Allergan Seeks Wider Approval for Lap-Band

 

More patients may now be candidates for the popular Lap-Band procedure.

lap band


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 Botox and Juvederm 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.

According to Reuters, 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 report will be reviewed and if it's approved, sales for Allergan could rise to $390 million by 2016. The company already controls about 66% of the gastric band market. The FDA panel will vote on Friday and the FDA generally follows panel recommendations. Allergan also is studying the Lap-Band in teens ages 14 to 17.