American Bariatric Surgery Society OKs Intragastric Balloons

Marlene Busko

February 27, 2018

The American Society for Metabolic and Bariatric Surgery (ASMBS) has just added intragastric balloons to its list of devices and procedures that it endorses.

The society reviewed the evidence and made the endorsement with the hope of getting American insurance companies to cover the procedure, in which a balloon is inserted into the stomach and filled with liquid or air so that an obese patient feels full sooner. The device is removed 6 months later.

Three such devices were approved by the US Food and Drug Administration (FDA) in 2015 and 2016 — and earlier in Europe — but the procedure is not covered by insurance in the United States.

Moreover, last year the FDA issued two safety alerts for the two liquid-filled devices.

As announced in the February issue of Connect, the society's online news magazine, the ASMBS previously approved the Roux-en-Y gastric bypass, duodenal switch, sleeve gastrectomy, and adjustable gastric banding procedures, and the intragastric balloon procedure is deemed as midway between surgery and medication.

"Intragastric balloon procedures may fill a treatment gap between medication and weight loss surgery and should be considered a standard intervention in the continuum of care for patients with obesity," said Samer Mattar, MD, ASMBS President, in the announcement.

"However, insurance coverage for this procedure is currently nonexistent," he added.

"It is our hope that our approval and the body of evidence that supports the appropriate use of the device will change that and more people will have access to a new treatment option for obesity."

Three FDA-Approved Devices, Two Safety Alerts

The ReShape (ReShape Medical) dual-balloon system and Orbera (Apollo Endosurgery) single-balloon system, which were approved by the FDA in 2015, are inserted endoscopically and filled with saline and methylene blue, or saline alone, respectively, and later removed.

The Obalon (Obalon Therapeutics) balloon system, approved by the FDA in 2016, consists of three balloons in a capsule that the patient swallows, which are then filled with air and later removed.

As previously reported, on February 10, 2017, the FDA warned that it had received several dozen adverse-event reports of balloon overinflation and other reports of acute pancreatitis in patients who had received a fluid-filled intragastric balloon. As a result, the companies included warning labels on these devices.

Then on August 10, 2017, the FDA issued an alert that five patients had died within a month of being implanted with a liquid-filled intragastric balloon system (three had died within 3 days). The agency recommends closely monitoring obese patients who receive one of these devices and reporting any adverse effects through MedWatch.

After reviewing the evidence and taking these warnings into consideration, the ASMBS has nevertheless endorsed the intragastric balloon system to treat obese patients. 

The society estimates that 5000 intragastric balloons have been implanted in the United States since these devices were approved by the FDA, which represents less than 3% of the 216 000 bariatric surgeries performed in the country in 2016.  

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