Authorities warn that two types of gastric balloons may have been a factor in five deaths shortly after surgery to implant it.
A common obesity treatment growing in popularity may have been connected to the deaths of five people who had the treatment shortly beforehand, although authorities are still trying to figure out what happened. As a result, the Food and Drug Administration is warning the public about gastric balloons, which is a treatment involving putting balloons inside a patient’s stomach in a bid to lose weight.
Four people died who recently had the Orbera Intragastric Balloon System, while the other person had used the ReShape Integrated Dual Balloon System. The FDA isn’t sure what the root cause of those deaths are, or what the death rate is of people who use the devices, and they can’t even say for sure it was the balloons that caused them. But all five people died within a month of getting the balloons implanted, and three died within three days.
The FDA is also looking into a pair of other deaths involving gastric balloons, one from each company.
“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,” the FDA said in a statement. “Four reports involve 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.
“All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. 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 (e.g., gastric and esophageal perforation, or intestinal obstruction). The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System).”