FDA updates gastric balloon warning after 5 deaths

FDA updates gastric balloon warning after 5 deaths

FDA updates gastric balloon warning after 5 deaths

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

Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.

An obesity treatment that involves placing balloons inside the patient's stomach may have resulted in five deaths since 2016, the U.S. Food and Drug Administration said in a new warning. Three people died just one to three days later.

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.

It is unclear whether the devices or the surgeries used to implant them caused the deaths, officials said. The other two died within a month.

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"The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System)", the FDA added. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery. The use of the balloon is complemented with counseling and nutritional support or advice.

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 US patients.

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

Last year America expended $2.5 billion on commercial weight-loss balloons. The agency recommends that doctors closely monitor patients who are using these devices.

"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.

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