July 28, 2015
The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.
The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.
The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.
“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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.”
The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.
There are currently three other FDA-approved devices to treat morbid obesity: the Allergan LAP-Band the Ethicon Endo-Surgery Realize Adjustable Gastric Band and the Maestro Rechargeable System.