Health Care

FDA updates gastric balloon warning after 5 deaths

FDA updates gastric balloon warning after 5 deaths

The balloon is created to remain in place for several months.

Four of the patients were implanted with Apollo Endosurgery's Orbera balloon, while the fifth was implanted with ReShape Medical's Integrated Dual Balloon System.

At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.

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 procedure involves a liquid-filled balloon placed in the stomach to make the patient feel more full and eat less.

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.

Five Die While Using Obesity Devices, FDA Says
FDA updates gastric balloon warning after 5 deaths

The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.

The company 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%", which is in line with what it reports in the directions for use of the device.

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. Three patients died 1 to 3 days afterward.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices.

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