FDA Panel Recommends Lap Band Expansion


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.

Financial Disclosures

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.

  • 1
  • |
  • 2
  • |
  • 3
Join the Discussion
blog comments powered by Disqus
You Might Also Like...