The Food and Drug Administration (FDA) recently approved a new surgically implanted device to help severely obese people lose weight. It is an inflatable band that is placed around the upper stomach to create a small gastric pouch, limiting food consumption and creating an earlier feeling of fullness. It is called the Lap-Band Adjustable Gastric Banding System and is manufactured by BioEnterics Corporation in California.

The band is inserted through a small incision and inflated with saline. It can then be adjusted over time through a portal under the skin. It is intended to remain in place permanently, although it can be surgically removed.

In clinical studies of the device's safety and effectiveness, patients who received the device were required to follow a severely restricted diet and to exercise at least 30 minutes a day. Tested in 300 patients over 3 years, the device helped most patients steadily lose weight. After 3 years, they had lost an average of 36% of their excess weight:

• 62% lost 25% of their excess weight
• 52% lost at least 33%
• 22% lost at least half
• 10% lost at least 75%

Two percent of patients gained some weight, while 5% neither lost nor gained.

A large majority of patients - 89% - experienced at least one side effect, including nausea and vomiting, heartburn, and abdominal pain. One in four had problems with the band.

The Lap-Band is intended for severely obese people - those who are at least 100 lbs overweight or twice their ideal body weight, who have failed to reduce their weight by other means.

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