Thursday, December 2, 2010

I think this could be great...

So the question is, will the FDA approve?

http://www.outpatientsurgery.net/news/2010/12/4

(If you don't want to click the link, the body of the article is copied below.)

Clinical trial showed significant weight loss among Lap-Band patients with BMIs between 30 and 40.

The number of patients eligible for Lap-Band surgery could skyrocket if the Food and Drug Administration accepts Allergan's request to significantly lower how obese someone must be to qualify for the surgery.

The answer could come as soon as tomorrow, when the FDA panel on Gastroenterology and Urology Devices meets to discuss Allergan's application to expand the use of the band for those who are less obese. The panel is expected to recommend or reject the application for full FDA approval.

The Lap-Band is currently approved for weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or with a BMI of at least 35 if the patient also has one or more severe health problems.

Allergen's application comes after a clinical trial conducted on 143 less obese patients with BMIs ranging from 30 to 40. According to the study results, 80.5% of all implanted patients lost 30% of their excess weight. Nearly 66% of all the patients with the Lap-Band lost at least 50% of their excess weight. The FDA yesterday acknowledged that the patients in the study experienced "statistically significant decreases in all measures of weight loss."

Nearly 20% of the adult population has a BMI between 30 and 35, more than double the population with BMIs above 35, according to federal statistics.

The American Society for Metabolic and Bariatric Surgery says that 220,000 bariatric surgeries of all kinds were performed in the United States last year, more than twice as many as in 2003.

This is another article about this, too. 

http://www.bloomberg.com/news/2010-12-01/allergan-lap-band-safe-for-use-in-broader-population-group-fda-staff-says.html

I don't know about marketing to adolescents, though....many opinions on that, I guess.



8 comments:

  1. I think it makes sense for people who have been obese or overweight for a long period at those BMI levels..
    I am sure they will have some strict guidelines for qualification.

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  2. We do Lap Bands on adolescents at my hospital with some incredible success and some not so great, but no major complications from not obeying band rules...yet. I would say the success rates on teenagers and compliance with eating guidelines are comparable to adults. Interesting stuff.

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  3. I think it could definitely help some overweight people from becoming obese. I'm sure the insurance companies will fight it though.
    Take care xoxoLinda

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  4. I had a BMI of 34 but I paid for surgery. Some clinics won't see you if you are not over 35. It is now considered a cure for type 2 diabetes which I was heading for. So the amount of money I spent saved my life. I haven't decided if it is an option for teens. It isn't magic so they still have to work with it.

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  5. I just left another comment on your previous post. Go read it now!

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  6. Right before my surgery there was a "band class" at my doctor's office about do-s and don't-s post surgery and one of the people in the class was a young woman. She wasn't a teenager anymore, but she was probably about 20-22ish. Anyway - several people asked questions about this and that. Her questions were about when she could start drinking and having sex again. Not that those aren't important questions - but when the nurse suggested abstaining from alcohol for a while - 6 months would really be best - she started ask follow up questions. Since beer isn't good, what other types of alcohol would be best; I mean I could just do shots if that's what you recommend. I'm sure I'm not doing it justice, but my only thought was - Um... sweetheart, I'm not sure you're ready for this yet.

    Just a little story...

    The rest - very, very interesting!

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  7. I Need your help! I didn't have much time but I tried the unflavored in a cup of soup today it didn't dissolve and I couldn't eat it. Do you have a suggestion for how to add it to soups? Do you add it to cold first, dissolve it and then warm it? Give me a hint! I have the click mocha protein and it is yummy!

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  8. I think this is a great idea! The adolescent part - I think it's a highly individualized situation and should be treated as such. I don't think there should just be blanket requirements if you're under 18. The Aussie bloggers will have to help me out here but I thought they already had lower BMI requirements to qualify for the band?

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