Five additional deaths have occurred in patients with two liquid-filled intragastric balloon systems used to treat obesity, the FDA announced on June 4.
Since 2016, the FDA has received reports of 12 patient deaths involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System, which both have a maximum placement period of six months. The agency has approved labeling changes to reflect this information and continues to monitor deaths and other related complications, including perforation of the stomach wall or esophagus, acute pancreatitis, and spontaneous hyperinflation.
The FDA continues to work with device manufacturers Apollo Endosurgery and ReShape Lifesciences to better understand the issue. Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems, the agency advised.