Makers Of Lap-Band Want Bigger Share Of The Market

Makers Of Lap-Band Want Bigger Share Of The Market

Following up the “Should She Go Lap-Band?” from Q&A a few weeks ago, I was sent this from Stephanie (and thank you, girl!)

An actual lap-band, from Allergan's own site.

Allergan Inc’s already approved stomach band was effective for reducing weight in a broader group of obese patients, U.S. reviewers said in documents released on Wednesday.

The maker of Botox, breast implants and other cosmetic products wants approval to promote the surgically implanted Lap-Band device to people with lower body mass indexes who are still considered obese. Wider approval could boost sales.

Allergan shares gained 0.3 percent to close at $66.46 on the New York Stock Exchange.

In an Allergan study, “there was significant decrease in all measures of weight loss,” Food and Drug Administration reviewers wrote in a summary prepared for outside advisers who will consider the wider use on Friday.

The company is seeking FDA approval to promote the Lap-Band for adults with a BMI of 35 or higher, or at least 30 plus one weight-related health problem such as diabetes or high blood pressure. A person 6 feet tall would need to weigh about 225 pounds (102 kilograms) to have a BMI of at least 30.

The Lap-Band is approved for adults with a BMI of at least 40, or at least 35 plus one other health problem. About 15 million Americans are candidates under the currently approved definition and about 27 million more fit under the broader group, Allergan said.

The company studied 149 patients in the less obese group. Nearly 81 percent of them had lost at least 30 percent of their weight at one year, FDA reviewers said.

No unexpected complications were reported. About 2 percent of device-related problems were considered severe, FDA staff said. One patient’s band had eroded and was removed, while another’s was repositioned in a new operation after it slipped.

The FDA reviewers said they had some questions about Allergan’s data, including whether the people who were studied represented the types of U.S. patients who would be eligible if wider use is approved. Most patients studied were white women, and nonwhite men were underrepresented, they said.

Collins Stewart analyst Louise Chen said she conservatively estimates Lap-Band sales could rise to $390 million by 2016. The device, which is placed around the upper part of the stomach to create a small pouch and limit food intake, already commands two-thirds of the $300 million to $400 million gastric band market.

Wider approval would be positive for Allergan, Chen said, but “uptake may be slow given the high unemployment rate” as many patients pay out of pocket for the device.

The surgery costs between $12,000 and $20,000, Allergan said.

More than 72 million U.S. adults are obese, which raises the risk of heart disease, stroke, diabetes and some types of cancer. Efforts to fight fat with a pill have fallen short, leading some patients to consider surgical options.

Allergan dominates other markets with products such as wrinkle smoother Botox and dermal filler Juvederm, making it an attractive takeover target for large drugmakers.

The FDA cleared the Lap-Band for sale in 2001. The device can be implanted through a small “keyhole” incision. The procedure is less invasive than stomach stapling or gastric bypass, which involves cutting and rerouting the stomach. Johnson & Johnson sells a rival device called Realize.

The FDA panel is set to vote on Friday afternoon on whether to recommend approval for the less-obese patients. The agency usually follows panel recommendations.

Doctors are free to implant the Lap-Band now in any patient they consider appropriate, but Allergan needs FDA approval to market the device for the wider group.

In a summary also released by the FDA, Allergan said its study findings “make it clear that the benefits of the weight loss exceed the risk of surgery and the risk of failure to treat” obesity.

Allergan also is studying the Lap-Band in teens ages 14 to 17.

From the Q&A on the lap-band:

For starters, I don’t understand why weight loss procedures are considered some great, grand solution to every obesity-related illness, especially when the only thing the surgery immediately solves is the “obese” issue – you lose the weight. You’ll still have the hypertension, you’ll still have the high cholesterol and you’ll still have the diabetes to contend with. It is not a cure all.

In fact, I can recall a conversation I had with an MD a while back regarding surgeries… because I feel some kinda way about how they are peddled as being The End All Be All To Curing The Real Health Woes In America. Her words to me were, “Surgeries aren’t intended to be a cure-all, they’re meant to aid the people who are genuinely unable to function because of the weight they’ve put on, or the people who actually need to quickly lose weight so that we can go in and perform other procedures. If there’s too much fat for us to go in and do what we need to do, then a procedure will be recommended for weight loss first… then the other procedures come afterwards.”

Excerpted from Q&A Wednesday: Should She Go Lap-Band? | A Black Girl’s Guide To Weight Loss

Now, if the idea is that because a person is limited in how much food they can take in because of the lap band, and that they don’t, in fact, have to actually change what they’re eating… that just means it’ll take longer to experience the same obesity-linked illnesses. Doesn’t mean those illnesses will never resurface.

From the comments on the Q&A post:

I have a friend who is 5’10″ tall and weighs around 425lbs. She gained the last 30lbs whole wearing a lapband that she just had removed in August. Somehow she ate the same amount of food in teeny tiny meals, ALL DAY! Since vegetables caused her indigestion, she didn’t eat them. So lots of meat and potatoes, and starches. Because she gained that extra weight, the lapband was rubbing against her liver causing pain and internal bleeding..

We get along as as long as the topic of food doesn’t come up. Now she’s on a mostly liquid diet of 1000 calories/day to lose weight in preparation of gastric bypass surgery in January. She said she doesn’t want to develop Type 2 Diabetes like me, so she going to get herself cut up. I understand her fear, but I cringe whenever I think of what she puts in her mouth. Since she’s limited to 1000 calories, she stocked up on fat-free puddings, and diet pop. I asked her to just do herbal teas, and a few squares of dark chocolate but she complained that that little bit wouldn’t fill her up. And she HATES water!

One more:

I wrote the post lap gastric bypass/calorie restriction post yesterday and I feel that there are some necessary clarifications to be made about bariatric surgery.

1) Whether lap band or bypass, you will regain the weight if you don’t change your behaviors. Period. Limiting calories to1,800/day, exercising, eating healthy food…that’s the only way to go to have long-lasting results.

2) The gastric bypass surgery functions quite differently from the lap band. The bypass removes approximately 95% of the stomach (although not following directions can cause it to stretch back to its original size) and affects the hormones released by the digestive system. These hormones affect how the body processes food, burns it, and can absolutely change your palate. Pre-surgery, my problems were with sugar (thankfully I didn’t have high blood pressure, diabetes, or any other co-morbid condition). Now, I can’t eat some natural sugars because I’m so sensitive to it. A slice of pineapple almost had me updating my will. I’m an outlier; all folks don’t have this experience. However, since sugar was my main problem, my surgeon and I are very confident of my success as I can no longer tolerate (nor do I crave it). I also work out 3x week with a trainer. This, in addition to the surgery, accounts for how I’ve lost more than 60% of my excess weight in less than 11 months.

3) The lap band physically reduces, though not permanently, the size of the stomach which limits intake. There is no cutting. It does NOT affect hunger hormones and there is no “dumping” syndrome, where the body rids itself of everything (it seems) if the patient eats too much fat or sugar in one sitting. Lap band folks can eat sugar, fat, anything they want, just in smaller quantities. This is why a significant proportion of lap band patients eventually have the bypass surgery.

No matter what you do (surgical or non-surgical intervention), your eating habits and exercise regimen will ultimately determine your weight and thus, your health. I had years of therapy before I had the surgery, which is partly why I’ve been successful. And for the record, I lost nearly 50 pounds BEFORE the surgery (30 pounds MORE than my surgeon required) because I was able to address many of my psychological issues around food and “practice” my post-surgery habits for a full 11 months before the surgery.

Bariatric surgery is not for everyone. No matter how good your intentions, how great your support system, you should not have the surgery until you’ve addressed emotional/psychological reasons for eating.

I’m a doctor and can address more specificities of the surgeries. However, I’m not here to give medical advice; that’s for your primary care physician.

One more thing: one can be too obese for the surgery. At my highest weight, 400+ pounds, there are surgeons who would not have accepted me as a patient. My surgeon, PCP, and therapist all knew that I was in it for the long haul and that I would comply with all requirements. No surgeon wants an extremely obese patient who can’t follow directions. It sounds callous, but it destroys their surgery statistics…and that matters quite a bit for reputational and malpractice purposes. I’m shocked that someone above stated that their 650 pound mother had a bypass. NO way surgeons at my Top 10-ranked hospital would have accepted her as a patient. She got very lucky.

There is one thing I’d like to highlight from the article:

Doctors are free to implant the Lap-Band now in any patient they consider appropriate, but Allergan needs FDA approval to market the device for the wider group.

In a summary also released by the FDA, Allergan said its study findings “make it clear that the benefits of the weight loss exceed the risk of surgery and the risk of failure to treat” obesity.

Allergan also is studying the Lap-Band in teens ages 14 to 17.

One final question:

Anyone notice that the end goal, here, is to ensure that people don’t have to stop eating how they want.. so that the food industry’s money isn’t affected by our weight loss? ‘Cause, I mean, if you actually lost weight by eating what you’re supposed to eat… the entire food system would have to change.

Update:

Allergan Inc.’s stomach-shrinking Lap-Band won a favorable vote from a federal advisory panel Friday, showing how surgery rather than drugs is increasingly gaining favor as a treatment for obesity.

The panel at the Food and Drug Administration voted 8-2 that the benefits of the Allergan device outweighed the risks of using it in a broader patient population.

[…]

The Lap-Band is already approved to treat adults with a body-mass index of 40 or more or a BMI of 35 with at least one obesity-related condition such as Type 2 diabetes or high blood pressure. Allergan wants to market the device to all adults with a BMI of 35 or those who have a BMI of 30 and one obesity-related condition.

Body-mass index is a measure of weight relative to height. A person who is 5 feet, 5 inches and weighs 180 pounds has a body-mass index of 30. [source]

Funny how that works out. Thoughts, y’all?

By | 2017-06-10T11:22:10+00:00 November 14th, 2014|Health News|19 Comments

About the Author:

The proud leader of the #bgg2wlarmy, Erika Nicole Kendall writes food and fitness, body image and beauty, and more here at #bgg2wl. After losing over 150lbs, Kendall became a personal trainer certified in fitness nutrition, women's fitness, and weight loss by the National Academy of Sports Medicine. She is also certified in sports nutrition by Precision Nutrition. She now lives in New York with her husband and children, and is working on her 6th and 7th certifications because she likes having alphabet soup at the end of her name.

19 Comments

  1. Erin December 9, 2010 at 1:10 PM - Reply

    I kind of hate the way lap band surgery is promoted. I have been around lots of people who do it who have horrible indigestion and vommitting due to continuing to eat too much. The thing that I really don’t get about it is that your stomach shrimks naturally when you eat less. I realize that is easier said than done, and I’ve no interest in judging those who go that route. But thats exactly the point. It IS harder than eating less, there IS more to know about making healthy choices, there IS an uphill emotional battle… and no surgery removes those obstacles either. In my, perhaps unpopular opinion (and coming from lifelong obesity until the last 2 years), if you aren’t ready emotionally, if you don’t “get your head right” to lose weight nothing will work for you. Not even surgery.

    • Erika December 9, 2010 at 1:14 PM - Reply

      *falls over and passes out*

      Agreed!!!!!!!!!!!!!!!! A-GREED!!!!

    • Denice Smith November 25, 2014 at 3:04 PM - Reply

      Amen!

  2. Terri December 9, 2010 at 1:50 PM - Reply

    At one point I had ‘briefly” considered the surgery, until I ran into a friend who had it and looked horrible. She had some major complications and was worse off health wise than she was before the surgery. I came to realize that there is no “quick fix”. No Pill, No Patch, No Diet, No Surgery that will fix it. I didn’t go to sleep one night and wake up the next morning overweight. Just like everyone else, I had to have my Ah-Ha moment and around the same time, I found this site. Everyday is a challenge but it does get easier. I have my moments but there are some things (Soda, Fried/Fast Food, White Bread, Boxed items, Pork Products) that I have been able to shed with no problems. Others (Drinking more water, remembering to pack my lunch everyday, keeping healthy snacks around) are a bit more of a challenge. But everyday I get better at listening to my body and figuring out what it needs. Every time I go to the Gym, I can feel myself getting stronger and stronger. Every time I go up the stairs without feeling like I’m going to keel over, I know I am doing the right thing. Is it hard? YES. Is it a challenge? YES. But every victory, every setback, every hurdle is MINE. No surgeon or plastic band is going to take credit for my hard work!!! I did it and now I am undoing it….one small CLEAN step at a time!!!

  3. Kimberly December 9, 2010 at 2:42 PM - Reply

    As someone who had the surgery, I do have to take issue with those who think it’s not “hard work” or it’s the “easy way”. It is offensive to me when someone like the above poster writes “No surgeon or plastic band is going to take credit for my hard work!!!” [Erika, I hope my offense to this comment doesn’t violate your posting rules.]

    I work extremely hard. I exercise 5x/week (3x with a trainer), take the stairs instead of the elevator, park far from store entrances, eat clean, and MOST importantly, see a therapist regularly. My surgeon can take credit for executing a proper procedure with no complications; she cannot and does not take credit for my success. On the flip side, she also doesn’t get the blame for other patients’ failures. If you don’t address emotional eating, you’ll regain the weight. If you don’t follow the rules, you’ll regain the weight. If you don’t exercise, you won’t lose the maximal amount of weight possible.

    As I’ve stated multiple times, bariatric surgery is a tool to jumpstart weight loss, not a permanent solution to obesity. Just because bariatric surgery is not for YOU doesn’t mean it’s not for SOMEONE ELSE. An extremely obese person with high blood pressure, diabetes, etc…is most likely not going to receive medical clearance to engage in a strenuous exercise program. They will have to slowly lose weight by restricting their caloric intake. If that same person has other serious health issues, bariatric surgery might be the only real option to quickly get enough weight off the person to address more significant co-morbid conditions.

    I do have issues with the FDA panel’s recommendation of lowering the BMI for surgery eligibility. If you’re 5’8″ and 230 lbs, that’s the minimum BMI for eligibility right now, assuming no co-morbid conditions. The new recommendation would be 5’8″ and 197 lbs. I wouldn’t recommend any patient with 50 excess lbs to undergo a surgical procedure that would only result in the loss of approximately 25 lbs in 12 months. Everyone thinks the band is safer than the bypass. While the hard statistics show more significant complications with the bypass (a mortality rate of 1.0%) versus the band (mortality rate of 0.1%), more patients have non-life threatening complications with the band. Band re-operation rates, due to slippage, erosion, etc.. run about 10%. Statistically speaking, that’s HIGHLY significant in the medical world. What other medical procedure would one willing undergo knowing there’s a 1 in 10 chance of having it redone?

  4. Cheryl December 9, 2010 at 3:22 PM - Reply

    @ Terry – I agree with you wholeheartedly!

    There is a guy here at work that had the gastric bypass. He looked really great for about a year (my employer will pay for either surgery and if you keep it off for a year, the plastic surgery for skin. Then slowly he started to get big again. The last time I talked to him, he had regained over 100lbs, he told me he put an entire pizza thru his blender so he could have it. If that is not an addiction, I don’t know what is.

    I wanted a quick fix, but the reality is there is no quick fix, and I got myself to this weight, one fatty, sugary bite at a time. The weight is coming off slowly (oh so very slowly) but I remind myself I am cultivating a lifestyle and setting an example for my girls so that they do not start out with bad habits.

  5. Denise @How mama Got Her Swag back December 9, 2010 at 5:36 PM - Reply

    OMG, this seriously disturbs me. I’m at 33% BMI and while I could stand to lose a few (which I actively am doing) I am nowhere near huge. That BMI percentage is hardly so fargone that you have to have surgical intervention. This is greed at it’s height. Good grief, folks, there are no magic pills. You simply have to hunker down and lose the weight the right way. It takes a lot longer to build a building than it does to destroy one. It’s the same with our bodies — rebuilding after weeks, months, or years of destruction is simply going to take longer than it did to get us here in the first place. UGH! I’m ranting now. Sorry, I’m just really upset about this.

  6. T.R. December 11, 2010 at 1:21 AM - Reply

    Okay this may sound like a stupid question but here goes. If you get the surgery, either of them, and still have to work out and eat healthy to loose and maintain the weight loss, why get the surgery in the first place? I mean that’s what everyone else is doing to loose and change their lifestyle. It doesn’t make sense to me. There are people who have had “morbid” issues and have started changing their eating and moving (and any exercise can be modified) and have seen results also. And if simply lowering you calorie intake is what is needed and you need to be “mentally and emotionally” prepared before the surgery to be successful, how is that any different from people who are attempting to loose the weight without surgery? I mean we have to do the same thing, as many people on this site have testified too. I’m thoroughly confused. I don’t get it.

    • VM December 11, 2010 at 12:10 PM - Reply

      @TR – I’m right there with you! Another thing I really don’t get is that before the patient has the surgery, the patient is remanded to lose a certain amount of weight by doing the same things you described in your comment – exercising regularly, eating less, keeping a food journal, eliminating certain items in his or her diet and eating more fruits and vegetables, whole grains, etc. I ask it, too – if one has to go through that, then, why have the surgery at all?

    • Kimberly December 18, 2010 at 1:56 PM - Reply

      Folks are wondering WHY have the surgery if you have to lose weight to have the surgery? Generally your surgeon will require you to lose 5% of your body weight to “prove” you are committed to the process and frankly, to make it easier to navigate through the abdomen during the actual surgery (they also require a liquid diet w/one per day the 2 weeks before surgery). Many, MANY surgeons have refused to operate on patients who couldn’t follow these simple instructions to lose a small amount of weight.

      There are folks for whom this very slow process (eating right, exercising, resisting temptation) is not an option in the long term. If you have severe co-morbid conditions (degenerative osteoarthritis, high blood pressure, diabetes, obstructive sleep apnea) and weigh 350 lbs, there is nothing you can do FAST ENOUGH to get the weight off. Exercise (other than pool-based) is really not an option if you CAN’T MOVE. If you weigh 350 lbs, cutting your caloric intake to 1,500-1,800 calories/day is enough to get 18lbs off of you within a few months. THEN, and only then, should you consider the surgery. The 100lbs or so a 350-pound person will drop in the first 9 months is enough to enable them to move more freely and begin an exercise regimen. The 4-6 weeks it takes for the swelling in the pouch (no longer called a stomach) to decrease is enough to get a TRULY COMMITTED patient to make changes.

      After this initial honeymoon phase, it is up to the patient. You can go back to eating crappy foods in small amounts and regain the weight. you can eat well, exercise, and continue to lose weight. As I’ve written repeatedly (and Erika and several others), you’ve got to get a grip on your emotional issues related to eating. If you fail to do that, NOTHING will work.

      Most of all, remember, if there were no significant health benefits associated with either surgery (lowering blood pressure, “curing” apnea, getting blood sugars to normal), NO insurance company would cover it.

      Could we please agree to disagree (to everyone) on the issue of bariatric surgery? If you think it’s “cheating” or the “easy way”, fine. If you’ve had the surgery and it saved/restored your life, you feel differently. For every Carnie Wilson or guy at your job who regained the weight and put pizza in a blender, there is a Star Jones or a woman at my job who has kept the weight off for 5+ years, which is the gold standard for “permanent” weight loss.

      I had no idea there was so much prejudice against those who opt for bariatric surgery. It’s really dishearterning and a real curiosity. Why not support someone who has the surgery, follows the plan, loses the weight, and “reboots” their life?

  7. Laz December 17, 2010 at 11:37 PM - Reply

    I considered the Lap Band surgery. Although I think my surgeon didn’t really think I should. I could tell by the way he spoke to me. However, he said it was my decision. I was already working out regularly but the weight just wasn’t coming off. I was discouraged and at my wits end. I also had gall bladder problems. The surgeon said I would have to have it removed if I wantd the surgery. But they also provided me with the diet plan. Well, after going on that diet plan. I discovered that I had not been eating properly. (GO FIGURE) I began to lose the weight slowly but surely. The kicker was I had been gaining muscle from the strength training. And let’s say it together “muscle weighs more than fat”. But like most,I was obsessed with the scale.

    Anyway, my point is I decicded not to have the surgery because I discovered the secret that really isnt a secret. Eat properly (clean and portion control), drink lots of water (I love my water) and work out (can’t believe I really enjoy this now). I look and feel like a brand new person. I am so happy I didnt have the surgery. I work daily at the issues that led me to being over weight. For me that is the key. It starts in the mind. No surgery, no powder, no liquid, no exercise…nothing. WE must tackle that thing….Whatever that thing is…Then everything will fall into place. Trust me. I am a living witness and I am enjoying the journey.

    • Kimberly December 18, 2010 at 2:02 PM - Reply

      Why did he discourage you from having the surgery? There is a reason he didn’t feel you were a suitable candidate. If you have a family history of heart disease, stomach cancer, it is very difficult to find a surgeon who’ll perform the procedure. If he felt that you were ambivalent about the procedure, he might have discouraged you. If you weren’t severely obese, he might have discouraged you.

      FYI: bariatric surgeons can and DO remove gall bladders during the lap band procedure. The surgeon removes the gall bladder FIRST, then, barring no issues, will place the band. I don’t know where you live, but I could name 10 surgeons where I live who do both procedures in one operation.

  8. VM December 18, 2010 at 1:59 PM - Reply

    @Laz: GOOD FOR YOU! So many people do not use critical thinking or reasoning when it comes to the decision of whether to have “weight loss surgery” or not. They just go ahead and do it because they’ve “tried everything and it has not worked.” If some open their minds to the possibility of making small changes in their life here and there (read: diet, exercise), then weight loss can be achieved, barring health issues/bone/joint issues or a metabolic disorder.

  9. sohappyididit December 29, 2010 at 11:24 AM - Reply

    I am so glad this is a free country and I have free will to do what I want with my body…whew! I had lap-band surgery and I am so happy that I did it! Everyone does not share my dreams so I told only a few close friends who are supportive of me being me. I am feeling great and I am glad that I am eating right, exercising and not hating on others who made the decision not to do it. I say ‘do you boo’ and keep it moving!

    I try not to pick and choose my sins along with not being critical of adults who make adult decisions.

    Hats off to all those who are trying to lose weight by whatever method works for you!

    Happy New Year!

    • Erika December 29, 2010 at 11:36 AM - Reply

      My first instinct told me to simply not publish this comment… but I want to make something very clear.

      I am not AGAINST the surgery. I am against fitness consumerism, the REPEATED idea that people cannot lose weight on their own and need to purchase a product in order to achieve success. Kimberly’s comments above are continually approved because she appears as PROOF of that. She had the surgery, changed her lifestyle, achieved some level of success.

      My PERSONAL philosophy – and this IS my site – is that we are beaten over the head, every day, with marketing that says we can’t do a damn thing on our own and need to give someone our money in order to do it. What about those of us who don’t have THAT money? Are we then screwed? What about the people who don’t have insurance and are maxing out credit cards to try to pay for this stuff?

      I have a PERSONAL problem with a society that thinks its okay to seek out secondary means of success without recognizing that they are SECONDARY. If you want the surgery, please get it – but failure to acknowledge that you’ll need to do the SAME THINGS as those who don’t get the surgery (as Kimberly has stated over and over again) basically means that you WILL be needing another procedure shortly.

      I don’t make it my place to judge how people reclaim their health, because there’s only ONE way to do that. All I can do is hope that people are going about it the right way. Nothing more, nothing less.

      • irene September 12, 2012 at 2:20 PM - Reply

        Hi Erika!i have written u before and I have a question I am 4’11 290lbs. And I am 27 years old. In order to have a child I need in vitro fertilization but I am not a candidate unless I lose 100lbs. The fertility specialist recommends lap band surgery but me and my husband are TERRIFIED!!! do u think I am able to lose that amount of weight in a year or less? Any info comments really anything u could offer me would be greatly appreciated. Thanks:)

        • Erika Nicole Kendall October 6, 2012 at 12:49 PM - Reply

          Do I think it’s possible? Yes. Do I think you should give yourself more time, especially considering the stress you’re dealing with currently? ABSOLUTELY.

  10. NL May 1, 2011 at 3:00 PM - Reply

    Hi all,
    I’m really glad Erika clarified her PERSONAL position on surgery – I’d thought she was all against it. Any-hoo, I’m totally with Kimberley, and she’s totally on point. Bariatric surgery (Yes, I had a gastric sleeve resection – no fussing with a band…) is NOT a cure all. There is really only one way to consistently lose weight and keep off any excess and remain healthy. It’s what Erika has said all over this site. Mindfully mind your calories going in and coming out. The surgery is a tool to help keep your MIND engaged on the weight loss process instead of the food in your fridge. My two cents. Oh, and I work out 5x a week for 40 – 45 minutes each time (cardio plus circuit training). Since my surgery in January, I’ve lost 44lbs – and counting.

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