FDA Expands Clearance for Allergan Lap Band Device - Dr. Clayton Frenzel | BodEvolve Cosmetic Surgery & MedSpa | Dallas-Fort Worth, Texas

FDA Expands Clearance for Allergan Lap Band Device

lap band device used in bariatric surgery, picture from Allergan Inc

photo by Allergan Inc

Last week, Allergan announced that FDA clearance had been granted for the Lap Band to be used by obese patients with a BMI of 30 and one related medical condition.

The FDA’s previous rule stated that the Lap Band (laparoscopic gastric band) was restricted to adults with a BMI of 40, or adults with a BMI of 35 and a related medical condition.

The approval was backed by a recent study of the lap band, which included this “less obese” patient group. 149 men and women were involved, who had been obese for 17 years, on average.

The trial would be defined as successful if at least 40 percent of them lost a meaningful amount of weight (about 30 percent of the excess) during the first year.

The results showed that, within one year of lap band surgery, over 80 percent of patients lost at least 30 percent of their excess weight, or the amount above their ideal body weight. 65 percent were determined to no longer be obese after the study. The progress of the group will continue to be monitored for five years.

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