Deceased
Thelma Katherine Holt
Demographics
79y, female
Coroner
Coroner Dr Jane Hendtlass
Date of death
2009-03-14
Finding date
2013-08-13
Cause of death
pneumonia in the setting of acute peritonitis due to perforated stomach (operated)
AI-generated summary
Mrs Thelma Katherine Holt, a 79-year-old woman with multiple comorbidities including obesity, vascular disease, hypertension, and prior Nissen fundoplication, underwent placement of a second intragastric balloon on 11 September 2008 for weight loss prior to hernia repair. On 30 January 2009, she presented with severe abdominal pain and vomiting. CT imaging confirmed gastric outlet obstruction from the balloon. Despite this, her gastroenterologist advised against urgent removal, citing lack of experience with balloons. She was managed conservatively with nasogastric drainage and fluids. The nasogastric tube was capped on 31 January without verifying patency. By 1 February, her condition deteriorated, and emergency surgery revealed large gastric perforation with peritonitis. She died 14 March 2009 from pneumonia in the setting of acute peritonitis. Key preventable failures included: Dr Merrett placing a second balloon in a high-risk elderly patient with complex comorbidities; failure to recognize significant gastric obstruction; capping the nasogastric tube without ensuring function; and administering large fluid volumes without monitoring output. Clinical lessons include careful patient selection for balloons, active monitoring for obstruction, and ensuring specialist advice is acted upon.
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IN THE CORONERS COURT AT MELBOURNE ‘Court Reference: COR 2009 1577 .
Form 37 Rule 60(1) Section 67 of the Coroners Act 2008 a |
Inquest into the Death of: THELMA HOLT
‘Delivered On: . 13 August2013 Delivered At: Coroners.Court of Victoria Level 11, 222 Exhibition Street Meélboumme:3600 Hearing Dates: 24-25 October 2011 Findings:of: . Jane-Hendtlass, Coroner Representation:
Mr, Winnéke appeared on behalf of Dr Marks and Dr Merrett. ‘
Dr P; Halley appeared’on behalf of Dr Prichard,
Ms F. Cockram appeared on behalf'of Dr'K. Bundy.
Police Cororial Support Unit + Sergeant T. Weir was present to assist the Coroner.
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1, JANE HENDTLASS, Coroner having investigated the death of THELMA KATHERINE HOLT
AND having held an inquest in‘relation to this death on 24, 25 October2011
. at MELBOURNE
find that the idéntity of the deceased was THELMA KATHERINE HOLT born.on 15 July 1929
and the death occurred 14 March 2009
at The‘Epworth Hospital, 89 Bridge Road, Richmond, Victoria 3121
from: 1(a) PNEUMONIA IN-‘A’SETTING OF PERITONITIS (DUE TO PERFORATED
in the following circumstances: :
2, Mis Holt’s medical history included cataracts,-asthma, osteoporosis, gastroesophageal reflux disease and hiatus hernia treated with a “Nissen fundoplication in 1995, hypothyroidism, hypertension, obesity, gout, chronic renal impairment, an aortic aneurysin repair in 1996, chronic low back pain as.a consequence of degenerative spine and obstructive sleep apnoea.
Her usual ‘general practitioner was.Dr Kay Bundy.
Mts Holt also had a long history of obesity. Medical management of her attempts ‘to lose weight included very.low calorie dicts, weight-loss medications, exercise programmes and, reférral to gastroenterologists.and.a respiratory physician.
Although she had sone success prior to about 2000, these treatments failed to maintain Mrs Holt’s weight reduction so that she became depressed and tinatile to go outside. She was prescribed Zoloft but Dr Bundy told:the Court that she was not:sure that Mis Holt’s mood
was sufficient to warrant a diagnosis of clinical depression.
pastrdetiterologist, Di Michael Merrett.
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Before he considered. physical intétvétition, Dr Méirett referred Mrs Holt-to a consultant physician in clinical nutrition, Dr Sharon Marks, to try: diet and pharmacological weight
loss.
Mrs Holt: did not lose enough weight using . these medical ‘procedures to change her
diagnosis:of obesity,
Therefore, on 29,.Maich 2007, Di Merrett performed an-upper-gastrintestinal endoscopy. at Frankston. Private: Hospital. He placed an Enterics intragastric balloon in Mrs. Holt’s stomach ‘and. inflated it with 600ntIs. saline, In the course. of the procedure, Dr Merrett
identified-a ‘moderate sized hiatus hernia (2-5cm).
'
Over the fiext-five months, Mrs Holt lost.22 kilograms in weight.
‘However, on-6 August: 2007, “Mrs Holt was diagnosed with an abdominal incisional hernia
that required surgical correction,
On 10 August 2007, Dr Merrett removed. Mrs Holt’s..inttagastric balloon ‘at Frankston
Private Hospital to énabie surgery to correct her-abdominal incisional hernia.
On.6. September 2007, Mr Paul Sitzler-repaired Mrs Holt’s abdominal incisional hernia ‘at the Epworth Hospital, This surgery was associated with subsequent:slow.recovery, wound,
and site infection and exacerbation of Mrs Holt’s respiratory disease.
On 26 March 2008, another surgeon, Mr John Leslie, noted that Mrs Holt had now been left
With a reciatrént hernia that would be better left to stabilise for a monith oF two.
Mr Lesiie said he could not operate again until Mrs Holt lost a fuither 10-20kg. He
Oti 11 September 2008; Dr Merrett placed a secorid intragastric balloon.at Frankston Private
Hospital to assist ‘with Mis Holt’s weight joss before repair of ‘her recurrent abdominal
incisional hernia.
At 11:35am on, 30 January:2009, Mrs Holt presented at the Emergency Department of the Epworth Hospital with symptoms consistent ‘with significant small bowel obsttuction. A Computed Tomogtaphy (CT) sean confirmed the diagnosis.
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Dr Peter Prichard discussed Mts Holt’s condition with Dr Merrett. They agreed to admit her
_ fo: the. Epworth Hospital for the weekend and deflate the balloon at Frankston Private
Hospital 6h 2 February 2009.
-However, Mrs Holt’s :condition: deteriorated. She was diagnosed with peritonitis. and
perforated stomach and transferred to the Intensive Care Unit at the Epworth Hospital.
At 1.45am'on 2: February 2009,. Assooiate Professor Peter Danne performed an emergency
explotatory laparotomy; He corrected.a gastric perforation and the outlet-obstruction which
ihesaid was-caused by Mrs Holt’s intrapastric balloon.
Mis: Holt recovered slowly after surgery and required admission.:to the Intensive Care ‘Unit
at-the Epworth Hospital.
On 10 February 2009, Assdciate Professor Datine re-opsited the laparotomy ‘to close the
abdominal wall and proceed with her bowel reconstruction.
Howeyer, ‘Mrs Holt’s condition continued to deteriorate and she underwent further
abdominal surgery. Her.abdomen became septic.
On 25 February 2009, Mis Holt suffered symptoms consistent with .a post-opsrative
cerebrovascular accident (stroke).
Active treatment was withdrawn.
on 12 March 2009, a CT brain sean found no acute intracranial abnormality On 14 March 2009, Thel mia Holt died.at the Epworth Hospital in Richmond.
The forensic pathologist whio inspected the body formed 'the opinion that Mrs Holt’s cause of death was pneumonia in the setting of acute peritonitis (due to perforated stomach) ©
(operated):
Accordingly, I find that Thelma Holt died of pneumonia in the setting of acute peritonitis
die to peiforated stomach,
This ‘Finding will review in more detail’ Mrs Holt’s background and ‘the -medical
management of her obesity and her abdominal incislonal hernia:
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thé reason that Mts Holt died.
Background
Thelma-Holt hada long history of gastric.reflux and obesity and related disorders. Her usual general practitioner was Dr Kay Buidy but she sometimes consulted other doctors in the South Road Family Clinic:
Th 1995, Mrs Holt uitderwent a Nissen fundoplication to correct her reflux. However, she continued to.gain weight.
Mrs. Holt also: sufferéd from. persistent asthma, depression, lower back pain, chronic renal failure, hiatus hernia and significant vascular disease.
34, Dr Bundy also teferréd Mrs Holt to-a respiratory physician, Dr Judith Morton. Di Morton referred her to two gastioenterologists, Dr. Gregoty Taggart and Dr Henry Debinski, and a general physician with a special. expertise in hypertension and vascular diseases, Dr Geoff Matthews.
Mrs Holt’s out of pocket medical expenses were covered by the Department of Veterans’ Affairs,
Dr Bundy attempted to assist Mrs Holt to iose weight using. diet, exercise and weight-loss medications including Reductil (sibutramine) and Xenical (orlistat):
‘However; Mrs Holt-did not lose weight.
On 6 Aptil:2004, Dr Richard Oei from South Road Medical Practice referred Ms Holt to a new ‘gastroenterologist, Dr Michael Merrett. .
° Dr-Merrett is a consultant physician in gastroenterology. His practice included non-surgical
: management of weight loss usifig endoscopic placement ofan inttagastric balloon under neuroleptic: anaesthesia. Mts Holt ‘instigated her refetral to Dr Merrett because she had heard about intragatric balloons and was thinking she Wotild like to try one.
capacity of the stomach:
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Dr Merrett worked closely with and-in the:same practice as a consultant physician in clinical
nutrition, Dr Sharon Marks.
Dr Marks is ‘a.general physician who specialises in clinical ‘nutrition and metabolism. She
lias téported publiély on her experience with managing 73 obese jpatients with 92 water-
"filled intragastric’ balloons over 6 years. In the overall patient. group, including eight patients
whose balloons deflated, the mean weight loss was 10.5 kg. In ‘the ‘patients with intact
balloons; amean weight loss-was 11,0 kg
Oh about 27 April 2004, Dr Merrett saw. Mis. Holt. Her Body. Mass ‘Index (BMD was 44.1kg/tn? so 'she would be-classified as Obese Class III by the: World Health Organisation.
However, Dr Merrett adopted this usual conservative ptacticé.and advised against iminediate use of'an‘intragastric balloon. Rather, on’4 May .2004,-he referred Mrs Holt:to.Dr Marks for
further management of her weightloss using exercise, diet. and pharmacology.
Dr Marks replaced Mrs Holt’s Reductil with Xenical and recommenced her Zoloft for depression. She-also referred her toa dietician and encouraged her to use a food replacement
product, Optifast.. Di Marks reviewed Mrs Holt every three months.
On or about 7 November 2004, Mrs Holt had a laparoscopic cholecystectomy at the Freemasons Day Procedure Centre.. Het recovery was associated with ongoing nausea and
reflux:-despite prescription of Nexium.
On 13 Detember 2004, Mis Holt returned to consult Dr Marks,
Mrs: Holt lost about 8kg over the next three years. She. was-still within ‘the range for diagnosis as: Obese Class III (BMI:41:8ke/m?),
From early 2006, Mrs Holt's oesophageal reflux and spasin:retutned. It did not respond to
Nexiutit ot Tazac.or het weight loss,
On 6 Deceniber 2006,. Dr Debinski noted that Mrs Holt-had developéd éither‘a hiatus-héernia
or a dynamic oesophagus secondary ‘to her Nissen fundoplication.
1 See for example:-S. Marks, “Intragastric Balloons Safe and Effective Against Resistant Obesity” 21 May 2008, Abstract T2:PS:52,
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On 18 December 2006, Dr Debinski performed a gastroscopy at Cabrini Medical. Centre.
He diagnosed Mrs Holt with another large higtus hernia and a lax wrap from the original Nissen ‘fundoplication. Dr Debinski attributed Mrs Holt’s significant teflux to, these eoriditions.
Further, of 22 Februaty 2007, Mis Holt’s weiglit had increased slightly when she consulted Dr-Marks and she «was quite despondent.. Dr Marks believed she would be suitable for
insertion of an intragastric balloon,
Mrs Holt -was.attracted by the potential of an intiagastric balloon to help her lose weight and accordingly reduce-her reflux. Stortiach batiding was excluded ‘becatise of her age.
On 1March 2007; Dr ‘Debinski wrote ‘to Mts Holt to arfange an. opportunity to discuss _
alternative measures to reduce her weight.
Further, on 16 March 2007, Dr Debiriski wrote to Dr Morton expressing concérn ‘that an intragastric balloon would exacerbate Mts.Holt’s reflux atid could potentially be dangetous.
Dr Debiaski also told Dr Moiton that Mis Holt had not been taking her Tazac (nizatidirié) which could-explaimher poor control of the reflux. He copied this letter to Dr Bundy,
On 21 March 2007, Dr Marks and Dr Merrett discussed Mrs Holt’s worsening oesophageal reflux ‘and her co-morbidities ‘with her and with Dr Debinski, At that stage, she was suffering painful. oesophagitis associated with her reflux and she was unable to ‘walk far because of ther respiratory disedsé. However, there was no evidence of an abdominal
incisional hernia,
Dr Merrett also wrote ‘to Dr Bundy supporting a decision, to insert an-intragastric balloon, Contrary to Dr Marks’ claims, he confirmed he had. placed. over. 100 balloons with an avetage weiglit loss of about 20kg; Hé also confirmed that the balloon could worsen her
féflux. Further, inaboit'5% of cases; thé: balloon has'to be removed :due to-complications.
However; Mrs Holt was determined to proceed with an intragastric balloon,
Accordingly, Dr Matks referred Mis Holt back to Dr Mertett.
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Mrs Holt’s first intragastric balloon
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On 29 March 2007, Dr, Merrett inserted. Mts Holt’s first Inamed enterics intragastric balloon at Como Private Hospital. He filled it with 600m! saline.
Dr Merrett. also noted a moderate sized hiatus hernia (2-Sem) with the gastroesophageal
junction raised to 37em from the incisors.
After this procedure, Dr Merrett referred Mts Holt back to Dr Marks and'the practice’s
dietician and psychologist.
By. 10 May. 2007, Mrs Holt had lost 10kg. She'lost a further 12kge in the following two.
‘months,
On 9 July 2007, Dr Merrett reviewed Mrs Holt. She was now withity Obese Category ID (BMI 36.6 kg/m’).
Dr Merrett was very pleased. He wrote:to Dr Bundy:
“She feels much improved and interestiigly has had no. reflux. syinptoms. since the balloon
was placed.”
Dr Meriett’s assessment of Mrs Holt’s condition during the period. that her first gastric
balloon was in place differed from that-of her.other clinicians:
Mrs Hoit-also-consiilted Di Bundy on 14 occasions between 5 April and 7 July 2007. ‘Dr Bundy told.the:Court: ,
“Tremembered after the:first balloon how iunwwell'she had been because she saw many tiinés y
ofter:the first balloon with all sorts of issues.“
In-particular, Dr Bundy cepoited: on-going gastroésophagedl reflux, pain, slight anaemia, rash'-and -urinary ‘tract infection as well as respiratory complications and gout. Dr Bundy prescribed ‘Tazac, Prodiene, paracetamol, antibiotics, prednisolone, an inhaler and Spireva
capsules, Xenical, Motilium. arid increased her Nexium.
” Burther, Mrs Holt consulted Dr Marks.on four occasions ‘between-5 April and-7 June 2007,
Dr Marks reported one episode of vomiting which was an expected. side effect early in the
placement of the intragatrstric balloon. However, she also reported on-going belching and
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halitosis, one episode of reflux and muscle aches and pains, that commenced when the intragastric balloon was inserted. Dr Marks presciibed chatcoal ag well as medication for gout. Di Marks also reported severe inflaimmatory changes ovet: Mrs. Holt’s abdomen and
groin as well as evidence of:iron deficiency.
On. 18 July 2007, Mrs Holt consulted Dr Bundy.about constipation, reflux and vomiting. Dr
Bundy diagnosed a large incisional abdominal hernia that had become obvious since her last
consultation on. 7 July.2007. She referred Mrs Holt:to a colorectal surgeon, Mr-Paul Sitzler.
On 18 July 2007, Dr Marks also referred ‘Mis ‘Holt back to Dr Merrett because of concern
the balloon-may have shifted. This referral was not activated.
On 23 July 2007, Dr Matks teported that-there was.a mass in- Mrs ‘Holt's abdomen. Dr
Marks was unable to confirin whether or not it was a hernia.
‘Mrs Holt’s abdoniinal.incisional hernia
On 6 August 2007, Mr Sitzler reviewed Mrs Holt. “He ‘noted that she had suddenly developed a significant upper abdominal wall hernia and sent her for further radiological
review,
ACT abdonien sean confirmed the diagnosis tnade by Mrs Holt, Dr Bundy and Mr Sitzler.
The ‘hernia included somé small bowei and possible transverse colon,
Althoygh her obeslty placed her at risk;. Mrs Holt had no known prior history of upper abdominal incisional hertia. Further, there had been no hemia deteeted in any of her -
niedical examinations or radiology prior to 18 July 2007.
Accordingly, Mr‘Sitzler-was:unsure whether Mis Holt’s symptoms were attributable to her
ititragasttic balloon or her abdominal hernia.
I accept the opinions of MrSitzler and Dr Bundy that there was tio evidence of an incisional
hetnia priorito 18 July 2007.
Accordingly, 1.do-not:accept:Dr Marks’ alternative proposition that Mrs Holt’s abdominal incisional hernia was unrelated to the balloon other than the fact that it becamemore visible
and she became inore.conscious of it once she had lost weight.
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-for‘removal of her intragastric balloon and notified Dr Bundy.
Mis Holt did not want to wait for surgery to correct her abdominal incisional hernia and Mr
Sitzler was conceined about. performing corrective: surgery on Mrs ‘Holt while the
dnttagastiic balloon was in place. He. discussed the issue with Dr Merrett and they agreed
that the balloon should be ietnoved before surgery to coriect the hernia.
On 8 August 2007, Mis: Holt constilted Dr Marks. Dr'Maiks referred het back to Dr Merrett
‘
Accordingly, on 10 August 2007, Dr Merrett: performed a further upper gastrointestinal
endoscopy at Frankston Private Hospital and removed Mis-Holt’s first intragastric balloon.
' Repair.of the:abdominal incisional hernia
On 6 September 2007, Mts Holt was admitted to ‘the Epworth Hospital. Mtr Sitzler successfully perforined a laparotomy to. repair the. ventral -wall incisional abdominal hernia with mesh and divide theadhesions, :
Howéver, on 9 September 2007, Mrs Holt’s respiratory. condition declined, her blood pressure dropped and she developed acute renal failure, lung collapse, chronic obstructive pulmonary disease, and left ventricular fibrillation, She was transferred to the Intensive Care Unit. On 10 September; she was stable and returned to the ward.
On 14 September 2007, Mrs Holt was discharged to rehabilitation at Cedar Court, Epworth, Camberwell. .
On of about 21 September 2007, Mrs Holt had a-fall at Cedar Court and injured ‘her back.
Ske was: diagnosed with soft tissue injury and discharged home ‘because she could not undertake-the appropriate exercises dué to the pain from herfall. Pain‘ persisted from her surgical site,
On 27 September 2007, Mrs Holt préserited:at the Epworth Hospital with-dischargeé from her wound near'the navel. Her treating-doctor was uisure whether there-was inflammation ora recurrence’of the ‘hernia, However, he prescribed antibiotics and indicated théeré was fo sign
of bowel obstruction.
On 3 October 2007; Mr Sitzler- noted discharge ‘from Mrs ‘Holt*s unibilicus andthe: distance _
between the discharge and the surgical wound. He formed ‘the view that there must be'some
defect at the basé of theiribilicus and referiéd her for an ultrasound,
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On-5 October 2007; an ultrasound of the anterior abdominal wall allowed drainage of 70%
ofa collection-anterior to the hernia-‘mesh.
On 17 October.2007, Dr Morton noted continuing tenderness of Mrs Holt’s lower thoracic
not seem infected and “was healing beautifully”.
On 18 Octobe. 2007, Mf Sitzler indicated that Mrs Holt was.improving.
However, on'31-QOctdber 2007, Mr Sitzler diagnosed-continuing persistent wound ‘infection.
_Accordingly, on 1 November 2007, a CT abdomen and pelvis detected a fluid collection.
within the anterior abdominal wall consistent with cither.a haematoma or an abscess.
Howevet,. it failed to identify any evidence of a fecurrent. hernia and no ititraperitoneal collections.
On-5' November 2007, Mr'Sitzler arranged for Mrs Holt to be admitted to Lineacre Private Hospital for intravenous antibiotics to:
*knock this:on it's head.”
On 7 November 2007, Mr Sitzlet was concerned that Mrs Holt was still in pain but he
believed the repait was sound.
_ On 22 December 2007, Mr Sitzler ordered.a further CT abdomen and pelvis because Mrs
Holt’s pain persisted from her incisional hernia repair: This identified a further large collection within the subcutanéous tissues of the mid abdomen.
On 29 December 2007, Mis Holt re-presented at the Epworth Hospital for an exploratory
laparotomy, Mr Sitzler-confirmed:that-mesh.on her hernia wound had-become infected.so
he. draitied, debrided and re-instated the mesh supporting the area and adiministered
antibiotics.
On 4 Januaiy 2008, Mrs Holt was discharged -home with support from Stanhope Nursing, Service.
On 4 February 2008, Mrs Holt: was re-admitted to Epworth hospital and Mr. Sitzler performed surgery under general anaesthetic to further drain, debride and excise infected
mesh on her hernia wound. Mr Sitzler was unsure whether Mrs Holt had a recurrent hernia.
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On 21 February 2008, CT abdomen and pelvis scans ordered by Mr Sitzler showed persistérit but reducing collection within the subcutaneous tissues of the anterior abdominal
wall and fat consistent with.residual-hernia,
Qn 13 March 9008, Dr Morton reviewed Mrs Holt: She found Mrs Holt’s abdomen. was:
“excnicialingly tender in the left iliae fossa along’ thé inferior edge of the hernia.” ‘Dy Morton réfertéd Mrs Holt-immediately:to. Mr Sitzler becauise.shé wasiconcerred that she had arecurrent incisional hernia.
On 13 March 2008, Mr Sitzler reviewed Mrs Holt. He told Dr Bundy that he did riot believe
clitically ‘there was a récuitrent hernia. However, he had difficulty judging ‘Mrs. Holt’s
abdomen and he serit het for-a further CT abdomen.
‘On 17.March 2008, Mrs Holt asked Dr Bundy to refer her to another surgeon, Mr John
Leslie, for a second opinion, Mrs Holt'told Dr Bundy that she sought this referral:
“Because... she'd had-so many problems after her last operation with Dr Sitzler, Mr Sitzler who'd repaired it and ... ail that complications in hospital and then the wound infection 86
she waitted someone else,”
Qn 20-March 2008, Mr Leslie reviewed Mrs Holt, He noted that Mrs Holt had now been.
left with a recurrent abdominal incisional hernia that had developed. when the. gauze was
removed and would be better left'to stabilise for,a month or two.
‘Me Leslie also:said that he required 10-20 kilograms weightloss before-attempting to further
surgically repait-the hemia. He recommended an abdominal ‘birder to support the hernia
and reduce Mrs Holt’s discomfort.
‘Dr Marks hiad also discussed an abdominal ‘binder with Mrs Holt. Mrs Holt told Dr Matks that she would:
‘sather be dead than wear an.abdominal binder forever ‘
Mis Holt told Dr ‘Bundy that she was determined to proceed with the second intragastric
balloon to achieve the required weight loss for. surgery:
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‘I'd asked her to delay the balloon she declined... she was keen to have the second balloon as Because she'd had such good weight loss the first time."
On 14: April 2008, Mi Leslie told Dr Biitidy ‘that Mis Holt’s incisional hernia continued to
bé'ténder at times: © , 7 “,..but it has not bothered her enough to remind her to get the binder she was going to obtain-to see if she.can control her symptoms this way.”
On 15 April 2008, Dr Bundy re-refétred Mrs Holt to Mr Leslie,
On 21 May 2008, Dr Morton. confirmed that Mrs Holt’s réspiratory condition was good despite the complications associated’ with her recuirent abdominal incisional hetnia. She was
walting for ith abdotniiual birder becatise Mr Leslie was hesitant about further surgery.
On 2 June 2008, Dr Marks wrote to Dé Bundy to say that Mrs Holt was keen to consider having ‘@ second intiapastrié balloon placed. "This would Have to occut either six.months
‘before or'six-months after the surgery contemplated ‘by Mr Leslie.
Oni 23 June 2008, Mr Leslie commented ‘that the abdominal hernia was ‘annoyitig but Mrs
Accordingly, surgery was not. urgent and she still needed to reduce her weight before. Mr
Leslie would perform the further surgery-required to repair the hernia, Mtr Leslie also:supported a decision in that regard. He told Dr Bundy in.a letter:
"I'd have no objection to her having a further intra gastric balloon if this was.thought appropriate in the.short.tevin, thoughI agree that having one.in situ during surgery would
probably be inappropriate.”
On 28 July 2008, Dr-Mark wrote to Dr Bundy to indicate she woiild facilitate Mrs.Holt’s referral for insertion of another: inttagastric balloon. ‘
‘On or. about September 2008, Mrs Holt had a fall. which.caused lower back and knee pain.
However, Mrs Holt refused to delay the insertion of her second gastric. balloon while’ she
was recovering from the full.
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Mis Holt’s second intragastric balloon
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On 11 Septémber 2008, Dr Merrett admitted Mrs Holt to: Como Private Hospital :and inserted a second intragastric balloon to assist with her weight loss:before further repair of her abdominal incisional hernia. He inflated the balloon with 600mI-saline and advised it
may be left'in siti for six months.
‘On or-about 14 September 2008,, Mis. Holt was discharged home to support from Dr Bundy.
cand Dr Marks. :
Mrs Holt.consulted Dr. Bundy 11 times between, 16 September 2008 arid 30 January'2009.
Through miost-of this:period, Mrs Holt complained of nausea, constipation, urine infection, reflux, light-héadedness, chest infection, low blood: pressure, atid finally sevete abdominal
pain. Pain also continved from her fall. She-also required potassium and iron supplements.
“On 10. October 2008, Mrs Holt consulted Mr Leslie, She felt-ill all ‘the time with painful
indigestion. Mr Leslie manipulated her hernia which: relieved her:constipation.
By 12 Novettiber'2008, Mrs Holt had lost 13 kilograms in two months. This weight loss
_ was Slightly slower than she had achieved with her first intragastric balloon. However, she
remained .23.5kg lighter than when :she fitst consulted Dr Merrett in 2004 and ‘she remaitied Obese Category II (BMI 35.9kg/m).
On 15 December 2008, Mr Leslie reviewed Mrs Holt’siabdominal wall. hernia. He arranged a CT ‘scan of the abdomen and pelvis due to soreness arid swelling in the area, Mr ‘Leslie
antanged for copies of these'CT scati results to.go to Di Bufidy’s practice.
‘The CT scan of Mrs: Holt's abdomen ‘and pelvis: showed the dritragasttic: balloon in her
stomach but there was'no abdominal aortic aneurism and ‘no left upper :quadrant:mass lesion.
‘When Mrs Holt saw Dr Bundy on.6 Januaty 2009, her respiratory infection had settled and he Was’ feeling ‘well but remained dizzy’ and ‘lightheaded, Dr Bundy ceased Mrs Holt’s diuretic medication ‘ oo
On ‘16 January 2009, Dr Marks advised a meal replacement programme to aceélerate Mrs
Holt’s weight Joss.
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On. 30 January 2009, Mrs Holt consulted Dr Bundy with a 24 hour history :of severe upper abdominal pain and voiniting-and a distended abdomen with a mass on the left side at the site of the ‘hernia:
“she was brotight:in by a neighbour, she was.too sick to drive and she'd been.tinwell sitice
the previous day and she complained of constant upper abdominal pain, vomiting and
everything she ate or drank anda dump in her.abdomen"
Dr Bundy was not sure whether it was the hernia-or the balloon:that was. the problem. ‘She taritatively diagnosed a bowel obstruction and referted Mrs Holt for transfer by atmbulance
tothe Accident and Emergency Department at the Epworth Hospital.
The Epworth Hospital
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At 11:35am.on Friday 30 January 2009, Mrs Holt presented at the Accident-and Emergency Departinent at the Epworth Hospital. She was:triaged Category 4.
At 12:15pm on 30 January 2009, .an abdominal x-ray showed a possible pyloric outlet
obstruction.
An x-ray is like a ‘snapshot’ in time and is ‘taken from a particular perspective. Therefore, it:
eatinot show dynamic changes in the position of the intragastric balloon relative to the
pylorus. However, inthe absence of ary other identified body, Lacdept the implication that
the balloon was.in.a position where it could be significantly obstructing the pyloric outlet.
At approximately 1:55pm, intravenous fluids commenced to rehydrate Mrs Holt after het
vomiting and a nasogastric tube was inserted to drain fluid from Mrs Holt’s stomach.
Tnitially, the nasogastric tube drained a whitish fluid but it would not have ‘been able to pass
food residue.
A registrar from the Emergency Department at Epworth Hospital ordered a CT abdomen
‘and. pelvis scan.
Dr “Petet Prichard, an experienced gastroeriterologist .and consultant physiciafi at the
Epworth Hospital and the Royal Melbourne Hospital, was one of the gastroenterologists on
call when Mrs Holt presented at the Epworth Hospital.
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At abéut 2:30m on 30 January 2009, Dr Prichatd was called -by the gastroenterology
registrar‘to review Mrs Holt and approve her admission.
Dr Prichard teviewed Mrs Holt and observed that.she was feeling comfortable and was-no
‘longer’ vomiting. ‘Then, he went personally: to: the tadiology department and looked at the
CT filins:and discussed them: with the-radiologist.
Froth‘ this discussion, Dr Prichatd-and thé radiologist foriied the opitiion ‘that the intragastric
‘balloon was. propeily: inflated :and in a position where it could. be causing a significarit
pyloric. obstriction. However, there was no excessive of gross distension. of Mrs Holt’s
‘stomach.
Associate Professor Dantie also saw food in Mrs Holt’s stomach when he:reviewed thie :CT
film. ‘Dt Prichard-¢onfirmed this impression. The radiologist also confirmed it verbally to
Dr Prichard but-did.not include it-in the report.
The subsequent written report of the CT abdomen and pelvis scan confirmed a 600ml fluid filled balloon impacted on the gastric outlet and obstructing the stomach; The small bowel seeiniéd collapsed. It-also showed a small aneurysm in her distal abdominal aorta with a
large ainount:of thrombus. The nasogastric. tube was .appropriately-in sit.
At 3. 30pm, a registrar from the Emergency Department at Epworth Hospital contacted Dr Marks. He explained to Dr Marks. that Mrs Holt had presented in an ‘ambulance with
vomiting, nausea and. some slight abdominal pain.
Dr Marks su gested they transfer Mis Holt that.afterioon-to the Frankston Private Hospital: However, the registrar advised that it was not possible to organise transport that afternoon.
Although: Dy Prichard was:aware of the issues raised by an intragastric balloon, ‘he had never seen.an intragasttic balloon before. Further, he did not have the necessary trainingand the © Epworth Hospital did not have the equipmerit-to non-surgically remove the intragastric balloon, DrPiichard consulted Dr Merrett.
Dr Prichard assured Dr Mertett that the CT. scan confirmed a significant outlet obstruction
“but Dr Merrett expressed some doubt that the balloon would be causing any. significant
‘obstruction,
16 of 47
141;
143,
148,
Dr Merrett -explained'to the Court:
“all patients even if they're well and not vomiting will have distension of the stomach with food debris and iit gives the. appearance of obstruction .but complete gastric outlet
iobstruction-doesn't'occur with balloons and.hasn't-been reported.”
‘Dr Merrett’ ‘s discussion allayed 1 Dr Prichard’s concems about. the relationship between the
intragastric balloon and the otherwise apparently significant obstruction,
After. hearing Dr Merrett’s eviderice at ‘the inquest, Dr Prichard cotifirmed that he“would agree with (Dr Meivett) fully” thatthe intragastric balloon was not causing the-obstruction.
‘Dr’ Mettett' offered“to be available: and was prepared: to ‘attend Mts Holt. at ‘the Epworth Hospital with his equipment if she deteriorated; He-also told the Court that:
“Lechiiically it would’ have béen possible for the balloon. to bé rémoved on the day but. there
was‘no indication at that time that we:needed to:do that,”
At 7:20pm on 30 January 2009, Dr Prichard.reviewed Mrs Holt’s condition. He observed her to be stable and arranged for her admission over the weekend. Dr Prichard.also ordered a
gastroscopy but there is no evidence that this occurred.
However, at 9:20pm. on 30 January 2009, Dr Prichard was. contacted regarding -Mrs Holt’s
incteased blood pressure, Although, Dr- Prichard -presctibed. a’ Glyceryl Trinitrate (GTN) patch at % 30pm, he was-not concemed by the increased blood pressure due to Mrs Holt's
‘other medical problems, which included hypertension,
At around midday of:early aftémooti-on'31 January 2009, Dr Prichard reviewed Mrs, Hollt.
‘He found her. to be ‘stable: and comfortable. dn particular, there-was: no evidence of gross
‘distension: of Mrs Holt’s stomach.
Dr Prichard ordered. capping of ‘the nasogastric tube and gentle fluids cormmenced orally
because he noted minimal drainage (Lonils). Dr Prichard advised nursing staff to cease
“fiiids and rédotimence pastric drainage if Mrs Holt did not toletate the capping and. oral
fluids.
17-0f AT
nage eect ee
149,
151,
152:
154,
Four: litres of saline had been admiristeréd by 12:15pm on 31 January 2009. aiid @ further litre by 4:35pm. There is no record of urinary output. However, it is vilikely that the
minimal noted by Dr Prichard drainage reflected a small volume of fluid in the:stomach,
By 13:00pm on 31 January’2009, Mrs.Holt was nauseous and experiencing pain. Nursing staff’ administered anti-natisea medication and morphine and attempted to contact Dr
Prichard biit he did not'respond.,
ul
‘By 12:05am on 1 February 2009, Mrs Holt’s symptoms had settled and she was. considered
stable, Dr Prichard otdered 1 milligram of Kytril if Mrs Holt’ $ naysea veturried, This was
not administered because there was no evidence ‘that ‘the ‘distension was. of a severe nature
‘and-the clisiical:assessinentof the:patient was that the stomach was. not gross.or distending
further.
Further, Dr Prichard was not:convinced that ‘Mrs: Holt’s symptoms were masked by her
‘atialgesia because-she only required.a low dose of morphine.and-only on two. occasions. He
told the Court:
. "Ongoing requirement for that sort of narcotic analgesta would be definitely of concern but
that was not the situation.”
However, at-8:35pm on 1.February 2009, Mrs Holt’s condition had deteriorated. Her blood
‘pressure-was 200/100mmHg; she was sweating, nauseous and.complaining of pain. .
Although ‘Mrs Holt’s condition initially responded to Maxalon and morphine, ‘by 12:00am oti 2 February 2009, the pain was ongoing ard she was referred to the ‘liitersive Care Unit
‘with a differential diagnosis:of gastric perforation.
Dr Prichard was of the view that this change in Mrs Holt’s condition would have occurred within about 30 minutes of the perforation occurring, that is at about 8.30pm on | February
The Intensive Care. Fellow, Dr David Chirovski, confirmed the. diagnosis of gastric
‘perforation and sought assistance from the on-call - surgeon, " Associate Professor Peter
Danne;
18 of 47
158,
160;
163,
At 1:45am on .2 February 2009, Associate Professor Danne ‘performed. an emergency
laparotomy.
"The laparotomy revealed:
. a large perforation Of the gastric wall high’ up ori the lessér curve due to gross distension of the stomach with ischaemia and/or of-mechanical splitting at that point,
Contamination, of the gastric contents (a'large ‘amount of food: and fluid) into the petitotieal cavity and obvious petitonitis; and
~ ballooh obstiuction of the pastri¢ outlet.
Associate Professor Danne surgically removed the intragastric balloon, performed a
peritoneal toilet and partial gastrectomy, clositig the perforation and the ischaemic. part of.
the lesser curve of the stomach, He closed Mrs ‘Holt’s abdomen witha VAC dressing.
Associate Professor Danne told the: Court:
“This is. my first contact with an intragastric balloon. I have to.say,and it's not a device that, when 1 talk arotnd with my colleagues that many of them have had contact with. It's not a conmionly used device. Certainly here anyway. I think there are parts of the world where itis commonly used but, ah,.so I've never before or after had contact with one.”
Mrs Holt rétuitied to the Intensive Care Unit: Associate Professor Datine was happy with her progress,
On 4 Febriaty 2009, Associate Professor Danne performed a second laparotomy to review Mrs Holt’s:surgical site; Hé found that the stomach was heiulitig well. However, the right
colon had infarctéd arid théfe were signs of ischaemia in the,small bowel.
Accordingly; rather than closing ihe slirgical site; Associate Professor. Danne maintained her
VAC dressing to allow continuing review. ”
2 A vac dressing promotés wound hedling by: applying a vacuum through a:special sealed dressing-and foam which
acts us the wound. contact material:and fillsithe wound.:The continued. vacuum draws out fluid ‘from the wound ‘and
increases’ blood flow to the area. The VAC dressing allows management-of an: open abdorien wound, which was
required for Mrs'Hott’s expected further laparotomy inspections,
19 of 47
Ie
164,
167,
168,
Mrs Holt teturned to. surgery seven more times, Her-wound healing was excellent but her
overall condition failed to improve: Ischaemia and/or infarction continued to develop in the gastrointestinal tract:requiting resection and anastomosis of the right colon, sigmoid colon and small bowel; ‘Her cardiovascular system, became unstable but then recovered; Her respiratory: status became compromised but improved as.her.inféction came under ‘control; ‘and Her central nervous syster declined so. that.she lost-all movement in her right hand and.
became:-aphasic.
On-4 February 2009, Mrs Holt’s caecum, (tight colon) was found to be necrotic and. asight
hemicolectomy (surgical resection of the large intestine) was performed.
Associate Professor Danne ‘told. the ‘Court that this. series of events was a cascade of recurring episodes-of ischertiia that, in his opitiion, were ditectly caused by the obstruction.
by the balloon. -
Associate Professor Danne was also ‘firm that the nasogastric tube did not perforate the Stomach:
“the nasogastric tube was in her stomach, it was sitting in its correct position. It's almost
unheard offora nasogastric nibe fo perforate'thé stomach abiis end."
He.also:said:
“there is absolutely no doubt that this stomach perforated because of the intragastric
balloon,” .
On 10 February’2009,. Mrs Holt’s abdomen was closed,
However, on 13 February 2009, the surgical registrar noted that Mis Holt was lacidotic
which ‘iridicated possible. further infarction. of a ‘segment of the gastrointestinal tract: Her
_ thyfoxin levels. were. low. Her’. ofeatinine was clevated, She had Jitermittent’ atrial
fibrillition, She had no bowel ‘sounds. ‘Her ‘blood pressure was low, She was
hiypoKalaemic.
20 of 47
At 8:00pm, Associate. Professor: Danie performed a further laparotomy. This revealed an iifarétéd sigmoid colon, A. Hattiianin’s rectosigmoidectomy. was péerforitied atid a. further VAC dressing.applied.
Mrs Holt did not respond positively after this time. By 17 February 2009, she was in renal failure; her albumin levels were low, she still had ‘intermittent atrial fibrillation and she was not sleeping. She remained on Continuous Positive Airway Pressure (CPAP) oxygen.
On 18 February 2009, the VAC dressitig was changed. Of 19 February, further lactic acidosis and clinical petitonitis necessitated further surgery fora jejurium (small intestine) ‘resection,
173, On 25 February 2009, Mrs Holt’s abdomen was closed with mesh closure and a VAC dressing over'the imesh; Shortly-after this final surgery, tests indicated that Mrs‘Holt had no imovenient in her tight hand and was'aphasic,
174, Mrs Holt ‘was also-differetitially diagiosed with having suffered a cerebrovascular accident (stroke),
175.- At 11:30am on, 5 March 2009, -after consultation with Mrs Holt’s family, Mis Holt was extubated and, on 6 March, active treatment-was withdrawn. Mrs Holt was moved to a ward with Intensive:Care suppott. .
Over the following week, Mrs Holt-showed no neurological improvement. Further, on 12 March 2009, a CT brain scan found no acute intracranial abnormality,
At 1:35am on 14 March 2009, Thelma Holt died,
‘COMMENTS ‘Pursuant to'section’67(3) of the Coroners Act 2008, I make'the followirig comment(s).connected with the death:
Avenue in. Moorabbin.
Mts ‘Holt ‘had a long history of obesity and other co-morbidities. Her usual general practitionér was Dr Kay Buridy but she sometimes consulted other doctors in the South
Road Medical Practice.
21,0f 47
Dr Bundy assisted Mrs Holt to manage her-weight includiiig Very low calotie diets and weight-loss medications: However, she did not lose weight and she developed further
weiglit-related coftplications including emphysema and. hypertension.
In 1995, Mis Holt underwent Nissen fundoplication surgery to correct her gastroesophageal
reflux-and her hiatus hernia. ‘Dutitig fundoplication surgery, the upper. curve of the stomach (the fundus) is wrapped around'the oesdphagus ahd séwii into place so that the lower portion
‘of the oesophagus passes tlrougtica small tunnel of stomach muscle..
Therefore, the Nissen fundoplication teduced the \ volume of Mrs Holt’s stomach ‘by
aemoving access to the fundus.
However, in'2003, Mrs Holt’s gasttoesophiageal reflux and.her hiatus hernia retumed: She also gained about 13 kg in-weight. She was within the Bady Mass: Index (BMI) range for diagtiosis:as World Health Organisation Obese Class II,
Mrs: Holt asked Dr Richard Oei from South Road: Medical Practice to refer her to Dr _. Michael Merrett. In December 2003, Dr: Gei made the referral.
Dr Metrett was a: gastroenterologist. His practice itlided. non-surgical management of
weight loss using endoscopic placement of an intragastric balloon under neuroleptic atiaesthiesia.
Di Meitett worked closely with. and in the same practice asa consultant physician i in clinical
huitrition, ‘Dr Sharon Marks.
Dr Merrett advised. against immediate use of an intragastric balloon, Rather, on 4 May 2004, he referred Mis Holt to Dr'Marks for further attempts to: lose weight using: diet :arid
pharmacology.
Mrs Holt ‘lost about: 10 kg.over-thé next’ three years. She tentained obese. She was still troubled by gastroesophageal teflux. and her hiatus hernia. She was still keen to try the
intragastric balloon,
Oni 29 March 9007, Dr Michael. Merrett performed a gastrointestinal-endoscopy and placed
an.intéagastric balloon in Mrs Holt’s stomach.
22.0f.47
13:
14,
2i.
24,
Mrs Holt lost 22 kilograms in five months, Her. level of obesity improved from Obese Class If to: Obese Class IL, °
However,.on 6 August 2007, Mrs Holt was diagnosed with a serious incisional abdominal
‘hernia ‘that had:developed over'a period of less than three weeks,
Despite her predisposition to incisional hernia because of her weight, Mrs Holt had no prior
history:of incisional hernia,
Mrs Holts. surgeon, Mr Paul Sitzler, was appropriately concerned about performing a
laparotomy to epair-the incisional hertia while the intragastric. balloon.remained.in place.
Accordingly, Dr Mettitt removed her intragastric balloon and, subsequently, Mr Sitzler repaired the hetnia.
Mrs. Holt did not resparid well to surgery. Shé was adiitted.to the Intensive Care Unit for'a day to. stabilise her-respiratory function. Further, her wound remained infected and she was
admitted to hospital on:three:occasions before November 2007.
Mrs Holt also began to regain. weight and her abdominal incisional hernia recurred.
Dr Bundy referred Mrs Holt to another suitgeon, Mr John Leslie. He would not operate until she lost. 10-20kg.
Mis Holt rejected the use ‘of a binder to support her hernia. Against the advice of her general practitioner, her respiratory physi¢ian and her original gastroenterologist, she asked
for-afid was administered asecond intragastric balloon.
Mts‘Holt was'supported in this decision by Dr.Merrett‘and her:new surgeon, Mr Leslie,
Mrs Holt was never comfortable ‘with Her:second intragastric -balloon.. She: complained. of nauséa, gastroesophageal reflux, pain, slight anaemia, dash and utinary tract infection as well
as respitatory cortiplications and gout.
On 30 January 2009, Dr ‘Bundy tentatively diagnosed a gastro-intestinal obstruction, She referred Mrs Holt for transfer by ambulance to the. Accident and Emergency ‘Department at
the Epworth Hospital.
23°0f 47
—
28,
29,
31,
‘Although the CT abdomen scan confirmed .a significant gastri¢ obstruction, her treating pastroenterology consultant accepted Dr Merrett’s advice that the intfagasttic balloon was unlikely to be causing the obstruction.
The plat. was for Mis Holt’s transfer to Frankston: Private. Hospital on Monday: 2 February 2009-so that Dr Merrett could remove the intragastric balloon.
However, on. 31 January. 2009, Mrs. Holt’s: condition deteriorated. - The - obstruction remained, Her stomach had perforated.
Assodlate Professor Peter Dating ‘performed -emergenoy surgery. He-confirmed that the intragastric ‘balloon was obstructing the gastric outlet and Mis Holt’s: stomach had
perforated.
Despite extensive efforts by Associate Professor Danne and Epworth Hospital Intensive
Cate Unit staff, Mrs Holt:continued to deteriorate.
On 14 March 2009, Thelitia Holt died of pneumonia in the setting of acute: peritonitis due to
perforated stomach (operated).
‘This review will discuss the circumstances in which Mrs Holt diedinchiding:
° Intragastiic balloons as part of a weight loss program, “6 Mrs Holt’s first intragastiic balloon;
. "Mis Holts incisional ‘hernia;
° Mrs Holt’s second intragastric balloon; and
It -will then make recominendations intended. to prevent further deaths occuring for the
reasons that Mrs Holt died.
24:0f 47
i
lhitragastric: balloon-as-part ofa weight loss program
Obesity is .an important public health issue in our community. The ‘Would. Health
‘Organisation has developed:a simple: means-of determining the level of risk associated with
particulat height. and weight ratios: the: Body Mass Index (BMi?
Individuals. with a BMI greater than 30kp/m” have statistically heightened isk of étironic
‘non-corinunicable. disease including. cardiovascular. disease and. hypértension, Type TI _ diabetes, pulridriary diséase, osteoporosis and gout, and psychological. effects including
eating-disorders,
Individuals with:a BMI greater than A0kg/m? are diagnosed in the highest category as-Qbese Class III.
Endogcopically placed intragastric balloons ‘are oné of several space-ocoupying devices available'to obese:patients.and their medical advisors who seek rapid. weight loss‘in order to improve:their ‘co-morbid symptoms: such as gastroesophageal reflux and-hiatus hernia or ‘to petform surgery. 4
As well as effectively reducing stomach volute, one of the most important.features of the
intragastiic balloon is that the volume is large enough.to cteate pressure on the wall of the
stomach to make the’ patient feel that they have eaten sufficient, This pressure on the
stomacki wall also changes ‘the level of a specific hormone.called ghrelin which is
responsible for satiety so itreduces the drive and the desire to eat. .
‘Dr Marks told the Coutt that the intragastric balloon also works by causing dilatation of the
fundus and.in this situation was.a-risk-for’ Mrs Holt because. of her other. co-morbidities: In the absence of a:functional. fundus, it is unclear. how this side effect would play out-on the
rest.of thé stomach,
A double blind study performed in Italy has shown that three month placement of a
Bioeniterivs intragastric.ballooit in.32. patients (meari age: 36,225.6 years, range 25-50 years;
mean BMI 43.721.5 kgm’, Yange 40-45 kg/m’) in association with. restricted diét was
i
3 For example, ‘Wotld Health Organisation; “Obesity: Preventing and Managing the Global Epidemic", WHO technical Report’ Series 894, Geneva:2000.
4 Departinent of Hunan ‘Seivices “Surgery for:morbid obesity: Framework for bariatric surgery in Victoria’ 8.public hospitals” (2009).
25:0f 47
42,
associated with statistically significant weight reduction when compared to sham procedure
plus dietS
Further, review of 2515 Italian patients with Bioenteries intragastric balloons (mean age: 38,945.6 years, vange 12-71 years; mean BMI 44.447.8 kg/m’, range. 28:0279.1/kg/m?) placed for six months demonistratéd satisfactory weight loss and improvement in co-
morbidities.°
Avothier review of 44 mild-or moderately dbese patients in Saudi Arabia (wiean age: 31
__ yeats; mean BMI 45 kg/m?) found use of Bidentetics intragastric balloons was associated
with at-average'of 13kg weight loss over:six ‘months,’ '
The Victorian-Government has developed guidelines for bariatric surgery in public hospitals jrieluding ‘use of intragastric ‘balloons, These specify the following appropriate selection
étiteria for prioritising:of patients for bariaitic interventions:
© ~~ a BMhof more than 40.o7:a‘BMI- of more ‘than 35 with medically important:co-morbid
obesity-related:conditions; © ~ aged'between 18 and ‘65 years;
e have tried but failed to achieve or maintain clinically beneficial weight loss using non-
surgical measures,
«have the motivation.and capacity to make the dietary and lifestyle changes needed for
asuocessful long-tetm-outcome from the-surgery;
@ havea realistic understariding of the'risks-and ‘benefits of the surgery;
e donot have significant medical contraindications to sutgery; and
e ~—_.do riot have psychiatric, behavioural or cogiiitivé conditions that impair their capacity
to: give informed conisent ‘or:commit'to post-operative :caré plans,*
Bot, 1
s A, Genco et a “Bjokinteties® ‘Tntragastiic Balloon (BIB*): a short-term, double-blifid,. tandomised, controlled, y nd
iotbidly obese patients” (2006)'30 International J. ‘Obesity’ 129.
intfapastric: balloon: ‘The Italian ‘Experience with 2515 patiéiits’, (2005) 15 Obesity
enim El- -Mogy;- vintagasteic balloon for obesity; A retrospective evaluation of
26:0f 47
. the Federal Government found that:iitragastric balloons:pose additional tisks to patients-and
do not provide additional clinical. benefits. when compared to the. standard treatment for
morbid obesity, They recommended against public funding for this procedure.
44... The. Minister for Health. and Ageing endorsed the Medical Services ‘Cominittee recommendation on 20‘May 2008. Accordingly, treatment with ani intragastric balloon is not
covered by Medicare, ?
“Despite. the.evidence for litile additional benefit of the intragastric. balloon in the loss of weight; its cost shoyld be considered -against a program of eating and. behavioural
modification.” '°
improvements were necessary before implementing-theit widespread use. u
Australia and, wotks in a Fremantle Hospital as a. consultant-surgeon and with specialist interest in upper gastrointestinal and hepatic biliary:pancreatic surgery. He was invited ‘to
provide independentexpert evidence in this-coronial investigation:
colleague who has had training and experience ’in using this device.
B Department:of Huinan Services “Surgery for morbid obesity: Framework. for bariatric surgery in Victoria’s public hidspitals” (2009). ‘ “Medical ‘Services Advisory. Conimittee, “Intragastric balloons for ‘the temporary management of morbid obesity”,
eral, “Tntragasttic’ balloon for-obesity “4, The Cochrane database-of Systematic Reviews 2007 Issue 1,
Bigjko, E.Wroblewski, &D,Andizgj,” Endoscopic treatment.of obesity”, Can.J Gastroenterol, 25
(2011) 627-33.
27 of 47
49,
54,
Associate Professor Peter. Danne-is an experienced #astrointestinal and general surgeon itt
‘Melbourne; ‘He had never seen an intragastric balloon before, He told the court that none of
his-colleagués had seen one either.
Associate Professor Bailal and Dr Oleg Svanidze, Senior Medical Director of. ‘Allergan (the intragastric. balloon manufactured), agreed that placement of an intragastric balloon is absolutely cotitraindicated in patients with previous: gasttic surgery and/or ‘a hiatus hernia dargerthandem.? «|.
‘Therefore, although Mrs: Holt’s weight placed her within :the range for diagnosis as: Obese Class Til, ste was.also-in the category of ‘patients for whom ihitragastric-balloons are:strongly
contiasindicated: @ She was’73 yeats.dld:when she:first asked Dr Metrett to insert an irittagastric:balloon;
« As well as obesity, she suffered from a number of relevant co-morbidities including
hiatus hernia, gastroesophageal reflux and vascular diseases © She-had.a Sem hiatus heiiiia; and
“© She had previously undergone a fundoplication which reduced her ‘stomach capacity
aiid probably changed the dilatation response to-an intragastric balloon,
Therefore, in-2004, Mis:Holt’s medizal advisers were consistent and appropriate in advising ©
her to-continue with alternative diet.and medication approaches to weightloss.
Accérdingly, Dr Merrett referred. Mrs Holt to Dr Marks for nutritional and. pharmaceutical weight lossimanagement,
Mrs Holt gained 7kgsover three years-using alternative diet.and medication as-advised by Dr Marks, She remained Obese: Glass: II]. However, she still. suffered from ‘hiatus hernia, gastroesophageal reflux and vascular disease. ‘She was still keen t6 try the intragastric ‘balloon; She was still in the category of patients for whom an. intra-gastri¢ balloon was
coritiaindicated,
-Seealgo: A, -Gened et al, ‘Biventerics:intragastric balloon: The:]talian: Experience with 2515. patients”; (2005) 15 Obesity Surgery 1161
28 of 47
Despite all these argunients against. managing Mrs. Holt’s obesity with an intragastric balloon, Di Marks referred Mis Holt backto. Dr Meriettfor its placement,
Mrs Holi’s first intragastric balloon
57,
59,
‘On 29 March 2007, Dr'Michael ‘Merrett performed a gastrointestinal endoscopy and placed ‘anv intragastiic:balloonin Mrs Holt's.stomach, At that time, Dr Merrett was: the only: gastroenterologist in Melbourné-zising intragasttic balloons for treatment:of obesity.: However, he had already been using them for about:seven years.
Accordingly, although. Mrs Holt was always a high tisk patient for use of an intragastric balloon, itis conderting that Dr Merrett told the :Coutt: “the presénce-of a hiatusherniaisn’t.an absolute contraindication...
it's a relative-contraindication, something.I'd prefer not to. be there:but we've'still had good results in patients who've had-hernias. If the patient-had a-large hiatus hernia I wouldn't place-a gastric balloon.”
Dr Merrett-also told the Court
. “Gswe were aware the patient had a fundoplication but it was difficult to see whether she'd
“had a fundoplication oF not because that Grea where the fundoplication would be looked
fairly normal 86 that It was fairly wide open at the time, (The findopli¢ation was) no
-contraindication.to placement.of the balloon.”
‘Dr Merrett ‘explained that his ‘opinion was. instructed by the ‘fact that neither procedure involves sutgical incision and consequent suturing of the ‘stomach wall because: these
‘procedures would ifctease the tisk of perforation.
On thé other hand,-neither Dr ‘Merrett:nor Dr Marks told Mrs Holt about ‘the: possibility of ‘gastric perforation ‘because. it was yery tare, they had no experience of it and it was ‘not
}
documented in the training manuals.
” De Metrett’s two explanations for placiig the intragastric balloon ‘without filly informing
Mis Holt about the:risk of gastiic perforation até initially iiconsisteiit ii the way ih Which
29 of 47
they reflect DrMerrett's :knowledge .of the risks ‘associated with insertion of a gasttic
balloon ina petson with Mrs Holt’s characteristics.
éértiplications of intragastric balloon placement. ,
e Swiss research indicates that 0.2%-:of patients suffer gastric pérforation:assotviated with gastric obstruction,”
« The ‘Itdlians treated 19: gastcic, obstriétions in ‘the’ first week of placement of the billoon. In all ‘these cases, the balloon was reinoved. Théy also had a gastric perforation rate of 0,19% or five out of 2515 patients.!4 Four had undergone previous gastric surgery, Two of these patients died and two were ‘successfully treated. by
laparoscopic repair after balloon retnioval.
¢ Saudi Arabian clinicians. had-one gastric perforation in 44 patients, *
© ' Jt was recognised by Alletgan who imanufactived the intragastric balloon in their advice to -remove the intragastric. balloon as 4 matter of emergency if it is causing gastric obstruction.
a:matter‘of'real concern.
65, In ‘the circumstances of managing Mrs Holt’s obesity;.it seems to me that Dr Merrett was acting in igolation-from his gastroenterology peers. In particular: « Dr Metrett was the only person in Victotia using this form of obesity matiagement in
2007 and .2009;.
“Fyidence-based Review-of the Bioenterics Intragastric Balloons for Weight Logs” (2008) 18
611, , “Bioenterics intragastric balloon:; The Italian Experience: with 2515 patients”, (2005) 15 Obesity
‘5 Abdulhameed -Al-Momen & Ibrahim El-Mogy, “Intragastric balloon for ‘obesity: A retrospective Evalustion of tolerance aud efficacy” (2005) 15'Obesity Surgery 101.
30 of47
e Although Dr Merrett had been ‘inserting intra-gasttic. balloons for seven years and had been involved in Mrs Holt’s treatment in 2009, he told the Court that he liad only statted a dialogue with bariatric surgeons if Sydney who also ‘use intragastric balloons in 2011;
° None of the other experienced and well qualified gastroenterologists giving evidence in
‘this Court had any experience with intiagasttic balloons;
potentially significant gastric obstruction; and
¢ Dé Mettett and Di Marks were friends with Dr Prichard but they said they would not
discuss work with him in a.social context.
From this evidence, I ‘have formed the view. that Dr Merrett was providing patients with
intragastric. balloons ‘without. any of sufficient professional peer support or critique of his
“work,
Accordingly, [have formed the opinion that the Royal Australasian College of Physicians
and the Gastroenterological Society. of Australia should introduce a mentoring service for
‘members -who.. practice in. bariatric gastroenterology using. intragastric balloons.
Recommendation 1,
Mrs Holt’s. ‘incisional hernia
70,
i.
Throughout the five months that Mrs Holt hosted her first intragastric ‘balloon, -she
experiéncéd continuing: gastroesophageal reflux and pain,
Further, on 6 Angust 2007, Mrs Holt was diagnosed with a Serioiis abdominal incisional
hernia that had developed overa period of less than:thtee weeks,
Although, her obesity.and -other co-morbidities placed Mrs Holt at-risk of developing an
lominal incisional hernia, there is no evidence that this had occurred before,
Tam unable to say whether-or to what degree Mrs Holt's gastric balloon and/or het rapid
Weight loss: over folir montlis -itifluéncéed the breach of her upper abdominal wall and
‘consequent development of her-incisional hernia,
31 of 47
EER ciceecee ee
72:
73,
Ti
However, Dr Merrett inflated the. balloon with.600mls saline in Mrs Holt’s stomach. This ‘volume was'within the iiflation' volume recommended and used in Europe:
e Allergan advise inflating the balloon with at least.400ml saline to reduce the risk of
obstruction and/or stomach.perforation as well.as to maximise its effectiveness, © Further, the Italiaii, Swiss and Saudi Arabian investigators uséd 500-700mls saline in
their patients,
However, in Coutt, Dr Marks producéed-an exhibit that-was filled ‘with 500mls salitie, Tt:was quite pliable-but she:pointed out that a balloon.with 600mls.salifie would be less distensible, Ittakes quite a bit of pressure'to add the extra: 100mls.
Further, Mis. Holt had undergohé.a Nissen fiitidoplication so. that the operational volume of
her. stomach was less'than it-would. otherwise ‘have been.
The coincidence of these. factors taiges the possiblity that Mrs Holt’s intragastric balloon and her vapid weight loss-contributed to: development of her first abdominal incisional hernia in late July 2007.
The particular-practical issues that influence my raising this possibility include:
« Mis Holt’s balioon had been inflated to-600mls so that it was large and quite inflexible
inher stomach;
° Mrs ‘Holt had ‘lost 22kg in five-months :including 12kg between 10 May:and 12 July: 2007;
loss because of the loss of fat; and.
Mts .Holt’s vascular diséase placed hér-atextra tisk Of:déeveloping an incisional hernia.
Dt Merrett: would Have been .able :to remove ‘the ‘intragasttic balloon if, in Mrs Holt’s
_ ‘tothe device, ,.
32 of 47
79,
However, Dr. Merrett reviewed. Mrs Holt once after insertion of her first intragastric balloon.
He was impressed by: her'weight loss.but he-did tot acktiowledge the effect it had on her health. Theréfore, hé doés riot know whethér .or to what degree the intragastric balloon
influenced development of Mrs Holt’ s-abdominal incisional hernia.
Accordingly, I have formed the view that gastroenterologists who are responsible for placing inttagasttic‘balloons should.cegulatly monitor their patients for abdorninal hernia while the balloon is in place and particularly. during periods of xapid weight loss.. Recommendation
On 6 September 2007, Mr Paul Sitzler successfully performed a laparotoiy ‘to repair Mrs
Holt’s veritral wall abdominal incisional hernia with mesh arid divide the adhesions;
Mts Holt’s surgery was associated with slow tecovery, wound afd site infection and
exacerbation of Mrs Holt’s respiratory disease,
On 13 March 2008, Mrs Holt’s.abdomen remained: “excruciatingly tender in the left iliac fossa along the inferior edge of the hernia.”
On 20 March 2008, another surgeon, Mi John Léslie, noted that Mis Holt liad tow been left
with a.cectirrent hernia that would be better left to stibilise for a month or two.
Mr Leslie said he could: not operate again until Mrs Holt lost a further 10-20kg. He zecommended an -abdominal binder to relieve Mrs Holt’s ‘discomfort from ‘the abdominal
incisional hernia. -
However, Mrs Holt ‘was unable to lose this weight. Further, she teflised to use a binder to
relieve her discomfort: ,
Mrs Holt was: very‘determined to have a.second intragastric balloon. She was supported by Dr Marks and Mr Leslie.
As Dr Marks told the Count:
“She was very, very determined to lose enough weight to ‘have that hernia repair:”
“However; Dr Matks also coticeded: °
33 of 47
2a
“she.can't.insist-on a balloon if we don't agrée to doit. The balloon was done for Thelma to
help her-as best we.could and L-believed at-the time that-she needed that-help.”
This xeflisal was not outside the contemplation of Mrs Holt, Dr Merrett or Dr Marks because
. Dr Merrett had refused to place an intragastric balloon in. Mrs Holt’s:stomach in 2004.
Futther, Dr Buridy, Dr Morton.and Dr Debiniski all advised her against using an intragastric
balloon.
11-2007; Dr Merrett had placed the first intragastric balloon at Mrs Holt’s insistence when she failed to lose weight-after over two years of management by Dr Marks.
DrMerrett kniéw’that, sitioe'then!
‘é She was'now 79 years-old;
She had. developed an abdominal incisional heinia while the first. intragastric balloon:
was in-place;
@ Stic ‘had experienced a complicated recovery from surgery to correct ‘her abdominal incisional hertia including acute renal failure, lung collapse, chronic obstructive pulmonary disease, and. left ventricular fibrillation as well as persistent peritoneal
infection and pain; _@ She xecently expetieuced a fall; ¢ Her respiratory and -vascuilar disease remained real issues for her; and
‘e Although she-did:not want'to use a binder, that-option was operi to her to manage-her
abdominal ‘incisional hernia,
He also. knew or should have known about the sisk of ‘significant gastric obstruction and
‘stomach peffotation associated with an intragastric balloon.
Therefore, the decision to-insert Mrs Holt’s sécorid intiagasttic balloon lay squarely with Dr
Merrett:
In my opitiion, no ‘gastroenterologist should place,a second intragastric balloon in a:patient
with Mis Holt’s characteristics and co-morbidities, Recommendation 3
34 of 47
Mrs Holt'’s: second intragastric: balloon
98;
On 11 Septéinber 2008, Dr Metieit inserted a second intragastric balloon to-assist. Mrs Holt
with her weight loss before: further repair of her: continuing abdominal incisional hernia,,
As before, Dre Merrett inflated ‘the balloon with: 600ml saline-and advised it may-be lett d in
site for: six. months.
Mrs Holt consulted.DrButidy 11 times between 16-September’' 2008 ‘and 30 Januaty.2009.
Again, she complained ‘of nausea, . constipation, utitie infection, teflux,. light-headedness, chest infection and low blood pressure, Pain continued from her fall. She also required
potassium.and iron supplements during this period.
Jn about4 4 motitlis, Mrs Holt lost ‘10kg,. She:feinaitied Obese Class II.
On 30:Januaty:2009, Dr Bundy ‘ealled an. anibulance-when ‘Mrs Holt presented: with severe
‘abdominal pain consistent with:gastric: obstruction.
Mrs Holts significant gastric outlet obstruction
103:
104,
At 11:35am.on-Friday 30 January 2009, Mrs Holt presented at the Accident and Emergency Department at the Epworth Hospital with symptomis consistent with gastric obstruction.
fy \
At 12:15pm, an x-ray confirmed the presence of the intragastric ‘balloon and distension of
the stomach suggested a pyloric ‘obstruction.
In the.absenice of ality. alternative: body capable of obsttucting the pylorus and in-the. context
‘of Mrs Holt's symptoms, 1 aécept that the intragastric balloon appeared to ‘be in a-position
where itcould significantly obstructthe:pylorus:
At about 2:30pm on 30 January 2009, the gastroenterology registrar called Dr'Petet Prichard to review Mis Holt. He formed the opinion thatthe intragastric. balloon was causing a ‘significant obstruction.
Dr Prichard 1s:an experienced gastroenterologist and consultant physician :at the Epworth Hospital and the Royal. Melbourne ‘Hospital, He was one of the consultant pastroenterdlogists on call when Mrs Holt presented at the Epworth Hospital.
35 ‘of 47
106.:
109,
111,
412:
113,
Dr Prichard had no practical experience with intragastric balloons. However, he had presented a paper to endoscopy colleagues ata national meeting on complications that endoseopists may enooutiter in, batiattic sutgery, Part of that presentation included intragastric balloons, .
Dr Piichatd also discussed the CT abdomen scan with the zadiologist, Together, they formed the opinion that Mrs Holt’s.ittragastric balloon was fully inflated, it was impacted at
' -the-gastti¢ outlet-and ‘it was significantly. obstructing the stomach: .1 fiote. ‘that ‘the small
bowel liad algo collapsed.
In the absence. of the x-ray and the CT scans, I cannot.make. a retrospective assessment about whether the intragastric balloon had inoved between 12!15pin and 2:30pm on 30
January 2009 :when'the x-ray and:CT. scans were performed.
However, at-that ‘time, Dr Prichard ‘interpreted ‘the ‘CT .abdomen. scan to show that the intragastric balloon remained in. a position where. it was still causing .a ‘significant
obstruction of the gastric outlet:
At about 3:45pin on 30 Januaty 2009, Dr Prichard ‘discussed Mrs Holt’s condition with Dr Merrett,
Cottiary to Dr Prichard’s opinion and that of the radiologist, Dr Merrett told: Dr Prichard that it was most unlikely that ‘the intragastric balloon was ‘significantly’ obstructing ‘the pyloric ‘outlet of Mrs Holt’s stomach. ,
DrMeirett'also told the Court:
“Tcan't find reference to balloons:causing complete nechanical-obstruction, ‘There are no_ reference on where a balloon ever producing that. They-do producé stasis as shown builined which give the CT scan appearance of obstruction but an obstruction is actually a dynamic eveitt, it's not at'a single point in time. “ .
have.no doubt that Dr-Merrett’s advice strongly influenced Dr Prichatd’s management of
Mis Holi’s syinptoms because!
¢ Dr Prichard was-é pérsonal.and ‘professional friend of Dr Meriett-and.Dr Marks;
36 of7
¢ Dr Prichard was experienced in managing gastric.obstructions but he had no experience
with intragastric balloons;
¢ Dr Piichard ‘approached ‘his: conversation with Dr Merrett with the opinion: ‘that the intragastric balloon was fully inflated, it was impacted at the gastric outlet and was obstructing the stomach;
*® Di Metfett’s explanation of the way ii which an- intragasttic. balloon Jooks-on a CT scan :is a plausible explanation of Mis Holt’s symptoms, particularly when she was
imeédicatediand before Dr Prichard ordered capping of her nasogastric tube.
@ DrPrichard told the Court:
“Dr Merrett was able to: reassure: me: that he felt that. it was not obsiructed. And having heard firtherevidence I would agree with him fully.”
114, Medical practitioners, including tho registrar and Dr Prichard, ate well aware that distension arising from wnimanaged gasttic obstruction causes gastiic rupture with associated peritoneal inféctions atid other seriéus complications.
not they accepted that it was.caused by obstruction: ¢ Mrs Holt-was 79 years old. As Associate Professor Danne-said:
“people in that age group who have cardiovascular-disease can end up with poor blood Stipply to certain areas which, when other pathological factors operate, ean then
facilitate more-easy rupture.”
¢ Mrs Holt ‘had d previous Nissen fundoplication. Four of five patients with reported gastile perforations associated with the BioEntétics intragastric ‘balloons had previous
pastfic surgery.
¢ Mrs Hoit's presenting symptoms were consistent with gastric obstruction.
16-4. Genci:ef al, “BioEinteries intragastric Balloon: The Italian Experience. with 2,515 patients” (2005) 15 Obesity Surgery: 1163. ‘
37 of 47
aay
oe
117:
118:
119,
121,
124..
@ ‘Theradiology was consistent with gastric obstraction anid collapse of the small bowel.
Alternatively, even if the gastilc. outlet was not physically obstructéd, Dr Merrett coriceded ‘thatthe dintragastric balloon -would-create stasis and reduce the. rate: of aiainage from the
‘
stomach;
Therefore, despite Dr Merrett’s advice; Dr Prichard was ill-adyised in. deciding to ‘treat Mrs Holt's symptoms conservatively rather than proceed. with surgery-on 30 or 31 January 2009
‘to removeithe intragastric ‘balloon snd.telieve the gastricdistension:
Further, on:31 January 2009, four litres of saline were administered completing at 12:15pm and a further litre by-4:35pm.
At8:35pm on 31 Janiuaty’2009, Dr Prichard reviewed Mrs-Holt attd noted minimal drainage (16mil) from the nasogasttic. tube, He ordeted the tube be capped sind gentle fluids coirimenced orally. Di Prichatd advised nufsing’staff to cease fluids and téecommience gastric
diainage if Mis Holt did not tolerate the cappitig atid oral fluids,
There ‘is-no record of Mis Holt’s urinary output during this period but, in:the-context of the
large-volume of fluid administered, it is unlikely that minimal drainage from the intragastric
“ tube deflected 4 sali volume of fluid in the stomach, This extra fluid would contribute to.
distetision in the stomacli, whethier or not thé pylorus was physically obstructed, At 1:00pm on 31 January:2009, Mrs Holt'became nauseous and had abdominal pain.
However, when mursing staff contacted Dr Prichard at 12:05am ‘on 1 February 2009, Mrs Holt’s: symptoins Had settled following administration ‘of anti-nausea medication and
iriorphiiieas ordeied by the medical féllow of duty. Mrs Holt was considered stable,
No attempt'was-made to replace Mrs Holt’s:nasogastric tube.
As Associate Professor Danne'pointed out to:the Court; minimal drainage. from a nasogastric
tube.in cltciiitistahees where there is also food in the stomach can.also indicate the tube is
blocked.
However; ‘the CT report did not refer to the food.coritents that Associate Professor Danne
and Dr Prichard identified when they looked at the films.
38 of 47
133,
Further, there is no evidence that anyone tried ‘to manipulate the: nasogastric tube or use.a
larger bore tube which would sediice the risk of blockage.
It is also unclear why ‘the nursing staffand the medical fellow chese not to-implement Dr Prichard’s eatlier order to.cease fluids and recommence.gastric drainage if Mrs Holt:did not
tolerate.capping of her nasogastric tube:and oral fluids.
Associate Professor Danne told the Court that, having diagnosed 'an obstruction:
“Sf my first-attempt to vélieve-the obstiuction with a simple nasogastric tube doesn't work,
then I- would be.doing something else and that sométhing else would be surgery.”
On ‘the other hand, Associate Professor Ballal told the Court he would try to. wait until after:
the weekend before: commiencitig a laparotomy:
“she's-very, very high-riskand I wouldn't want to embarkon anything like that on a weekend
when there's less expertise-around. I would rather wait until a Monday when there is avery
large number of expertise around in cuse things do not-go as planned.”
However, even with that proviso, Associate. Professor Ballal aiso agreed that, if the nasogastric tube was iiot draining so. the stomach was becoming more disterided, any upper gastrointestinal surgeon would know that perforation was a:teal risk and.would do whatever they:could to minimise that risk even if they did-not have’the.expertise to-extract the. balloon
endoscopically:
Accordingly, [am table to understand why an experiénéed gastroeiterologist like Dr Prichard. did :not. check that Mrs Holt’s nasogastric tube was operating-cortectly or make alterative arrangements :to address thé. potential consequences.of failure to drain fluid from
the naso-gastri¢:tibe.
Associate Professor Danie and Dr Prichard agreed ‘that thé stomach perforation occurred on
Accordingly, I find: that. ineffective use of: the nasogastric ‘tube in conjunction with administration of Jarge amounts of fluid and ‘failure to monitor fluid output could have
contributed to perforation of Mrs‘Holt’s:stomach:
39 of 47
|!
i tt
134,
139,
140,
141,
142,
143,
‘Therefore, Dr Prichard’s decision ‘to cap the nasogastric ttibe on 31 January rather than
check whether it was patent and operational may have:contributed to Mrs Holt’s death.
In the absence of evidence about what De Piichard would liave done ‘and how Mrs Holt
“-wotild. have responded. if the nasogastric tube had ‘been reinstated, I ati utiable to. say ‘whether or to what degree the nursing staffs failure to comply with the cojisultant
gastioehtetologist’s direction influenced Mrs Holt’s death, Recommendation 3
At 8:35pm on.1 February 2009, Mrs Holt’s condition ‘had detetiorated. Her blood pressure
-was 200/100mmHg;:she was:sweating; nauseous and complaining of pain.
Mrs Holt initially responded to Maxalon and morphirie but, by 12:00am on.2 February:2009,
the pain was ongoing and. she was tefetred to the Intensive Care Unit with a differential
diagnosis:of gastric perforation,
The. Intensive Care Fellow confirmed the diagnosis. of gastric petforation and sought
assistance fiom the on-call surgeon, Associate Professor Peter Danie,
At 1:45am on 2 February 2009, Associate Proféssor. Danne pérformed an emergency
laparotomy.
‘The laparotomy revealed:
« a large perforation of the gastric wall high'up on the:lesser cuitve due to gross distetision
of the-stomach with-ischaemia-and/or or mechanical splitting at that point;
“e contamination of :the gastric contents (a large amount of food ‘and -fluid) into the
petitoneal cavity.and-obvious petitonitis; and
‘-@ balloon obstruction ofthe gastric outlet,
On the evening of 1 Februaty 2009, Dr Prichard did-not anticipate Mrs Holt’s perforation.
He told :the court that. he yvould, have -had ‘no ‘hesitatioti in ‘contacting Dr. Merrett if her
‘Condition had detetiorated sufficiently to justify removal.of her intragastiic balloon,
Further, Dr ‘Prichard remained:unconvinced that-Mrs Holt’s. perforation ogcurred because of
igross'distension of her‘stomach on;the:evening‘of 1 February 2009.
De Prichard suppoited his opinion by indicating that Mrs Holt’s stomach was never grossly distended. Further; he said.there was no evidence Of pressiife tiecrosis‘related to the balloon
40 of 47
jee
144,
145,
147,
and the perforation was anatomically well removed from the site of the intragastric balloon
_ and the alleged blockage.
‘However, without seeing Mrs Holt, Dr Métrett accepted that ‘distension, of Mts Holt’s stortiach preceded and caused the perforation but he still did not accept that the distension
was’ caused by obstruction by the iivtragasttic ‘balloon.
Dr Merrett also accepted that stasis ‘was a normal tesponse tothe intragastric balloon, This would have slowed drainage of the stomach whether or not the gastric outlet was also
significantly blocked;
aity presumption is, that. the stomaeh was distended and in the. presence. of other factors, perhaps-vascular insufficiency that was enough to,produce.an ischemic perforation. T think
that's. a likely reason.”
Accordingly, Dr Merrett told the Court that he would now consider vascular disease as a
conitta-indication to placement of ani intragasttic balloon:
“T would consider it more éarefiully ‘than I have in the past. I know for surgical weight loss and pailenis ‘having Jap-banding and various bypass type procedures, vascular disease would be a major contraindication. Because placement.of balloon is an endoscopic procedure, vascular disease wouldn't have seemed to:be such an important issue but I think given that gastric distension occurs, ts possible that we'll consider it moré as. a
contraindication dn the future,”
Having considered all these opiiiions, I have formed the view that the perforation. of Mrs Holt’s stomach: would. tiot necessarily, ot probably, have: been caused directly by: the intragastric balloon pressing.on ‘the stomach wall,. Therefore, it: would-not necessarily be
: physically related to the position of the balloon.
Rather, perforation of Mrs Holt’s stomach resulted from, distension caused by the increasing volume. of the ‘stomach: content. This volumé in the stomach would. reflect fluid accumulation which was-unable:to redistribute through the gastrointestinal system ‘because of either capping: oF blockage of the intragastric: tube and/or significant obstruction of the pylotie outlet by the ‘balloon. and/or stasis caused by the balloon and/or; possibly, small
bowel effects:caused’by the abdominal incisional hérhia.
41 of 47
Ser
149,
153,
154,
Further, in the context of Mrs Holt's' known co-morbidities and circumstances including her intragastric balloon, vomiting, vascular disease, atid abdominal:incisional hernia with recent difficult recovery from surgery, T have. formed the opinion that the: préssure required to breach the stomach wall at its weakest point-was probably'‘less than Would otherwise have been the case. The weakest point could be determined by existing or developing ‘ischaemia
of ‘the:stomach ‘wall and/or.physical pressure points from the fluid or the balloon that would
Dr Prichard’s managetrient of Mrs Holt was independently reviewed by Associate Professor Paui Desrnond, Ditector of the Department of Gastroenterology at St Vincerits Hospital.
Tn:the opinion of Associate Professor Desmond, Dr Prichard’s management of Mrs Holt
“was:
“apptopr' iate and would be widely accepted by. :the majority of Gastroenterologists
Pp actistig: in Aiste aiid,”
Associate Professor: Desmond explained his opinion by referring to Dr Prichard’s lack of personal experience with intragastric balloons and Mis Holt’s stable condition when Dr Prichard reviewed her on 30 & 31 Janvary and 1 February "2009; He. also’ says. that ischaemic gastric perforation was atl unforeseeable complication of Mrs Holt’s presentation
duritig this period.
On its face, Associate Proféssor Desmond’s opinion applies the civil standards required. to determine whether ot not Di Prichard was negligent in his management of Mis Holt. These standards-are onily of peripheral relevance to.the coronial investigation of Mrs Holt’s death.
‘Froth a systems perspective ‘and in fulfilling my prevention role, Assoeiate Professor
Desmond’s opinion raisés further Wider issues about the way in which gastroenterologists:
sréspond to-unusual circumstances.and assess the advice. of-their colleagues.
In particular, in forming the opinion that it was appropriate. for-Dr Prichard to cap Mrs
-Holt’s nasogastric'tube, Associate Professor Desmond stated that it was normal practice to
allow free drainage without ‘suction from. ‘the nasogastric tube, Associate Professor Désmorid also-acknowledged that-it was possible that the slow drainage reflected’ a blocked
42-0f 47
156,
ot kiviked tube vather than an empty stotriach. However, in these circumstances, the patient
would usually Voniit.and would definitely be nauseated,
T note that'Mrs Holt became nauseous and had abdominal pain at 11:00pm ‘on 31 Jamiaty
. 2009, that is three hours after the nasogastric tube was capped. In that sense, Associate ‘Professor ‘Desmond, supporis..my opinion that Dr Prichard’s capping. of Mrs Holt’s
nasogastric ‘tube and failure to: review its effects was one of a tuniber of factors that contributed to. Mis Holt’s:death.
Having investigated the’circutristances of Mrs Holt’s:death, Ihave formed the opinion that,
despite and ‘because of. her Obesity Class III, ‘Mrs Holt was always an unsuitable: candidate
for'an intragastric balloon because: ie Mrs:Holt was'77 years-old;
disease; and e Mts Holthad previous Nissen fundoplication and cholecystectomy.
Further, evén:if Mrs Holt’s fitst intrapastric balloon-was justified, Dr Merrett-should never have agreed to-place her second intragastric balloon because he knew or should have known
that:
.¢ Mrs Holt-was now 79 years old;
® Mis Holt’s:prior-co-morbidities continued; ‘© Mrs Holt'was riow Obesity:Class TL; @ Mis Holt had:ateewirent:abdominal incisional hernia;
e Mrs Holt refused. to :adopt alternative measures to tmanage her discomfort from
recurrent abdominal incisional hernia; and
correct her incisional ‘hernia.
43.0f47
159,
160,
161,
. Therefore, patients who seek insertion of-an:intragastric: balloon must be carefully screened
anid rejected if they do not othérwise meet:the guidelines determined bythe:gastroenterology
profession.and the manufacturer of the device: Recommendation.4
‘Mis ‘Holt did net wécover from’ perforation of Her stomach. Peritonitis is the usual
‘consequence:of perforation. Associated ischaertiia was always’a possibility in.a woman with
her.cozmorbidities.
Associate Professor Danne told the:Court that the cascade of recurring episodes of ischemia
that required further surgery was, in his-opinion; directly caused’ by the obstiuction bythe
~ ‘balloon,
However, this is too simplistic. ‘Ini-miy opinion, a series of ‘systems faihives led to Mrs Holt’s
stomach perforation and her failure to-:respond'to intense management of the consequences.
These:systenis failures included:
@ Mrs Holt’s insistence on having a intragastric balloon as a ‘one stop’ solution to her
obesity issues;
». Mes Holt’s iapid-weighit loss and its possible association with development of her first
abdominal incisional-hernia;:
@ ‘Mis Hoit’s slow recovery from surgery to correct. the abdoniinal incisional hernia
which-resulted in on-going inifection and a écurrent hernia;
e Mfrs Holt’s weight. gain. while she recovered fiom surgery ‘to correct the abdominal.
incisional hernia; ,
‘e Dr Mertett’s expressed ‘belief that significant gastric obstruction was not a known,side
effectof: intragastric balloons;
« Dr ‘Merrett’s insertion ofa second intragastric balloon agaitist ‘the advice-of Mrs Holt’s
general practitioner, her respiratory physician.and her usual gastroénterologist; 'e Developiéiit-of significant paattic abstraction arid/or stasis associated with stomach
44 of A7 -
© Mis Holt’s. transfer .by ambulance to the Epworth Hospital rather than Frankston Hospital:on 30 January 2009;
Dr Piichard’s acceptance of Dr Mertett’s advice that it was unlikely that :the initragastiic: balloon would. significantly. obstruct Mrs Holt’s pyloric outlet and she should be stabilised.and ‘hydrated over.the: weekend; ‘
Dr Prichard’ failure. to. check ‘the intragastric tibe for blockage prior to capping it on
¢ Administration of five litres of intravenous fluids on 31 January 2009 without measuring fluid outputs or continuing to-use thé intragastric tube for draiiiage;
¢ Failure of Epworth tiedical ‘arid nursing staff to notify Dr Ptichard ‘that Mis Holt was not tolerating capping of lier intragasttic tube;
significant. apparent Dbstrnetign
@ Mrs Holt’s short: term response to ‘Maxalon and morphine so. that suspicion of
perforation was allayed ‘onthe eventing of. IF ebruary: 2009,
Many of these systems issues arose becausé.Dr Meirett was the ‘sole.ptovider of-services to place: intragastric balloots: in. Victoria and Dr Prichard was inexperienced with intragasttic’balloons.
Correction of any one of these system failures may have ‘preventéd Mrs: Holt’s gastric, perforation and/or changed the circumstances of Mrs Holt’ 8 death,
Pursuant to section ’72(2) of the Coroners Act 2008, L make the following recommendation(s) eontiectéd with the: death:
AS of 47
. That thé Royal Atistralasian :College of Physicians and thé Gastroenterological Society of
Australia facilitate-a training and mentoring service arid a recording mechanism for adverse
—
events for meiibers who piactice in bariatric gastioenterology using intragastric balloons,
2: That the Royal Australasian. College of Physicians and the Gastroenterologioal. Society: of
1 Australia develop. a clinical update and/or media sélease advising gasttoenterologists
" abdominal theénia. while the: balloon is in place and particularly during, periods of rapid weight loss.
3,. ‘That the Royal Australasian College of Physicians and the: GastiGénterological Society of
Australia develop a clinical update and/or thedia felease advising gastroenterologists trot to
__ place a second intragastric balloon ina patient with Mrs Holt's characteristics and comorbidities:
i 4, That the Epworth Hospital ensures nursing staff-and hospital medical staff follow the
directions of consultant physicians arid, where they choose ‘not to follow thosé directions
thatthe reason for not doing ‘$0 is communicated back to. the consultant physician.
5, That the Royal Australasian College of Physicians and the Gastroenterological ‘Society of i Australia develop a clinical update and/or media release advising gastroenterologists that | patients who seek insertion of an, intragastric balloon should be carefully screened and rejected if they do not othetwise ineet the guidelines determined by: the gastroenterology
profession and:the:manyfacturer of the.device,
'| direct that‘ copy of this finding 'be provided to the following:
President , Gastioenteroiogical Society of Australia President, Royal Australasian:College of Physicians 7 ‘Group Chief Executive, Epworth Healthcare
460047
i i if i i
Signature:
Date;-13.August:2013
47 of 47
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