Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Henrietta Brewer
August 12, 2017

The weight loss system, which the FDA first issued a safety warning for in February, involves the inflation of balloons in patients' stomachs via a micro-catheter. In three cases, the person died one to three days afterward.

"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices", the agency said.

The agency is also reviewing two additional deaths, one from each company, that could be related to "potential complications associated with balloon treatment".

The FDA said that it has not yet determined whether the weight loss devices or the surgery that implanted them is the cause of the deaths but it already issued an alert so doctors would closely monitor the patients who have them.

Four deaths involve the Orbera® Intragastric Balloon System made by Apollo Endosurgery and 1 death involves the ReShape® Integrated Dual Balloon System manufactured by Reshape Medical. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries. Both systems can be placed in the stomach for up to 6 months to help obese people lose weight.

The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices. Apollo, which says it has sold 180,000 of the devices globally, said it was preparing a statement. The exact causes in three of the deaths remained unknown. It has not received any product liability claims in connection with the five deaths.

A fourth patient died from a stomach hole and a fifth from a tear in the esophagus.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.

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