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The FDA has approved a , adding to a fat-busting device arsenal that includes gastric banding and a vagal nerve stimulator.
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 comorbidity such as hypertension, high cholesterol, or diabetes.
It's placed into the stomach using an endoscope, and once it's inflated it is meant to diminish 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 less than 30 minutes, according to the agency, which noted that the temporary device should be removed 6 months after insertion.
In a 326-patient clinical trial, patients on the device lost an average of 14.3 pounds over 6 months, compared with 7.2 pounds for those in the control group. Those on the device managed to keep 10 of those pounds off 6 months after the device was removed.
Although some gastric balloon devices are already on the market in Europe and South America, no gastric balloon has ever been approved in the U.S. before. That's due to disastrous trials from the 1980s of other intragastric balloons that involved serious complications and some deaths.
The ReShape device seeks to prevent some of those complications by including two balloons instead of one. The idea is that should one balloon rupture, the other will keep it "afloat" in the stomach so that it doesn't migrate into the small intestine where it could cause an obstruction or perforation.
FDA cautioned that side effects during the placement procedure include headache, muscle pain, and nausea, and in rare cases severe allergic reactions, heart attack, esophageal tear, infection, or breathing difficulties.
Side effects once the device is in place could include vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion, the agency said.
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 to the vagal nerve stimulator and now the gastric balloon, obesity specialists have had a wide swath of new treatments open to them in the last few years, as the FDA also approved a handful of new obesity drugs, including Contrave, Qsymia, and Belviq.