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| T01-26 | Print Media: 301-827-6242 |
| June 5, 2001 | Consumer Inquiries: 888-INFO-FDA |
FDA today approved a new surgically implanted device to help severely obese people lose weight. The product, the Lap-Band Adjustable Gastric Banding System, made by BioEnterics Corporation of Carpinteria, Calif., 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 lbs. overweight or who are at least twice their ideal body weight--who have failed to reduce their weight by other methods such as a supervised diet, exercise and behavior modification programs. Severely obese people usually have serious health problems such as hypertension, gall bladder disease, and diabetes, resulting from their excess weight. For them, being overweight is a serious health issue, not just a cosmetic problem.
The Lap-Band is intended to remain in place permanently, but it can be surgically removed, if necessary. People who get the Lap-Band will need to diet and exercise in order to maintain their weight loss. Previously the only surgical treatments available for severe obesity were more invasive procedures such as stomach stapling and gastric bypass.
FDA approved the Lap-Band based on a review of clinical studies of safety and effectiveness conducted by the manufacturer.
BioEnterics studied 299 patients age 18 to 55 who were implanted with the Lap-Band at eight medical centers in the United States. 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. Sixty two percent 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%. Two percent of patients gained some weight, and 5% neither lost nor gained.
Eighty nine percent of patients experienced at least one side effect. These included nausea and vomiting (51%), heartburn (34%), abdominal pain (27%), and band slippage or pouch enlargement (24%). Nine percent of patients needed to have another operation to correct a problem with the device. Twenty five percent 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.
Consumer Information on: LAP-Band® Adjustable Gastric Banding (LAGB®) System - P000008
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Hypertext uploaded by jch 2001-JUN-05.