WEDNESDAY, July 29, 2015 (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.
It's approved for people with a body-mass index of 30 to 40 who also have a chronic condition related to obesity, such as high blood pressure, 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 six months.
The product was evaluated in clinical studies involving more than 325 people aged 22 to 60 who had at least one chronic health condition related to obesity. Those who used the device lost an average of 14 pounds, compared with control group participants who lost an average of 7 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, the FDA said.
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.
The FDA has more about this approval.