SILVER SPRING, Md., July 29 (UPI) -- An inflatable balloon device has been approved by the Food and Drug Administration to help obese patients lose weight without surgery.
Unlike LAP-band and gastric bypass, the new device, called the ReShape Dual Balloon, does not change the shape of the stomach. Instead, a balloon is inserted through the mouth, into the stomach, and inflated with a sterile solution. By filling space in the stomach, triggering feelings of fullness, and possibly by other mechanisms researchers said they don't yet understand, the balloon can be left in for up to six months to help patients lose weight.
"In the past, bariatric surgeons have had few options to offer patients who did not qualify for bariatric surgery," said Dr. Ninh Nguyen, past president of the American Society for Metabolic and Bariatric Surgery, in a press release. "The approval of ReShape opens up a new opportunity for these patients or patients who are not ready for surgery, by providing an effective nonsurgical treatment to help them with their weight loss and a path to a healthier lifestyle."
The balloon was tested in a clinical trial with 326 patients between the age of 22 and 60 who had at least 1 obesity-related health condition, such as high blood pressure, high cholesterol, and diabetes. Researchers gave half the group the balloon, and a control group underwent the endoscopic, out-patient procedure but did not have the balloon inserted.
When the device was removed six months after insertion, participants in the group that received the balloon had on average lost 14.3 pounds, while members of the control group lost about 7.3 pounds each. Six months after the device was removed, patients who'd had the balloon inserted kept off an average of 9.9 pounds of the 14.3 they lost with the implant.
"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 Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, in a press 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 be easily removed."