Five More Deaths Associated With Anti-Obesity Balloons, FDA Says

At least five more patients have died after using intragastric balloons to treat their obesity, bringing the total number of fatalities over the past two years to 12, the FDA said.

“We have been carefully tracking adverse events, including a total of 12 deaths over the past two years that have been reported in patients with two balloon devices used to treat obesity” said William Maisel, director of CDRH’s Office of Device Evaluation.

The devices, liquid-filled balloons branded as the Orbera Ingragastric Balloon System and the ReShape Integrated Dual Balloon System, are manufactured by Appolo Endosurgery and ReShape Lifesciences, respectively.