Saturday, December 4, 2010

FDA panel approves Lap-Band for the LESS FAT

So all of posts until now have been happy, better yourself type posts. While I prefer writing those I feel posts like this one have their place and importance as well.

Today I read an article which stated that the FDA panel which voted on December 3, 2010, 8-2, voted yes to approving the lap band for lower BMI patients. This decision gives patients with a BMI of 35 and a BMI of 30 with 1 co-morbidity access to lap-band surgery. The previous qualifications across the board for weight loss surgery were a BMI of 40 (100lbs over weight) or a BMI of 35 with 1 co-morbidity (ie: hypertension, diabetes, obstructive sleep apnea etc.).

I have to say, as a former lap-bander for almost 3 years, I am shocked, outraged and PISSED OFF!!!! Here is why: Lets start with how this whole ordeal came up to begin with.

"Allergan is looking for approval to lower those BMI cutoffs to 35 and 30 respectively. Allergan estimates that about 15 million Americans are eligible for the Lap-Band under the current guidelines, but that 27 million people would be eligible for the procedure under the new, broader classification"
For those of you who don't know who Allergan is, they are one of the largest producers of the actual Band used in the Lap Band surgery. So who stands to profit from this decision... ALLERGAN and surgeons!!! What about the patients who can now have weight loss surgery... Well lets look at some statistics shall we...

In a study done in the US by Ren, Horgan and Ponce (2002) "115 (patients) have been followed for at least 9 months, and 43 have been followed for at least 12 months. A retrospective analysis of prospective data gathered from these patients is presented. The percent excess weight loss was 35.6% at 9 months and 41.6% at 12 months. The average body mass index decreased from 47.5 to 38.8 in 9 months and from 47.5 to 37.3 in 12 months."

There were 15 complications, in 12 patients, within the first 9 months alone, which required a second surgery. While this doesn't seem so bad, these are only results after a one year study. so at 1 year 10% of patients had a complication. Now lets look at a 10 year study...

In a study done by Suter, Calmes, Paroz and Giusti (2005) "Lap-Band was performed in 317 patients, average weight was 261lbs, and mean BMI was 43.5 kg/m2 (range of 34-78). 105 (33.1%) of the patients developed late complications, including band erosion in 9.5%, pouch dilatation/slippage in 6.3%, and port-related problems in 7.6%. Major reoperation was required in 21.7% of the patients. The mean Excess Weight Loss at 5 years was 58.5% in patients with the band still in place. The failure rate increased from 13.2% after 18 months to 23.8% at 3, 31.5% at 5, and 36.9% at 7 years.


So we see at 1 year the average complication rate is about 11% and at 7 years, more than triples to almost 37%. This second article goes on to say that each year after the complication rate goes up by another 3-4%. so by 10 years this leaves, conservatively, 46% of people who have Lap Band Surgery by year 10 will have had one major complication, which will most likely involve a second surgical procedure. THAT IS ALMOST HALF!!!!! Is your head spinning yet???

Did you know?? Clinical success with the Lap-Band is considered to be losing 50% of your excess weight in 2 years. So for someone with a BMI of 30-35 they are only expected to drop 3-6 points on the BMI scale which is about 20-30lbs. The article that presents the findings of the 10 year study goes on to say, "Only 60% of the people who do not have major complications at 10 years out are successful and maintain that weight loss.

For those of you who aren't good with numbers, this means out of 100 people, who are all 5'5'' and weigh 265lbs, at 10 years post op from lap band surgery ....

46-49 of them will have had at least 1 major complication, and need their band removed.
25-30 of them will lose about 50lbs and maintain this weight loss (and still be considered OBESE)
20 - 25 will not have a complication or achieve successful weight loss with the band
2-5 will do fabulously!

Do you all see where I am going with this? No? Ok let me continue... Back to the article that got me all riled up in the first place... It states...
If the lower threshold is approved, the Lap-Band label would state that the device is only to be used in adults who have failed "more conservative weight reduction alternatives, such as supervised diet, exercise, and behavior modification programs."
Ok  seriously!!! Seriously!!! SERIOUSLY!!!!!!! SERIOUSLY!!!!!! What the F**K! Have we not all done this... Did you have to provide a diet history to your surgeon? I did!! TWICE! I gave in the same exact one both times and just changed the dates. So really... It's like the psych eval (topic for another rant) We know exactly what to say, exactly what to write, how to act, talk, come across, pull the blindfold whatever... Oh and by the way... my diet history.. I MADE IT UP!!! Who the heck can be expected to remember exactly what dates they used Atkins for 3 days in 2002? I can't... Unless you keep a detailed journal to reflect back on this is going to be made up. So I can say I have failed 347 diets in the past year but no one will ever know if its true. But lets forget this issue for now because I have an even more important issue...

Lets talk about the complications that people who need their band out face... Erosion, slippage of the band, esophageal scaring, adhesions and port and tube problems are the most common issues with the band. This Article I read about the FDA approving this procedure for lower BMI patients stated....
"The Lap-Band has the benefit of being adjustable and removable."
Ok.. The band is adjustable, and you can draw your own opinions on that if you would like. I personally do like that fact. The lap band however is generally not a removable device. It isn't permanent, that's true... but it is not entirely removable. Removable suggests that your body will go back to the state it was in prior to the band being placed. THIS IS NEVER TRUE! You will always have adhesions and scaring on your stomach which depending on the severity may not allow you to revise your surgery or may limit your options. The stomach where the band was doesn't automatically spring back to open. I and many other previous banders threw up for a month or so after having their band removed!!  If you were throwing up often while you had the band in, removing the device will not remove the damage you have done to your esophagus. So you can revise your band but you can NEVER remove it.

Just so you know... I didn't only write this because I'm super pissed off, I wrote this because I want all of you to care enough about your body to get educated and do the research! If you do decide to have a lap-band I will support you the whole way through, especially if you are making an informed and educated decision. If you would like sources feel free to post below and I will send em your way. I am not afraid to say I don't know or I'll get back to you, or point you in the direction of someone who would know.

To our health,
xoxo
Sleeve Pixie

9 comments:

  1. Fabulous! Yeh.. great points here with the article.. One huge thing with any WLS is that it does not do everything.. the band will not carry the weight off and keep it off as the bypass won't, weigh loss surgery takes a lot of research and understanding before jumping under the knife
    Elle Williams

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  2. Thank you Elle for bringing this up!! I forgot to mention this point simply because I think I was just riled up and excited to post this. I cannot tell you how many people told me I FAILED my band... NOPE... my band failed me. Its faulty at best... I hope people actually read this before a person who is 5'6'' and 186lbs considers having SURGERY! This isn't a joke! Its SURGERY... Im saddened... DEEPLY SADDENED :-(

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  3. Wow. I'm having my band removed Tuesday after 2 years of fills and getting food stuck and vomiting. I initially lost 30 pounds during the liquid and soft phase but have gained all but 3 pounds back. I hate this band and can't wait to get it out. I'm revising to a gastric bypass but after reading the above I AM PETRIFIED! However, I am grateful to you for enlightening me. :)

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  4. I wish I had known all this info when I was banded. :(

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  5. There are reasons I don't like AGB.

    You've nailed them.

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  6. I did great with my band for about 1 1/2 years and then started haveing reflux so bad that I had to sleep sitting up and was taking tums, malox, pepcid, and everything else you could imagine and most of the time none of that even worked. When my surgeon went in to remove my band and do my revision to the bypass, there was so much damage from the band that he took the band out and closed me back up and made me wait close to 4 months for my stomach and esophagus to heal up. Went through all of that to only lose 60 lbs (of which I regained over half when he took my fill out trying to help my relfux). I would never recommend the band to anyone. If the one something less invasive I would suggest the Sleeve.

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  7. its a money maker, charge to put it in, charge to F around with it for a handful of years and then charge to take it out. Sleeve is the way to go for restriction only. Keep getting the word out.

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  8. My band and I got along great, until I lost my insurance and could no longer get a fill. Now of the 65lbs that I originally lost (pre and post op), I have gained 15lbs of it back. I have had my band for 18 months today, and have not had a fill in 14 months.
    I tell you if I had the funds available, I would revise to the sleeve.

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