Called the Lap-Band Adjustable Gastric Banding System, the device is made by California firm BioEnterics System.
It's placed through a small surgical opening and fitted around the upper stomach. Then it is inflated with saline and can be tightened or loosened, creating a small stomach pouch to limit food consumption and create an earlier feeling of fullness, the agency said.
The FDA said the Lap-Band is intended only for severely obese people, those at least 100 lbs overweight or twice their ideal body weight and who have failed to lose weight by diet, exercise, and other programs.
The agency said that Lap-Band recipients still need to diet and exercise to maintain their weight loss.
The band is intended to remain in place permanently but can be removed if necessary.
The only other surgical treatments for obesity have been more invasive. These procedures generally require a large abdominal incision and physical reshaping of the stomach, such as cutting, stapling, or rerouting with a gastric bypass.
In clinical trials, the Lap-Band was implanted in 299 patients at eight medical centers. The patients were required to follow a severely restricted diet after the device was implanted and to exercise at least 30 minutes a day.
Most patients steadily lost weight during the three-year study, averaging 36% of their excess weight. Two percent of the patients gained weight and 5% remained the same.
About a quarter of the patients had the band removed because of side effects or insufficient loss of weight. Some 89% experienced at least some side effects, which included nausea and vomiting, heartburn, abdominal pain, and band slippage.
Earlier in the campaign to win FDA approval for their band devices, company representatives had suggested some of the side effects could have been due to varied amounts of physician training and experience with the device, as well as the way some of the patients had been selected to participate in the clinical trials.