FDA: Temporary Balloon Device Effectively Treats Obesity

The FDA has approved a new balloon device for the treatment of obesity without invasive surgery.

The ReShape Dual Balloon device works by taking up room within the stomach, triggering feelings of fullness, and is inserted into the stomach through the mouth. The procedure takes less than 30 minutes and only requires mild sedation. The device is designed to work in conjunction with a medically supervised diet and exercise plan.
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The device is temporary, and meant to be removed 6 months after insertion. Patients are encouraged to maintain weight loss after removal by continuing to follow the diet and exercise plan laid out during the time the balloon is in use.

The device is intended for obese patients with BMI of 30 to 40, for whom past attempts at weight loss have failed.

In a study of 326 obese patients, patients randomly selected to receive treatment with the ReShape Dual Balloon (n=187) lost an average of 14.3 pounds, while controls lost only 7.2 pounds after 6 months. Post-removal, patients kept off an average of 9.9 pounds.

Common side effects include vomiting, nausea, abdominal pain, gastric ulcers, and indigestion.

—Michael Potts

Reference:

FDA. FDA approves non-surgical temporary balloon device to treat obesity [press release]. July 28, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm.