NSW Deputy State Coroner Magistrate Ryan handed down her decision regarding post-operative bariatric surgery complications resulting in the death of a much-loved mother and grandmother on 26 April 2018¹. The patient died from sepsis as a result of gastric perforation following the procedure.
Aside from the statutory obligation to determine cause and manner of death, the inquiry centred on three key issues:
- Whether the patient was a suitable candidate for the bariatric procedure known as IntraGastric Balloon procedure [IGB]
- Whether the patient was warned of and consented to the risks of IGB
- Whether the post-operative advice and care was adequate.
The patient, aged 67, had struggled with weight gain following the birth of her two children. Her past medical history included anxiety, hypertension and sleep apnoea. Importantly, severe reflux necessitated a partial fundoplication to be performed in 2012.
In January 2015 the patient had a BMI of 46 and had suffered two seizures thought to be related to her sleep apnoea – directly associated with her obesity. This led her to research surgical options that might be available to her. This included a consultation with another surgeon who recommended reversal of her fundoplication as well as substantial dietary and lifestyle variations. The patient did not return to that surgeon following the consultation.
After researching the IGB, an inflatable balloon temporarily placed into the stomach to create the feeling of fullness and limit the capacity for food intake, the patient attended a weight loss clinic, had pre-operative consultations and ultimately underwent the procedure on 22 June 2015.
The inquest heard evidence that the surgeon used the Spatz 3 device. In 2015, the manufacturer of the device did not publish directions on its use, rather it referred to the directions for a device called the Obera fixed device which was formally in use before the Spatz device was introduced.
The Obera directions which were current at the time the procedure was performed stated that one of the contraindications for its use was ‘prior gastrointestinal or bariatric surgery’.
The court heard evidence that peer-reviewed research current at the time listed prior-gastric surgery as a contra-indication and that the Position Statement of the American Society of Gastrointestinal Endoscopy identified previous gastric surgery as ‘an absolute contraindication’.
Risks versus benefits discussion
The surgeon gave evidence justifying his decision to proceed with the IGB procedure. He said that he considered the patient’s partial fundoplication placed her at a much lower risk than had she undergone a full fundoplication previously. The experts disagreed with this evidence, relying on the peer-reviewed literature available at the time which made no distinction between the extent of previous gastrointestinal surgeries nor the two devices. The Coroner concluded that performing this operation in these circumstances was “a significant error of judgment” and that “there was no evidence to support the proposition that an IGB device . . . was safe or appropriate”.
In relation to whether the patient was warned of the risks and benefits of the procedure the Coroner could find no reference to these discussions in the surgeon’s notes stating ‘These are wholly inadequate consisting in each case of little more than a few scrawled lines’.
In relation to whether or not the patient ought to have been made aware of the contraindication of previous gastrointestinal surgery as per the manufacturer’s instructions, she stated that “There can be no doubt that [the patient] was entitled to know this”.
Post-operative care and advice
The Coroner found that the post-operative advice given to the patient led to a delay in her seeking treatment. The patient started vomiting and dry-wretching post-operatively and became severely dehydrated. The post-operative instructions stated “If after two days you are experiencing any severe nausea or vomiting” the surgeon should be contacted. The Court heard evidence from the patient’s son that she did not seek assistance earlier as she was following the instructions. Therefore, by the time the patient presented to hospital, she was so severely dehydrated, the gastric perforation and resulting sepsis was past the point of no return.
The Coroner, after hearing expert evidence, found that, had the patient sought medical attention on 23 June (day one post-op) “her chances of surviving would likely have been enhanced”.
Lessons for our members
- Whilst there is always debate in medicine about the validly and efficacy of various trials and literature, peer reviews and literature will frequently be referred to and relied on by experts and the courts in a legal setting. We encourage you to stay up to date in your speciality.
- In this case, although the surgeon said that he did weigh up the risks versus benefits of the prior gastrointestional surgery, there was a missed opportunity to have his recommendation peer reviewed. A second opinion by an equally-qualified surgeon can only benefit the doctor and the patient where there are increased risks or uncertainty as to next steps.
- The doctor’s lack of clear and thorough documentation led to blunt criticism by the Coroner. Contemporaneous entries in the medical records are crucial for any defence of a complaint or claim.
- Ensure your post-operative instructions are clear and thorough and ensure patients and their carers understand that advice or treatment can be sought at any time post-operatively.
It is important to note that the surgeon was commended for his co-operation, insight and significant changes to his practice since the tragic event. He was deeply remorseful.
The Coroner recommended that the Australian and New Zealand Metabolic and Obesity Surgery Society consider developing guidelines and compiling outcome data for all bariatric patients.