FDA Panel Recommends Lap Band Expansion

Lap band manufacturer Allergan requests expansion to those less obese.

ByABC News
December 2, 2010, 2:05 PM

Dec. 2, 2010— -- A U.S. Food and Drug Administration advisory committee voted 8-2 Friday in favor of expanding use of the popular Lap Band weight-loss device for use on those who are less obese, potentially expanding the eligibility for surgery from 13 million Americans to nearly 32 million.

The decision comes in response to a request by Lap Band manufacturer Allergan to lower the recommended body mass index needed to qualify for the procedure.

And, like a majority of the FDA panel members, many experts also believe that the time has come to expand eligibility for the weight-loss procedure.

In Lap Band surgery, an inflatable ring is placed over part of the stomach to reduce the amount of food consumed. The procedure had already approved for people categorized as morbidly obese, or adults with a body mass index, or BMI, of at least 40, and those with BMI of 35 who have at least one obesity-related health problem.

The panel now recommends the BMI lower limit drop to 35 for those with no related health problems and 30 for those with weight-related medical problems. Patients categorized as obese but who weigh 34 pounds less than the original indication would qualify.

"I do not believe that when we have an effective procedure people should be denied this choice because of the word 'obesity,'" said Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York, who said even those who are not categorized as obese or morbidly obese may still benefit from the surgery.

Many experts debate whether BMI, or body mass index, is an accurate indicator of obesity. BMI, which is calculated through a height-to-weight ratio, does not take into account bone density and muscle mass, also important indicators of whether a person who has an otherwise high or low BMI can still be considered healthy.

Many doctors calculate body fat percentage, which takes protein and muscle weight into account, according to Dr. Nick Nicholson, a bariatric surgeon at Baylor University Medical Center in Houston.

"We say to our patients for a better indication of how far they've come, quit weighing yourself once a day, start measuring yourself once a month," said Nicholson.

For Roslin, the expansion recommendation provides a "freedom of choice" he equates with other cosmetic procedures.

"This is not that different from women having liposuction, face-lifts or even more radical procedures," said Roslin. "Why, for example, can you have any sort of aesthetic procedure you like, but someone with, let's say, a BMI of 32 who doesn't feel good about something, how they look, why should these people be denied their freedom of choice?"

Eighty percent of those who were moderately obese, who received Lap Band surgery, lost an average of 40 pounds, according to a study that Allergan submitted to the FDA committee. But almost 90 percent experienced side effects, such as nausea, discomfort eating and reflux, although less than 1 percent of those who underwent surgery died from complications, according to Allergan.