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FDA panel approves Lap Band for the less obese
by Samia Sehgal - December 5, 2010 - comments
The latest recommendations will allow people with BMI of 35 without any related health problems and those with BMI of 30 but with weight-related medical problems to go for the weight-loss procedure.
An advisory committee for the U.S. Food and Drug Administration (FDA) has given the green signal to expanding the use of the popular Lap Band weight-loss device, by allowing it to be used on people who are less than severely obese. A formal FDA approval may soon follow.
An FDA advisory committee voted 8-2 on Friday in favor of using Lap-Band stomach-restricting device in less obese patients.
Lap Band manufacturer Allergan had submitted a request with the authorities to lower the recommended body mass index (BMI) that is obligatory for a patient to qualify for this procedure.
FDA lowers the lower limit for Lap Band procedure
The surgery involves an inflatable ring, which is placed over part of the stomach to cut down the amount of food consumed. People categorized as morbidly obese, or those with a BMI of at least 40, and also people with BMI of 35 but suffering from at least one obesity-related health problem are all eligible for the procedure.
The latest recommendations will allow people with BMI of 35 without any related health problems and those with BMI of 30 but with weight-related medical problems to go for the weight-loss procedure.
The latest recommendations will allow people with BMI of 35 without any related health problems and those with BMI of 30 but with weight-related medical problems to go for the weight-loss procedure.
The latest approval would mean that patients categorized as obese but who are as much as 34 pounds less than the original indication can also avail the weight-loss surgery.
With the latest FDA approval, as many as double the number of Americans may qualify for the procedure.
This is just the initial step, which may eventually lead to the availability of other types of weight-loss surgery to people with moderate obesity.
“I see this as the first step in the march toward changing the standard of care,” said E. Francine Stokes McElveen, the consumer representative on the committee.
Does the expansion of Lap-Band use expand the “freedom of choice?”
“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.
He added that even those who are not counted as obese or morbidly obese may avail the benefits of the surgery.
The expansion of Lap-Band use indicates there is more “freedom of choice,” according to Roslin.
“This is not that different from women having liposuction, face-lifts or even more radical procedures,” said the doctor. “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?”
The committee also voted in favor of the device’s safety, confirming that risks, if any, were outweighed by the benefits. FDA is not bound to act on the committee’s recommendation, but it usually does.