Good news for "lightweights" seeking lap band

justjudy
on 2/16/11 9:24 pm - Canton, MI

FDA Expands Gastric Band Indication

 
By Peggy Peck, Executive Editor, MedPage Today
Published: February 16, 2011
 
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WASHINGTON -- The FDA has sanctioned use of gastric banding for weight-loss surgery in a wider range of patients -- those with BMIs of 30 or more, rather than a minimum BMI of 35.

The FDA approved Allergan's Lap-Band System for adults with a BMI of 30 to 40 and at least one obesity-related comorbidity, such as diabetes.

Patients also must have tried and failed more conservative weight-loss therapies such as diet, exercise, and weight-loss medications.

According to a company press release, some 37 million Americans will be covered by the expanded indication. The product was previously approved for a narrower range of individuals: those with BMI of 40 or more, BMI of 35 or more with at least one comorbid condition, or at least 100 pounds of excess weight irrespective of BMI.

The approval to reduce the BMI threshold was based on the FDA review of 12- and 24- month data from a prospective, single-arm, multicenter study with five years of follow-up.

The company said it planned to follow study participants for an additional five years as part of its postmarketing surveillance.

Additionally, "there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal Database," the company said.

The lap-band study, which was initiated and supported by Allergan, recruited 149 patients who had a mean excess weight of 62.8 lbs and had been obese on average for 17 years. All 149 underwent the LAP-BAND System procedure.

The primary endpoint was clinically meaningful weight loss at one year. The trial stipulated that at least 40% of the patients needed to achieve that endpoint.

Clinically meaningful weight loss "was defined as at least 30% Excess Weight Loss (EWL)" meaning a weight loss equal to at least 30% of the difference between the patient's normal weight and his or her baseline weight.

Allergan said that "83.9% of the patients lost at least 30% of their excess weight at the one-year timepoint, more than twice the percentage required for success. More than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study."

The secondary endpoints for the trial were improvement in obesity-related conditions including dyslipidemia, type 2 diabetes, and hypertension, as well as improved quality of life.

About a third of patients with the comorbid conditions "saw their conditions resolved after one year," according to the company.

An FDA advisory panel determined by a vote of 8 to 2 in December that the product was adequately safe for the indication sought by Allergan. It also voted 8 to 1 that it was effective.



 

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Judy
            

livelaughloveme
on 2/16/11 10:17 pm
Will this change the insurance company requirements (BCBS of AL)?
jlo669
on 2/16/11 10:46 pm - bohemia, NY
I had surg 5 years ago with high bp and arthritis serverly in my knees with a BMI of 36.  I had to pay a lawyer to appeal to the state and it worked.  I hope it will get easier but the requirments now from what they are today it's insane.  Other then the appeal I didn't have to do a supervised diet or anything I got lucky.
Kate -True Brit
on 2/16/11 10:52 pm - UK

Do you knew, i am unsure about this! Great if the person has co-morbidities - but it seems to me that this might bring banding closer to being seen as cosmetic surgery.  And that would, IMO, be wrong. Banding is a major op with all the risks that entails and there can be, as we all know, later complications resulting from the surgery.

Buit good to see that the FDA voted 8:2 that it wa safe and 8:1 that it was effective!

Highest 290, Banded - 248   Lowest 139 (too thin!). Comfort zone 155-165.

Happily banded since May 2006.  Regain of 28lbs 2013-14.  ALL GONE!

But some has returned! Up to 175, argh! Off we go again,

   

(deactivated member)
on 2/17/11 12:02 am
My thoughts exactly Kate...I would really hate for others to view the band as an elective cosmetic procedure..there are already too many misconceptions about weight loss procedures...
fairy_kissez
on 2/17/11 1:39 am - Albuquerque, NM
This is no bueno!!! The lapband is NOT for everyone, and now we are going to have all these people running out to get one. So once the lapband is considered cosmetic where does that leave all of us??? Right now my insurance pays for my fills....if it is seen as cosmetic will they stop paying for them?

We thought there was band bashing before let the games begin....good grief.

Jen

lapband in 2008 at 298lbs , lowest weight was 183lbs , Band almost killed me and removed in 2011. No revison because to much damage for revision.

Anti Lap-band advocate!

                       

justjudy
on 2/17/11 5:10 am - Canton, MI
I didn't expect these responses and am not sure that I agree that this will result in lap band surgery being seen as cosmetic.

Since a BMI of 30 is considered obese, this means that obese folks could have lap bands earlier and perhaps prevent the complications that come with even higher BMIs and morbid or supermorbid obesity.  

I would have appreciated having a lap band much sooner, when I was still able to move and had far fewer pounds to lose. I think too that the data bares out that lighter folks with lower BMIs are more successful with the lap band than those like me who started with a BMI of over 48. 

No one should have to "fatten up" to have WLS, and I know some who have deliberately gained weight in order to meet the minimum requirement of a BMI of 35, because, like all of us, they were unable to lose weight permanently through diet and exercise.

I'm thinking this policy change could be a good thing.

Judy
            

(deactivated member)
on 2/17/11 6:18 am
I have mixed feelings about this.  However, it would have been nice to have the band before I got co-morbidity's and so fat.  As usual the main board is having a field day over this.  What galls me  is the person who started the post from what I understand has seizures from her RNY.  Maybe she should have gotten the band.    And the fellow who has had soooooo many complications from his RNY calling the band a choke chain and referring to it as a form of S and M.  Maybe he should have gotten a band.    I can understand people who have had band surgery and are not happy with it.  They have the right to critisize,  But the prople who haven't had a band.   Like I said, "maybe they should have gotten the band.     Maybe they wouldn't have so many health problems and have a lot less to ***** about.  Instead of making it their lifes mission to moan and groan everyday on this sight.
bandhope
on 2/18/11 12:39 am - TX
I was banded over three years ago. My BMI was not high enough to qualify for insurance to pay. During the time of my surgery I saw people just like me struggling and living very unhealthy lives that were willing to gain weight to qualify for surgery out of desperation or waiting to be "sick enough". I was not willing to risk my health further to qualify so I made a choice to pay for the surgery out of pocket. I have been blasted by both sides. I often felt stuck in the middle. I was not "fat enough" or "sick enough" for some people, but yet I was living an unhealthy life and struggling just like any other obese person. I was a ticking time bomb for future issues and I took steps to prevent that for happening. I have been healthy for over three years now thanks to my band and my dedication to changing my life. I don't regret a single second! You can check past post where the typical question is posted....do you have any regrets and the most popular answer is always...I regret not doing this earlier. Hmmmmmm......
Best wishes to those who struggling with obesity. You have choices and people fighting to help. There is always hope and you are not alone.
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