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December 3rd, 2010
07:14 PM ET

Lap-Band for lower BMI safe, FDA panel says

A Food and Drug Administration advisory committee on Friday
voted that the new proposed Body Mass Index requirements for Lap-Band weight
loss surgery are safe, effective, and that benefits associated with the surgery
outweigh the risks.
Now the FDA must make a final decision on whether to approve the medical
device for patients with lower BMIs than previously allowed.
Eight of the ten members of the Gastroenterology and Urology Devices
Panel cast votes saying that lowering the BMI requirement from 35 to 30 for
people with weight-related health issues would be a safe and effective means of
losing weight.
Under the new proposed guidelines, a person who is five feet, eight
inches tall would have to weigh at least 197 pounds, not 230, as was previously
the case.
"Overweight people who have a BMI of 30 to 35 have a significant burden
of medical problems associated with their obesity," says Dr. Robin Blackstone,
President-elect of the American Society of Metabolic and Bariatric Surgery. "We
really support making the band available to folks who need that kind of help."
The FDA meeting was held at the request of Allergan, Inc., the
manufacturer of the Lap-Band device. Allergan also conducted the study
presented to the advisory committee.
The panel heard from a variety of speakers, including Stephanie
Quatinetz, whose daughter Rebecca died two months after getting a Lap-Band.
Quatinetz argued that lowered BMI requirements would allow people who were not
obese enough to get the device, causing health complications that could be
fatal.
Laparoscopic Adjustable Gatric Banding, or LAGB, is the second most
common type of bariatric surgery. It's a less invasive operation compared to
gastric bypass, the most common procedure. If the proposed BMI guidelines are
approved, Allergan says more than thirty million Americans would have BMIs
within the newly eligible range. Yet the American Society of Metabolic and
Bariatric Surgery says only a fraction of overweight people actually opt for
weight loss surgery.
Dr. Karen L. Woods chaired the panel meeting. Dr. Woods is a stockholder
in Allergan, Inc. but was granted a waiver by the FDA. She did not cast a vote
on the new guidelines. In a statement regarding her waiver the FDA said, "Dr.
Woods was selected because she has expertise in therapeutic endoscopy, which is
important for the deliberations of the panel, and has experience serving as a
chair."


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soundoff (115 Responses)
  1. LS

    The real question with Lap-Band and Gastric bypass is whether it WORKS in the LONG TERM, even many celebrities regain the weight several years after they initially lost weight after weight loss surgery. If celebrities can't even do it, then I wonder what the long-term results are for the normal population. If the these surgeries don't produce long term, sustainable weight loss, then I don't see how the risk of surgery outweighs the long term benefit.

    In terms of the arguments that overweight people just need to eat less and exercise more, it's not that simple. Take 2 young ladies who both eat a balanced 2500 calorie diet. One women has a naturally fast metabolism, fidgets a lot, but is otherwise sedentary. The second women eats the same amount of calories and even walks briskly for 60 minutes each day, but her metabolism is naturally slower and she does not fidget a lot, so she continuously gains a few pounds a month and can't seem to lose it. A third young women, might eat only 1500 calories a day, exercise regularly, but has to be on an atypical antipsychotic and an SSRI that caused her to gain 50lbs and makes it virtually impossible for her to lose the excess weight.
    See how it's not that simple folks??? There are many genetic and environmental factors involved, some of which are controllable some of which are not.

    For example, I'm in a women my 20's. I exercise about 10 hours a week. My exercise regime includes lap swimming, exercise classes, weight lifting, ab exercises, running, and hiking, kayaking or other outdoors activities when weather and time permits. I also try to walk as much as possible, which is in addition to the 8-12 hours a week I spend formally exercising. I also count calories almost everyday and try to eat a protein and fiber rich diet under 2300 calories a day (can't easily go under that, I have a really bad sweet tooth and all that exercise makes me hungry). I drink a lot of water too. Weight-wise I'm "obese," and it's very difficult and slow for me to lose weight. If I "fall off the wagon" for a even few days, I'll gain weight. No medical conditions have been uncovered that would explain why despite large calorie deficits per day, I can't lose significant amounts of weight, but I assume it's mostly genetic as many members of my family exercise a lot and eat healthy foods but are still significantly overweight.

    So it's not just as simple as walking briskly 30-60 minutes a day and cutting out dessert. Your body doesn't like to lose weight, so it ADJUSTs. Exercise you do regularly burns less calories and your metabolism slows down if you drastically reduce your caloric intake. Overtime, even lab rats gain the weight back because your body tries to maintain a certain weight.

    I hope that helps.

    December 13, 2010 at 21:29 | Report abuse | Reply
  2. ana

    Ok, here's one more comment to all those people with the "eat less, move more" mantra. It doesn't always work!! I'm sorry, but we have ruined our metabolisms. I yo-yo dieted my entire life, thanks to an overwieght mother. She finally had to have WLS or die about 6 years ago. It saved her life and she lost 300 lbs. While going with her on her journey, I learned so much. I came to understand that it was a tool. But I was still determined to lose the weight on my own. I swam, I worked out, I ate healthy and less. Low carb, high fiber, you name it, I tried it. In a year, including the time I took the prescription Meridia for 6 months I lost a grand total of 5 lbs. That was working out 5 times a week people. My metabolism simply needed a kick start. I had Gastric bypass 2 years ago. I've lost 145 lbs. I'm a comfortable 148 lbs on a 5ft 5 inch frame. Although on the BMI scale I"m still considered overweight, I don't look it, or feel it. I eat very healthy now. I learned the rules and follow them. I'm my own advocate when it comes to my vitamins and lab work. You can not go into the surgery thinking it's the easy way out or you will fail. It's a tool to be used. The major benefit for me is that I don't have acid reflux anymore. I was taking 4 to 5 zantac a day. Having my esophagaus stretched because of damage. As for the lap band. It's failure rate is too high for me. All I can suggest if someone is reading this and considering WLS, do your research, there are several kinds. FInd a good Bariatric Center that can help you decide which one is best for you. Know that you will have to follow-up for LIFE. It's not a quick fix. But know that WLS is a better answer than all thes "miracle drugs" that they keep coming out with and then pulling because of terrible side-effects. I have an aunt who was a pioneer of WLS 30 years ago. She is healthy and has maintained her loss.

    December 14, 2010 at 10:01 | Report abuse | Reply
  3. Name Calling is for Kids

    I am a 29 year old woman with Bi-Polar II disorder.

    I'm 5'2" and weigh 183 pounds. My BMI is 33.5.

    My medication (lithium) is life-sustaining and not negotiable. My normal weight 6 years ago was 140, which was PERFECTLY FINE with me. Then, I got extremely ill and was hospitalized due to my condition for 18 days because of it's severity.

    They put me on the lithium and it saved my life. Unfortunately, it also caused me to gain 60+ pounds within a year. I've been a committed dieter, trying everything : Atkins, Weight Watchers, Nutrisystem, simple calorie counting, even becoming a vegan. All of these included exercise.

    The most I ever lost was 7 pounds. 7 Pounds in 6 years. This is emotionally devastating when you put so much effort into something and get nothing for it.

    My ACL all but tore this year because of my weight. My ankles lock while I sleep and hurt frequently. This has made exercise harder as I do not want it to fully tear, so I am limited in terms of the cardio I can do.

    For all of the people that keep saying, "Stop being a pig and close your mouth.", I'd like you to consider being in my shoes for the past 6 years, and then see how you feel about this surgery being offered to more people. I would hate to be as judgmental as the name callers on here, but I can't help to think you'll probably classify my illness as "lack of self control" too. I can only hope you'll never have to experience it.

    December 26, 2010 at 20:51 | Report abuse | Reply
  4. MIchelle

    For all you calories in calories out people – do you know that person who has lost weight burns fewer calories than a person of the same weight who has never lost weight. Let's do a though experiment. Imagine that do be the same size you are now you have to a) exercise 15% more every single day or b) eat 15% less every single day. Just to stay exactly the size you are now. Could you do it? Look at the guy next to you having a cookie. Or cheese on his burger. Not for you. That birthday cake for your office mate? Not for you. How about a relaxing beer after work? Nope! Try having the stuff that keeps you alive be your worst enemy and have everyone look down at you because you're not 15% more disciplined than they are. What a life.

    February 20, 2011 at 12:29 | Report abuse | Reply
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