Stomach Balloons Get New Warning Following Deaths

By the Editors

The FDA is warning clinicians about the possible risk for death in patients who have liquid-filled intragastric balloons designed to promote weight loss.

Since the agency's last warning, five more patients have died. Four of these deaths were due to gastric perforation 1 day to 3.5 weeks after the balloon was placed. Less information was available on the fifth fatality. This brings the total number of deaths to 12 since 2016.

The balloons are intended to be placed for a maximum of 6 months. Clinicians should warn patients of the possible complications, including balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation. Patients should be closely monitored during treatment for acute pancreatitis and spontaneous hyperinflation.