FDA reports five deaths related to weight-loss balloons

Five Die While Using Obesity Devices, FDA Says

Gastric balloons are among many different devices on the market to treat severe obesity.

FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. 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. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly. The enterprise said it "received no product liability-related claims in connection with these five cases", and noted that the incidence rate "remains less than 0.01%", exactly what's specified in the directions of use of the gastric balloon. Three patients died 1 to 3 days afterward.

Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert.

The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.

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The other two deaths occurred within a month or less of having the procedure. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.

According to NBC News, Apollo says it reported the deaths to the FDA itself.

MORE: I Swallowed a Balloon For Weight Loss and Lost 40 Lbs. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation.

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They said that from January 2006 to March 2017, 21 patients using the Orbera device died.

A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve US patients.

'The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity'.

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