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?