Deaths Reported Following Placement of Stomach Balloons for Obesity Treatment

By Kelly Young

Edited by André Sofair, MD, MPH

The FDA is recommending that clinicians closely follow patients who've had liquid-filled intragastric balloon systems placed to treat obesity.

The alert follows reports of at least five deaths — four in patients with the Orbera Intragastric Balloon System and one with the ReShape Integrated Dual Balloon System — within days or weeks of the procedure.

The FDA has not been able to pinpoint the root cause of death, or whether the deaths are tied to the device or to the procedure to place the device. The agency notes there were two additional deaths related to treatment complications — gastric and esophageal perforations.

Earlier in 2017, the device makers added warnings to their labels noting an increased risk for acute pancreatitis and spontaneous balloon over-inflation.