The American Society for Metabolic and Bariatric Surgery has added the intragastric balloon to its list of approved devices and procedures, following an extensive review and safety analysis, the organization announced in a press release.
Intragastric balloons were approved by the FDA in 2015 for the treatment of obesity in patients with BMI between 30 kg/m² and 40 kg/m². Depending on the device used, one or two balloons are endoscopically inserted into the stomach and inflated with saline. Patients are advised to follow a medically supervised diet and exercise plan for the 6 months the device is in place, and then following its removal, to maintain weight loss.
“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,” Samer Mattar, MD, ASMBS president said in the release. “However, insurance coverage for this procedure is currently nonexistent. 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.”
About 5,000 intragastric balloons have been implanted since FDA approval, according to ASMBS estimates, which represents less than 3% of the 216,000 bariatric surgeries performed in the United States in 2016.
As Healio.com previously reported, a 2017 meta-analysis of 10 randomized controlled trials and 30 observational studies published in the American Journal of Gastroenterology, patients who received intragastric balloons experienced superior improvements in obesity-related metabolic risk factors compared with dietary interventions, and the balloons were associated with a low rate of adverse events. However, investigators acknowledged the evidence is limited by small study sample sizes, lack of long-term follow-up data, and a limited number of randomized controlled trials reporting metabolic outcomes.
For a procedure or device to receive approval from the ASMBS, an application must be submitted by a society member in active practice. The application is preliminarily reviewed by the society’s executive committee, where three-quarters of the group must agree to submit it for full review by the ASMBS Pathway for Approval of New Devices and Procedures Committee. The committee was formed in 2016 in response to the growing number of new products and procedures emerging for the treatment of obesity.
Once committee review is complete, the executive committee can either accept or reject the application or vote to post it for ASMBS member comment. At least 75% of the executive committee must approve the application before the device is endorsed and sanctioned by the ASMBS as a treatment option.
Application forms are available on the ASMBS website at: asmbs.org/pathway-for-approval-for-new-devices-and-procedures. – by Regina Schaffer