FDA Advisory Panel Votes to Expand the Use of Allerganís Lap-Band Device to Less Obese Patients

 

More patients are now candidates for Allergan's popular Lap-Band procedure.

An FDA panel voted on Friday to expand the use of the popular Lap-Band device to less obese adults. 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.

Lap Band Device For Less Obese


Allergan had sought to gain approval for a wider group of patients requesting approval 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.