Non-Surgical Balloon Device Approved for Obesity
Inflated in stomach, it may create sense of fullness.
(HealthDay News) -- The ReShape Integrated Dual Balloon System has been approved by the U.S. Food and Drug Administration to combat adult obesity. Inflated inside the stomach, the device appears to create a sense of fullness, although how it works isn't completely understood, the FDA said in a news release.
The system is approved for people with a body mass index of 30 to 40 kg/m² who also have a chronic condition related to obesity, such as hypertension, high cholesterol, or diabetes. The device is intended for people who have unsuccessfully tried other weight-loss methods. Placed in the stomach via the mouth by endoscopy, the device avoids invasive surgery and does not change the shape or appearance of the stomach, the FDA said. Users are urged to follow a medically supervised diet and exercise regimen. The device is designed to be removed after 6 months.
The product was evaluated in clinical studies involving 326 people aged 22 to 60 who had at least 1 chronic health condition related to obesity. Those who used the device lost 14.3 pounds, compared with control group participants who lost 7.2 pounds, the FDA said.
The most common side effects included headache, muscle pain, and nausea. More rare yet more severe side effects included severe allergic reaction, heart attack, esophageal tear, infection, and breathing problems.
People who should avoid the device include those who have had gastrointestinal or weight-loss surgery, those diagnosed with inflammatory bowel disease, large hiatal hernia, or delayed gastric emptying, or those who have an active H. pylori infection. Pregnant women and daily aspirin users also shouldn't use the device.
The system is produced by ReShape Medical, based in San Clemente, Calif.