The American Society for Metabolic and Bariatric Surgery (ASMBS) has added the intragastric balloon to its list of approved procedures and devices. The announcement was made today and comes following an extensive review and analysis of safety and effectiveness data, and public comment from ASMBS members.
Intragastric balloons were approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of obesity in patients with a body mass index (BMI) of between 30 and 40. Depending on the device used, one or two balloons are inserted into the stomach through endoscopy, and then inflated with saline. The balloon takes up space inside the stomach so patients feel full faster and with less food. Patients are advised to follow a medically supervised diet and exercise plan for the six months the device is implanted, 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,” said Samer Mattar, MD, ASMBS President. “However, insurance coverage for this procedure is currently non-existent. 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.”
The ASMBS estimates that about 5,000 intragastric balloons have been implanted since its FDA approval, which represents less than 3 percent of the 216,000 bariatric surgeries performed in the United States in 2016.
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 Executive Committee (EC), 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, which was formed in 2016 in response to the growing number of new products and procedures emerging for the treatment of obesity.
Once the committee review is completed, the pros and cons of the application are presented to the EC who can either accept or reject the application or vote to post it for ASMBS member comment. After all comments have been received, at least 75 percent of the EC must approve the application before the device is endorsed and sanctioned by the ASMBS as a treatment option. Applications forms are available at http://asmbs.org/pathway-for-approval-for-new-devices-and-procedures, on the ASMBS website.
In addition to the intragastric balloon, ASMBS approved devices and procedures include:
- Open procedures, as deemed appropriate by the surgeon
The members of the ASMBS Pathway for Approval of New Devices and Procedures Committee include the current chairs of Clinical Issues, Insurance, Quality, and Emerging Technology committees and the president of ASMBS Integrated Health.