A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery.
The device is indicated for patients with a body mass index of 30 to 40 kg/m2 and 1 or more obesity-related conditions who have failed previous attempts at weight loss through diet and exercise alone. It is inserted into the stomach through an endoscopic procedure and, once in place, is inflated with a sterile solution. The balloon is meant to be temporary and should be removed 6 months after insertion.
Approval was based on a placebo-controlled study finding that 187 patients randomly selected to receive the device lost 14.3 pounds on average by 6 months, compared to 7.2 pounds in controls. Six months after removal, treated patients had kept off an average of 9.9 pounds, according to an FDA press release.
Potential side effects include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.