FDA Updates Warning on Intragastric Balloons After 5 Deaths

FDA Updates Warning on Intragastric Balloons After 5 Deaths

The FDA last week issued an updated warning letter on intragastric balloons to alert health care providers to 5 deaths that occurred over the last year in patients treated for obesity with the liquid-filled balloon systems.  The original warning, that the FDA issued 6 months ago,  addressed two possible adverse events, over inflation with either liquid of gas as well as instances of acute pancreatitis.

All of the deaths occurred within a month after the balloon placement, in 3 cases one to three days following. In several other cases patients developed acute pancreatitis and the balloons were removed early. Despite the timing, the FDA has not drawn conclusions about the links with the balloon.

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)

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.

Intragastric Balloons Used as an Alternative to Bariatric Surgery

Physicians insert gastric balloons by means of a minimally invasive endoscopy. They they inflate the balloons with a sterile liquid or gas and they stay in place for 6 months. The intended result is for patients to lose from 5 to 10 percent of their weight because they eat less feeling fuller given the displacement caused by the balloons.

The procedure, a less invasive and less expensive intervention than gastric bypass surgery, has only been performed 5,000 times in the United States since the FDA approved its use in 2015. Physicians have performed the procedure 220,000 times, largely in Brazil, Mexico and Europe.

The FDA has said that it will work with the manufacturers to better understand the causes of the deaths and will monitor complications. The Agency also urged physicians to monitor closely patients that they implant with the devices.




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