The FDA has approved a gastric balloon device to treat obesity. The ReShape dual balloon system is indicated for obese adults who have a body mass index (BMI) of 30 to 40, and at least one other obesity-related condition such as hypertension, high cholesterol, or diabetes.
The ReShape dual balloon is temporarily placed into the stomach using an endoscope and then inflated. It decreases obesity by triggering feelings of fullness, "or by other mechanisms that are not yet understood," according to the FDA press release. The outpatient procedure takes approximately 30 minutes and the device should be removed 6 months after insertion.
In the clinical trial that led to agency approval patients on the device lost an average of 14.3 pounds over 6 months, compared with 7.2 pounds for those not treated with the device. Importantly, those on the device managed to keep an average of 10 pounds off 6 months after the device was removed.
Although some gastric balloon devices are already on the market in Europe and South America, this is the first gastric balloon to be approved in the U.S. The FDA cautioned that side effects that may occur during the placement of the balloon include headache, muscle pain, and nausea, and in rare cases severe allergic reactions, heart attack, esophageal tear, infection, or breathing difficulties.
The device is contraindicated in patients who've 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 an active H. Pylori infection. It's also not intended for pregnant women or for those who use aspirin daily.
There are three other devices approved to treat obesity in the U.S. These include Allergan's Lap-Band, Ethicon's adjustable gastric band, and a vagal nerve stimulator. In addition the FDA has also approved several new anti obesity drugs.
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