On April 27, the FDA issued a letter to clinicians providing details on two postapproval studies of liquid-filled intragastric balloon devices used for weight loss.
The agency first reported in 2017 two specific risks for the Orbera and ReShape liquid-filled intragastric balloons: spontaneous hyperinflation and acute pancreatitis. In the new letter, the FDA said that the postapproval studies found a small number of these events, whereas there were none reported in the studies used in their premarket approval applications. In the Orbera study, six of 258 (2.3%) patients experienced balloon hyperinflation, and no hyperinflation events were reported from the ReShape study. In the ReShape study, two of 159 (1.3%) patients experienced acute pancreatitis, and no events of acute pancreatitis were reported in the Orbera study.
The FDA also provided updates in 2017 and 2018 about the potential risk of death with liquid-filled intragastric balloons. No deaths were reported in the postapproval studies; however, 18 deaths have occurred worldwide since the devices were approved in 2015, including eight patients in the U.S. (five with Orbera and three with ReShape).
Sales and distribution of the ReShape device were stopped on Jan. 1, 2019, but the FDA will continue to work with Apollo Endosurgery, the manufacturer of the Orbera device, to ensure that the product labeling includes the postapproval study findings.