Weight Loss Intragastric Balloons Linked To 5 Deaths

Georgia Reed
August 13, 2017

Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full.

Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food. In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach. Both systems can be placed in the stomach for up to 6 months to help obese people lose weight.

The liquid-filled intragastric balloon systems have been used as a treatment for obesity, said the FDA alert issued on Thursday. 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 (e.g., gastric and esophageal perforation, or intestinal obstruction).

"The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc.to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation", the agency said. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"-one from each company". The other is a dual balloon system made by ReShape. The agency recommends that doctors closely monitor patients who are using these devices.

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In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.

Still, the company said it has not received product-liability claims in connection to those five cases, and it has not received information from physicians and hospitals indicating that its Orbera device had caused those deaths.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.

Apollo Endosurgery also said that 21 deaths have been reported in the last 11 years, from January 2006 to last March, out of more than 277,000 Orbera balloons distributed during that time period.

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