The product, the Lap-Band Adjustable Gastric Banding System, is made by BioEnterics Corporation of Carpinteria, California, USA. It is an inflatable band that is placed around the upper stomach to create a small gastric pouch. This limits food consumption and creates an earlier feeling of fullness.
The band is implanted by laparoscopic 'keyhole' surgery, and is then adjusted over time - either tightened or loosened - to meet individual patient needs.
Once the band is in place, it is inflated with saline. Subsequent adjustments are made through a portal under the skin.
The Lap-Band is intended for severely obese people - those at least 100 pounds overweight, or who are at least twice their ideal body weight - who have failed to reduce their weight by other methods.
The device is meant to remain in place permanently, but it can be surgically removed, if necessary.
|Laparoscopically implanted Lap-Band reduces the gastric pouch size.
|US Food and Drug Administration|
Previously the only surgical treatments available for severe obesity were more invasive procedures such as stomach stapling and gastric bypass.
The FDA approved the Lap-Band based on a review of clinical studies of safety and effectiveness conducted by the manufacturer.
BioEnterics studied 299 patients (18-55 years) who were implanted with the Lap-Band at eight medical centers in the US.
Patients were required to follow a severely restricted diet after the device was implanted and to exercise at least 30 minutes a day.
During the course of the three-year study, most patients steadily lost weight, and by 36 months had lost an average of 36% of their excess weight.
62% of patients lost at least 25% of their excess weight; 52% lost at least 33%; 22% lost at least 50%; and 10% lost at least 75%.
2% of patients gained some weight, and 5% neither lost nor gained.
89% of patients were found to experience at least one side-effect. These included nausea and vomiting (51%), heartburn (34%), abdominal pain (27%), and band slippage or pouch enlargement (24%).
9% of patients needed to have another operation to correct a problem with the device.
25% had their entire Lap-Band Systems removed, mostly because of adverse side-effects.
In about one-third of those patients, insufficient weight loss was also reported as a contributing factor to the decision to have the Lap-Band removed.