Balloon obesity devices linked to 5 patient deaths, says FDA

Molly Cranna for TIME

The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice. 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.

Four of the cases involve Apollo Endo Surgery's Orbera Intragastric Balloon System while one involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.

"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", the FDA said.

The five people died within a month or less of having the balloons inserted.

The company said the product can help overweight people lose more than three times the weight that diet and exercise alone can. "Patients with questions about this FDA update should contact their physicians directly". In February, the FDA had issued a preliminary warning to medical providers to carefully monitor such reactions.

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Apollo Endosurgery (NASDAQ:APEN) says its ORBERA device has proven to be safe over the years in clinical trials and since its approval by the FDA in August 2015.

The company has not received product-liability claims as a result of any of the deaths, it said.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

Apollo said it reported all five deaths of Orbera patients in the U.s., Mexico, Brazil and Great Britain to the FDA and has had no indication that any were related to the device or its insertion procedure.

'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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