Allergan applies for wider LAP-BAND approval

Tuesday, 05 October 2010 15:23

Allergan, the makers of the Lap-Band AP System, have applied to the U.S. Food and Drug Administration to make the device available to more Americans.  The FDA has announced that its panel of outside advisers will meet on December 3 to discuss whether the qualifications for gastric banding should be modified.

The Lap-Band System, which was approved by the FDA in 2001, is currently available to individuals who have a BMI of at least 40 or a BMI of 35 with other co-existing medical conditions, or who are at least 100 pounds overweight. The Lap-Band is approved for use in adults only.

Currently, bariatric surgeons may use the device as they see fit, including in teenagers;  however, Allergan is not allowed to market the device to those who do not meet the approved qualifications. The company is asking the FDA to formerly approve the device for use in patients with a BMI of 35 or a BMI of 30 with other medical conditions.

With weight-loss surgery rates continuing to increase, the change could mean a wider patient base for Allergan, whose Lap-Band currently represents two-thirds of the adjustable gastric band market, notes Reuters.  The Los Angeles Times predicts that more moderately obese adults with type 2 diabetes would also be likely to undergo gastric banding, which has been shown to help control diabetes.