Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approval for Balloon Device

Non-surgical device treats obesity

Uses: ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is a balloon device to facilitate weight loss in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2.

Delivery: The device works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. It is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. Once in place, the balloon device is inflated with a sterile solution.

More Information: The approval was based on a clinical study involving 326 obese participants aged 22 to 60 years who had at least 1 obesity-related health condition. In the study, 187 individuals randomly selected to receive the device lost an average of 14 lbs. when the device was removed at 6 months while the control group lost an average of 7 lbs.

Side Effects/Risks: Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and indigestion. The device should not be used in patients who have had previous gastrointestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H. Pylori infection, those who are pregnant or use aspirin daily.

Source: FDA web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455103.htm. Updated July 16, 2015. Accessed August 3, 2015.

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