Interventional gastroenterology

Death after “unwise” IGB surgery sparks call for new guidelines

Gastroenterologists have made several changes to their practice following the death of a woman who had intragastric balloon (IGB) surgery despite it being contraindicated, a NSW coronial inquest has been told.

A 67-year old NSW woman, Margaret Pegum, died from sepsis caused by a perforation in her stomach wall on July 6, 2015, a fortnight after her IGB was further inflated, the Coroners Court of NSW heard.

The woman had the device implanted around two months earlier by Dr George Marinos, a highly experienced gastroenterologist who had performed over 700 such procedures, at the GBA Clinic in Sydney.

Mrs Pegum – who was classified “Class III obese” and had obstructive sleep apnoea – had previously undergone a partial fundoplication in 2012 to repair a hernia.

The coroner noted that previous gastric surgery was recognised as a contraindication for IGB in product information and medical literature, because it elevates the risk of stomach perforation.

Dr Marinos was “well aware of this fact” but believed the risk of perforation would be mitigated by the fact her fundoplication had been partial and the use of a Spatz 3, which can be inflated incrementally at lower volumes than an alternative gastric balloon device, the inquest heard.

Considering Mrs Pegum’s strong clinical need for weight loss and enthusiasm to have the procedure he concluded it was not too dangerous to proceed.

But the court heard Dr Marinos’ assumptions around risk mitigation were not supported by peer-reviewed evidence and his decision to proceed was “unwise”.

In evidence, Dr Marinos accepted this and acknowledged the lack of evidence that it was safe and appropriate to proceed. He expressed “sincere and genuine” regret for Mrs Pegum’s death, and said his practice – now renamed BMI Clinic – had introduced some important changes to patient selection procedures and no longer offered IGB procedures for patients who have had any kind of fundoplication.

The court accepted there had been “genuine reflection” by Dr Marinos and his team over the incident, and acknowledged the changes being made at the BMI Clinic.

The coroner also noted that Mrs Pegum was not informed about the recommendations on use of IGB for patients with prior gastric surgery or its low success rate.

“It cannot be known whether [her] decision concerning an IGB procedure would have been different had she been advised that it was contraindicated in her case, and that it had relatively low prospects of providing sustained weight loss,” said Deputy State Coroner Elizabeth Ryan.

“Given her reported enthusiasm for the procedure, it is possible her decision would not have changed. Nevertheless it was information she and any other patient in her situation was entitled to know.”

Dr Marinos said a revised Informed Consent document had been adopted providing greater detail about the risks associated with IGB. And patients were now directed to contact the clinic ‘immediately’ to report ‘any significant symptoms (including vomiting) to ensure these are managed appropriately.

More broadly, the case highlighted a need for a professional body to provide more guidance to clinicians who perform the procedure, particularly given that bariatric procedures are becoming more popular, the coroner concluded.

She recommended that the Australian and New Zealand Metabolic and Obesity Surgery Society consider developing guidelines for IGB procedures and a data registry of outcomes for all bariatric procedures.

These guidelines should cover patient selection and exclusion criteria, indications and contraindications, risks, appropriate follow up care and advice. The register could provide evidence-based information to guide clinicians and patients about bariatric options, she suggested.

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