FDA: Balloon device for obesity treatment recently approved
The FDA recently approved the ReShape Integrated Dual Balloon System, a new balloon device to treat obesity without invasive surgery in adults, according to a press release.
“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,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can easily be removed.”
The device is delivered into the stomach through the mouth in an outpatient procedure that usually takes less than 30 minutes. The device takes up room in the stomach by being inflated with a sterile solution. The stomach’s natural anatomy is not changed or altered by the device. After 6 months, the device should be removed, and patients should follow a medically supervised diet and exercise plan.
The device is intended for use in adults with obesity and a BMI of 30 to 40 kg/m2, and limited to patients with one or more obesity-related condition.
In a clinical trial of 326 adults aged with 22 to 60 years with obesity and one obesity-related condition, 187 participants selected to the receive the device lost an average of 14.3 lbs after device removal compared with 7.2 lbs in participants who did not receive the device.
Possible side effects of the device include vomiting, nausea, abdominal pain, gastric ulcers and feelings of indigestion.