The U.S. Food and Drug Administration has received reports of five deaths associated with liquid-filled intragastric balloon systems used to treat obesity.
In an alert issued Thursday, the FDA said four reports involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
In all five cases, death occurred within a month or less of the procedure to place the balloon. In three reports, the patients died in as little as one to three days later.
“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices,” the FDA said in a statement.
The intragastric balloon systems work by placing one or two deflated…