The Lap-Band device is a popular surgical product used to shrink the stomach so that obese patients can cut back on their eating. made by manufacturer Allergan, the Lap-Band was approved for sale in 2001 and is currently approved for use in adults with a BMI of at least 40 or at least 35 plus another health problem.
Allergan is looking to gain approval for a wider group of patients. They would like it to be used for patients with a BMI of 35 or higher or at least 30 plus another health problem. A BMI of 30 is considered obese.
Clinical trials showed that the adjustable silicon stomach band improved health-related quality of life in people who aren’t as heavy as current users, according to regulators.
A FDA report showed that no deaths or “unanticipated adverse effects” occurred with the device.
Allergan is looking to sell Lap-Band for treating people who have a body mass index of 35 or even 30 for those with other complications
Allergan conducted a study and found that patients had a “significant decrease in all measures of weight loss,” wrote FDA reviewers in a summary to be reviewed by an outside group of advisers. There were no unexpected complications and about 2% of device-related problems were considered severe.
The advisory committee to the Food and Drug Administration voted 8 to 2 that the benefits of Lap-Band surgery exceeded the risks for patients in the lower range of obesity. It voted 8 to 2 that the device was safe, and 8 to 1, with one abstention, that the device was effective.
The F.D.A. usually agrees with its advisory committees, but it was not clear when a decision would be made