FDA: Safety Alert on liquid-filled intragastric balloon systems

Editor's Note

The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery (San Diego, California), and one involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc (San Clemente, California).

At this time, the FDA says it does not know the root cause or incidence rate of patient deaths, nor have they been able to definitively attribute the deaths to the devices or insertion procedures.

All five deaths occurred within 1 month or less of balloon placement.

Posted 08/10/2017] AUDIENCE: Surgery, Gastroenterology, Health Professional ISSUE: FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.