FDA warns of overinflation, acute pancreatitis with certain intragastric balloons for weight loss

The FDA on Monday issued a Letter to Health Care Providers detailing risks for hyperinflation and acute pancreatitis observed in post-approval studies for two liquid-filled intragastric balloons indicated for weight loss, both approved in 2015 and manufactured by Apollo Endosurgery.In the studies, 2.3% (6 of 258) of participants using the Orbera balloon system experienced hyperinflation of the balloon with events occurring from within a week of a placement to 23 weeks; 1.3% (2 of 159) of participants using the ReShape balloon system experienced acute pancreatitis — one participant at 3Read More

Share on facebook
Share on twitter
Share on linkedin