, branching into smaller branches to supply organs within the
pelvis. A plain x-ray of the abdomen
(6/5 of process) taken in the Victoria Infirmary when the pursuer was later
admitted there with an infection showed the metallic embolisation coil placed
in the damaged artery, about halfway between the midline and the lateral bony
wall of the pelvis. The images shown in
Dr Lingam's article (about which he did not know until after the event)
must have emanated from his department. All the x-rays from his department should have
been kept in a film packet, but, as far as he knew, it had never been seen
again.
[39] The procedure which he had carried out on the pursuer was not
an unusual one: he did selective
embolisation of internal iliac artery branches, or of the whole artery on
occasions, for a number of different reasons. The commonest one was done electively for treatment
of uterine fibroids and it gave him a lot of experience at doing this type of
catheterisation. In cases of bleeding he
occasionally did it for trauma, particularly pelvic fractures, and for
obstetric haemorrhages, particularly postpartum haemorrhages, where patients
had uncontrollable bleeding after giving birth. He was relatively inexperienced in the
procedure at the time but it went very straightforwardly and he did not find it
a particularly difficult procedure to do. The technique of embolisation for treatment of
this had first been described in the American Journal of Obstetrics and
Gynaecology in 1979. The gynaecologist
in this case was sufficiently aware to call upon him to stop the bleeding. By the time he was called upon the pursuer had
lost quite a lot of blood. There was no
way in which he could be definite about which branch of the internal iliac
artery was involved, particularly as the pursuer had had major gynaecological
surgery, involving the tying off of arteries supplying organs which had been
removed and the opening up of new arteries to supply the tissues within the
pelvis. It could be that the branch
involved was not even a named branch: it
was roughly in the area of the uterine artery and the vaginal arteries in 6/18
of process. It was roughly in the
position where you would expect the uterine artery to be, but the pursuer's
uterine artery would have been tied off at the time of her hysterectomy.
[40] In cross-examination Dr Urquhart accepted that the
pursuer's uterine artery would have been divided when she had her hysterectomy.
The remnant would have become
permanently blocked and atrophied, but it was likely that other vessels would
have opened up to supply the tissues in the area around where surgery had been
done. The process of opening up of other
arteries was known as collateralisation, and connected to that there was what
was sometimes referred to as the collateral blood supply. The bleeding artery might well have been part
of a collateral blood supply that developed after the hysterectomy: if it was, while he was not a surgeon, he
certainly imagined that the position of the artery would not necessarily have
been one that could have been anticipated by a surgeon with a normal knowledge
of anatomy. If he had done an angiogram
in this type of patient he would not have expected the anatomy of the arteries
shown to correspond to any text book picture. On that assumption the pursuer's vessel
anatomy might have been unique. If his
embolisation service had not been available a vascular surgeon might have been
called on to tie off the more major vessels supplying the area: in the case of
obstetric haemorrhage that was the traditional way of trying to stem postpartum
bleeding before embolisation became better known. It was probably correct that, in the absence
of his service, what would have been done would have been that the internal
iliac artery itself would have been tied off, but simply tying off one source
of blood supply did not necessarily prevent bleeding in a branch vessel. The image from the Victoria
Hospital (6/5 of process) was a
two-dimensional image of the pursuer lying down. It was not possible to tell from the x-ray
image the depth in the pursuer's body at which the metallic coil was appearing,
but he knew from the angiographic images and from experience roughly where in
the pelvis these vessels were. The x-ray
image indicated that the coil was within or at the upper part of the pelvic
cavity, and, in terms of being in a medial or lateral branch of the internal
iliac arteries, it was clearly in a medial branch because, if it was in a
lateral branch, it would be lying much further to the side. There was no anatomical point of reference: it
was a relative concept, some of the branches being towards the midline and some
towards the lateral aspect. This was a
branch of the artery that had branched medially back in towards the pelvic
organs. One could not reach any
conclusion from the x-ray as to the position of the coil relative to any of the
organs within the pelvis. All the x-ray
really did was to allow you to orientate the position of the coil, and
therefore where the artery was within the bony structures, which were not
visible on the angiographic images. It
was not close to the lateral bony wall of the pelvis: it was about midway between the pursuer's
midline and the lateral bony wall of the pelvis.
[41] Dr Urquhart explained that he had no experience at all in
gynaecological surgery and that he was not familiar with the operation of
colposuspension. He had never before or
since the case of the pursuer been called on to assist surgeons doing a
colposuspension. The technical details
of the operation were not important to him: all he needed to know was where, in gross
terms, the bleeding was thought to be coming from as that shortened quite a lot
the procedure of looking for the source of the bleeding. It was not possible, applying his wider
experience as a radiologist, to say where the bleed was relative to the
ileopectineal ligament as that was not a structure which was imaged in
radiology and therefore not one he was really familiar with in radiological
terms. His understanding was that the
ileopectineal ligament was related to the side wall of the pelvis and the bleed
clearly was not close to the side wall of the pelvis. The bleed was about three centimetres
medial to the side wall of the pelvis and about four and a half centimetres
lateral to the midline.
[42] In re-examination Dr Urqhuart stated that the coil had
been placed in an undamaged part of the medial branch, and that the location of
the damage was at a point different from the location of the coil, directly
inferior to where the coil was placed, as indicated on the angiographic x-rays.
In relation to the question of
collateral blood supply, the uterine artery provided blood to the uterus and,
once the uterus was removed, it would be redundant, but there would be other
tissue filling that space and there might be a collateral blood supply
developing to the vaginal vault, although the vaginal artery was the primary
source. He was not aware that many
colposuspensions were carried out on patients who had had hysterectomies and
that in these cases no unusual arteries were seen. The x-ray did not tell us anything about
whether the medial branch of the pursuer's internal iliac artery had been
created as a collateral blood supply.
The evidence of the experts
(i) Dr Alan Brown
[43] Dr Brown held the post
of Senior Consultant Obstetrician and Gynaecologist at the Royal Infirmary of
Edinburgh, heading a team of about 18 consultants, until his retirement
from the National Health Service in May 2004. He had since then carried on private clinical
and medico-legal practice. His curriculum vitae is 6/45 of process. He qualified MB, ChB from the University
of Edinburgh in 1963, became a
member of the Royal College of Obstetricians and Gynaecologists in 1968,
became a Fellow of that college in 1981 and a Fellow of the Royal College
of Surgeons of Edinburgh, without
examination, in 1990. He first became
a consultant with an academic appointment at the University Hospital of South
Manchester, where he remained for eight years, until he returned to Edinburgh.
His major subspecialty interest was
urogynaecology. As a senior registrar in
Edinburgh between 1970 and
1975 he was seconded with a research fellowship from the Medical Research
Council to do urogynaecology training at the Middlesex
Hospital in London,
where he was trained by Mr Richard Turner Warwick and the
radiologist Dr Graham Whiteside. In Manchester
he was asked to set up the Urodynamic Unit at the University Hospital of South
Manchester. He developed the unit in
conjunction with the consultant urologist Robin Barnard and worked with
him there for the following eight years. On his return to Edinburgh
in 1983 he set up, in conjunction with the urologists, the
Urogynaecological Unit at the Western General
Hospital. From 1983 his urogynaecological practice
had been both in the Western General Hospital,
where the diagnostic side of things was done, and the Royal Infirmary, where
the surgery was done. Along with another
consultant he was responsible for the urogynaecology services and the two of
them did virtually all of the urogynaecology for the hospitals' catchment area.
Urogynaecology basically encompassed
lower urinary tract problems in women. The commonest urinary problem that women had
was incontinence, of which there were two types. There was genuine stress incontinence (GSI),
which predominantly resulted from childbirth, and overactive bladder (formerly
called detrusor instability). Dealing
with incontinent patients was the main element of their work. He had first started doing colposuspensions
under the guidance of Mr Warwick in London
in about 1972. He did
colposuspensions, the gold standard procedure, until about 2000 when
keyhole surgery and the tension free vaginal tape procedure (a much less
traumatic procedure) came in. He had
carried out as lead surgeon in the region of 1,000 to 2,000 plus
colposuspension operations. He had also
had a medico-legal interest since 1979 when he was invited to join the
Cases Committee of the Medical Protection Society, one of the three medical
defence organisations in the UK.
He was on that committee assessing all
the obstetrics and gynaecology cases going through over the following 12 to 15 years.
When he ceased that he was asked to do
medico-legal work. He had produced over
50 publications, including 14 peer-reviewed articles and 18 chapters
for text books. He had written
predominantly on urogynaecology, sexual dysfunction, medical litigation in
obstetrics and gynaecology and some problems of gynaecology in the elderly
patient. Both Dr Ramsay and Mr Jarvis
were well known to him.
[44] Dr Brown had prepared two reports about this case - the
first (6/26 of process) dated 5 September 2001
and the second (6/42 of process) dated 21 June 2005
(which essentially gave an update on the pursuer's condition). When he wrote his first report he was relying
on information obtained from the medical records. He had not had statements from Dr Lingam
and Dr Hassan but he had listened to their evidence in court. He had written the section of the Digest of
Operative Procedures dealing with colposuspension (6/11 of process) in 1992.
He explained that colposuspension was a
specialist operation as it was done in an area of the abdomen different from
the area in which a gynaecologist usually operated. A junior doctor in training would learn to do
an abdominal hysterectomy before he would learn to do a colposuspension. In incontinence procedures the surgeon was
going into a different area of the pelvis, the retropubic space behind the
symphisis pubis. Access to that area was
more difficult for the surgeon. The
method described by Dr Lingam and Dr Hassan was different from the
method he described in the text in that he instilled 100 ml of fluid into
the bladder to help define the bladder edge more clearly, whereas they just
used the balloon of the Foley catheter to define the bladder neck (the junction
of the urethra and bladder edge in the midline), but their method was
acceptable. It was important to define
the bladder edge so that the surgeon did not damage the bladder and confined
the stitches to outwith the urethra and the bladder edge. Fat would then be displaced and any scar
tissue from previous surgery divided. That gave access to the area in question. When a vein was cut it was destroyed, but that
did not matter. With the Burch procedure
the stitches were put just further out from the urethra right up to the level
of the ladder neck. To give him a better
ability to define the area the surgeon put two fingers into the vagina to
elevate it and give him much more control of the situation in the event of
troublesome bleeding. What Dr Lingam
defined was the Tanagho modification of the Burch procedure, where the stitches
are put a little more laterally, so her fingers would therefore be more lateral
to where he would put them in the Burch procedure. Having cleared the area of fat and any
troublesome blood vessels the surgeon had also to clear the area of the
ileopectineal ligament of predominantly fatty tissue. He would then under normal circumstances have
about three to three and a half centimetres of ileopectineal ligament there to
work with. The surgeon would be standing
on the patient's left and working on the right side of the patient's body. He would have two fingers in the vagina with
his index finger pressing up on the tissue through the vagina to give him a
dome of tissue there and he would take a bite through the whole vagina and go
across to the ileopectineal ligament on the same side and put a stitch through
that at the nearest good anchoring point. Having done that, he would put a clip on both
these sutures and just lay it there. Most surgeons would do two or three stitches. His stitches would be fairly close to the
mid-urethra and the second one would be nearer the bladder neck, as shown on
Figure 7 in his text. Having done
the right side, he would go through the same procedure on the left side and
deal with any troublesome bleeding with the diathermy but if it was more
problematic he would push his finger up inside the vagina and put a separate
stitch on one side and then the other side of the bleeding and then tie it to
control the bleeding. Some bleeding was
to be expected in the course of this procedure because the area in question was
a very vascular area, but it was venous bleeding. It was relatively normal to have some bleeding
and that was why a drain was inserted.
[45] So far as the Tanagho modification of the Burch colposuspension
was concerned, the problem with colposuspension was that if the surgeon
elevated too highly the outlet of the bladder was obstructed and this caused
urination difficulties, so Tanagho's idea was to put the stitches more
laterally to give a less tight elevation of the bladder neck to make it less
likely to cause outlet obstruction. With
the Burch procedure the stitches were put through the vaginal wall more towards
the midline and pretty close to the urethra, whereas with the Tanagho
modification they were put more laterally through the vaginal wall, as shown on
p 85 of 6/17 of process. The more
lateral the surgeon went in the bladder, the closer he was to the ileopectineal
ligament.
[46] The operation note on p 45 of 6/7 of process gave a
reasonable amount of information, but he would be expecting a trainee to be
giving much more detail in an operation record. He agreed with Dr Lingam that she should
have detailed the location of the sutures when she talked about sutures to the
right and left side. In any event he had
heard the evidence of Dr Lingam and Dr Hassan. Whatever the quantity in terms of litres, the
pursuer suffered a massive blood loss during the operation. If the second bleed was caused by Dr Lingam's
needle, it was more likely that it was caused when she was working in the
paravaginal (and not the ileopectineal) area. The first bleed was in the ileopectineal
ligament area. In her evidence Dr Lingam
had described the Tanagho modification, whereas in his evidence Dr Hassan
had described the Burch colposuspension. These were not the same procedures, and Dr Hassan
had not described the same thing as Dr Lingam. When asked for his opinion about why the first
episode of bleeding occurred, Dr Brown replied:
"Well, the
ileopectineal ligament is an avascular structure. It's a ligament. As in any muscle, there is a tendon at the end
of it, and that's what we would call ... It's equivalent to a ligament, and it's
a relatively avascular structure, but, of course, you know, it is supplied by
blood but at a microvascular level, as it were. The only significant source nearby is lateral
to the ileopectineal ligament, and when I'm teaching colpossupension ... when I
taught colposuspensions, I made the trainee aware of where that bleeding was so
that it could be avoided, and my assumption is that she must have in some way
damaged that blood supply."
[47] He had indicated where the blood supply might be in diagram 3.30
of Grant's Anatomy (6/18 of process): he was focusing on the branch from the
inferior epigastric artery and vein. It
was his understanding that a misplaced stitch caused the first bleed because
that was the only significant vascular area near to the ileopectineal ligament.
If the surgeon went too far laterally
there was a risk that he would hit that area. There was a plexus of veins attached to the
artery, and it was the venous area which tended to be more at risk. As bleeding does not occur spontaneously,
something must have happened to the blood supply to cause the bleed, and he
postulated that it was the needle that caused the bleeding. If the Tanagho modification was being properly
carried out that should not happen. Whether
it was the Burch method or the Tanagho modification which was being used, there
was never a need to go too far laterally on the ileopectineal ligament,
because, if you do, you were likely to damage a vessel. Dr Lingam's
evidence that she placed one stitch medially and the other as laterally as
possible strengthened his feeling that she damaged the right ileopectineal
vessel by going too far laterally. With
reference to Negura's 1993 article "Haemorrhagic Risks in the Burch
Procedure" in the International Urogynaecology Journal (6/46 of process), it
had been written, not in one of the first line journals, but in a
well-recognised and reputable journal. An aberrant vessel was a vessel which was not
normally there. The article stated:
"The retropubic
space has a well defined vascular anatomy which must be known to the operating
surgeon in order to avoid haemorrhagic complications. Of particular importance are the aberrant
obturator vessels, which are always present and are usually hidden in a fat pad
at the lateral margin of Cooper's ligament."
He agreed with the first sentence
but the second sentence was a contradiction in terms as an aberrant vessel was
not there in the majority of cases. At
the foot of the page the authors stated:
"The reader must not be confused by the term
aberrant, as it is truly a misnomer since the vessels are always present,
although usually unseen."
[48] In two other places in the article the authors quoted
statements that the aberrant vessel was present in a certain percentage of
cases. Under the heading "Initial Entry
into the Retropubic Space" the authors stated:
"Approaching the
space more medially leads directly to the anterior vesical and retrosymphysial
vessels, which may be injured in the process. On the other hand, a more lateral approach may
injure the inferior epigastric artery and vein, or the aberrant obturator
vessels."
He agreed with the above statement.
He also agreed with the statement in the
introduction that life-threatening haemorrhage in the Burch procedure was rare.
In the pursuer's case the bleed from the
ileopectineal ligament was not life-threatening but the second bleed was. The authors of this article appeared to be
saying that in 25% of cases there would be damage to the aberrant obturator
artery if the surgeon went to the most lateral part of Cooper's ligament. It was certainly not his experience, as Dr Lingam
suggested, that there was a 25% chance of causing damage if the surgeon applied
sutures to the ligament. It was not an
accepted fact that putting stitches into the ileopectineal ligament normally
was a problem because colposuspension was the gold standard procedure. In his opinion the article did not give Dr Lingam
any justification for asserting that in 25% of cases you will have damage in
that area. What the authors were doing
in the article was to highlight the aberrant obturator vessel. The reference in the article to vessels being
hidden in a fat pad at Cooper's ligament accorded with his own experience. If you wanted to place a suture there you had
to clear the fat away so that you could see the vessels. If you put a stitch into a blind area you were
likely to do damage, and in this situation you would do damage to one of these
vessels.
[49] So far as the second bleed was concerned, it appeared from the
evidence of Dr Urquhart that the damage was to a medial branch of the
right internal iliac artery (shown in diagram 3.29 of 6/18 of process). If you did damage to an artery it was likely
to bleed. If you cut it, it would bleed
instantly. Then, because arteries were
pulsatile (elastic structures) the bleeding would be spurting, and the bigger
the artery the greater the amount of bleeding would be. Then the artery would go into spasm, causing
it to contract, but it would still bleed. There was the possibility of the vessel
retracting, so that within a minute or two of its having been cut it would have
pulled back and become very difficult to see. He was suggesting, on the basis of Dr Urquhart's
evidence, that the artery might have pulled back after it bled. It was likely that the artery was the anterior
artery branching from the uterine artery close to its origin, not close to the
uterus, was the artery that was involved. He was asked if he could postulate how that
artery was involved and he replied:
"Well, in
colposuspension procedures the constant problem we have are the venous
structures because they're easily visible, and we should never see an artery as
such. Now, arteries of course are of
different sizes, but when they branch and branch, the small ones we of course
call arterioles, very small branches, you know, like the branches of a tree,
the terminal ones, or the root, and so certainly with a Burch colposuspension I
have never been aware of an artery in the area where I put my stitches, and
from my discussion with my colleague, because he is more ... he does the Tanagho
procedure, he also is not aware of seeing arteries as such, so my assumption is
that the second stitch was put lateral to the vaginal area in the region of one
of these vessels, these arteries."
[50] Dr Lingam had said that the second stitch was as lateral as
possible. He was postulating that the
tissue was picked up outwith the vaginal area. He did not believe that would be an aberrant
blood vessel to cause the second bleed, as Dr Lingam had suggested. He had certainly had no experience of aberrant
vessels when doing a Burch colposuspension, even in patients who had had a
hysterectomy, and his colleague had not mentioned any aberrant vessels. If there were a significant aberrant vessel
it would be visible. The surgeon should
not put the needle into an area if he had not ascertained what vessels might
lurk there. Any fat should have been
cleared away and there was absolutely no excuse for putting blind sutures in. Fat could be easily displaced and if it were
not damage might occur. He did not
agree, on the basis of his own experience and his reading of the literature,
with averment at p 20E of the Closed Record that major haemorrhage such as
that suffered by the pursuer was a recognised complication of colposuspension. The common problem from bleeding with
colposuspension was from the veins. In
general terms the blood loss from a standard colposuspension, either the Burch
or the Tanagho modification, would be less than 500 ml, an amount that could be
dealt with without any transfusion.
[51] In "Surgery of Female Incontinence" by Stuart Stanton and Emil
Tanagho (6/19 of process) the following was stated at p 100:
"Intraoperative
complications include injury to the urethra and bladder, venous haemorrhage from
paravesical veins and ureteric ligation. ... Venous haemorrhage is managed by
diathermy, over-sewing or the use of Sterispon. Any remaining venous bleeding usually ceases
as soon as elevation of the paravaginal fascia has been completed."
Stuart Stanton had been the
leading urogynaecologist in this country for 15 or 20 years and this text
book was well known. It was relevant
that he did not mention arterial bleeding at all, which would be the general
experience of surgeons. Dr Brown
had found only two articles in the medical literature which mentioned
haemorrhaging. One was a Turkish article
(6/38 of process) in the Australian and New Zealand Journal of Obstetrics and
Gynaecology which he had found on the Internet and which mentioned 10 cases of
massive haemorrhage, only 8 of which required blood transfusion, in 360 cases
of colposuspension. As their definition
of massive haemorrhage was not stated the article had to be discounted. The other article was an American article by Baker
and Drutz who stated that blood loss for normal colposuspension ranged from 50
to 1500 ml in their series, but that if the colposuspension was associated
with another procedure, such as a hysterectomy, the range was 50 to 5000 ml.
He took from that that a colposuspension
on its own did not normally give rise to massive haemorrhage. When several procedures were done the blood
loss could always be much higher. In his
opinion you should not get arterial bleeding at all in the course of a
colposuspension. The surgeon should not
go into an area where there was a risk of arterial bleeding. In his opinion the second bleed in this case
ought not to have occurred. It was his
belief that if Dr Hassan had done this operation on his own the second
bleed would not have occurred: he would
have done it a different way from Dr Lingam, and he had much, much more
experience than she had. With the
Tanagho approach, although the surgeon went laterally, he did not go outwith
the area of the vagina into the area where there were arteries. If that was what Dr Lingam did, that
would be a failure on her part. He saw
significance in the fact that there were two sources of blood loss in this
case. It told him that the procedure was
done in an inexpert manner.
[52] On the question of Dr Lingam's experience at the time, he
considered her experience in the procedure of colposuspension to have been
extremely limited. Considering it had
been virtually six years since she had done colposuspensions regularly, her
experience was out of date. When dealing
with this procedure recent experience was, in his opinion, absolutely crucial. Dr Lingam had done only one
colposuspension, possibly two, and observed two in the previous six years. Had she come to his unit he would have had her
in theatre doing a hystectomy as she was a fifth year specialist registrar, and
he would have seen how she did them and assessed whether she was competent. Then he would have had her assisting him doing
colposuspensions. Once she had assisted,
re-orientated herself and knew the technique used in his unit and was
comfortable with it he would let her do colposuspensions, but not in obese
patients. Six years not doing a surgical
procedure was a very long time and colposuspension was a specialist procedure
in a difficult, inaccessible area of the body: the surgeon therefore had to be
re-orientated and comfortable in that area with recent experience. Dr Hassan was not entitled to have
accepted Dr Lingam's statement that she was experienced. He did not require to go the length of looking
at her curriculum vitae but he should
have asked her questions about her colposuspension experience, when it was, how
many she had done, where it was, her past and recent experience: you could not
take these things for granted. He found
it very unsatisfactory that she had been in the unit for a month and not been
to theatre to see or assist in a colposupension before she was allowed to do
one after a six year gap of doing 16. It was up to the individual surgeon
to decide which technique suited him or her, but he would expect anyone who
worked with him to do his procedure. He
considered it bizarre that Dr Lingam described what she did as the Tanagho
procedure and Dr Hassan described it as the Burch procedure. Dr Hassan was not au fait with the Tanagho procedure as such. He had been trianed in and he did the Burch
procedure. He had been supervising Dr Lingam
doing an operation in a way that he himself would not have done it, although he
seemed to think that she was doing a Burch colposuspension. In his view what ought to have happened when
Dr Lingam was at the Southern General Hospital, had he been running the
unit, was that she would have been in theatre many times assisting him and he
would have assisted her, for example, in doing hysterectomies to gauge her
general experience, and then he would have expected her to have assisted him on
several colposuspensions before allowing her to put some stitches in and then
doing the operation under his supervision. When she came to do the procedure he would
have expected her to follow the Burch route. If she had been taught the Tanagho approach he
would have expected her to learn the Burch procedure in his unit as she would
have come to his unit to be trained. She
was a year 5 specialist registrar still in training and he would have
assessed even the senior specialist registrars who came to him and not have let
them operate on their own. On the basis
that she was allowed to do one and then another colposuspension on the morning
of 26 August 1999
with her training and experience he would fault the supervision she had at the
Southern General Hospital. The matter of
obesity was of relevance when considering this issue because it was much more
straightforward to operate on a thin patient because there was less fat, less
blood and the tissues were much closer to you. Obesity added a major extra dimension,
particularly in a complicated procedure such as a colposuspension. The fact that she had had a previous
hysterectomy would not have had any real relevancy. He would certainly not have allowed Dr Lingam
to operate as lead surgeon on the pursuer, whether the pursuer was described as
obese or not. He would have allowed her
to start on non-obese patients after she had observed him over several cases
and he had had the opportunity to assess her surgical skills. He thought she would have had to have done 10
or 15 normal weight patients before he would have allowed her to do the
next grade of obesity. He would not
allow a junior doctor to do a very obese patient until she had done at least 30
or 40 colposuspensions, and then only under supervision because very obese
patients were very, very tricky. The
pursuer's BMI was 34 and the BMI of a normal weight patient was 20 to 25. The warning zone, which could be described as
overweight, was 25 to 30 and 30 to 40 was described as obese, with 40 to 60
being very obese. 30 to 40 was a significant level of obesity. The anaesthetist considered her to be
significantly obese when he noted her as being "obese ++": obesity was a crucial factor in anaesthesia as
it made the anaesthetic and endotracheal intubation much more difficult.
[53] On the day of the operation Dr Lingam was being supervised
by Dr Hassan. If she was placing
sutures out of position he should have noticed that. He should have made clear what had happened
and that if it happened again he would take over. His own practice would be to take over if it
happened on more than one occasion. If
it were the case that sutures were placed out of position for a second time,
there was no excuse for Dr Hassan not stopping that. On the first occasion he should have given a
warning and told her that she had to do exactly what he said.
[54] Dr Brown was asked for his views on the question of a
collateral blood supply. It was averred
in the defences at p 17C:
"The pursuer is
likely to have developed collateral vaginal blood supply following upon the
tying off of the remnant of the pursuer's uterine artery, the pursuer having
undergone hysterectomy in 1994."
His observations on that hypothesis
were as follows:
"I have done
many hundreds of hysterectomies and I have done many hundreds of
colposuspensions on patients who have had hysterectomies and I have never seen
a collateral blood supply, and I would not expect a collateral blood supply to
develop following a hysterectomy because at a hysterectomy the main blood
vessel which is tied is the uterine artery, which supplies ... it is the main
supply to the body of the uterus and the cervix, which is part of the uterus, and
so when the hysterectomy is done, when the uterus is done, when the uterus is
removed, there is nothing there so there is no need for a collateral blood
supply."
[55] He went on to explain that the uterine artery shrivelled up and
became redundant. He had never seen a
collateral blood supply. A collateral
blood supply became necessary when there was a need to get blood to a
particular area of the body. When the
uterus was removed the uterine artery shrivelled up and the adjacent structures
which might also have been supplied secondarily by the uterine artery now
relied on their primary source, the vagina on the vaginal arteries, and the
ovary on the ovarian arteries. He had
not read or had experience of a collateral blood supply following hysterectomy and
he did not believe it existed.
[56] Dr Brown did not accept Dr Hassan's hypothesis that
damage to the branch of the internal iliac artery might have been caused by the
lifting part of the procedure and that particular vessel being stretched. In every colposuspension, whatever method was
used, the tissues were lifted up by a couple of centimetres, and even if an
intact vessel were there he would not expect damage to it to occur. If there were any merit in Dr Hassan's
hypothesis colposuspension would not have become the gold standard procedure
that it was for 30 years: if you
were likely on a regular basis to tear arteries when you elevated the tissues
the procedure would fall into disrepute. Even if a significant artery were picked up he
would find it difficult to believe that it would be damaged to the extent that
it would bleed. There was nothing in his
experience or in the medical literature to support Dr Hassan's hypothesis
on this point.
[57] Later in his evidence Dr Brown pointed out that if you
elevate an artery there was the possibility that you could damage it. It was a basic principle of surgical practice
that if you were dealing with arteries you should never put them under tension,
as that could stretch and damage the artery. Accordingly, if in a colposuspension you did
elevate an artery (and he had never seen one and it was his understanding that
you did not see one in the Tanagho modification), even an intact one, you could
damage it and cause haemorrhage. To have
elevated an artery in the course of colposuspension the surgeon would have to
have gone well lateral of the vaginal area, right to the side wall of the
pelvis. He could put a stitch round it
and, if he elevated it, there was the danger that he could traumatise it and
cause bleeding, but that should not happen. The medical literature referred to venous
haemorrhage and stopping it by elevating the tissue because it was a low
pressure system, but there was no mention anywhere of dealing with arteries.
[58] At p 17E of the Closed Record it was averred:
"It is likely
that the haemorrhage was caused when Dr Hassan separated or reflected the
bladder from the vagina, or when the endopelvic fascia was separated."
In Dr Brown's opinion Dr Hassan
did very little separating and reflecting of the bladder, that having been done
by Dr Lingam at the start of the procedure, but in any event he thought it
highly unlikely that the haemorrhage was caused by separation or reflection of
the bladder from the vagina. The tissues
were overlain by fat and to clear the area the surgeon had to clear the fat
away: by pushing it away he could damage the small vessels, but the resultant
bleeding would be instantaneous and dealt with at the time by diathermy or
electrocautery. It could not be left because
the longer it was left the more bleeding there was and the more difficult it
was to see the area. Moreover, such
bleeding would always be venous bleeding: he could not conceive of any mechanism whereby
the major haemorrhaging in this case could have been caused by that part of the
procedure.
[59] Dr Brown had considered the report by Mr Jarvis (7/10
of process) in which the latter stated in para 22:
"The sutures
having been placed medially first of all a suitable point is then selected
anywhere along the ileopectineal line which does not seem to involve a blood
vessel and which can result in satisfactory suspension because it is close
enough to the medial suture."
Mr Jarvis appeared to be
talking about the ileopectineal ligament and it was difficult to say whether he
was talking about the Burch or Tanagho procedure. In the Burch procedure the surgeon sought to
place the sutures more medially than laterally and at the nearest point to the
placement of the vaginal sutures so that they did not have far to travel. There was no discussion by Mr Jarvis
about placing sutures as far laterally as possible. Mr Jarvis was referring exclusively to
the ileopectineal ligament and did not mention any deeper bleeding. Dr Brown's view was that the major
haemorrhaging was caused at the time when the work was being done to the
vaginal wall. Mr Jarvis went on to
state:
"It would seem
to me that there were two possible causes for the haemorrhage. The first is
that during the process of dissection in order to display the ileopectineal
line and to dislocate the bladder medially on each side in order to insert
sutures bleeding could be caused and this is an inherent risk within the
procedure."
The above passage rather suggested
he was talking about the Tanagho modification as he was pushing the bladder
towards the midline so that he could put the more lateral suture in. The bleeding which Mr Jarvis was talking
about was venous bleeding, not torrential bleeding, and it should be easily
controlled by diathermy, or, if it were more persistent, by stitch. There was a plexus of veins which could be
very thick, very juicy veins and damage to them could cause heavy bleeding,
which would be required to be dealt with there and then. Mr Jarvis continued in his report:
"Alternatively,
a needle used in placing a suture into the ileopectineal line inadvertently
caught a blood vessel in the floor of the operating field, in the underlying
muscle, and that bled."
The ileopectineal line was a
distinct area which was virtually avascular and there was no muscle in that
area. The muscle was much deeper and a
stitch being put into the ileopectineal ligament should not be anywhere near a
muscle. If the stitch were near a muscle
the surgeon was in the wrong place and there was certainly no blood vessel in
the floor of the ileopectineal ligament: if he was talking about deeper, then
of course there were blood vessels.
[60] At para 25 of his report Mr Jarvis dealt with Dr Lingam's
experience as follows:
"Dr Lingam
confirms that at the time of the operation she was a final year Trainee
Specialist Registrar with a special interest in urogynaecology and had
significant previous experience in carrying out colposuspension."
Dr Brown did not agree with
that observation. Her experience of
colposuspension was as a senior house officer and a senior senior house
officer, which were very junior grades, and it was six years before this
operation, and then more recently she had done one, at the most two, and
observed two, so her experience was very limited and significantly out of date.
He was certain that most, if not all, of
his urogynaecology specialist colleagues would agree with that. In his opinion there was no room at all for a
contrary view to be reasonably held.
[61] In relation to the first bleed Dr Brown had indicated that
there was a blood source lateral to the ligament. He concluded that Dr Lingam entered that
area because that was the only area where there was a significant blood supply
in relation to the ileopectineal ligament, and in her operation note she
mentioned the ileopectineal vessel. There were no other vessels in that area
capable of providing what she described as an active blood loss. The second bleed was from an arterial source
lateral to the vaginal area where Dr Lingam would have been working. His conclusion about how that blood loss
occurred was that when she placed her second more lateral suture she either
went round an artery or traumatised an artery and the damage occurred in the
process of the suture being tied. One
would come across a branch of the internal iliac artery well lateral towards
the side wall of the pelvis, a distance of the order of two centimetres. He envisaged the major haemorrhaging happening
by either the needlepoint being put through the vessel when a suture was being
placed, in which case one would expect immediate bleeding, or the wall of the
vessel being damaged, in which event it would remain intact for the time being,
or the vessel being encircled and damage occurring when the tissue was elevated
to suspend it. In relation to the bleed
on the ileopectineal ligament side he believed that there had been direct
trauma to the vessel or bruising to it. Normally a traumatised vessel bled
immediately, but in this case the bleeding came later, which was difficult to
understand, unless the vessel wall was traumatised and damage was done in the
process of tying. He envisaged trauma
from the needle skirting or abrading the vessel wall rather than going through
it, which one would expect to cause immediate bleeding. If you traumatised a vessel the first thing
you got was bleeding, and the spasm element came in later to contract the
vessel and reduce the level of bleeding.
[62] Dr Brown considered the amount of blood loss in the case
of the pursuer. The operation note
referred to blood loss of five litres and later to an estimated blood loss of
about six to seven litres. Those figures
represented a massive blood loss, more than one would ever consider possible or
acceptable in this sort of operation. The haemoglobin level of 42 grams per
litre (p 89 of the records) was a seriously low level of haemoglobin
indicating a massive blood loss. The
blood pressure recordings after 1pm
were of seriously low blood pressure, indicating heavy blood loss. The pursuer was in clinical shock and
ephedrine (adrenaline) was administered to raise the blood pressure. The anaesthetist had estimated blood loss at
over seven litres, and he would place a great deal of reliance on that. The pursuer's life was in danger. What happened in this case could never be
considered a recognised complication of colposuspension, and there was no
support in the literature for a contrary view. Nor was there any indication in the medical
literature that neurological damage (which the pursuer had suffered) was a
recognised consequence of the procedure. It was highly unlikely that you would ever get
a blood loss of seven litres from a venous haemorrhage.
[63] Dr Brown explained that, on the basis of his medico-legal
work, he was fully aware of the legal test for medical negligence (Hunter v Hanley 1955 SC 200; Bolam v Friern Hospital Management Committee
[1957] 1 WLR 582). The following passage then occurred in his evidence:
"But just
looking to the first blood loss in the area of the ileopectineal ligament,
would causing that with a needle be a failure to exercise the skill and care of
an ordinarily competent registrar acting with all reasonable care? - Yes.
And similarly
with regard to the second blood loss, would causing that with a needle be a
failure to exercise the skill and care of an ordinarily competent registrar
acting with ordinary skill? - Yes."
[64] In his report of 5 September 2001
(6/26 of process) he stated in his comments and conclusions at pp 4-6:
"Colposuspension
is a very specialised procedure which is performed deep in the pelvis. It is often difficult to do because of such
factors as obesity, poor access and increased vascularity. Therefore, it should only be carried out by a
gynaecologist experienced in the operation or a senior trainee supervised by an
appropriately trained senior colleague."
[65] There were several factors in this case which in my view led to
the major problems encountered:
1 Ms Greenhorn was significantly obese
The anaesthetic record states that Ms Greenhorn weighed 90 kg at
the time of the operation. Her height is
5' 4", so her Body Mass Index (a calculation of the degree of obesity) was
34, which is almost midway through the 'Obese' category. This colposuspension, therefore, would be technically
more difficult and hazardous to perform and it was not a suitable case for a
surgeon inexperienced in the procedure.
2 Inappropriate delegation of surgery
It appears that at Ms Greenhorn's colposuspension Dr Lingam was a
Senior Registrar and Dr Hassan a Staff Grade doctor. Dr Lingam applied the sutures initially
but following the heavy bleeding Dr Hassan took over. The inference from this is that the Senior
Registrar was being taught the procedure under the supervision of Dr Hassan.
In the context of Ms Greenhorn's
degree of obesity this was an inappropriate degree of delegation to Drs Lingam
and Hassan. This can lead to an
increased risk of complications and this is what happened.
3 Inappropriate placement of sutures
The sutures placed by Dr Lingam damaged the right ileopectineal
vessels. This should not have happened
as these sutures should have been inserted into the ileopectineal ligament
closer to the symphisis pubis, i e well away from the ileopectineal vessels. The supervising surgeon, Dr Hassan,
should have ensured that the sutures were appropriately placed, but he did not
and this resulted in unnecessary bleeding and replacement of the stitches.
It is also
probable that the sutures inserted deep in the right side of the pelvis were inappropriately
positioned too laterally, and this resulted in the torrential and
uncontrollable haemorrhage which was stopped only after embolisation of a
branch of the internal iliac artery.
4 The degree of intraoperative haemorrhage
and long-term morbidity experienced by Ms Greenhorn are not recognised
sequelae of colposuspension
It is recognised that heavy bleeding may be experienced at colposuspension
because of the generous blood supply around the bladder base and urethra. But the excessive haemorrhage which occurred
in this case resulted in misplaced sutures disrupting a major blood vessel
lying laterally, deep in the pelvis. ...
Thus the degree
of morbidity suffered by Ms Greenhorn is a direct result of the surgery
and is an unacceptable complication of this colposuspension resulting from
substandard and negligent care in my view.
I have been
performing colposuspension since 1972 and have never experienced such a massive
blood loss at this operation. However,
as stated before, it is a specialised procedure which can be very difficult and
dangerous when done by inexperienced doctors, and I must conclude that this is
likely to have been a major factor in this case.
...
Conclusions
My conclusions are that there has been substandard and negligent care in the
management of Ms Greenhorn's colposuspension. This is because:
1 With her level of obesity the
colposuspension was not suitable for a trainee surgeon to do.
2 There was inappropriate delegation in
this case to Drs Lingam and Hassan, as well as inadequate supervision of Dr Lingam
intraoperatively by Dr Hassan.
3 As a result, sutures were misplaced
at several stages of the operation which caused torrential and uncontrollable
haemorrhage.
4 The degree of intraoperative
haemorrhage and the continuing long-term morbidity suffered by Ms Greenhorn
are not recognised and acceptable consequences of colposuspension."
[66] He confirmed that these conclusions represented his considered
view. So far as conclusion 2 was
concerned, he was blaming Dr Hassan for having allowed Dr Lingam to
carry out the operation at all as lead surgeon, based on her lack of recent
experience. His opinion remained the
same after having heard the evidence of Dr Hassan. What he asked her was not sufficient. He should have asked her specifically what her
level of experience of colposuspension was and when she had gained that
experience. From his evidence it sounded
as though he thought that she had come straight from the Royal Infirmary
Urology Department, where she had done colposuspensions, to the Southern
General Hospital. He seemed to have been
labouring under a misapprehension about her experience and he also assumed that
because she was a fifth year trainee registrar she had up to date experience. On reconsideration he believed Dr Hassan
was an experienced surgeon at colposuspension, so it was reasonable for him to
have supervised. He was also blaming Dr Hassan
for inadequate supervision of Dr Lingam during the operation, with the
result that bleeding occurred in two separate areas. He should have stopped her
going to the places where the bleeding was caused.
[67] In cross-examination Dr Brown agreed that a major
haemorrhage was simply a haemorrhage in which there had been a large blood
loss: it did not have any special or technical meaning beyond indicating a
large blood loss, based on the amount and duration of the bleed. The pursuer had bled for about an hour before
her bleeding was slowed to a manageable extent. That was a lengthy period over which to bleed.
Had Dr Hassan's first stitch to the
deep pelvis found the bleeding artery and ligated it that would have stopped
the bleeding. This was a major
haemorrhage because the vessel continued to bleed for as long as it did. With venous haemorrhage one was always able to
find the bleeding and stop it. Here it
was an artery that was involved and that was why they were not able to stop the
bleeding: you should not be in the
position that you cannot find the source of the bleeding because you should
never have caused the haemorrhage in the first place. According to the anaesthesia record (6/7 of
process, p 35) 14 pints of fluid were administered to return the
circulation to its normal situation. The
haemoglobin level on 29 August (p 82) showed that over the operation
the pursuer had dropped her haemoglobin by 3 grams per litre, so there had
been a degree of undertansfusion. He did
not accept Mr Jarvis' contention (7/10 of process, para 8) that the
level of blood loss was 3.5 litres. Whether it was 3.5 or 7 litres, the pursuer
had gone into shock. It was his position
that massive haemorrhage was an unknown complication of colposuspension: he had no personal knowledge of it and he had
not been able to find any literature concerning it, but not all complications
were always written up in the literature, and he accepted it could happen. Even if the bleed from the branch of the
interior iliac artery had been only a litre he would still have felt that there
had been an inappropriate placement of sutures: it was the source of the
haemorrhage that was more relevant than its degree as the surgeon should not be
in the area where he could damage an artery. In his experience bleeding in colposuspension
was always controllable because of its venous nature. His position was that damage to a branch of
the internal iliac artery indicated negligence, whether the blood loss was one
litre or seven litres. He was
prepared to accept that Dr Hassan and others might well have had
experience of a massive haemorrhage in a colposuspension, but it certainly did
not feature in the medical literature. Blood loss was always greater when doing
concomitant surgery because more than one operation was being done. In this case what was done was a
colposuspension without additional surgery. The article by Negura et al in 1993 appeared to be suggesting that in the authors'
experience there could be severe bleeding by damage to an artery by a needle in
the vaginal area during a colposuspension, but the article was not a major
article, it gave their impression based on the Romanian experience and it was
not something that he would consider to be a significant addition to the
literature of haemorrhage in colposuspension. His reading of the article was that it was
referring to arteriolar, not arterial, bleeding.
[68] Dr Brown accepted that there were large and small
arteries, just as there were large and small veins. The veins around the bladder edge and the
urethra could be quite substantial. In
the area in question arteries tended to be smaller than veins and the surgeon
did not see them because they were so small and did not impinge on his
operative field. At the point of the
vaginal artery and the vaginal vein going down through the pelvic area he
imagined that the arteries and veins would be of comparative diameter. Arteries carried (red) oxygenated blood from
the lungs to the various organs and muscles and veins carried (bluish)
deoxygenated blood back to the lungs. Veins tended to be a bit bluish in colour and,
arteries, because they were thicker walled, tended to be whiter. A surgeon could tell immediately on looking
what was an artery and what was a vein just from his experience and their
appearance. Moreover, arteries pulsated,
whereas veins did not, so movement as well as colour distinguished. Veins contained valves that helped conduct the
blood. Vessels in the pelvis lay on
various structures, such as muscle or fat: they did not pass through empty
space. Arteries could be entirely
encased in muscle. Spasm and retraction
were both forms of reaction to damage sustained by the wall of an artery, which
contained elastic tissue and a very thin layer of muscle as well. When an artery was cut the first thing it did
was bleed and there would be pulsatile spurting of the blood as it came out. It would thereafter at some point go into
spasm (meaning the muscular element of it contracted) to try to reduce the
blood loss: it in effect narrowed itself and constricted the amount of blood
that was able to escape from it. If
there were a hole in the artery wall but the artery were not severed all the
way through He would still expect to see
blood loss. He would imagine that the
artery could then still go into spasm, but it was not a phenomenon that a
surgeon would necessarily see happening as it was more of a radiological
phenomenon, but he would expect bleeding if an artery were damaged but not
transected. He would not know if there
would be spasm in that non-transected artery, but for retraction to happen the
artery would need to be completely severed. If an artery were damaged by a suture or a
needle it was not likely that it would be completely severed: the most likely
scenario would be the needle going through the middle of the vessel, damaging
it and therefore causing bleeding. Depending on the type of needle, there was the
possibility that the vessel could be cut. If a J-shaped needle were to come in contact
with an artery the most likely damage would be piercing of the vessel and
bleeding. He imagined it would be
possible to damage the artery without piercing it. If the needle had not penetrated the vessel
but had encircled or skirted it the suture could cause damage during the knot
tying process and the elevation of the suture. His position was that if the initial damage to
the artery wall was caused by a needle or a suture it was unlikely that the
artery at that point would become completely severed. It was known from Dr Urquhart's imaging
that the artery in this case was completely severed. If tissues containing an artery were stretched
and the artery put under strain it could be torn and there was the possibility
if it were put under a lot of tension that it could be transected. On his view there ought to have been bleeding
whenever the artery wall in this case was penetrated, whether by a point or by
separation. He was postulating that in
this case the rupture of the artery wall happened at the tie of tying the
sutures and elevating the tissue and not at an earlier stage: if there had been direct damage to an artery
earlier one would have expected bleeding at that point. He found the explanation suggested by Dr Hassan
and Dr Lingam that the artery might have gone into spasm, preventing any
bleeding being evident, difficult to believe. The penetration of the artery wall, whether or
not it was a complete severing, in his view occurred when these sections were
tied.
[69] Dr Brown accepted that his experience was of doing the
Burch colposuspension. He would not
expect to see any arteries in his operative field when doing a Burch colposuspension.
He had no experience of the Tanagho
modification, had never done one and had never been present when one was done. He had no idea that the colposuspension in
this case was a Tanagho modification until he had heard the evidence as it was
not evident from the operation note. He
had stopped doing colposuspensions in 2000. Between 1995 and 2000 he did an operating list
once a week and sometimes if there were spare lists he would do another
operating list, half as lead surgeon and half watching a junior surgeon doing
it. When asked whether he considered
himself "competent to do a colposuspension tomorrow" he replied that he would,
because of his length of experience, although he would prefer to do it on a non-obese patient to get back into it.
[70] He was postulating that Dr Lingam put her second stitch
into tissue other than the wall of the vagina, in the region of the lateral
vaginal wall. He did not know that it
had a specific name, but it was perhaps muscle tissue or tendonous tissue: he had never been down in that area of the
anatomy to see what it might be because in a Burch colposuspension he never had
to go there. He was proceeding on the
basis of his understanding of the anatomy of the pelvis. He had never seen the area. He was speculating that there was something
down there for Dr Lingam to have caught with a stitch. He was familiar with the pearly white vaginal
wall: if you pushed up tissue from below
you were going to put it under a lot of tension and it was likely to be a pale
colour because all the vessels had been stretched and pushed out of the way. It should be fairly obvious when inserting a
vaginal stitch that you were putting it in the right place. In his explanation it had to be accepted that,
in addition to putting a stitch through the pearly white vaginal wall, Dr Lingam
caught an artery. Considering Dr Lingam's
level of experience, he did not think it would have been obvious to her that
she had caught some other material in her suture, but he would have hoped that
it would have been obvious to Dr Hassan. The next stitch would be on the ileopectineal
ligament directly above and he was postulating that the ligament suture went
beyond the ligament. It was possible
that she missed the ligament entirely, and that was what he was suggesting. He was talking about her putting a stitch in
the pelvic wall lateral to the ligament. If the blood came from the ileopectineal
ligament itself, that would be contrary to the explanation he was postulating. It followed that if the bleed came from the
ileopectineal ligament Dr Lingam must have put her stitch somewhere in the
ligament. For his explanation that she
put the stitch in the pelvic wall to be correct Dr Hassan would not have
noticed that she had missed the ligament. One would have expected Dr Hassan to have
noticed. The ligament was a pearly white
structure and the pelvic wall, where the vessels were, was a bluish colour as
it was covered by a plexus of veins. When
he put a suture into the ileopectineal ligament he did not get bleeding, so
from that he inferred that there were not small blood vessels behind it, but as
it was a living structure it had a blood supply. He did not have the experience of putting a
needle into the ileopectineal ligament and causing bleeding. The stitch had to go through the back of the
ligament, the part one could not see during the operation: the stitch was first inserted on the front of
the ligament and it then went through the back. His experience when putting the stitch through
the back of the ligament taught him that there was not something behind it. If Dr Hassan was correct that one suture
applied to the ileopectineal ligament stopped the first bleed, then Dr Brown
accepted that he must be wrong about the bleeding coming from a vessel in the
pelvic wall, but the operation note said he applied "sutures" (in the plural).
[71] So far as the main bleed from deep in the pelvis was concerned,
Dr Brown accepted that three different possible explanations had been put
forward by other witnesses - damage caused during blunt dissection, damage
caused by the insertion of stitches and damage caused by the tying of stitches.
The blunt dissection was not likely to
have been the cause of the bleeding because that was the first thing done in
the retropubic space and if there was any damage to vessels in that area you
would expect immediate bleeding. He
accepted that during blunt dissection blood vessels might be stretched to the
point where they tore because scissors as well as swabs were often used to displace
tissues. If there was a larger vessel in
that area and it was torn, you would expect it to bleed. The delay between the blunt dissection and the
bleeding becoming apparent was about 15 to 20 minutes. He could not accept that a vessel might go
into spasm and not bleed. When the
stitches were being tied if a significant artery had had been included in that
area of tissue which was to be elevated and tied he could foresee the
possibility of it being stretched and torn during that process - really getting
caught up in the stitching process. It
was presumably the artery being pulled up with the stitch around it that put it
under tension: it was not being
garrotted, it was being pulled. If it
were elevated to an extreme degree he would envisage there would be "cheese
wiring", but that was less likely than just being stretched and torn. The artery would start bleeding as soon as it
was torn. Putting the suprapubic
catheter in would take in the order of five minutes. The surgeons would be concentrating on making
an incision in the abdominal wall and connecting up the catheter: they would not be concentrating on the
retropubic space and it was a possibility that they would fail to notice blood
coming from deep in the pelvis. If the
vessel was torn and eventually gave way there might be a significant delay
before the bleeding started. The
bleeding would not commence until there was a fracture in the artery wall. The bleeding might be quite small when the
artery was torn and increase when it was divided.
[72] When Dr Brown prepared his report (6/26 of process) he had
the hospital records and information from the Scottish Health Service about the
grade of the surgeons involved and on that basis he reached his initial
opinion. He had then no information
about what specific experience Dr Lingam and Dr Hassan had in the
procedure. He was confident that he
could express a professional opinion concerning fault on the basis of the
information available to him. He now
accepted that Dr Hassan would be an appropriately trained senior
colleague. He was able on the basis of
the hospital records to reach the view that the sutures had been placed
inappropriately because from his experience of the operation one would not
normally cause bleeding from the ileopectineal ligament requiring several
sutures to stop it and sutures should not have been placed in the lateral side
wall in the deep pelvis. He assumed that
it was a needle or a suture or the process of completing the procedure that
caused the bleeding because bleeding did not happen spontaneously. He inferred in his report that Dr Lingam
was being taught the procedure by Dr Hassan because that was why she had
come to the unit: he knew that the
Southern General Unit was the main unit for teaching junior doctors this
technique. He did not feel that Dr Hassan
should have delegated this operation to Dr Lingam in view of the pursuer's
significant obesity. He said in his
report that this was an inappropriate degree of delegation to Drs Hassan
and Lingam because he did not at the time know the level of experience of Dr Hassan
as a Staff Grade doctor: he would not normally have expected a Staff Grade
doctor to be teaching a fifth year senior registrar this operation in an obese
patient. He found out about Dr Hassan's
experience only within two weeks of giving evidence. Dr Hassan had more experience than many
consultants who did colposuspensions, but not more than consultants who
specialised in urogynaecology. In
general terms one would not have suspected a Staff Grade doctor to have had the
level of experience in this operation that Dr Hassan had. In writing his report he had made an
assumption as to Dr Hassan's experience. He had said in his report that this could lead
to an increased risk of complications and that this was what happened because
you were more likely to encounter complications, and indeed serious
complications, if you had inexperienced doctors doing operations. He had assumed that the experience of both
doctors was relatively low. One reason
why he reached the view that there had been substandard and negligent care was
because there had been inappropriate placement of sutures, and the other
reasons were that the patient was obese and there had been inappropriate
delegation of surgery. In his report he
had said that "as a result sutures were misplaced at several stages of the
operation", but he should have said "two stages". He considered that he had sufficient
information in the hospital records to enable him to make the assumptions and
reach the conclusions which he did. He
would have considered it unwise and substandard practice for whoever allowed
her to do a colposuspension at the Queen Mother's Hospital in 1998 to have done
so. When he wrote his report he had no
idea what her experience was in colposuspension. The opinion which he had expressed in court
was based on the evidence given in court by Dr Lingam and Dr Hassan. It was fine for a specialist registrar,
appropriately supervised, to do the operation.
[73] Dr Brown did not agree with the view of Mr Jarvis that
colposupension was not a particularly difficult operation and did not accept
his statement that virtually every gynaecologist in the United
Kingdom performs or has performed
colposuspension during training or independent practice. He strongly disagreed with eh statement by Mr Jarvis
that it was not a procedure to be reserved for the urogynaecologist alone: the
view nowadays was that only they should do this procedure, but he would guess
that there were still general gynaecologists up and down the country who did
colposuspensions. In relation to obesity
Mr Jarvis stated at p 12 of his report:
"The difficulty
with obesity, potentially, is two-fold. Firstly, because the fatty layer is thicker,
it is also more vascular, but that increased vascularity applies only to the
fatty layer and the fatty layer in this case was not the cause of the excessive
haemorrhage. There is no doubt that
obese patients are more likely to have a superficial haematoma post-operatively
but that was not a problem in this case. The second problem related to obesity is the
potential difficulty of access in that the surgeon may be operating deeper into
a wound than would be the situation in a thin patient. However, unless the patient is grossly obese,
that is not generally a problem."
Dr Brown did not accept the
first and last sentences in the above passage: otherwise he agreed with it. The venous supply tended to be more
significant in the fat patient, and "grossly obese" referred to the extreme end
of obesity: he described a BMI index of
40 to 60 as very obese, and "grossly obese" was not a term that he used or had
seen. He assumed that by "grossly obese"
Mr Jarvis meant a BMI index of 50 to 60, but access was always more
difficult in obese patients, not just the grossly obese. It was a matter of a difference of opinion: in
contrast to Mr Jarvis, he perhaps attached more significance to risks
arising from obesity, and his impression would be that the majority of
urogynaecology specialists would consider obesity, not just gross obesity,
would increase significantly the risks of this operation.
[74] At para 21 of his report Mr Jarvis stated:
"It is further
suggested that the surgical technique itself was inappropriate in that the
sutures placed in the ileo-pectineal line should have been placed closer to the
symphysis pubis and that they were therefore placed too laterlally. It is argued that they were placed too close
to the internal iliac artery and that the sutures should not have been placed
close to the internal iliac artery."
According to Dr Brown in that
passage Mr Jarvis was confusing the ileopectineal sutures and the internal
iliac artery. Mr Jarvis continued
at para 22:
"There are,
however, errors with this logic. Firstly, the records do not say exactly where
in the ileopectineal ligaments the sutures were placed. Whilst indeed the bleeding when it occurred
was controlled ultimately by embolisation via the right iliac artery, it was
not the artery itself but a branch of the artery which was the cause of the
bleeding. That branch was not named and
perhaps it doesn't even have a name. The
exact site of the bleeding was not known. Virtually all of the arteries in the female
pelvis will arise from, ultimately, the internal iliac artery. It is the main blood vessel supply to the
pelvis. Even a blood vessel in the
midline will arise from the internal iliac artery. Secondly, it is not usual practice to place
the the sutures in the ileopectineal ligament in a very specific place or
indeed to avoid a particular place. The
placement of sutures is governed not specifically by the anatomy of the
ileopectineal line but where the sutures are in terms of supporting the bladder
neck and proximal urethra."
Dr Brown agreed with the above
passage with the exception of the statement that it was not usual to place the
sutures in the ileopectineal ligament in a very specific place or to avoid a
particular place: he disagreed because
at the lateral end or beyond the end of the ileopectineal ligament there were
blood vessels which needed to be avoided.
Initially in the Burch procedure there were four stitches at each side,
but that had been modified over the years to two or three.
[75] At para 23 of his report Mr Jarvis stated:
"Haemorrhage is
unfortunately an inherent risk in any surgical procedure however careful the
surgeon is and however clearly the anatomy is known and displayed. Small blood vessels cannot always be
visualised and even a small artery can bleed significantly when caught by a
needle or damaged during the process of dissection. Reading these records and the papers so far
available to me, I cannot state for certain why the haemorrhage occurred or the
exact blood vessel which bled. The
degree of bleeding is totally out of keeping with a needle being placed through
any of the sutures within the ileopectineal line itself. Those blood vessels are much too small. I do not believe that the internal iliac
artery was damaged, but rather a branch of the internal iliac artery. It would seem to me that there were two
possible causes for the haemorrhage. The
first is that during the process of dissection in order to display the
ileopectineal line and to dislocate the bladder medially on each side in order
to insert sutures bleeding could be caused and this is an inherent risk within
the procedure. This bleeding can be
difficult to control. Alternatively, a
needle used in placing a suture into the ileopectinael line inadvertently
caught a blood vessel in the floor of the operating field, in the underlying
muscle, and that bled. I have no way of
knowing which of these two was the more likely scenario, although the doctors
concerned may have additional information upon this point. I consider very strongly that either of these
explanations are (sic) inherent risks
within the performance of the operation and do not indicate care below the
standard to be expected simply because bleeding occurred."
Dr Brown agreed with the above
passage except to the following extent. He did not accept that blunt dissection was
the first possible cause of major haemorrhage. He did not know what Mr Jarvis meant by
"the floor of the operating field" or "the underlying muscle" as these were not
anatomical descriptions. There was not a
muscle in relation to the ileopectineal ligament. In the course of a colposuspension, if the
stitches were being put in the appropriate and recognised places you would not
expect this extent of bleeding. Dr Brown
was asked the following question and provided the following answer:
"So can I ask
you if it is possible to inadvertently catch a blood vessel with a suture
needle, why do you exclude that as a possibility in this case? - Well, with
colposuspension, whether it be a Burch procedure or a Tanagho modification, ..
the bleeding which one would normally deal with and, from my own experience,
from my discussions with my colleagues and from My reading of the literature,
is venous bleeding, and, therefore, it is certainly possible to put a stitch
through a vessel and, indeed, a vein, but to put it through an artery which
bleeds to the extent that this has done, I would consider that the needle must
have been placed outwith the normal area that we should be putting stitches
in."
[76] Dr Brown strongly
disagreed that the artery which was damaged might have been an aberrant artery,
perhaps from a collateral supply because of the tying of the uterine artery at
hysterectomy as he had done many hundreds of colposuspensions on patients who
had had hysterectomies and he had never seen an aberrant blood supply. He could not accept the concept of an aberrant
artery following a hysterectomy. He
supposed it was possible to have an aberrant artery but he had not been aware
of any aberrant blood supply in that area in the many colposuspensions he had
done over the years.
[77] In re-examination Dr Brown accepted that the bleeding was
controlled or reduced by the packs that were used due to the pressure that they
exerted in the area, but there would have been a little bit of bleeding at the
same time. The balloon used by Dr Urquhart
would have been a better way of controlling the bleeding by blocking the two
main arteries in the pelvis. The major
blood letting was taking place before these two procedures. His reading of the situation was that the bleeding
was uncontrollable in spite of the various stitches inserted because there was
retraction of the artery, which was a well recognised surgical phenomenon. The bleeding was uncontrollable because they
could not find the source of the bleeding. If the bleeding had been in an area where they
ought to have been operating there should not have been any real difficulty in
controlling the bleeding. There would be
no difficulty in finding the source of venous bleeding. In his opinion arterial damage should not
happen during the course of a colposuspension. If the haemorrhaging that Dr Hassan had
experienced in Ireland
in 1985 was caused by arterial bleeding that reflected substandard performance. In his experience life-threatening
haemorrhage in the Burch procedure was not, as stated in the Negura article
6/46 of process, rare: it was non-existent. In his opinion life-threatening haemorrhage in
the course of that procedure caused by arterial damage would be as a result of
substandard care. There was a distinction
to be drawn between arteries and arterioles: arterioles were the much smaller
blood vessels which permeated all the tissue and were supplied by the main
channels, which were the arteries. Arterioles
were very much smaller and more widespread than arteries and were not seen
because they were so small and integrated within the tissue generally. If an arteriole were damaged the amount of
bleeding would be very much less than that from an artery and it would be much
easier to control by electrocautery or sutures. He agreed with the following statement in the
Negura article:
"Although
Tanagho recommends that the anchoring sutures should be introduced through the
anterior vaginal wall as far laterally and parallel to the urethra as possible
in a figure-of-eight fashion, the lateral vaginal margins, where the important
branches of the long vaginal artery are located, should be protected and
avoided. However, if significant
bleeding occurs at the lateral margin of the vagina after suture placement, this
can be controlled by keeping tension on that suture while other suture are
being placed."
Negura was there talking about
arteriole bleeding. Arterial bleeding
could be controlled in the same way.
[78] When one talked about what was a recognised complication of a
particular procedure, such as venous haemorrhaging, it was implicit that the
complication in question could occur without negligence on the part of the
surgeon. Venous bleeding was a
recognised complication of colposuspension but it was his understanding that
massive haemorrhaging would always involve substandard or negligent surgery. The surgeon doing a Burch colposuspension did
not see arteries but would be able to see arteries in other procedures such as
abdominal hysterectomy, where the uterine artery was palpated. Generally he did not see any difficulty in
being able to visualise arteries if they were in the operating field. It was his understanding that there were not
specific designated arteries visible when the Tanagho modification was being
done. Arterioles caused arterial
bleeding of a much lesser quantity. If a
needle were put through an artery so that it was not transected but the lumen
of it was damaged the first thing he would expect to happen would be some
bleeding. For an artery to retract it
would have to have been severed and the pursuer's artery ended up in a severed
condition. He envisaged that that
happened because either in the process of inserting the second paravaginal
suture a major artery was undermined and left intact or the vessel wall could
have been traumatised and the bleeding would have occurred only following the
tying of the suture (meaning the elevating of that block of tissue), thereby
putting the artery under tension, stretching it and severing it. That mechanism was not inconsistent with the
use of a J-shaped needle. The use of a
J-shaped needle was a little more difficult than the use of an ordinary
round-bodied needle: during the process
the arc of movement of the surgeon's hand was much wider, and he presumed that
there was involvement of the artery at that point. It should have been obvious to Dr Hassan,
if he was paying attention, that Dr Lingam was not doing the Burch method.
He himself had had no experience of
blood loss when putting the sutures into the ileopectineal ligament: if they were put into the body of the
ileopectineal ligament there should be no bleeding. To him the concept of being behind the
ileopectineal ligament was a difficult one: in relation to the depth and thickness of it
he had not recognised a vessel in the years that he had been putting sutures
through that ligament. He could not
envisage any way in which the surgeon could make contact with a blood vessel
when going through the depth or thickness of the ileopectineal ligament. He could not envisage the first bleed, which
was described as an active bleed, being from a minor blood vessel. If, as Dr Lingam thought, it was arterial
bleeding, he would say it came from the pubic branch of the inferior epigastric
artery, which coursed towards the ileopectineal ligament at its lateral end. If the exact spot of the bleeding could be
visualised one suture should be able to deal with it, but if it could not you
would need more. If one suture did the
trick clearly another would not be applied. In his experience of that area there were the
artery and a series of veins and it would therefore be difficult, but not
impossible, to deal with the bleeding with one suture.
[79] In relation to the question of the expertise of the surgeons,
the fact that there were two separate sources of blood loss had an impact on
him when considering that. When doing a
colposuspension one would not expect bleeding from the ileopectineal ligament
on placing sutures there. One could
damage a vein when placing the deeper stitches and that could happen in the
best of hands because they were all-pervasive, but that could be dealt with. To have two sources of bleeding in a
colposuspension suggested that inexpert surgery was being performed. When medical techniques changed even a
consultant required to learn the new technique. In relation to the aberrant blood vessel
theory, an aberrant vessel normally applied to the usual route of a vessel not
being taken and so it was a normal anatomical variation. In relation to the collateral blood supply
theory, this was a well recognised concept anatomically and surgically and
happened in gynaecological practice in various situations, but he was not aware
from his clinical experience, discussions with colleagues over the years or
reading the literature of the presence of a collateral blood supply occurring
after abdominal hysterectomy. He did not
find any support in Mr Jarvis's report for these two notions.
(ii)
Mr Jarvis
[80] Mr Jarvis became a
consultant obstetrician and gynaecologist in 1981, having had a special
interest in urogynaecology since the mid 1970s. His curriculum
vitae is 7/11 of process. He holds
the qualifications of BA in Physiology (Oxford,
1969), BM, BCh (Oxford, 1971), MA (Oxford,
1971), FRCS Ed (1975), MRCOG (1977) and FRCOG (1989). He held the post of Consultant in Obstetrics
and Gynaecology at St James's University
Hospital, Leeds,
one of the largest teaching hospitals in Western Europe,
from 1981 to 2002, when he retired from the National Health Service, and during
the same period he was Honorary Senior Clinical Lecturer at the University
of Leeds, where he continued to
lecture. He was Consultant in
Gynaecology in private practice at the BUPA
Hospital, Leeds,
a post he had held since 1981. Among
other things he had contributed chapters to a series of textbooks and published
widely in peer-reviewed journals, particularly in relation to urogynaecology. In clinical practice between a third and a
half of his time was spent specifically on urogynaecology. He had over the years performed surgery for
GSI, including several hundred colposuspensions. It was part of his role as a consultant
gynaecologist to train doctors in the performance of surgical incontinence
techniques. He was on the Council and
one of the committees of the Medical Defence Union and had lectured at various
legal meetings. He was involved in
medico-legal work for both claimants (62%) and defendants (37%) and also
accepted joint instructions (1%).
[81] Mr Jarvis had prepared a report dated 23 February 2005 (7/10 of process) on
the pursuer's case. Since writing his report he had seen Dr Brown's report
and been provided with information about the factual evidence given by Dr Lingam,
Dr Hassan and Dr Urquhart. The
information set out in the report about the pursuer's medical history and the
operation was taken from the hospital records. On the basis of the haemoglobin levels noted
he thought that the blood loss was in the region of 3.5 litres. He thought that an estimate of 7 litres
was an over-estimate of blood loss, but whether the blood loss was 3.5 or 4.5 litres
it was still a very, very significant blood loss and he was not in any way
underestimating it: it was mandatory
that it be staunched. If it had not been
staunched the pursuer would probably have died.
[82] Mr Jarvis had not previously seen the curriculum vitae of Dr Lingam (7/4 of process), but was shown
it when giving evidence. When he wrote
his report he was not aware of the particular pattern of her experience. He thought he had previously seen Dr Hassan's
curriculum vitae (7/1 of process). From the theatre logs (7/5 of process) he
thought there was no doubt about his ability to supervise a training surgeon
doing a colposuspension: he appeared to
have carried a rather formidable percentage of the hospital's workload for that
type of surgery. In giving his opinion
at para 13 of his report he stated that there was a significant blood loss
as a complication of the procedure and he had no reason to change that view. The blood loss was significantly greater than
one would normally encounter at the procedure and the vast majority of patients
who underwent colposuspension did not require any transfusion.
[83] Mr Jarvis stated that in his practice he still performed
Burch colposuspensions, but fewer than a small number of years ago because of
the increasing popularity of the operation known as the TVT (tension free
vaginal tape procedure). He did not
think that his colposuspension was either a Burch or a Tanagho: he did it with two non-absorbable sutures
placed on either side of the proximal urethra and the bladder neck in order to
produce a non-compressible platform. He
placed one of the two sutures at a level of where the urethra and bladder
joined the bladder neck and the second suture slightly further down towards the
patient's legs alongside the proximal urethra: in terms of how close the sutures were to the
urethra, he placed them at a position where they would not cut through the
urethra but would take a satisfactory bite of the vagina in a place where he
had already judged that the vagina could be elevated. Judging where the vagina could be elevated was
important. Some surgeons put a finger in
the vagina to elevate it, but he did not do that: he had an assistant place a tightly wrapped
swab on the end of a sterile instrument into the vagina, directed the
assistant's hand to make the swab elevate the vagina and then placed his suture
into an elevated part of the vagina without suturing the swab into the vagina. It accorded with his understanding of the
Tanagho modification that the surgeon would try to put the second vaginal
suture as far laterally as possible in the vaginal wall. He personally did not try to place the suture
as far laterally as he could: he
consciously attempted to place the suture in the vagina in a place which would
give him the elevation which he required. He could think of times when the suture was in
a fairly lateral position. As long as
the suture was placed in the vagina there were no specific risks attached to
placing it in that extreme lateral position. He then placed the lateral bite of the suture
anywhere along the ileopectineal line that he believed would result in
satisfactory elevation, ensuring that he did not catch one of the many tiny
blood vessels that were present on the ileopectineal line: he did not have a specific place that he aimed
for, and there was no specific place on the ileopectineal ligament that he
tried to avoid. As a generalisation
ligaments had very little in terms of blood supply and there were frequently
tiny (1, 2 or 3 mm) thin walled vessels on the surface of the
ileopectineal ligament. Catching them
was a nuisance more than a problem because the bleeding was slight and would
stop either with time or with pressure or with diathermy or by inserting a
figure-of-eight suture around the bleeding point. It was not a problematical bleed and would
certainly not be a bleed that would give the sort of problems which the pursuer
suffered, by which he meant the very dramatic loss of blood that she had. He himself had experience of inserting a
suture in the ileopectineal ligament and producing a bleed, perhaps in 10% of
patients, but he did not recall ever having caused a significant bleed at that
point of the procedure. He recalled
having to put in a figure-of-eight suture to stop the bleeding in
certainly no more than half and perhaps less than half of that 10%. It would not be the first manoeuvre that he
would perform: he would first of all use
pressure and then diathermy.
[84] Considering para 17 of his report dealing with haemorrhage
as a complication of colposuspension, he explained that he was talking about
haemorrhage from any point in the operation and trying to observe from the
literature the different ways that one might be able to quantify haemorrhage. He was able to find from the literature a
range of blood loss associated with colposuspension. There was a paucity of scientifically valid
studies in the form of prospective controlled studies. At para 17 he stated:
"Haemorrhage
sufficient to require blood transfusion occurs in probably less than 5% of
women undergoing colposuspension but significant haemorrhage resulting in the
need for further surgery is recorded in 6% of patients undergoing this
procedure (Stanton and Cardozo, 1979, British Journal of Obstetrics and
Gynaecology, 86, 693-7). A further study
shows that 1 woman in 45 who underwent a colposuspension had an
intra-operative blood loss of greater than 1 litre (Alcalay, 1995, British
Journal of Obstetrics and Gynaecology, 102, 740-5)."
It was his position that the
literature supported the above figures.
[85] In relation to the pursuer's more serious haemorrhage, the
source of that bleed had been identified as a medial branch of the internal
iliac artery. He had seen Dr Lingam's
paper (7/9 of process) about this haemorrhage. He was not able to identify from Figure 1
in that article where the artery would be when it began to bleed. It was likely that the vessel concerned was
not a named vessel and he could only presume where it was. The fact that it was a branch of the internal
iliac artery would mean that it was in the pelvis. It was medial to the pelvic side wall, but
that did not go far in identifying the exact point of damage. He suspected that it was a blood vessel which
was coursing through muscular tissue in the pelvis, either muscle overlying the
pelvic side wall or muscle on the floor of the pelvis. The bleeding was not from the ileopectineal
vessels. On first reading the papers he
had thought that it was probably the obturator artery that was involved, but he
had to exclude that as the bleeding continued after the surgeons had secured
the obturator artery. He did not believe
it could be any remnant of the uterine artery because the pursuer had
previously had an abdominal hysterectomy, but it was possible that it was a
vessel which happened to be very close to where the uterine artery was. It could have been a new blood vessel as part
of the healing process post-hysterectomy, but it was his belief that it was a
branch of the internal iliac artery that had always been there and happened to
arise from the internal iliac artery at a point close to where the uterine
artery used to arise.
[86] At paras 19 and 20 of his report (cited above) he dealt
with Dr Lingam's experience. The
more senior trainees who used to be with him in Leeds were almost all fifth year
trainees, people who were within 12 months of being considered as
appropriately trained for consultant practice, and they would perform under
supervision a lot of the surgery, including colposuspension, on patients under
his care. Senior trainees had to operate
in order to obtain the necessary practical skill: there always had to be a
first time for any surgeon with any operation. When he wrote his report he did not
specifically know if Dr Lingam had ever previously performed a
colposuspension as a lead surgeon. He
knew that she had a specific interest in urogynaecology and that she was a
final year trainee, and since colposuspension was then the commonest procedure
performed, he made the assumption that she had performed colposuspensions as
lead surgeon. He thought he also had the
report of Dr Carty describing her as an experienced gynaecological
surgeon. He also made the assumption
that she must necessarily have observed colposuspensions. When he said in his report that, as a general
principle, Dr Lingam was a wholly appropriate person to perform the
operation he meant that a senior registrar with a specific interest in
urogynaecology in the last year of training was a totally appropriate person to
perform the operation. So far as the
operation itself was concerned, colposuspension could be a technically
challenging procedure in patients undergoing a repeat colposuspension, and
although the pursuer had undergone previous surgery through the abdominal wall
and into the pelvis, the operative area of colposuspension, namely, the
retropubic space, was not an area in which there had been previous surgery: it was a matter of knowing the anatomy and
performing the dissection, and if the surgeon knew the anatomy and performed
the dissection along certain principles it was not a particularly difficult
procedure to perform. Gynaecologists in
training were expected to be able to perform a wide range of surgery and
colposuspension, before the mushrooming of TNT, was the commonest procedure
performed for GSI.
[87] Having received further information about Dr Lingam's
experience in colposuspension since he wrote his report, he wished to add the
qualification that he was concerned that, although she had performed a
reasonable number of colposuspensions in the past, she had performed only two
in the recent past, one of which was on the same morning, and he did not think
that performing two colposuspensions over a period of several years meant
someone could be described as having a particular interest in urogynaecology. Had he been the more senior surgeon present
with her he would not have had her performing all of the procedure: each of them would have performed half of the
procedure. He would have performed the
procedure on one half of the pelvis and she, under his supervision, would have
performed the procedure on the other half of the pelvis. There was nothing unique in the way he
practised and he was sure that was how many others would train or refresh
surgeons in the procedure of colposuspension. If he had not personally known her experience
he would have made enquiries of her before the operation about her experience
in colposuspension. When he first met
his senior trainees he asked them to bring him up to date on their surgical
experience and if there was any particular surgical procedure that they wished
to learn while with him, so he thought he would have known Dr Lingam's
experience before the operation began. He
would not have begun the operation without knowing what her experience in
colposuspension was. If he had had no
concerns about how she performed in the first colposuspension of the day it was
at least possible that he would have let her do the second operation as lead
surgeon under his supervision.
[88] So far as obesity was concerned, there was nothing special
about colposuspension in contrast to other procedures which involved incising
through the abdominal wall. Obesity gave
rise to increased risks for the patient in relation to both the anaesthetic and
the surgery. The first problem was
getting through the initial fatty layer below the abdominal wall because it was
particularly vascular. It could be time
consuming and a little frustrating trying to ensure that the fatty layer had
stopped bleeding before proceeding deeper. The second problem was potential difficulty of
access. Sometimes a long instrument had
to be used and he felt he was less in control with it than he was with the
instrument he normally used. This was
not generally a problem unless the patient was grossly obese. The majority of the patients upon whom he
performed colposuspensions were overweight and perhaps about 10% were obese. He believed that the pursuer's BMI of 34 made
her fall into the obese category. A
final year trainee within a year of the potential of being in independent
practice should be able to operate upon obese women. Dr Lingam had to get the experience of
operating on obese women in different procedures. The pursuer had had three previous operations
through either the same or comparable incisions and he did not believe that
that would have added to the difficulties of the colposuspension, although it
might cause the surgeon to take slightly longer in reaching the operation site.
[89] In para 21 of his report he dealt with the question of the
surgical technique. He understood there
to have been two separate sources of two distinct bleeds. So far as the suggested cause of the first
bleed was concerned (Dr Lingam missing the ileopectineal ligament and
putting her suture into a vascular area of the pelvic wall, thereby causing
damage to a blood vessel situated there), it made sense as a theoretical
possibility but not as a surgical event. The whole principle of the operation was that
the lateral ends of the sutures were placed into the ileopectineal line. Accordingly, if Dr Lingam placed these
sutures into an area of fatty tissue lateral to the ileopectineal line, she did
not understand the principle of colposuspension, as opposed to having the
technical ability to perform the procedure, which seemed to him highly
improbable in a final year trainee who had performed or observed 30 colposuspensions.
Secondly, she was being supervised by a
doctor who probably performed more of the surgery for GSI in the hospital than
any other doctor, and he would surely have noted, in the course of either the
earlier operation or that on the pursuer, that her practice was to use, not the
ileopectineal line, but somewhere else. He did not really understand how that could
logically be the site where she put the sutures. If she had been trying to put her suture into
the ileopectineal line but missed it and put it into the pelvic wall in error
there were three points to be made. First, the ileopectineal line was about five centimetres
in length and so a pretty big target to miss totally. Secondly, Dr Hassan would surely have
noticed that she was trying to suture the wrong tissue. Thirdly, according to the operation note the
sutures were tied and a platform of tissue obtained and then the sutures had to
be cut in order to try to obtain access to the bleeding point. If the surgeon put one end of the suture
through a piece of fat instead of the ligament and then tried to tie and
elevate a platform of tissue, the suture would simply cut out of the fat and
there would not be a suture there to take down to try to find the bleeding
point. The ileopectineal ligament, which
was adherent to bone and a very nice piece of tissue, was used because it was a
firm anchor for the suture: the fat pad
had no tension and would be wholly useless as an anchor: on being tightened the suture would just cut
through the fat and there would be no suture to cut later on. The ileopectineal ligament was very
distinctive because it was almost white: fat was yellow, muscular tissue was varying
shades of red and muscle often had over it a thin layer of fascia which was
white and then dulled down the redness of the muscle, but it was still a
reddy-brown colour. He had great
difficulty in understanding how any surgeon could mistake a piece of fat for
the ileopectineal ligament. If the bleed
was from a vessel in the fatty pad and the ileopectineal ligament was sutured, then
that suturing ought to have no effect whatsoever on staunching the bleeding. In relation to the major bleed, so far as
concerned the suggestion that Dr Lingam, in looking to place her second
vaginal wall stitch as laterally as she could, might have gathered up in her
suture some adjacent tissue containing the vessel that was damaged, that had to
be a possibility. There was connective
tissue at the lateral end of the vagina through which there must be vessels
running. It was possible that the branch
of the internal iliac artery that was damaged could have been in that region in
that the blood supply to the upper half of the vagina arose at least in part
from a branch of what was previously the uterine artery, which traced back to
the internal iliac artery, so pre-hysterectomy some of the blood supply would
have been through a branch of the internal iliac artery: some of the smaller vessels that remained
might be branches of the internal iliac artery or of the pudenda artery.
[90] In order to put a stitch in the vaginal wall blunt dissection
had to be carried out to identify the wall and get all the other tissues away
from the vagina itself. There were three
possible ways of identifying the vaginal wall. The first was that the fibres of the vagina ran
very specifically in a longitudinal direction along the long axis of the vagina
and it was the only tissue in that area with fibres running in that direction. The second was that it was a lighter colour
than the surrounding tissues. He himself
would describe it as light pink but was aware that a lot of people described it
as pearly white. The third was either an
instrument or a finger in the vagina: the surgeon inside the pelvis should be able
to feel either the instrument or the finger in the vagina through a relatively
thin area of tissue and he would then positively know that that area of tissue
was the vagina. If Dr Lingam had
her gloved hand inside the vagina and was elevating it she would be feeling her
own finger. Any tissues that might snag
in with the lateral suture on the vaginal wall were not the same colour as the
vagina; they were reddish, reddy-rust, that sort of colour. The surgeon was trying not to catch other
tissue but Mr Jarvis thought that if the surgeon did do so he would be
aware that that had happened: it would
be very difficult for him to fail to notice. If he were supervising a trainee surgeon he
would notice if that had happened and if a complication of the size which
occurred in the pursuer's case happened he would record that within the
operation note. The suture was tied
under tension and if a blood vessel had been caught in it then it was likely
but not certain that the blood vessel would not bleed because it would be
either kinked or occluded, so if that were the site of the blood vessel the
bleeding would probably, but not certainly, cease. If the suggestion were that the piece of
tissue with the artery was caught in the lateral vaginal suture and damaged
when it was tied, he had difficulty visualising that as an explanation for the
bleeding. He did not associate
stretching a blood vessel with it snapping and then haemorrhaging and had not
known of it ever being described. It was
likely that what would happen first to an artery that had been transacted was
that the wall of the vessel would go into spasm (muscle contracting being the
spasm) and there would be relatively little bleeding initially. If the spasm wore off and the vessel had not
clotted then there would be bleeding. He
thought that the interval between the transaction and the bleeding could be
almost any length of time within reason, ranging from a few seconds through to
several minutes. If the vessel were a
vein the bleeding would be immediate because veins cannot go into spasm.
[91] In dealing with the possible explanations put forward for the
two haemorrhages, Mr Jarvis set out his position as follows:
"Well, what's
been put to me have been several different hypotheses and explanations. The lateral pelvic wall fat pad explanation I
don't see of any relevance to this case because of the incredulity that I have
of mistaking fat for the ileopectineal line and nobody noticing. The concept of a blood vessel close to the
lateral wall of the vagina being somehow or other elevated and then snapping,
transecting itself and bleeding, it seems to me to be something that, if it
were possible, ought to happen in various sites in which we operate from time
to time, and I am unaware of such an explanation for any bleeding that I've
ever known, and the concept that a blood vessel was directly damaged with a
needle has to be a theoretical possibility as one of the possible explanations,
but I have not seen such a problem that I'm aware of where the vessel just
disappears out of sight. My difficulty
is that I just don't know exactly how this major haemorrhage occurred. I have difficulty visualising a mechanism
which will explain all the facts that we do know about it."
He explained that he did not really
visualise the concept of a vessel that could be transacted lying free within
the pelvis and then just disappearing freely out of the way. Most arteries could retract, but very little,
because they were not running through a free space. There were some arteries which ran almost
through their own channels, but a branch of the internal iliac artery would not
be such an artery, and he did not see how it could retract more than a matter
of millimetres: he had difficulty with the concept of a vessel which was lying
free transacted and able to retract out of the way.
[92] The pelvic floor was essentially a funnel-shaped muscle which
ran 360 degrees around the pelvis, arising all around the pelvic side wall
and front and back of the bone and meeting in the midline. It supported the organs of the abdomen and
certain structures pierced through it, predominantly the urethra, the vagina
and the bowel. The pelvic floor
essentially surrounded the vagina totally, but there was relatively little of
it in front of the vagina. The wall of
the pelvis was the outermost area to which the pelvic floor was attached and it
therefore surrounded the floor of the pelvis. The pelvic floor and the pelvic wall were
distinct but contiguous structures. He
could visualise Dr Urquhart's description of the bleeding end of the
artery being about 3 cm medial to the bony side wall of the pelvis and
about 4.5 cm from the midline. Those measurements suggested it was not a
vessel on the pelvic side wall itself that was bleeding, a branch of a vessel
on the pelvic side wall: it was not the
internal iliac artery that was bleeding but a branch of it. He believed that the vessel must have
originated on the pelvic side wall but been situated at its point of bleeding
on the pelvic floor. He could say that
it was not on the pelvic side wall because of Dr Urquhart's figures and on
the evidence from the operation note that blood was welling up below the
ileopectineal line he presumed that meant the pelvic floor or perhaps a vessel
just above the pelvic floor. He believed
that there was no connection between the first bleed from the ligament and the
second bleed from the artery: the bleed
from the ligament was a relatively trivial venous bleed, which was not uncommon
on inserting or removing a suture, whereas the bleed from the artery was a
major life-threatening haemorrhage. He
himself had had experience of removing a suture from the ileopectineal ligament
in a minority of cases because he was not happy with its position in terms of
elevation and sometimes it bled and sometimes it did not, but any bleed was very
trivial and easy to manage. At para 23
of his report he had stated that haemorrhage was unfortunately an inherent risk
in any surgical procedure, however careful the surgeon was and however clearly
the anatomy was known and displayed. Surgery
involved the dissection and cutting of tissues, which had a blood supply,
otherwise they would be non-viable, and bleeding of some degree was therefore
an inevitability in surgical procedures. The process of dissection involved tissue
separation, either by sharp dissection using scissors or a knife, or by blunt
dissection using a finger, and during either of these processes blood vessels
might be injured if not first visualised and secured. A small vessel might not be visualised if
covered by the tissue through which the surgeon was dissecting. In colposuspension the surgeon came across
more veins than arteries. The arteries
usually ran through or behind structures. The largest arteries, such as the obturator
artery or the internal iliac artery on the pelvic side wall, had names, but
most of the blood vessels that a surgeon came across were unnamed branches of
named blood vessels. There had to be
arterial blood supply in an operation field. There was a correlation between the size of an
artery and the amount of blood that might be lost from it: survival after bleeding from the aorta, the
largest artery in the body, could be counted in seconds. The internal iliac artery was certainly a
major vessel and the bleeding vessel in this case was certainly significant.
[93] In his report Mr Jarvis had stated that he could not state for
certain why the haemorrhage occurred or which blood vessel bled. Having since been informed of the evidence, he
still did not know the exact blood vessel in that he did not associate it with
a name: he merely visualised it as being
a branch of the internal iliac artery running away from the pelvic side wall
towards the midline of the body and relatively deep down in the pelvis. He could only hypothesise, rather than give a
definitive reason, for the bleeding having occurred. It seemed to him that there were two facts
which had to be explained: the first was
that the bleeding occurred relatively late into the operation, and the second
was that the bleeding came from a vessel relatively deep within the pelvis. He thought that at some stage during the
operation an artery was damaged, that it went into spasm and retracted to some
degree and, as time went on, it relaxed and the major bleeding became apparent.
He did not think that such a vessel
itself would be found on the ileopectineal line. He could only visualise a vessel having been
inadvertently caught by a needle during insertion of sutures on the right, or
perhaps less likely, during the dissection, and that it was not seen to bleed
at the time but commenced bleeding with time as spasm relaxed. The needle catching an artery was a known risk
of the procedure as the needle was very sharp and frequently (as in this case)
J-shaped. Although the surgeon tried to
control exactly where a needle was in the tissues, it was sometimes quite a
difficult manipulation and angulation to make the needle go through the
ileopectineal line. Hypothetically he
could visualise the needle catching underlying muscle which did not require
much to bleed at the time, but an artery within that vessel had been damaged
and subsequently bled. He believed that
could happen despite appropriate care by the surgeon; he believed that such was
an inherent risk of manipulating needles of a non-straight shape within the
pelvis. He thought that when he wrote
his report he had not fully appreciated the timing at which the major bleed
became apparent and, had he done so, he would have said that, while both
scenarios were possible, the needle scenario was much more likely than the
blunt dissection scenario to have caused the major bleed. The damage could have been caused by
attempting to place the suture either into the ileopectineal line or into the
vagina. There was no way of identifying
at what stage in the procedure the damage was caused, save that it was during
the suturing portion of the procedure, putting the two sutures on each side,
which meant four bites of tissue for four placements of the needle on each
side.
[94] In his report, in relation to the two alternatives which he did
identify, he said that he considered very strongly that either of these
explanations were inherent risks within the performance of the operation and
did not indicate care below the standard to be expected simply because such
bleeding occurred. That remained his
view in the event that the cause of the bleeding was the hypothesis advanced by
him. It remained his view, as stated at
para 26 of his report, that significant haemorrhage was an uncommon but
well recognised complication of colposuspension, whether the haemorrhage was
venous or arterial. He believed the
literature was clear and to the effect that between 1% and 5% of patients who
underwent colposuspension had a transfusion. His own experience suggested that it was in
the lower part of that range. He had no
figures on the percentage of patients who had a blood transfusion as large as
the one the pursuer received, namely, seven units of blood. The fact that the vagina had been elevated and
the sutures to the ileopectineal ligament secured tended to suggest that the
incorporation of part of the pelvic floor into the vaginal stitch had not taken
place.
[95] The cross-examination of Mr Jarvis began with the subject
of Dr Lingam's experience of colposuspension. On being advised in full of the details of her
experience, he did not agree that it was sadly lacking but readily acknowledged
that it was relatively limited and less than he had understood it to have been
when he wrote his report. In the five or
six years before her appointment to the Southern General Hospital she had
had limited experience of and exposure to colposuspension. If he had been her supervisor, in her first
colposuspension there she would either have been assisting him in performing
all of it or he would have done half and she would have done half, but he would
not have given her the whole of the procedure to do. He would not have had her being lead surgeon
on the patient before the pursuer. In
relation to the information which ought to have been elicited from her about
her previous experience with colposuspension, he would have commenced a
conversation with a fairly open question asking about her experience of and
exposure to colposuspensions: he thought
recent experience in any surgeon was always very important because surgeons,
like anybody, could become de-skilled. He saw it as being the duty of the supervisor,
before giving her a whole procedure to do as lead surgeon, to satisfy himself
that she had appropriate recent experience with the procedure. He thought it was the duty of the supervisor
to obtain the information from the trainee, not the other way around. Had he known the true position the language
which he used in his report on this subject would not have been as strong as it
was since he then understood that she had greater experience than she had. When he wrote his report he had a report from Dr Lingam
dated 14 October 2002,
which was not a production in the case and he guessed that his knowledge of her
experience came from that document. Her
experience as outlined to him in court was significantly less than he would
have expected from the description of her as a final year trainee with a
special interest in urogynaecology. In
his report he had stated that she was a wholly appropriate surgeon to perform
the procedure, but he would not necessarily say that he would not have used
language of that kind had he been aware of the true position. If he had been Dr Hassan and had watched
her perform the previous colposuspension totally as lead surgeon (whether that
was right or wrong) he would then have made a judgment as to whether or not he
would be content with her performing the next operation with him as an
assistant, and if his conclusion was that she was sufficiently skilled to be
doing this under his supervision, then he would have allowed her to do so. Had he himself been the supervisor on that
day, he would have done the first operation with Dr Lingam assisting him
and they would have operated half each on the pursuer. In his own practice he was very keen to make
trainees progress, but he liked them to progress at a steady rate under his
supervision with minimal risk to patients (surgery not being free of risk, even
when he performed it). In his practice
when he was training a doctor to do colposuspensions he would have had that
doctor do other, simpler procedures, such as hysterectomy, removal of ovarian
cysts and so on, first of all. Trainees
tended to move to more specialist units, such as urogynaecology or
gynaecological cancer, fairly late on in their five year training
programme and they did procedures such as hysterectomies or ovarian cysts when
working in more general units in the earlier part of their training. One took into account a series of factors of
which obesity, with consequent difficulty of surgical access, was one.
[96] Mr Jarvis was taken through the operation note composed by
Dr Lingam. It did not state where
on the ileopectineal ligament the sutures were, but he would not normally have
stated where they were anchored. He would
have stated that the sutures were attached to the perivesical tissues, which
meant the vaginal wall. At para 22
of his report he had assumed that Dr Lingam had placed the vaginal sutures
through the anterior vaginal wall and out of the lateral vaginal wall. Where he placed the second suture depended
upon what elevation looked like after he had approximated his first suture. By "medially" in his report he was referring
to the vaginal bite - then the lateral bite, the ileopectineal bite, was
selected. He had presumed that Dr Lingam
had done something similar to what he would have done as there was nothing in
the operation note to make him think that she had not. He found it more logical to judge the second
suture, having approximated but not tied the first as he knew then how much or
how little he had to achieve with the second suture. He did not have a consistent place for the
second suture because where it was placed depended upon the elevation he had
obtained with the first, but it would be very close in its position to the
first suture. After reading the
transcript of Dr Lingam's evidence, he accepted that she first put two
sutures into the vaginal wall and then two sutures into the ileopectineal
ligament, which was different from the way he did it. When he wrote his report he had assumed that
she had done it the same way as he did. The Tanagho modification involved placing the
sutures as far laterally as possible in the vaginal wall, with the proviso that
the sutures still went through the full thickness of the vaginal wall (6/17 of
process, p 84). His sutures would
be slightly medial to the sutures drawn in figure 5-4.10 of the production. His first pass of the needle was closer to the
urethra than was shown there, but the exit suture was probably in the same
place as shown in the diagram. He had
presumed that Dr Lingam would have taken a full thickness bite of the
vagina; he was not sure he presumed specifically where in the vagina she took
the bites, although, had he made a presumption, he would have presumed that it
was done in a manner comparable to the way in which he did it, because he
thought that was the way in which most surgeons in the UK did it, rather than
the way in which Tanagho did it. At the
time he wrote his report he had not been told what she had actually done. It did not follow that if the suture was put
in the vaginal wall as far laterally as possible that the surgeon also required
to go to a lateral position in the ligament when he came to marry up the suture
in the ligament, because the position he went to in the ligament would have
been determined by two things - (1) where along the length of the vagina the
suture was; and (2) what elevation he
was trying to achieve. How medial or
lateral the suture was in the vagina did not predetermine where it went on the
ileopectineal line. He assumed that she
was not making for any specific area in the ileopectineal line, save that she
was trying to avoid any visible little vessels there and to achieve a
satisfactory elevation. He did not think
that the description of the Tanagho modification stating that the suspending
sutures were attached to Cooper's ligaments, not toward the midline, but
straight above their location within the vaginal wall, was suggesting that the
surgeon seek to match up the suture in the lateral end of the vaginal wall and
the suture in the ligament. He would
have taken that description as meaning that wherever in the vaginal wall, along
the length of the vagina, the suture was placed, the surgeon moved virtually
horizontally across to the ileopectineal line. If it were the position that Dr Lingam
sought to place the sutures in the ligament as far laterally as possible, that
was something of which he was unaware at the time of writing his report. He was not aware that her position was that
she was carrying out the Tanagho modification and placed her sutures in the
vaginal wall as far laterally as possible and matched that up by placing her
sutures in the ligament as far laterally as possible. When giving evidence earlier he was proceeding
on the assumption that she put her vaginal sutures in laterally, but he was
unaware that she always had a specific area of the ileopectineal line that she
would aim for. He had been unaware that
her approach in the vaginal wall had been to place her sutures as far laterally
as possible: he had thought that her aim had been to go into the lateral
portion of the vaginal wall. The words
"as far lateral as possible" brought a risk of going further than the vaginal
wall, but she did not seem to have missed the tissue she was aiming at because
there was elevation in this case. The
ileopectineal ligament was an absolutely obvious structure and he did not see
how a surgeon could misjudge it, whereas he acknowledged that the surgeon could
misjudge the vagina.
[97] Mr Jarvis thought it was coincidence that there had been
bleeding both at the right ileopectineal ligament and to the right side of the
vaginal wall because the right ileopectineal line bleeding was almost certainly
venous as it was very easily stopped, with one suture, he thought. He accepted from the operation note that it
might have been more than one suture, but he still did not believe that the
bleeding was arterial. The surgeon
concerned was the best person to say whether or not it was arterial bleeding,
and if Dr Lingam said it was arterial bleeding, then he had to accept her
word, but he expressed some surprise. He
did not believe that he had ever seen arterial bleeding from the ileopectineal
ligament. There were branches of named
arteries in the general area of the ileopectineal ligament which may run in
more than one direction because of the collateral circulation. If contact was made with an artery in the
course of applying a suture to the ileopectineal ligament that was something he
had not come across and he had difficulty in visualising where the artery was
to work out how it could happen. If a
surgeon was intending to apply a suture to the ileopectineal ligament and
somehow missed it and applied the suture to another structure, then of course
that structure could contain an artery. He could visualise that if a surgeon missed
the ileopectineal ligament totally he could damage an artery, but he did not
visualise how a suture could be covering such a block of tissue that it would
involve the ileopectineal ligament and non-ileopectineal ligament tissue
because when the surgeon put a stitch through the ileopectineal ligament he did
not pick up any other tissue. He could
not contemplate branches or a branch of the inferior epigastria artery being in
the general vicinity of the ileopectineal ligament because the artery was on
the outside of the bone and the ligament on the inside of the bone. He had proceeded on the assumption that the
bleeding in the area of the ligament was venous bleeding of the type that one
expected in a minority of patients in the course of this procedure and that
could be dealt with comfortably. He had
not developed any mental picture of the amount of blood from the ligament bleed
other than that it was not the major component of the pursuer's significant
blood loss. Dr Lingam's evidence
that the bleeding from the ileopectineal line was arterial must imply that at
one point a needle was not in the region of the ileopectineal ligament. If the blood vessel which was caught was there
to be seen, that would be substandard care, but if it was out of sight in a
muscle, that would not be substandard care because when the surgeon took the
bite of tissue with a needle, especially a J-shaped needle, he did not have
perfect control over where the needle point was.
[98] Arterial bleeding had to be part of the overall risk of
bleeding in a colposuspension, albeit not as common as venous bleeding. He believed that the literature referred to
bleeding without being more specific about whether it was venous or arterial. The reference in Hurt's article (6/17 of
process) was to venous bleeding. The
textbook "Surgery of Female Incontinence"
(2000) by Stanton and Tanagho (6/19 of process) referred to venous bleeding. He could not offhand point to any literature
that would support the proposition that arterial bleeding was a recognised
complication of colposuspension, but he could not visualise how all haemorrhage
could be only venous when all tissue had an arterial supply and venous
drainage. Venous bleeding was more of a
problem than arterial bleeding in colposuspension because of the plexus around
the vagina. At para 17 of his
report he referred to the paper by Stanton and Cardozo (6/33 of process) which
mentioned as a possible complication venous haemorrhage requiring laparotomy. He could not say whether the paper by Alcalay
specified venous or arterial haemorrhage. He himself had published in 1994 in the
British Journal of Obstetrics a survey of the literature but did not believe
that he had distinguished between venous and arterial haemorrhage. Arterial haemorrhage was a significant matter
in any operation. He accepted that
between the mid 1970s and shortly after 2000 colposuspension was the commonest
procedure performed in the UK
for GSI, but he would not have expected that in the literature there would
necessarily have been a major distinction made between arterial and venous
haemorrhage. He acknowledged that in
this case the pursuer's life was in danger because of the haemorrhaging and he
was in absolutely no doubt that the interventional radiologist saved her life. He had had two patients who had had major
haemorrhage after colposuspension: one
case was venous, and in the other case it was the view of the vascular surgeon
that it was the obturator artery that was involved, but the patient did not
lose as much blood as the pursuer. He
thought he had performed at least 500 colposuspensions over the years.
[99] Mr Jarvis stated that there was no increased risk if the
surgeon, in going laterally, nevertheless stayed with the vagina and
ileopectineal ligament, but if he went too far laterally and missed the vagina
or ileopectineal ligament, then there was an increased chance of hitting the blood
vessel. As he had said earlier, the
ligament was so visible that he had difficulty in seeing how the reasonably
competent surgeon could miss it. If the
surgeon went through the ileopectineal ligament, then that was not substandard
care: if she missed it, then that was substandard care. If it was an arterial bleed at the area of the
ileopectineal ligament then he believed it was from either muscle which lay
deep to the pelvic floor or the soft tissue lateral to the ligament. In order to make contact with the muscle the
point of the needle would have to penetrate downwards into the muscle during
either the process of inserting the needle through the ileopectineal ligament
or picking it up and out of the ileopectineal ligament. The muscle would be closer to the ligament
towards the front of the pelvis and further away towards the back of the
pelvis, about 3 or 4 mm from the ligament at its closest. He was postulating that a surgeon exercising
ordinary care and skill in putting a suture through the ligament could
nevertheless travel that distance with a J-shaped needle and involve an artery
and a muscle with the suture. The soft
tissue area lateral to the ileopectineal ligament contained veins and arteries.
Almost every vessel within the pelvis
could have its origin traced back to the internal iliac artery as that was the
main artery to supply the pelvis. He
believed that the epigastric artery supplied more superficial tissues, such as
the lower abdominal wall itself, rather than the structures deep within the
pelvis. If a surgeon totally missed the
ileopectineal ligament and inserted a needle lateral to the lateral end of it,
then he could pick up an artery or vein in the area of soft tissue being
described. He was not able to visualise
how the surgeon could take a bite out of the ligament and also make contact
with the arterial supply: the J-shaped
needle was being manipulated in a vertical plane, and that event would require
it to be used in an oblique or horizontal plane.
[100] Mr Jarvis could not visualise how, in putting a suture into
the lateral end of the vaginal wall, Dr Lingam could have made contact
with a medial branch of the internal iliac artery. His understanding was that after hysterectomy
the blood supply to the vagina came exclusively upwards from the vessels below.
Diagram 3.29 on p 200 of
Grant's Anatomy (6/18 of process) showed the vaginal arteries arising, not from
the uterine artery, but from the internal iliac artery itself, and so his
objection based on a blood supply only from below would not be valid. Although it was generally stated that the
vaginal arteries branched from the uterine artery, Grant was an anatomical
expert and his diagram showed vaginal arteries arising as medial branches of
the internal iliac artery, totally missing out the uterine artery, and he was
prepared to proceed on the basis that Grant's anatomy showed the correct
depiction of these vessels. Based on
that anatomical layout, a suture which came out of the lateral vaginal wall
could make contact with a branch of the vaginal artery. He was not sure that he would expect a surgeon
at colposuspension to visualise the vaginal artery or that he had ever done so.
Every exit suture that he put in the
vagina was as lateral as lateral could be within the vagina because it was
coming out of the vagina on the lateral wall: if he placed that suture just a little bit
more lateral he would be out of the vaginal wall. When the exit suture came out of the lateral
wall of the vagina he picked it up with an instrument. If he continued taking the suture without
picking it up and back into his clamp, if he just kept making it move laterally
and went too far, that would be substandard because that was not what the
operation was designed to do: the
operation was designed to pick up the full thickness of the vaginal wall and
pick up the needle once it had pierced out of the vagina. He did not accept that it was a more likely
explanation that Dr Lingam, in inserting that suture, went too far
laterally and made contact with the medial branch of the internal iliac artery
than the pelvic floor explanation which he had suggested. A damaged artery had less strength than an
undamaged one, so Dr Brown's basic hypothesis about what happened was
possible, but he did not see why it should be favoured over his pelvic floor
explanation. He accepted that if Dr Brown's
hypothesis was the correct one there was substandard care at that part of the
operation. If there were two sources of
arterial bleeding, although he could not anatomically explain the connection,
he would be much less comfortable calling it coincidence. When he accounted for the delay in the massive
haemorrhaging by spasm he was thinking of a gap of ten or fifteen minutes. When the damage was caused some blood came
out, and how much was a matter of degree depending on the size of the hole made
with the needle and the rapidity with which spasm occurred. If (as in this case) the vessel was severed he
would expect some blood loss at the time of that occurrence, but how much blood
loss there would be would depend upon how quickly (sic) the vessel went into spasm. He believed that the spasm was a very rapid
physiological response and from his practical experience it happened almost
instantaneously. He was saying that
there would be some blood letting, which would stop very quickly (sic).
[101] At p 15 of his report he put forward two possible causes for
the major haemorrhage. When he wrote his
report he was assuming that the major haemorrhage was from a branch of the
internal iliac artery which had been damaged at some part of the
colposuspension process, but he made no presumption about the part of that
process at which it occurred. When he
said in his report "Alternatively, a needle used in placing a suture into the
ileopectineal line inadvertently caught a blood vessel in the floor of the
operating field, in the underlying muscle, and that bled" he was referring to
the area which was closer to the pelvic floor and that was why he referred to
the ileopectineal line in that sentence. He was also pointing to that area for the
major haemorrhage. If the bleeding was
to the pelvic floor it was many more times likely that it was one of the two
sutures which went through the ileopectineal line, rather than a suture which
came through the lateral wall of the vagina, which caused the damage. The ileopectineal line was the area closest to
the pelvic floor. According to Figure 3.31
at p 202 of Grant's Anatomy the vaginal artery pierced the pelvic
floor but did not run on it. He did not
think it more likely that the damage to the medial branch of the internal iliac
artery was caused at the time of the vaginal suture rather than at the time of
the ileopectineal ligament suture. The
vaginal artery, whether it arose from the internal iliac or the uterine artery,
was always present, yet it was not caught by a surgeon each time sutures were
put through the lateral vaginal wall, if he was doing the job properly. Even doing the job properly he could catch the
vessel in the pelvic floor. He favoured
the latter hypothesis because the suture which came down from the ileopectineal
line would be close to the pelvic floor, especially in the more anterior
position of the ileopectineal line, whereas the vaginal artery was not close to
where the needle was brought out, so he thought that the distance between
catching the vessel in the pelvic floor via the ileopectineal ligament was
shorter than the distance between catching the vaginal vessel from the lateral
vaginal wall. If his hypothesis was correct,
Dr Lingam was not negligent. If the
needle was pulled out too laterally when it came out through the lateral
vaginal wall, she would be negligent. The statement in the operation note "bleeding
from deep pelvis and lateral vaginal fornix" was almost compatible with all
hypothesis: the deep pelvis was more
compatible with his hypothesis and the lateral vaginal fornix more compatible
with that of Dr Brown. The
reference to the lateral fornix took the area away from the ileopectineal line
but the reference to the deep pelvis put it with the pelvic floor. The deep pelvis was inconsistent with the
damage being in the area of the vaginal wall.
[102] The first explanation when he wrote his report related to the
process of dissection and he said he could not choose between the two possible
explanations he was putting forward. He
now chose between them. As the suturing
was closer in time than the dissection it seemed more logical to look at the
suturing than the dissection, which he thought could be discounted. In his report he used the word "inadvertently"
as synonymous with "accidentally", meaning the event was not the intention of
the surgeon. He was also saying that it
was consistent with reasonable care for that to have occurred. He did not know which side Dr Lingam
would do first in the operation. It was
his practice to do the right side first. He stood on the patient's left to operate on
her right side and completely tied up the right side before changing round. He did not make an assumption as to how Dr Lingam
did it and he was not sure that the tying was of relevance in his thinking as
the injury occurred during the suturing side of things. Whether the haemorrhage was four or six litres
did not specifically matter: it was a big haemorrhage.
[103] If Dr Lingam said that she placed her sutures as far
laterally as possible and Dr Hassan thought they were placed in a medial
position, they both could not be correct. He would have expected Dr Hassan to have
been aware where his trainee was placing her sutures, then his level of
supervision fell below the standard to be expected. He agreed that suffered a life-threatening
major haemorrhage due to damage to a medial branch of the internal iliac artery
caused by the operating surgeon and by a suture, or, more precisely, a needle. The damage could not have occurred within the
normal operating field, but being out of the normal operating field may be an
inherent part of surgery. If the surgeon
put the needle through the ileopectineal ligament and out through the vagina
major blood vessels were not, as a rule, caught. If the surgeon's needle caused the damage by
inadvertently catching the pelvic floor, it was outside of the operating filed
but that was not an event that he would criticise. His hypothesis did not amount to negligence on
the part of the surgeon, but that was not why it was his preferred hypothesis: it was because it was a sad fact that no
surgeon could control the point of a needle with absolute accuracy 100% of
the time. He did not feed into any
aspect of his approach to the case the fact that Dr Lingam had no real
experience of colposuspension at the time as, on his hypothesis, experience
would not be a factor, whereas it could be in the competing hypothesis. The fact that there was bleeding from two
distinct areas did not lead him to say that it was therefore more likely that
the care was substandard. He could not
offer a logical connection between the two areas of blood loss, but they were
distinct in the sense that Dr Hassan was able to stop the first blood loss
but not the second. If there were two
areas of arterial damage that did not impact upon his approach to the case. On his hypothesis the major haemorrhaging was
caused by the suture immediately after it had gone through the ligament. He did not know if it was the second suture or
the first. If, as he had originally
thought, the first bleed was venous, he thought it was caused by the suture
going into the veins. The bleeding would
have been immediate and would have continued unless it spontaneously clotted. As no bleeding was noticed in the area of the
ileopectineal line until the suprapubic catheter was inserted that supported
the view that the bleeding was arterial. He thought it improbable that the surgeons had
not noticed it. Since he could not
connect the two episodes of bleeding, the logic had to be that it was two
different manoeuvres at the same part of the procedure in the ileopectineal
line which caused them. He had no way of
knowing if it was the same suture which caused two lots of damage or two
sutures which each caused one lot of damage. He did not associate the ileopectineal line
with arteries or arterial bleeding, so, if he were forced to accept that there
was bleeding from an artery on the ileopectineal line because that was the
evidence of the surgeon, then either there was an artery on the ileopectineal
line or both surgeons had failed to notice that where the lead surgeon was
operating was not on the ileopectineal line. He did not think that the latter was credible,
but he accepted that it would be negligent.
[104] On considering Grant's Anatomy Figure 3.29 Mr Jarvis
explained that the pelvic floor was the area above the pubic bone. The pelvic wall stemmed from the side of that
area and went up the side of the pelvis. The ileopectineal ligament was located in the
pelvic wall. The Figure showed the
location of the internal iliac artery and its branches some way away from the
area of the ligament attached to the wall. Figure 1 in Dr Lingam's article (7/9
of process), which he had not seen before, was a picture showing what the
authors termed was damage to the internal iliac artery. He did not have the expertise to interpret the
picture and say that the area of damage was quite some distance removed from
the pelvic wall. According to the
operation note Dr Carty applied sutures to the base of the bladder and the
vagina: that target was not consistent
with his hypothesis, but Dr Carty's sutures did not stem the bleeding, a
fact which did fit in with his hypothesis. The note went on to record "bleeding welling
up in the pelvic side wall". If Dr Hassan's
description in evidence of the bleeding coming from the pelvic wall were to be
accepted that would effectively mean that his hypothesis would have to be
rejected because it clearly could not have been coming from the pelvic floor. If, as Dr Hassan said, the bleeding was
coming from the urethra, that would take it a long way away from the area of
the ligament, but he thought that that did not make sense because the urethra
was not lateral to the vagina but the vagina was underneath and lateral on both
sides to the urethra. It was not
anatomically possible for the bleeding to come from lateral to the vagina and
from the urethra. In his opinion the best
evidence about where the bleeding was coming from had to be the evidence from
the procedure which stopped the bleeding. The suturing was nothing to do with securing
the bleeding: it was Dr Urquhart
who secured the bleeding. He thought
that was because Dr Hassan and Dr Carty were putting sutures in the
wrong place, rather that because the vessel had retracted and they could not
reach it. Dr Urquhart's evidence
supported his evidence about where the damage was coming from as it was not two
to three centimetres lateral to the vaginal wall or the vaginal wall or the
urethra but further lateral to that point and he believed the vessels in
question to be running through the pelvic floor. He postulated that all the damage occurred
because of the use of the needle at the ileopectineal ligament, although not
necessarily by the same pass of the needle.
Dr Hassan was able to stem the flow from the ileopectineal
ligament. Having read the transcript of Dr Lingam's
evidence, he was not so sure as he had been earlier that the first episode of
bleeding was arterial and he now wished to maintain his position that the first
bleed was venous. There could have been
a delay in the surgeon noticing venous bleeding because it was obscured by the
tying of the suture on the right and initially accumulated out of vision, so
that it came within the vision of the surgeon only when there was a sufficient
volume. Venous bleeding from the
ileopectineal line was not usually a very significant amount of bleeding, but
venous bleeding from the vaginal wall could be very significant. Another possible explanation for the fact that
it was venous bleeding was that the surgeons were not paying attention. In relation to what he had said earlier about
the use of the needle, the surgeon could not hold a J-shaped needle in a needle
holder obliquely and stitch, but it must be theoretically possible that if he
were to turn the needle holder in an oblique way he would get the same result,
an oblique insertion.
[105] In re-examination Mr Jarvis stated that his reading of Dr Lingam's
evidence was that initially her view was that she was uncertain whether the
first bleed was arterial or venous and that she ultimately concluded that it
might well have been arterial. There was
in his view a development of thought going on through her evidence. He was in doubt about whether Dr Lingam
herself was certain in her eventual acceptance that it was an artery. In his evidence Dr Hassan identified a
bleed from the ileopectineal ligament itself. Mr Jarvis had never seen an artery in the
ileopectineal ligament or a diagram suggesting that there was an artery in it,
although he was sure that there were arteries in the underlying bone. If the bleed was from the ligament it was
highly improbable that it was arterial because of the basic anatomical
situation, Dr Hassan's description of a wee slight bleed, which did not
sound like any arterial bleed that he (Mr Jarvis) had ever seen and the
ease with which it was stopped.
[106] Reverting to the question of the vaginal sutures, Mr Jarvis
explained that there was a J-shaped needle attached to suture material held by
an instrument called a needle holder, which he referred to as a clamp. The reason for that was that all needles which
were used internally were too small to be held and controlled by the surgeon's
fingers. The surgeon manipulated the
needle holder, which was about six or seven inches long, to control the
needle. When using a J-shaped needle he
put the clamp on the downward stem of the J. The clamp consisted of two pieces
of metal attached together at a hinge, the hinge being closer to the non-needle
end, and at the non-needle end were two hollow circles through which the
surgeon inserted a finger or thumb in order to control the hinge. The surgeon's grip was similar to the grip on
a pair of scissors. A surgeon placing a
suture in the vaginal wall had to have an entry point and an exit point for his
needle in the course of making that suture. The entry point, as already stated, was the
anterior vaginal wall, meaning the front of the vagina. Usually the needle exited through the lateral
vaginal wall, so that its course was through a 90 degrees arc, the purpose
of which was to obtain a relatively solid piece of tissue to use as the base of
the support of the bladder neck. In
colposuspension the surgeon was always trying to cut through the lateral wall
of the vagina with his needle. Tanagho
advocated a relatively conventional bite for the first vaginal suture but that
the entry point of the second suture in the vagina should always be lateral to
the first, rather than in the same area as the first, but still coming out of
the lateral wall of the vagina. A second
clamp (or some similar instrument) was needed in order to pull the needle right
through out of the lateral wall. Without
such a clamp the needle could project three to five millimetres. If Grant (6/18 of process, p 200, Figure 3.29)
drew the vaginal arteries as coming off the internal iliac artery then he
wholly accepted that that was something which would occur. If the vaginal arteries were from the uterine
artery they would disappear with the hysterectomy. They ran between the lateral vaginal wall and
the pelvic wall and then branched as they approached the vaginal wall with a
view to supplying blood to the vagina. As a general rule the surgeon never saw these
vaginal arteries when doing a colposuspension because they were already in the
process of branching and they entered the vaginal wall in its lateroposterior
quadrant. He believed that if it were
possible to pull the vagina around they could be seen as they were not covered
by tissue. It had been suggested that if
the surgeon pulled the needle much more laterally than would be usual that
could damage the artery, and, while he thought that was theoretically possible,
he did not think it was very likely because there was no particular point in
such a manoeuvre, but, more importantly, the only way of freeing the J-shaped
needle was to pull the blunt base of the J slightly laterally and so the sharp
bit was always pointing back at the vagina, not towards the area where the
vaginal arteries might be. A straight or
curved needle could have done what had been suggested, but he did not see that
a J-shaped needle could have done it. The only way in which he could think of what
had been suggested having been done was if the surgeon did not take the needle
round its curve but just pulled with rather a lot of strength, thus taking out
the needle and a patch of vagina attached to it, but that would be quite a
strong manoeuvre and he could not seriously propose that anybody would do that;
moreover, there was clearly no evidence of a hole being made in the vagina in
this case. He thought it was unlikely
that if damage had been caused to a vaginal artery by a needle the supervising
surgeon would not notice: the action
that would be required by the lead surgeon would be so odd that a supervising
surgeon ought to see that action and the damage would result in some blood loss
prior to spasm and retraction. If a
vaginal artery were severed it was capable of bleeding from both ends. In this case Dr Urquhart located one end
of the bleeding artery. There were two reasons
for the inability of two surgeons to see that severed vessel: first, the limited visualisation because of
the pool of blood in which the surgeon was trying to operate, and, secondly,
retraction of the artery by contraction of the muscle within its wall. The severed ends of a vaginal artery would
retract a distance backwards along the course of the artery. If the severed end of the vaginal portion was
still able to obtain blood from below, it would remain as viable muscle within
the wall of the artery and could contract towards the vagina. The other end of the severed artery would
retract backwards towards its origin, in the direction of, but not as far as,
the pelvic side wall. Dr Urquhart
did not block an artery where blood was coming upwards or laterally, so the
hypothesis that the cut vessel was a vaginal artery with its collateral circulation
would not totally fit with his actions. His action would have stopped the bleeding
from only one end, namely, the lateral end coming from the pelvic side wall
towards the vagina: it would not have
stopped the bleeding coming from below upwards. If the bleeding point was about 3 centimetres
from the pelvic side wall and about 4.5 centimetres from the vaginal
midline then it was really quite a way lateral from the vaginal fornix, about
3.5 centimetres. In the context of
a colposuspension 3.5 centimetres lateral from the edge of the vaginal
wall would be a very long way for the surgeon to go adrift and it was not the
sort of distance that he would expect a supervising surgeon to miss. He would expect the supervising surgeon to
intervene by either the use of words or by placing a hand on the trainee's
operating hand.
[107] Returning to his own hypothesis of bleeding from a vessel buried
in the pelvic floor, he thought that when Dr Hassan referred to trying to
put stitches in the deep pelvis he meant the pelvic floor or towards the pelvic
floor, as opposed to the vaginal fornix, which was not the pelvis. The risk of catching an artery contained
within muscle was not unique to colposuspension: it was a complication of all surgery which was
not surface surgery (surgery on the skin). He was sure that every surgeon understood that
that risk existed. He expected that in
the literature there would be some estimate of the frequency of significant haemorrhage,
but he did not expect it to be specific about whether it was arterial or
venous. He did not implicate the
pursuer's previous hysterectomy, her BMI of 34 or Dr Lingam's lack of
experience in causing her major bleed.
The applicable law
[108] It was accepted that the test
which fell to be applied to determine whether there had been medical negligence
was that laid down by Lord President Clyde in the well known case of Hunter v Hanley 1955 SC 200,
namely, that the pursuer had to prove that the doctor in question was guilty of
such failure as no doctor of ordinary skill would be guilty of if acting with
ordinary care. In order to establish
liability where it is alleged that there has been a deviation from normal
medical practice the pursuer must prove (i) that there was a usual and normal practice;
(ii) that the doctor had not adopted
that practice; and (iii) that the course
which the doctor adopted was one which no professional man of ordinary skill
would have taken if he had been acting with ordinary care (per Lord President Clyde
at p 206 in Hunter; Maynard v West Midlands Regional Health Authority [1984]
1 WLR 634; Sidaway v Governors of Bethlem Royal Hospital [1985]
AC 871; and Bolitho v City and Hackney Health Authority [1998]
AC 232). Expert evidence falls to
be tested according to the criteria in Bolitho.
It follows from the second leg of the
test in Hunter that where there are
competing bodies of medical opinion in relation to matters of medical or
surgical practice it is not for the court to prefer one to the other. The law is summarised by Lord Hodge in Honisz v Lothian Health Board [2006] CSOH 24.
[109] The fact that Dr Lingam was a surgeon in training and the
fact, according to the pursuer, she lacked relevant recent experience, were not
relevant in applying the test. The
standard of care expected of an inexperienced doctor learning a surgical
procedure is the same as that of an experienced doctor of her grade. To that extent the standard of care expected
is objective: Wilsher v Essex Area Health Authority [1987] 1 QB 730
per Mustill LJ at pp 750E-751D and Glidewell LJ at p 774A-E.
Although the decision of the Court of
Appeal in that case was reversed by the House of Lords no criticism was made of
the approach taken by the Court of Appeal to the test to be applied.
[110] It was submitted on behalf of the pursuer that if the court
accepted Mr Jarvis's hypothesis or was unable to make a finding about the
manner in which the arterial damage was caused a prima facie inference of negligence had in any event been raised
which the defenders had failed to rebut. Cases such as Ratcliffe v Plymouth &
Torbay Health Authority 1998 Ll L R (Med) 162, Bovenzi v Kettering Health Authority [1991] 2 Med LR 293 and Hendy v Milton Keynes Health Authority (No 2) [1992] 3 Med LR 119
supported the proposition that if an occurrence was not a known complication of
a medical procedure or was so rare, that itself could support an inference of
negligence. If the court were to accept
that arterial damage was not a known complication of colposuspension and should
not occur in the exercise of reasonable care, it was submitted for the pursuer
that the defenders had failed to rebut the inference that reasonable care was
not exercised. In any event, even if it
was not possible to go that far, it was submitted that because of the rarity of
such an occurrence, the chances of an innocent explanation became very slight
and the burden on the pursuer was more easily discharged (Brooke LJ in Ratcliffe).
Discussion and conclusions
[111] The following points were
made on behalf of the pursuer in an effort to focus on the critical issues. First, there was no dispute that the second
and significant source of blood loss was from a branch of the internal iliac
artery. Secondly, in light of the
evidence of Dr Brown and Mr Jarvis, there were two live hypotheses as
to how the damage occurred. According to
Dr Brown it occurred when Dr Lingam moved out of the operating field
to some extent while applying sutures to the vaginal wall. Mr Jarvis's final position was that it
occurred when a suture was being applied to the ileopectineal ligament and the
needle penetrated a muscle in the pelvic floor and damaged an artery. That explanation was not focussed by the
defenders n Record and the explanations put forward by the defenders at p 17D-E
of the Record had not been supported by expert testimony. Thirdly, Mr Jarvis accepted in his
evidence that for the surgeon to move outwith the operating field while
applying sutures to the vaginal wall and so to damage the artery would be
negligent: it followed that if it were
to be found that the damage had been so caused there was no dispute between the
expert witnesses that that would constitute negligence.
[112] The submission for the pursuer was that she had proved that the
massive haemorrhage had occurred because Dr Lingam moved outwith the
operating field when applying the second suture and in so doing caused the
damage to a branch of the internal iliac artery. If that were so then, in light of the evidence
of Dr Brown and Mr Jarvis, that she fell below the standard of care
to be expected of the reasonably competent senior registrar.
[113] It was further submitted for the pursuer that Dr Lingam
lacked the necessary recent experience to carry out the colposuspension
operation on the pursuer as lead surgeon. Although Mr Jarvis had in his report
(7/10 of process) supported Dr Lingam in carrying out the operation as
lead surgeon, it was clear after his evidence that he had been under a
misapprehension about the nature and extent of her experience in
colposuspension. The fact that she
lacked the necessary experience might not in itself mean that there had been
negligence in the way in which the operation had been conducted, but it was a
relevant consideration to have in mind when deciding what inferences could be
drawn from the problems that occurred in the course of the operation.
[114] There was no dispute between the experts that Dr Hassan had
a duty to supervise Dr Lingam and it was submitted for the pursuer that he
had failed in that duty in two respects. First, he had failed to investigate with her
the extent of her experience. Secondly,
he had failed to supervise her adequately during the operation. It was contended for the pursuer that a
combination of inexperience and lack of supervision had conspired to create a
situation of unnecessary risk for her.
[115] The submission for the defenders was that the cause of the major
haemorrhage was a suture needle snagging an artery in the pelvic floor and
that, as any surgeon, however careful, could catch a blood vessel on the pelvic
floor during colposuspension, this did not amount to negligence on the part of Dr Lingam.
Dr Lingam was sufficiently experienced to undertake the operation on the
pursuer as lead surgeon if she was supervised by Dr Hassan. Dr Hassan
was not negligent in allowing Dr Lingam to perform the operation as lead
surgeon under his supervision. There was
no reason to conclude that the massive haemorrhage suffered by the pursuer was
caused by any inexperience on the part of Dr Lingam. If the court accepted the cause of the major
haemorrhage which the defenders suggested, there was no negligence on the part
of Dr Lingam or her supervisor Dr Hassan and, in any event, even if
there was negligence on the part of Dr Lingam, there was no evidence that
this was a matter which her supervisor (a) could have seen was about to happen; or (b) could have seen had happened.
[116] I now turn to consider each of the alleged heads of negligence.
(i)
Dr Hassan's allowing Dr Lingam to perform the colposuspension
[117] I have set above at para 6 Dr Lingam's experience in
colposuspension before she performed as lead surgeon under the supervision of Dr Hassan
the operation on the pursuer. Both Dr Brown
and Mr Jarvis agreed that there was a duty on Dr Hassan to have
questioned Dr Lingam on her previous experience, in particular in carrying
out colposuspensions, and that he failed in that duty. Dr Hassan in his evidence in effect
accepted that he carried out an inadequate inquiry. According to him, he asked her what
colposuspension operations she had done and she said that she was interested in
urogynaecology, she had worked in the Urology Department and did
colposuspension operations. He did not
think that she gave any indication as to how many colposuspensions she had
previously done, and indeed it was his view that it was not relevant for him to
know how many she had done "because once she said she had done and she's
competent, I just take her word". He was
under the impression that she had done colposuspensions at the Royal Infirmary
before coming to the Southern General Hospital and he thought "if we've got
somebody who's a senior registrar who's interested in gynaecology and doing a
urogynaecology job in a Urology Department, I'd be satisfied with that if she
told me that". He accepted that he did
not know when she was working at the Royal Infirmary or for how long she had
worked there. He then said that he
"asked her just before coming to us, so she came straight to the Royal from us,
so these are recent experience" (sic).
[118] It is in my opinion quite clear from the evidence that, before he
allowed Dr Lingam to operate on the pursuer (and also on the patient
before her) Dr Hassan had no clear idea about the nature of her experience
in doing colposuspensions and how recent it was. He did not know how many colposuspensions she
had carried out as lead surgeon and when she had done them. It was accepted on behalf of the pursuer that
he might have been to some extent misled by what Dr Lingam told him, but
submitted that he did not go far enough to satisfy himself about the extent of
her recent experience. I accept that
that is the case. At one stage in his
evidence Dr Hassan went as far as to say "I expect her to be a skilled
surgeon, otherwise she wouldn't be a senior registrar". In my view that reply shows that he made an
unfounded assumption about her experience and surgical ability. When Dr Lingam's actual experience was
put to Dr Hassan he expressed the view that if in the previous five to six years
she had done only one colposuspension as lead surgeon that might suggest that
she lacked recent experience but did not mean that she would not be able to do
the procedure and he would not allow someone with that experience to do the
operation on her own with a junior person, only if a senior person would be
with her in theatre. It was his view
that it was appropriate that she should act as lead surgeon, but only with a
more senior assistant.
[119] The evidence of Dr Brown was that Dr Hassan was not
entitled to accept at face value Dr Lingam's statement that she was
experienced: it was his opinion that he
required to ask her questions about her colposuspension experience, when she
had done colposuspensions, how many she had done, where she had done them, and
what was her past and recent experience. In his view the detail of her experience could
not be taken for granted. Dr Brown's
interpretation of Dr Hassan's evidence was that Dr Hassan had been
acting under a misapprehension about her experience and had assumed that
because she was a fifth year trainee she had up to date experience. When Mr Jarvis wrote his report he
stated that Dr Lingam was a wholly appropriate surgeon to perform the
procedure but when he expressed that opinion he was proceeding on the basis of
a report from her dated 14 October 2002.
I do not know what the precise contents
of that report were, but it appears from the evidence of Mr Jarvis that it
did not disclose the details of Dr Lingam's experience as spoken to by her
in evidence. It was the position of Mr Jarvis
that when he wrote his report he understood that Dr Lingam had greater
experience than she had. He considered
it to be the duty of the supervisor, before giving Dr Lingam a whole
procedure to do as lead surgeon, to satisfy himself that she had appropriate
recent experience with the procedure. His evidence on this point is set out in full
at para XX above. In my opinion the
burden of that evidence is that, had he been the supervisor and known the true
position about Dr Lingam's experience he would not have allowed her to
carry out as lead surgeon the operations on the pursuer and the previous
patient.
[120] In light of the evidence of Dr Lingam, Dr Hassan, Dr Brown
and Mr Jarvis on this point, I am satisfied that Dr Hassan, before
allowing Dr Lingam to carry out as lead surgeon the colposupension on the
pursuer was under a duty to satisfy himself by appropriate inquiry that she had
sufficient recent experience of the procedure and that he failed in that duty
and was therefore medically negligent to that extent. That failure in duty by Dr Hassan did
not, of course, cause the pursuer's injury but it is clearly a relevant
background against which to consider the events which occurred at the
operation. The same comment applies to
the substantive fact that Dr Lingam lacked the required recent experience
to act as lead surgeon.
(ii)
The performance of the colposuspension by Dr Lingam
[121] The central question which I have to determine is whether Dr Lingam
was professionally negligent in her performance of the colposuspension. There were, as mentioned above, two separate
sources of bleeding noticed in the course of the operation. It does not, of course, necessarily follow
that the first bleed to have been noticed was the first which occurred. It is not suggested that the first source,
which was associated with the ileopectineal ligament, caused or contributed to
the neurological injury suffered by the pursuer for which she seeks damages and
its relevance is therefore limited. The
point made on behalf of the pursuer was that the fact that it occurred could
assist in relation to the expertise displayed by Dr Lingam in the course
of the operation, particularly if the source was arterial.
[122] It was Dr Lingam's evidence that the procedure which she
undertook was not a Burch colposuspension but the Tanagho modification, which
to her meant that a different number of sutures were used in different
positions from the Burch method. She
described the procedure in full in her evidence. She explained that her first suture to the
vagina would be slightly medial, just lateral to the urethra in order to
support the bladder neck and that the second stitching must be as lateral as
possible to support the proximal urethra without obstructing it. In applying her sutures to the vagina she
would not pick up or use the paraurethral tissue and she would place two
sutures on each side, one medial and the other as lateral as possible. She said that she placed her lateral suture in
the vaginal wall and the position of her suture in the ileopectineal ligament
was largely determined by the position of the vaginal suture below it. She was aware that if she went too laterally
on the ligament damage could be caused to blood vessels running down the side
of the pelvic wall and that this risk was avoided by visualisation of the
ligament and the pelvic wall. Dr Hassan's
evidence was that he saw Dr Lingam place two sutures in the right wall of
the vagina and he had then no concern that there were in any way being placed
inappropriately. There was no immediate
bleeding when they were placed and no other sign that any damage had been
caused. He saw Dr Lingam insert the
sutures in the ileopectineal ligament and had no concern that those sutures
were in any way being placed inappropriately. There was no immediate bleeding from the
ileopectineal ligament and no sign of any other damage to it. There was no sign of bleeding when the vagina
was elevated and the sutures tied or during the removal of the Foley catheter
and the placement of the suprapubic catheter, a process which usually took
between 10 and 15 minutes. It was
only after the suprapubic catheter was inserted and it was being checked that
it was safe to close the abdomen that bleeding was noticed. It appeared initially to be a little bleeding
from the right side, more significant than the bleeding normally seen. It then came up out of the abdomen into the
wound, overflowing the pelvis. He took
over and cut the stitches but blood was still welling up out of the pelvis into
the abdominal wound. Suction was applied
and swabs used to see if the bleeding could be controlled. He saw bleeding in the ileopectineal ligament,
which he described as "wee slight bleeding from there", put a stitch on it and
the bleeding stopped altogether. He said
he thought this bleed most probably occurred because the needle went through
the ligament and must have pierced a vessel. He could not see any vessel in the ligament
and usually there were no blood vessels there. In his view Dr Lingam had not gone too
far laterally and had been in the medial part of the ligament.
[123] Dr Lingam accepted that the initial source of blood loss was
active blood loss which was not normal and, at least at one stage in her
evidence, that it was arterial. According to the operation note that blood
loss was stemmed by the application of sutures by Dr Hassan and according
to Dr Hassan himself only one suture had to be applied.
[124] It was Dr Brown's view that the source of this first bleed
was arterial and that the bleed had been caused because Dr Lingam had gone
too far laterally when placing the second suture and so damaged a branch of the
inferior epigastric artery. He suggested
that Dr Lingam's attempt to insert a suture in the right ileopectineal
ligament failed so that she missed the ligament completely and that she
inserted the suture into a fatty pad of tissue or onto the pelvic side wall,
both of which structures might incorporate blood vessels. Mr Jarvis, having read Dr Lingam's
evidence (in which she clearly vacillated about whether the first bleed was
venous or arterial) expressed the view that it was venous. There would be no delay in a venous bleed
appearing.
[125] Dr Brown's view on this point was subjected to strong
criticism on behalf of the defenders. It
was submitted that the factual basis for his view was clear, that his view did
not meet the evidence given and that to accept it would involve rejection of
the evidence given by Dr Lingam and Dr Hassan regarding a matter upon
which they were not challenged. It was
at best an inference or hypothesis seeking to explain the presence of blood on,
but not coming from, the ileopectineal ligament and assumed significant, rather
than merely trivial or incidental, blood loss. It did not explain why a suture or sutures
placed by Dr Hassan in the ileopectineal ligament stopped the bleed. Dr Hassan attached no particular
significance to this bleed, which he said he stopped easily. It had not been suggested to Dr Hassan
that he had sutured a vessel in the fatty pad or pelvic side wall to stop the
bleed: he said that the blood was coming
from, and that he sutured, the ligament. As Dr Hassan's suture or sutures to the
ligament stopped the bleed, the natural inference was that the bleeding vessel
was associated with the ligament itself. The evidence of Mr Jarvis was that
bleeding from the ligament requiring suturing occurred in 5% of
colposuspensions and that it was normal and not problematic. Dr Brown accepted that his view could not
be correct if the blood was coming from the ligament and that it could not
explain why Dr Hassan would be able to stop the bleeding by suturing the
ligament. In any event, according to Mr Jarvis
the view of Dr Brown contained an internal inconsistency. The evidence of Dr Lingam and Dr Hassan
was that the sutures were tied without problem, thereby elevating the vagina in
the desired manner, and that they remained tied until cut down by Dr Hassan
to facilitate investigation of the haemorrhage. Dr Brown's mechanism required that during
the tying of the right lateral suture sufficient force was applied to the
artery to tear it. That in turn meant
that the two ends of the suture must have been sufficiently anchored so that
the artery was, in effect, the weakest point, but missing the ileopectineal
ligament and suturing through a fatty pad or into the pelvic wall would not
have provided a secure anchor because when the surgeon tried to tie the suture
it would cut out of the tissue. Dr Brown's
view could therefore not explain how the suture could be tied or be effective
in elevating the vagina. It was
inherently unlikely that Dr Lingam missed the ileopectineal ligament with
the right lateral suture because (a) the
principle underlying colposuspension, and common to its variants, was elevation
of the vagina and its attachment to the ileopectineal ligament; (b) Dr Lingam had experience of the
procedure, albeit little recent experience; (c) Dr Hassan was an experienced trainer in
the procedure and was watching where Dr Lingam was placing the sutures;
(d) the ileopectineal ligament was
distinct in appearance from fat and from the pelvic wall and could not easily
be confused with them; (e) missing the
ileopectineal ligament with the suture ought to have been apparent to both Dr Lingam
and Dr Hassan; and (f) neither Dr Lingam
nor Dr Hassan considered that the suture had been placed other than in the
ligament, although they differed about whether it had been placed laterally or
medially. Accordingly, there was no
reason to conclude that Dr Lingam had missed the ileopectineal ligament
completely and damaged a blood vessel in the fatty pad lateral to the ligament
or in the side wall of the pelvis: the
more likely explanation was that the bleed was merely incidental to Dr Hassan
cutting the sutures to secure a view of the more serious bleeding.
[126] In my opinion there is considerable force in this submission for
the defenders, which is really unanswerable. Having considered the whole evidence on this
point, I find that I am unable to make any finding about whether the source of
this first bleed was venous or arterial. It therefore follows that the pursuer has
failed to establish that it was arterial. The delay in the bleed being noticed points to
its being arterial, but the fact that it was stemmed by the suture or sutures
applied by Dr Hassan points to its being venous. Further, in light of the criticisms of Dr Brown's
view on this point set out in the above submission for the defenders, I do not
accept the evidence of Dr Brown about how this bleed occurred. I am not persuaded that the bleed was merely
incidental upon Dr Hassan cutting the sutures to secure a view of the more
serious bleeding, but I do not require to make any finding about what caused
the bleed. It was for the pursuer to
prove that it was caused in the way suggested by Dr Brown and she has
failed to do so. It follows that I make
no finding of professional negligence against causing Dr Lingam in
relation to this first bleed.
[127] So far as the second bleed, the major haemorrhage, is concerned,
it is agreed in a joint minute that this was from a branch of the internal
iliac artery. The internal iliac artery
is the principal artery supplying blood to the pelvis. It divides into a large number of branches as
it enters the pelvis. These branches may
be found throughout the pelvis. The
source of this haemorrhage could not be identified during the attempts to halt
it in theatre. The only factual evidence
about its source came from the intervention radiologist Dr Urquhart, who
located the bleeding artery by radiological imaging and performed vessel
embolisation on the pursuer and succeeded in stopping the haemorrhage. He confirmed, with the assistance of the
photograph in the article which 7/9 of process, that the vessel in question was
a medial branch of the internal iliac artery. He said that it was halfway between the
midline and the lateral bony wall of the pelvis and to calculate the bleeding
point as being about 3 centimetres medial to the side wall of the pelvis
and about 4.5 centimetres from the midline. According to him the anatomy of the internal
iliac artery is quite variable, particularly in a patient with previous
multiple operations, and it was not really possible to say which anatomically
named artery it was, if it had a name. Under reference to Grant's Anatomy Figure 3.29
(6/18 of process) he said there was no way of being definite about what branch
of the internal iliac artery the vessel was, particularly as the pursuer had
undergone major gynaecological surgery. A number of relevant organs had already been
removed and the arteries supplying them tied off. In his view new arteries would have opened up
to supply the tissues within the pelvis. The vessel might not even have been a normal
branch. It appeared to be roughly in the
area where the uterine artery and the vaginal arteries were shown in the
Figure. He could only speculate that
that it was situated in the region of the arteries that would have supplied the
vaginal vault and whatever tissues were left following upon the previous
surgery. It could not have been the
uterine artery as it would have been tied off at the time of hysterectomy, but
it was roughly where you would expect to see the uterine artery. He suggested that the artery might have been
part of a collateral blood supply that developed after the hysterectomy and
that its position would not necessarily be anticipated by a surgeon. In this type of patient he did not expect the
arteries to correspond to any textbook picture and it was possible that the
pursuer's vessel anatomy was unique.
[128] Dr Lingam said that her reference in the operation note to
"the deep pelvis and lateral vaginal fornix" was a reference to the general
area of the vaginal arteries as shown in Grant's Anatomy, Figure 3.29. Mr Jarvis accepted that the reference to
the "vaginal fornix" was unhelpful to his hypothesis and he relied on the
reference to "the deep pelvis" to support his hypothesis that an artery in the
pelvic floor was the source. In
cross-examination Dr Lingam agreed that she could not say from where
precisely within the pelvis the bleeding was coming from, and in re-examination
stated that she would not say that the source "was most definitely the vaginal
artery" but that at the time of the operation that was where the blood was
coming from.
[129] Dr Hassan's evidence was that he focussed on the general
area of the vaginal wall side of the operation. He said that the bleeding was coming from an
area where the stitches had been put in the vaginal wall, from the urethra. In cross-examination he said he said that he
"realised stitching this sort of vaginal area was not going to stop the
bleeding" and he called Dr Carty. He
also said that it was very difficult to locate how far from the area they were
operating in the medial branch of the internal iliac artery was. Mr Jarvis accepted that the fact that
efforts to staunch the blood were targeted towards the area of the bladder and
the vagina was not consistent with his hypothesis but contended that, as the
bleeding was not controlled, that might suggest that the chosen target area was
incorrect. On the other hand, it is
likely that the surgeons present at the time would target the area where they
saw the blood coming from, and there is the possibility that the severed artery
would have retracted, making identification difficult.
[130] Dr Brown thought it likely that Dr Lingam had caught
some non-vaginal tissue in the suture to the lateral vaginal wall and that that
tissue incorporated the branch of the right iliac artery and subsequently
caused the haemorrhage. It was his
opinion that arterial bleeding should not occur in the course of a
colposuspension because the surgeon should not go into an area where there was
a risk of arterial bleeding. He accepted
that, while venous bleeding was to be expected because the area in which the surgeon
was operating was a very vascular area, arterial blood loss was not to be
expected because the surgeon should not be operating in an area where damage to
an artery might be caused: arterial
damage reflected substandard performance by the surgeon. Mr Jarvis thought that the most likely
cause of the major haemorrhage was that Dr Lingam's needle had caught a
branch of the internal iliac artery buried in the floor of the pelvis while she
was suturing the ileopectineal ligament. It was his view that, however careful the
surgeon may be, there was always some risk of this happening. The needle, which was controlled by the surgeon
using the needle-holder or clamp, had to be inserted through the ligament and
twisted round. It was submitted for the
defenders that injury to a vessel positioned in the pelvic floor was consistent
with the evidence of Dr Urquhart about the location of the embolised vessel and
the inability of the surgeons to find the bleeding point. It was contended that Dr Lingam's
insertion of the needle in the right ileopectineal ligament would have been her
last insertion and that that went some way to explaining the delay in the
bleeding being apparent.
[131] I am satisfied on the evidence which I have heard that arterial
bleeding is not an accepted or recognised risk of colposuspension. No evidence was produced from the medical
literature to show that it is a recognised risk. If it were a recognised risk then I have no
doubt that, because of the serious and potentially fatal consequences which
could flow from its occurrence, it would have been not only mentioned but also
emphasised in the medical literature dealing with the subject. Mr Jarvis, although unable to cite any
reference in the medical literature to the risk of arterial damage in the
course of colposuspension, mentioned his personal experience of one
colposuspension in which he damaged an obturator artery. It seems to me that this evidence shows that
arterial damage is indeed exceptional case because it was the only case of
arterial damage which Mr Jarvis was able to cite from his long career,
and, moreover, he was able to explain how it came about in the absence of
negligence. The only other reference in
evidence to a case of possible arterial damage as the mention by Dr Hassan
of a case in Ireland
in about 1986, but there are no details available about the nature of that
bleed and how it was caused and I therefore do not think that much can be made
of that evidence.
[132] As arterial bleeding is not a recognised risk of colposuspension,
it is next necessary to ask what the cause of the arterial bleeding in this
case was. I have summarised above the
hypotheses proffered by Dr Brown and Mr Jarvis on the location of the
arterial bleed. Dr Brown thought
that the damage to the arterial branch was caused while Dr Lingam was
working in the vaginal area and that, when applying her lateral suture there,
she moved into the area of the vaginal arteries. He suggested that the delay in the appearance
of the haemorrhage was because in placing the second and more lateral suture Dr Lingam
went round and traumatised an artery and the damage was caused when the sutures
were elevated. He accepted the theory of
arteries going into spasm and retraction and stated that there would be some
initial bleeding at the time the transaction occurred and before spasm and
retraction. Dr Brown thought that Mr Jarvis's
hypothesis that the haemorrhage occurred when the bladder was reflected was
highly unlikely as bleeding at that stage in the procedure was always venous. When asked when the damage to the artery could
have been caused, Mr Jarvis said it could have been either when Dr Lingam
was placing a suture into the ileopectineal line or into the vagina and that it
would be pure speculation to confirm one or the other. He had difficulty with the concept of there
being an artery near to the lateral vaginal wall because in his opinion the
blood supply to the vagina came in two directions - upwards and downwards from
what would have been the uterine artery supplying the uterus, but that
following a hysterectomy the uterine artery was divided and ligated and all the
blood supply to the vagina after a hysterectomy was coming upwards from the
area of the vulva. That was an important
consideration for him in rejecting the idea that the haemorrhage was from an
artery near to the lateral vaginal wall. In cross-examination, after looking at Grant's
Anatomy, he agreed that the vaginal arteries were displayed as arising from the
internal iliac artery itself and that his objection based upon the direction of
the blood supply was not valid.
[133] When Mr Jarvis wrote his report and also when he began
giving evidence he was not aware that Dr Lingam had placed her sutures as
far laterally as possible in the vaginal wall. He accepted that he could understand how a
surgeon could misjudge the vagina but not the ileopectineal line. He initially said he could not visualise how a
suture placed in the lateral wall of the vagina could make contact with a
branch of the internal iliac artery but later, in cross-examination, after
being referred to Grant's Anatomy, he accepted that this was possible and that,
if it happened, it would constitute substandard care. He agreed that Dr Brown's hypothesis was
a possible explanation but was not prepared to accept that it was more likely
than the explanation which he himself advanced.
[134] It was submitted for the defenders that there were problems with Dr Brown's
hypothesis. It was Dr Brown's view
that when Dr Lingam placed her more lateral suture she either went round
or traumatised an artery and the damage occurred in the process of the suture
being tied. He revised his view of the
scope for arterial damage by stretching in the course of his evidence. He initially discounted stretching of the
artery as a likely factor but subsequently incorporated it into his mechanism. It was therefore not his initial explanation
for the haemorrhage. He was not aware of
seeing arteries as such in the area of the vaginal wall. The style of colposuspension which he
performed meant he did not operate in that area. He had no experience of performing, or even of
being present during, a Tanagho colposuspension. He had not himself seen the area and was not
sure what tissue it might contain. He
accepted that he was speculating that there would be something in the area to
catch with a suture and his view appeared to have been based upon an
interpretation of an anatomical diagram in Grant's Anatomy. His explanation depended upon both Dr Lingam
and Dr Hassan having failed to notice that some additional unintended
tissue containing the blood vessel had been gathered in the suture. This failure would have to have persisted from
the point the needle was passed through the tissue and there would have been an
opportunity to notice that this had happened up to the point in time at which
the suture was cut. Neither Dr Lingam
nor Dr Hassan noticed anything despite the fact that the vaginal wall was
distinct in colour from the surrounding tissues. It was the view of Mr Jarvis that it
would be very difficult to fail to notice that adjacent tissue had been pulled
into a suture, and he dealt in detail with the suturing mechanism in
re-examination. He found it difficult to
see how the needle could have been withdrawn from the lateral wall of the
vagina with its tip lateral to the vagina so that it caught the artery. From the radiological position of the
embolised vessel as spoken to by Dr Urquhart the distance which the tip of
the needle would have to have travelled lateral to the vaginal wall was of the
order of two centimetres, and in the view of Mr Jarvis this was too
great a distance for an experienced supervisor to have failed to have noticed.
[135] The following criticism was made of Mr Jarvis in the
submission for the pursuer. Notwithstanding that, unlike Dr Brown, he
had had access to the surgeons who had operated, he proceeded on the basis of a
number of assumptions about how Dr Lingam had carried out the operation. He had assumed that she had carried out the
operation in the same way that he himself would have done, whereas in fact the
way in which he would carry it out differed in a number of respects from the
way in which she carried it out. He was
not aware that she would seek to go as far laterally as possible with her
second sutures to the vaginal wall and the ileopectineal ligament. In order to maintain his hypothesis he
essentially sought to ignore the eyewitness accounts of the bleeding from Dr Lingam
and Dr Hassan. If Dr Brown's
evidence about the location of the haemorrhage were to be accepted, then Dr
Jarvis's hypothesis was wholly undermined. In his report Mr Jarvis postulated two
possible causes for the haemorrhage, namely, the initial part of the dissection
involving the dislocation of the bladder and that a needle used in placing a
suture into the ileopectineal line inadvertently caught a blood vessel in the
floor of the operating field. In his
report he said "I have no way of knowing which of these two was the more likely
scenario". In evidence in chief he
initially said that the damage could have been caused by placing a suture into
either the ileopectineal line or into the vagina, but then went on to indicate
that he had difficulty with it being an artery near the lateral vaginal wall
because the blood supply to the vagina following upon a hysterectomy came
upwards from the area of the vulva. In
cross-examination he said he could not visualise how a suture placed in the
lateral wall of he vagina could make contact with the artery. It was only on being referred to Grant's
Anatomy that he accepted that that view was not valid and that the vaginal
artery could be injured with a suture as it came out of the lateral vaginal
wall, while contending that that was no more likely an explanation than his
hypothesis. It was submitted that these
references showed that Mr Jarvis was not wholly consistent in his approach
to what caused the haemorrhage. In
re-examination he gave detailed evidence about how he would carry out suturing
to the vaginal wall, in relation to which two points could be made. First, Dr Lingam was not asked about how
precisely she would apply the sutures using the J-shaped needle and, in particular,
whether her approach was the same as that of Mr Jarvis. Secondly, it was never suggested to Dr Brown
in cross-examination that the manipulation of the J-shaped needle would be such
that it could not be pointed towards the artery adjacent to the vaginal wall. That suggestion was made by Jarvis only in his
re-examination. He also raised in his
re-examination the possibility of some bleeding from the other end of the
dissected artery and appeared to make the point that Dr Urquhart required
to deal with only one bleeding end rather than two. This matter was never put to either Dr Brown
or Dr Urquhart for their comments.
[136] I have not been persuaded by the hypothesis put forward by Mr Jarvis
for the cause of the arterial damage. In
my view the criticisms of his evidence made in the submission for the pursuer
are well-founded. I consider that his
hypothesis was far fetched and unsupported by the evidence. I think that in coming to his view he placed
too much reliance on the reference to the pelvic wall in the operation note and
that he in effect left out of account the reference to the vaginal fornix. I also think that his evidence failed to take
sufficient account of the evidence of Dr Lingam and Dr Hassan about
where they considered the haemorrhage to be coming from. Further, I take no account of his evidence
about the use of the needle given in re-examination. This was the first time this point was raised
in evidence and it would be quite unfair to the pursuer for me to take it into
account to any extent. Had this matter
been considered to be of any significance by the defenders it should have been
put to Dr Lingam, Dr Hassan and Dr Brown. As matters stand I do not know what their
evidence on this point would have been.
[137] Although the rejection of Mr Jarvis's hypothesis does not
automatically result in the acceptance of that of Dr Brown, I have reached
the conclusion that the probability is that Dr Brown was correct in his
evidence about how the haemorrhage came about, for the following reasons. First, as I have found above, arterial damage
is not a recognised complication of colposuspension. Secondly, I think that it is not without
significance that an arterial bleed occurred in the course of a colposuspension
being carried out by a trainee surgeon who lacked recent experience of the
procedure. Thirdly, Dr Brown's view
is consistent with the evidence of Dr Lingam and Dr Hassan about
where the haemorrhage appeared to be coming from. Fourthly, Dr Urquhart's evidence is
consistent with initial damage in the area of the vaginal wall and inconsistent
with damage to an artery located in the pelvic floor.
[138] In any event, following upon my finding that arterial damage is
not a recognised complication of colposuspension and in light of the
authorities referred to above, as well as Cassidy
v Ministry of Health [1951] 2 KB 343, I am of the opinion that, once
arterial damage has been proved by the pursuer, that raises a prima facie inference of negligence on
the part of the defenders which it is for them to rebut by acceptable evidence.
There has been no such evidence in this
case. It is sufficient for the pursuer
to show that she suffered arterial damage without proving precisely how that
occurred: it is then for the defenders to prove that it occurred without
negligence on their part. In Cassidy Denning
LJ (as he then was) said that a plaintiff is entitled to say: "I went into
hospital to be cured of two stiff fingers. I have come out with four stiff
fingers, and my hand is useless. That should not have happened if due care had
been used. Explain it, if you can." Similarly, in my opinion the pursuer in
this case is entitled to say: "I went into hospital to undergo the routine
operation of colposuspension. I have come out with a neurological injury which
was caused when a branch of my internal iliac artery was damaged during the
operation. That should not have happened if due care had been used. Explain it,
if you can." In my judgment the defenders have failed to explain how the
pursuer sustained her injury without negligence on the part of the operating
surgeon.
(iii)
Dr Hassan's supervision of the operation by Dr Lingam
[139] It follows in my opinion
from my foregoing findings that he must have been negligent in his supervision
of the performance of the operation by Dr Lingam. Had he been exercising
reasonable care in his supervision of her she would not have been allowed to
execute the manoeuvre which caused damage to a branch of the internal iliac
artery and the pursuer's consequent neurological injury. What I find remarkable in this respect is that
he thought that Dr Lingam was carrying out a Burch colposuspension when in
fact she was carrying out a Tanagho modification.
Decision
[140] I shall repel the
pleas-in-law for the defenders, sustain the first plea-in-law for the pursuer
and award damages in the agreed sum of ฃ40,000. No formal interlocutor will be pronounced
until the questions of interest and expenses have been determined at a By Order
Hearing.