FDA Approves ‘Belly Balloon’ Device for Weight Loss
Obese Americans struggling to shed pounds have a new weight-loss option: The U.S. Food and Drug Administration on Tuesday approved a temporary, implanted balloon device to treat obesity.
The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) works by taking up space in the stomach and causing a feeling of being full. People would typically use the device for no longer than six months, the FDA explained in a news release.
The device is placed in the stomach through the mouth during a minimally invasive outpatient procedure using an endoscope. The procedure typically takes less than 30 minutes and is done while a patient is under mild sedation.
Once in place, the balloon device is inflated with a sterile solution, the FDA explained in a news release.
The device does not change the stomach’s natural anatomy, according to the agency. Patients are told to follow a medically supervised diet and exercise plan, to help them lose weight while they have the device in their stomach and to maintain weight loss after the device is removed.
“This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed,” Dr. William Maisel, acting director, Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the news release.