7 reports of death tied to obesity treatment since 2016
by Kristina Fiore, Deputy Managing Editor, MedPage Today August 10, 2017
The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity.
In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. In three of those cases, the patient died within one to three days of having the balloon inserted.
Four of these reports involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical.
The FDA noted that for these five cases it doesn’t know “the root cause” of the problem. It also can’t determine the incidence rate of patient death, nor could it “definitively attribute the deaths to the devices or the insertion procedures for these devices” — meaning they couldn’t tell if death was due to gastric or esophageal perforation, or to intestinal obstruction, or to some other cause.
Two additional reports of deaths in the same time period — since 2016 — were also noted in the FDA letter. One was related to gastric perforation with the Orbera Intragastric Balloon System and one to esophageal perforation with the ReShape device.
The FDA said it’s working with both companies to better understand what’s causing these issues, and to monitor potential complications of acute pancreatitis and spontaneous overinflation. It also emphasized that it had mandated ongoing post-approval studies for the devices.