Five People Die After Using Weight Loss Balloons for Obesity

Five Die While Using Obesity Devices, FDA Says

Five Die While Using Obesity Devices, FDA Says

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.

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States regulators have revealed.

It's still unclear whether there's a definitive link between the devices and the deaths. The balloon is created to remain in place for several months.

The alert from the FDA does not mean that the agency has definitively proven that the balloons caused the deaths, but that they are looking into it.

The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient's stomach to help them with portion control.

Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include USA patients.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon. "Patients with questions about this FDA update should contact their physicians directly". The exact causes in three of the deaths remained unknown.

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

The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System.

This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said. These are spontaneous overinflation, with liquid or gas, of the devices and acute pancreatitis.

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