New York Times
Agency Approves Stomach Band Implant Intended to CurbObesity
WASHINGTON, June 5 (AP) -- A band that can be implanted around the stomach and tightened to help severely obese people lose weight won government approval today.
The Food and Drug Administration said it approved the Lap-band Adjustable Gastric Banding System, which is made by BioEnterics System of Carpinteria, Calif.
The band is place around the upper stomach using keyhole surgery, which requires only a small opening.
Once in place, the device is with saline and can be tightened or loosened. It creates a small stomach pouch that limits food consumption and creates an early feeling of fullness the agency said.
The agency said the Lap-Band was intended only for severely obese those at least 100 pounds over weight or twice their ideal body weight and who had failed to lose weight by diet, exercise and other programs.
Severe obesity can lead to serious health, including high blood pressure, gall bladder disease and diabetes.
The agency said people who had the Lap-Band implanted would still need to diet and exercise to maintain their weight loss.
The band is intended to remain in place permanently but can be removed.
The only other surgical treatments for obesity have been more invasive, like stomach stapling and 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 afterward 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 25% of the patients had the band removed because of side effects or insufficient weight loss. Some 89% experience at least some side effects, which included nausea and vomiting, heartburn, abdominal pain and band slippage.
Dr. Ted Rothstein
June 14, 2001