FDA Approves 'Belly Balloon' Device for Weight Loss

By Ashwin Subramania - 29 Jul '15 14:04PM

The Food and Drug Administration has approved an inflatable device which can help obese patients lose weight without surgery.

The ReShape Dual balloon is inserted into the stomach through the mouth of the patient and then filled with a sterile solution.

As the balloon begins to fill space in the stomach, it triggers a feeling of fullness.

The device can be typically used for a period of 6 months and can be inserted through a minimally invasive procedure by using an endoscope.

The procedure should typically take less than 30 minutes when the patient has been given a mild sedative.

"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."

During the study, 326 participants between the ages of 22 and 60 were included for the trial. All participants atleast had 1 obesity related health condition such as diabetes, high cholesterol or high blood pressure.

Half the participants in the group were given the balloon while the other half underwent the endoscopic procedure but did not have the balloon inserted.

When the balloon was removed 6 months later, researchers found that participants who had the balloon inserted lost an average of 14.3 pounds while the rest lost 7.3 pounds each.

Six months after the device was removed, patients who had the balloon inserted managed to keep off an average of at least 9.9 pounds of the 14.3 they had lost while having 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."

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