Stomach Balloon Approved By FDA For Weight Loss

The U.S. Food and Drug Administration (FDA) has approved an inflatable balloon device to help obese patients lose weight without surgery, according to a news release.

The new device, unlike LAP-bands and gastric bypass, does not alter the shape of the stomach. Called the ReShape Dual Balloon, the product is inserted through the mouth into the stomach and then is inflated with a sterile solution. When the space is filled in the stomach, it triggers feelings of fullness and can be left in for up to six months to help patients lose weight.

The product was tested in a clinical trial on 326 patients between the ages of 22 and 60 who had at least one obesity-related health condition, including high blood pressure, diabetes and/or high cholesterol. Participants received Researchers gave half the group the balloon while 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. "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."

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