FDA Panel Recommends Lap Band Expansion

Lap band manufacturer Allergan requests expansion to those less obese.

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.

Long-Term Studies Suggest Some Short-Term Effects

Long-term studies suggest that almost a third of people who undergo the procedure regain the weight they initially lost or have the surgery reversed. Many even risk fatal complications from the procedure, said ABC News chief health and medical editor, Dr Richard Besser.

Still, Lap Band is considered a relatively safe and effective way to lose weight for the morbidly obese for whom dieting by itself doesn't work, or for those who experience other medical complications from weight gain, such as type II diabetes.

Since the product's initial introduction internationally in 1993, the Lap Band procedure has been used in more than 600,000 procedures worldwide, according to Allergan.

According to Nicholson, the benefits of doing the surgery at a lower BMI far outweigh the risks.

"You're more likely to have a heart attack, renal failure or stroke at that weight than to have the surgery," said Nicholson. "Doing the procedure earlier at a lower BMI, our chances of reversing those or preventing them completely are much higher."

But according to Dr. Ken Fujioka, director of the Center for Weight Management at Scripps Clinic department of Diabetes and Endocrine in San Diego, expanding the group of people eligible for the procedure may also increase the likelihood of risk that comes with surgery.

"When you go to the public and bring this forward, you're going to have patients that say they have these problems, just so they can have the procedure," said Fujioka. "We run a very large weight management center and all the time we see them inappropriately asking for surgery because they're either not heavy enough or they are heavy but don't have medical problems."

Many patients considered eligible for the procedure are often advised by their doctors to go through mental and physical screening tests, and even attend counseling sessions and seminars.

According to Roslin, no other intervention has the same degree of weight loss as Lap Bands.

"There is no other disease besides obesity where people believe prevention and treatment are the same. Prevention and treatment are not the same thing."

While for many Americans adopting a healthy lifestyle can prevent obesity, it may become a point of nearly impossible return for those already considered obese, especially for those who develop weight-related medical problems such as diabetes or hypertension, said Roslin.

For those patients who may be considering lap band surgery, the categories of obese and morbidly obese should bear no concern, he said.

Allergan is the same company that manufactures Botox. The request to expand Lap Band use will likely prove to be a controversial one, as some say such an approval could push the band further into the realm of cosmetic elective surgery. And the fact that the chairwoman of the FDA committee considering the request owns stock in Allergan will likely do little to quell this controversy.

While the heads of FDA advisory panels do not vote, in this case, Dr. Karen Woods, the chairwoman of the FDA advisory committee making the determination, could stand to gain financially from an affirmative decision, according to Besser.

"It is disturbing that the person who's heading the review committee has stock in that company," Besser told "Good Morning, America." "Allergan has a lot to benefit if this is approved."

In early November, Woods, a gastroenterologist, disclosed financial gains of $10,000 to $25,000 in Allergan stockholdings. Woods' interests were disclosed publicly on the FDA's website, and despite her standing, the FDA granted her a waiver to oversee Friday's panel.

"On rare occasions and consistent with our standard procedures, FDA scientists believe the expertise of a particular scientist is important enough for a scientific advisory committee to justify a waiver for conflict of interest," Meghan Scott, a spokeswoman for the FDA, wrote in a statement to ABC News. "FDA grants the waiver to assure that the panel has the right expertise to provide well-informed recommendations to the agency."

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