The U.S. Food and Drug Administration notified healthcare providers on June 4 that five more deaths were reported in patients using weight loss balloons, taking the total death toll to 12 since 2016.
The reported deaths were due to liquid-filled intragastric balloon devices made by ReShape Lifesciences Inc. and Apollo Endosurgery Inc., the regulatory agency said in a news release.
The balloons work by taking up room in the stomach to make the patients feel full faster.
The FDA approved labeling changes to reflect deaths possibly associated with weight loss balloons, and is monitoring complications related to their use.
"The FDA continues to work with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices," William Maisel, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release.
