Re-post: Report complications/failures directly to the FDA!!!

(deactivated member)
on 12/5/11 7:03 am - Califreakinfornia , CA
This whole surgeons trying to make their own surgery stats look like legitimate, unbiased " scientific data " has been on my mind all morning since I first came across that link.

How many lurkers have actually followed that link and believed it to be truthful, unbiased, and legitimate ? The poster of the link thought it was " scientific data " so I'm sure others thought this information was legitimate too.

OH needs to hire someone who will put together a video tutorial on how to search for legitimate sources and supply links to UNBIASED scientific data.
Denise M.
on 12/5/11 7:31 am
Pummy, you know I work in the field of medical research.

Honestly, I have minimal faith at best in published research sometimes!  On the news you hear this causes cancer but wait!  Next week whatever it is cures cancer!

It's all in the spin and the data set you choose to focus on.  Plus I work with people who I wouldn't trust any farther than I could throw.  If I don't trust them, I certainly don't trust their work. 

I printed an article from Bariatric Times and there's an ad from Allergan in there.  

The ad says in the first year, the patients lost 65% of their EWL and in the 2nd year, it was up to 70%.  However, out of the 650,000 bands sold, their study included a scant 143 people.  And the ad says the "currently available Year-2 results are based on a database snapshot of an incomplete data set that has not been source verified."

Who knows what to trust?  I just know my experience was not what I expected and that's the most important thing to trust for me.
   
(deactivated member)
on 12/5/11 7:44 am - Califreakinfornia , CA
(deactivated member)
on 12/5/11 7:20 am - San Jose, CA
Biased study by surgeons with a vested interest in the outcome.

Here are a couple of more recent reports:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2216704/?tool=pu bmed

From Himpens:
The most serious challenge to a bariatric operation is time. Indeed, many patients will experience weight regain starting some 2 years after the procedure. Few series report on results beyond 5 years; those that have, report dismal longterm results. Re-operation rates continue to rise after 10 years or more.9 In fact, this high incidence of re-operations has pushed researchers into developing a biodegradable band, with the intention of complete disappearance of the band before dreadful delayed complications can occur. Besides material breakdown, the most frequent causes of re-operation are: insufficient weight loss, intractable gastro-oesophageal reflux, pouch dilation or band slippage, and intragastric migration of the band. Whereas some authors can treat this latter complication by endoscopic means,10 most surgeons still rely on a laparoscopic or even ‘open’ approach for band removal. Replacement of a band after slippage or migration is, in our experience and in most others,11 quite unsatisfactory. Some surgeons, however, do not hesitate to replace a band once, twice, or even three times. The therapeutic attitude of some authors towards adjustable band complications is sometimes quite surprising; achalasia-like malformations of the oesophagus, for example, are now judged acceptable by some.12 This disturbing evolution is hardly compatible with the prime intention of the procedure itself, namely minimal aggression to the body.

Many band patients will need another bariatric operation at some point in the future, be it for obesity recidivism or for adverse effects of the technique. There is substantial evidence that re-do operations are technically more demanding, more prone to complications, and less effective than primary ones. Quite logically, the number of conversions into laparotomy will be markedly higher in the re-do situation. The incidence of complications in re-do bariatric surgery is significantly higher than in first comers.13 The pouch is more difficult to construct and will often end up being too large because excessive scarring obscures the view and renders dissection hazardous. Quite often, surgeons will be forced into adapting their technique to the anatomical changes induced by the band and switch to an operation they are not accustomed to, like biliopancreatic diversion.


And here is a study from 2011:

Arch Surg. 2011 Jul;146(7):802-7. Epub 2011 Mar 21.

Long-term outcomes of laparoscopic adjustable gastric banding.

Himpens J, Cadière GB, Bazi M, Vouche M, Cadière B, Dapri G.

Source

The European School of Laparoscopic Surgery, Department of Gastrointestinal Surgery, Saint Pierre University Hospital, Brussels, Belgium. jacques_himpens@hotmail.com

Abstract

OBJECTIVE:

To determine the long-term efficacy and safety of laparoscopic adjustable gastric banding (LAGB) for morbid obesity.

DESIGN:

Clinical assessment in the surgeon's office in 2009 (≥12 years after LAGB).

SETTING:

University obesity center in Brussels, Belgium.

PATIENTS:

A total of 151 consecutive patients who had benefited from LAGB between January 1, 1994, and December 31, 1997, were contacted for evaluation.

INTERVENTION:

Laparoscopic adjustable gastric banding.

MAIN OUTCOME MEASURES:

Mortality rate, number of major and minor complications, number of corrective operations, number of patients who experienced weight loss, evolution of comorbidities, patient satisfaction, and quality of life were evaluated.

RESULTS:

The median age of patients was 50 years (range, 28-73 years). The operative mortality rate was zero. Overall, the rate of follow-up was 54.3% (82 of 151 patients). The long-term mortality rate from unrelated causes was 3.7%. Twenty-two percent of patients experienced minor complications, and 39% experienced major complications (28% experienced band erosion). Seventeen percent of patients had their procedure switched to laparoscopic Roux-en-Y gastric bypass. Overall, the (intention-to-treat) mean (SD) excess weight loss was 42.8% (33.92%) (range, 24%-143%). Thirty-six patients (51.4%) still had their band, and their mean excess weight loss was 48% (range, 38%-58%). Overall, the satisfaction index was good for 60.3% of patients. The quality-of-life score (using the Bariatric Analysis and Reporting Outcome System) was neutral.

CONCLUSION:

Based on a follow-up of 54.3% of patients, LAGB appears to result in a mean excess weight loss of 42.8% after 12 years or longer. Of 78 patients, 47 (60.3%) were satisfied, and the quality-of-life index was neutral. However, because nearly 1 out of 3 patients experienced band erosion, and nearly 50% of the patients required removal of their bands (contributing to a reoperation rate of 60%), LAGB appears to result in relatively poor long-term outcomes.


Mean excess weight loss was 48%.  That means the average person with a lap band for 12 years was a statistical bariatric FAILURE.

But of course, those statistics won't apply to YOU.

Bexie
on 12/2/11 9:56 am - MO
My husband is 2 years, 11 months out from his band.  He has had no complications, no resurgery, no over-restriction.  He has lost a little over 200lbs.  He walks daily, runs after our nieces and nephews.  It has not been an easy road, but it has not been fraught with pitfalls around every corner.  For some people the band works, for some it doesn't.  Just like Angioplasty works for some and not for others, Spinal Fusion works for some and not for others, and plastic surgery works for some and not for Kenny Rogers.
Ready For A Change
MARIA F.
on 12/2/11 10:22 am - Athens, GA

That's great that your husband has done so well with his band to date. However you do know that the long term outlook for him (or you) is not good. Why do you think you seldom see a bandster that is 5 years out? And on the rare occasions that you do see one......haven't most of them had at least a 2nd surgery?? Why do you think that many bariatric surgeons now are refusing to do the band? And why is it that most that do still do it are removing more than they are putting in???

Keep in mind that there are many ppl that lose massive amounts of weight with the band. But if they are just going to have complications in a few years and have to have a 2nd surgery just to be able to keep it, or a 2nd surgery to remove it..why not just go with a safer, more effective WLS to begin with? 

 

   FormerlyFluffy.com

 

Lori S.
on 12/2/11 10:25 am - MI
 What do you consider a "safer" more "effective" surgery?

 

MARIA F.
on 12/2/11 11:10 am - Athens, GA

Good question. As far as more effective, I would say DS, RNY and VSG. As far as safer, I would say VSG and RNY long term would be safer. DS I would think statistically would be also, but I'm not exactly sure about that one. DS seems to have more complications than VSG and RNY, but as far as "safety", I would think that it would have fewer complications than the band long term, but they could tend to be more serious.

What does everyone else think as far as safer and more effective long term???

 

   FormerlyFluffy.com

 

Lori S.
on 12/2/11 11:39 am - MI
 I would agree VSG would be a good choice.  I know for me I would have no problem going that route if I needed to.  I don't know enough about DS to make any comments.   RNY kind of scares me.  I know of a few people who have had or are having many problems with RNY many have lost the weight and then gain most if not all of it back.  Or they have lost all the weight they need to but look awful, malnouished and sickly and are still losing.    I don't personally know many people who have had any kind of weight loss surgery but the few I do know I seem to be doing the best, again I don't know very many.  But I do know that all surgeries can have there problems/failures.   My surgeon is doing more and more VSG today then he did 4 yrs ago when I had my surgery done.  He still does a lot of bands too.  

 

MARIA F.
on 12/2/11 3:35 pm - Athens, GA
On December 2, 2011 at 7:39 PM Pacific Time, Lori S. wrote:
 I would agree VSG would be a good choice.  I know for me I would have no problem going that route if I needed to.  I don't know enough about DS to make any comments.   RNY kind of scares me.  I know of a few people who have had or are having many problems with RNY many have lost the weight and then gain most if not all of it back.  Or they have lost all the weight they need to but look awful, malnouished and sickly and are still losing.    I don't personally know many people who have had any kind of weight loss surgery but the few I do know I seem to be doing the best, again I don't know very many.  But I do know that all surgeries can have there problems/failures.   My surgeon is doing more and more VSG today then he did 4 yrs ago when I had my surgery done.  He still does a lot of bands too.  
I would prefer VSG if I could revise, although I would feel just as comfortable revising to RNY. You do see a lot of regain in some RNY'ers, and that is a concern, but from my perspective (this coming from someone who never got restriction).........at least the RNY works well initially. I kind of feel like that will generally get you to goal or close to it, but once the honeymoon phase ends, the weight from that point on can depend entirely on you. I would have loved to have been able to lose the amount of weight I have lost thus far w/o being hungry all the time. :-(

DS I think is a wonderful procedure! Espcially for the SMO and those with diabetes. With DS you have to be much more vigilent about the vits though. And I don't think I would be able to maintain the vitamin schedule so I wouldn't do DS for that reason. All my friends that have it love it though!

 

   FormerlyFluffy.com

 

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