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Nonsurgical Weight Loss Device
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JAMA
A newly approved balloon device is intended to aid weight loss in obese adults without the need for invasive surgery.
ReShape Medical, Inc
Rebecca Voelker, MSJ
The ReShape Integrated Dual Balloon System is placed in the stomach via the mouth through a minimally invasive endoscopic procedure that usually takes less than 30 minutes while the patient is under mild sedation. Once in place, the balloon is inflated with sterile solution, which takes up space in the stomach and may trigger feelings of fullness.
Patients should follow a medically supervised diet and exercise plan to aid weight loss while the balloon is in place and after its removal. The device is meant to be temporary and should be removed 6 months after insertion. It is indicated for adults who have a body mass index of 30 to 40 and 1 or more obesity-related conditions such as hypertension, elevated cholesterol levels, or diabetes.
In a trial involving 326 obese participants with at least 1 related health problem, 187 who received the balloon device lost an average 14.3 pounds over 6 months compared with 7.3 pounds for those who underwent endoscopy but didn’t have the balloon inserted (http://1.usa.gov/1IqHqYZ). Six months after balloon removal, participants in the treatment group maintained a 9.9-pound weight loss. Potential adverse events include headache, abdominal pain, nausea, and gastric ulcers.