For those who prefer science to water cooler conversations...read it and weep.

Ms. Cal Culator
on 11/24/09 11:34 pm - Tuvalu
As a result of a debate about LapBand complications, we've had a couple of people who decided to conduct what I guess are fun little polls regarding various surgeries.  But since none of those are controlled in any way, I found a few studies that were peer-reviewed and made the same point I was trying to make.

Now, those who proudly announce that they "don't believe in statistics" won't care...they prefer "data" they pick up at church or the nail shop.  But there are SOME people who believe in reason, so this is for them...even though the reading is a bit more challenging than say, People or USA Today.



1--This study explains that the LapBand success/fail breaking point seems to be a BMI of 46.  That is, the higher the BMI is over 46, the less chance the patient has of losing even half their excess weight.

Surg Obes Relat Dis. 2009 May-Jun;5(3):310-6. Epub 2008 Oct 7.

Failure of adjustable gastric banding: starting BMI of 46 kg/m2 is a fulcrum of success and failure.

Snyder BScarborough TYu SWilson E.

Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.

BACKGROUND: To determine the body mass index (BMI) located at the fulcrum of success and failure in a prospective study conducted at the University of Texas Health Science Center at Houston. On average, our patients whose percentage of excess weight loss (%EWL) was >50% at 1 year had a significantly lower BMI than those with <30% EWL.
METHODS: We prospectively collected the weight loss data for 430 patients who had had an adjustable gastric band placed. We stratified the %EWL within 1 year for patients with a BMI of 30-59 kg/m2. A line was generated for the %EWL over time for BMI groups of 30-39, 40-49, and 50-59 kg/m(2) and compared with the average %EWL over time. The y-intercepts of the resulting four lines were graphed against the average BMI for each group.
RESULTS: The generated y-intercept line had an R2 of .9237. Using the equation of this line and the known y-intercept for the average, we solved for x, resulting in a BMI of 46 kg/m2. Patients with a BMI <46 kg/m2 had a 50% EWL at 1 year, and those with a BMI >46 kg/m2 had only a 33% EWL at 1 year. The %EWL between the groups was significantly different at all measured intervals (P <.0001).
CONCLUSION: A BMI of 46 kg/m2 identifies those at high risk of failure to lose a significant percentage of excess weight after adjustable gastric banding and *****quire closer follow-up. Furthermore, patients who have a BMI >46 kg/m2 should be advised that their weight loss might be suboptimal at 1 year.

PMID: 19136307 [PubMed - indexed for MEDLINE]

~~~~~~~


2--Then there is the issue of "time."  Over time, as additional bands that were included in the original study fail for various reasons, the "success rate" only gets worse  This is MY issue.  When I was banded in 2002, we knew less than we do today.  I think I recall the FDA going by a three year study.  Well, stuff happens after three years, as this study explains.

That is why I tend to discount "newbie" experience.  As this study shows, by the time they got to nine years out, 40% of the bands failed.  And by failed, that means "failed to help the patient lose even HALF of their excess weight."  


Obes Surg. 2008 Mar;18(3):251-5. Epub 2008 Jan 24.

11-year experience with laparoscopic adjustable gastric banding for morbid obesity--what happened to the first 123 patients?

Tolonen PVictorzon MMäkelä J.

Department of Gastrointestinal Surgery, Vasa Central Hospital, Hietalahdenkatu 2-4, 65280 Vaasa, Finland.

BACKGROUND: Few long-term studies regarding the outcome of laparoscopic adjustable gastric banding for morbid obesity have so far been published. We report our 11-year experience with the technique by looking closely at the first 123 patients that have at least 5 years (mean 86 months) of follow-up.
METHODS: Data have been collected prospectively among 280 patients operated since March 1996. Until March 2002 (minimum 5-year follow-up), 123 patients have been operated laparoscopically with the Swedish band. We report major late complications, reoperations, excess weight losses (EWL) and failure rates among these patients, with a mean (range) follow-up time of 86 months (60-132). EWL < 25% or major reoperation was considered as a failure. EWL > 50% was considered a success.
RESULTS: Mean (range) age of the patients (male/female ratio 31:92) was 43 years (21-44). Mean (range) preoperative weight was 130 kg (92-191). Mean (range) preoperative body mass index was 49.28 kg/m2 (35.01-66.60). Patients lost to follow-up was nearly 20% at 5 years and 30% at 8 years. Major late complications (including band erosions 3.3%, slippage 6.5%, leakage 9.8%) leading to major reoperation occurred in 30 patients (24.4%). Nearly 40% of the reoperations was performed during the third year after the operation. The mean EWL at 7 years was 56% in patients with the band in place, but 46% in all patients. The failure rates increased from about 15% during years 1 to 3 to nearly 40% during years 8 and 9. The success rate declined from nearly 60% at 3 years to 35% at 8 and 9 years.
CONCLUSIONS: Complications requiring reoperations are common during the third year after the operation, and almost 25% of the patients will need at least one reoperation. Mean EWL in all patients does not exceed 50% in 7 years or 40% in 9 years and failure rates increase with time, up to 40% at 9 years.

PMID: 18214633 [PubMed - indexed for MEDLINE]


3--And this study reports that "another procedure of choice for obesity" should be used because, by seven years out, only 43% of the patients maintained even a 50% excess weight loss.

Obes Surg. 2006 Jul;16(7):829-35.

A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates.

Suter MCalmes JMParoz AGiusti V.

Department of Surgery, Hôpital du Chablais, Aigle-Monthey, Switzerland.

BACKGROUND: Since its introduction about 10 years ago, and because of its encouraging early results regarding weight loss and morbidity, laparoscopic gastric banding (LGB) has been considered by many as the treatment of choice for morbid obesity. Few long-term studies have been published. We present our results after up to 8 years (mean 74 months) of follow-up. METHODS: Prospective data of patients who had LGB have been collected since 1995, with exclusion of the first 30 patients (learning curve). Major late complications are defined as those requiring band removal (major reoperation), with or without conversion to another procedure. Failure is defined as an excess weight loss (EWL) of <25%, or major reoperation.
RESULTS: Between June 1997 and June 2003, LGB was performed in 317 patients, 43 men and 274 women. Mean age was 38 years (19-69), mean weight was 119 kg (79-179), and mean BMI was 43.5 kg/m(2) (34-78). 97.8% of the patients were available for follow-up after 3 years, 88.2% after 5 years, and 81.5% after 7 years. Overall, 105 (33.1%) of the patients developed late complications, including band erosion in 9.5%, pouch dilatation/slippage in 6.3%, and catheter- or port-related problems in 7.6%. Major reoperation was required in 21.7% of the patients. The mean EWL 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.
CONCLUSIONS: LGB appeared promising during the first few years after its introduction, but results worsen over time, despite improvements in the operative technique and material. Only about 60% of the patients without major complication maintain an acceptable EWL in the long term. Each year adds 3-4% to the major complication rate, which contributes to the total failure rate. With a nearly 40% 5-year failure rate, and a 43% 7-year success rate (EWL >50%), LGB should no longer be considered as the procedure of choice for obesity. Until reliable selection criteria for patients at low risk for long-term complications are developed, other longer lasting procedures should be used.

PMID: 16839478 [PubMed - indexed for MEDLINE]



One other critical thing to remember while reading is that "success" is defined in the medical literature as 50% excess weight loss.  They are not talking about losing ALL your excess weight.  Yes, that happens.  But it happens just as often as someone losing NONE of their excess weight.  

So what the medical literature is discussing is how likely it is that a hundred people who weigh 300 pounds and should weigh 150 pounds will get to 225 pounds or less. In other words, they'd call 225 pounds for these people "a success."  And what they are saying in these studies is that:
1--probably 25 of those bands will need to come out; and,
2--of the 75 bands that remain in place, after seven to nine years, maybe 45 of those people will weigh 225 or less...the remaining 30 people will weigh somewhere between 225 and 300.
3--That means that of 100 people who weigh 300 pounds and should weigh 150, maybe 45 of them will get to a weight somewhere between 150 and 225...and 55 of them will weigh between 225 and 300 when it's all said and done.


I'm not saying that NO ONE should get the band, although I'd fight like crazy to talk a family member out of one.  (And I have.)  What I am saying is that IF the band is a good choice for some people, it should be marketed to that group and not to every fat person who walks in the door...because now, we know better what the likely results will be.

Sue







Purple Passion
on 11/24/09 11:43 pm - Little Falls, NJ
Interesting read.

I know some people that have done great with the band and kudos to them.  I knew I would be a failure with it.  Besides, I couldn't stomach the idea of having the band and port in my body.

Rachelle
Looking for a possible revision.
257/190/150 

Elizabeth N.
on 11/24/09 11:48 pm - Burlington County, NJ
Thank you Sue. With this post, you will save someone from getting this worthless (and should be outlawed) device, and that's a very good deed.
LeaAnn
on 11/26/09 7:59 am - Huntsville, AL
On November 25, 2009 at 7:48 AM Pacific Time, Elizabeth N. wrote:
Thank you Sue. With this post, you will save someone from getting this worthless (and should be outlawed) device, and that's a very good deed.

(deactivated member)
on 11/24/09 11:54 pm - San Jose, CA
There is also this study: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2698858/?tool=pu bmed

Patient Saf Surg. 2009; 3: 10. Published online 2009 May 29. doi: 10.1186/1754-9493-3-10. PMCID: PMC2698858
Copyright © 2009 Guller et al; licensee BioMed Central Ltd. Safety and effectiveness of bariatric surgery: Roux-en-Y gastric bypass is superior to gastric banding in the management of morbidly obese patients Ulrich Guller,corresponding author1,2 Lazar V Klein,1 and John A Hagen1 1Center for Excellence in Bariatric Surgery, Humber River Regional Hospital Finch Site, University of Toronto, Department of Surgery, Toronto, ON, M3N 1N1, Canada 2Department of Surgery, Division of Visceral Surgery and Transplantation, Inselspital, University of Bern, 3010 Bern, Switzerland corresponding authorCorresponding author. Ulrich Guller: [email protected] Received February 17, 2009; Accepted May 29, 2009.

  Results and discussion There is mounting and convincing evidence that laparoscopic gastric banding is suboptimal at best in the management of morbid obesity. Although short-term morbidity is low and hospital length of stay is short, the rates of long-term complications and band removals are high, and failure to lose weight after laparoscopic gastric banding is prevalent.
Conclusion The placement of a gastric band appears to be a disservice to many morbidly obese patients and therefore, in the current culture of evidence based medicine, the prevalent use of laparoscopic gastric banding can no longer be justified.

 
justjudy
on 11/24/09 11:54 pm - Canton, MI
I missed the previous discussions about lap band surgery, so forgive my jumping in here.

I am a science person, a nurse practitioner dedicated to evidence based practice.  You have provided us with some great reading materials. I totally concur that EVIDENCE in the form of controlled studies is superior to anecdotal conversation. 

But why anyone wants to engage in these "my surgery is better than yours, so there" conversations is beyond me. Any of us could pull up similar studies about every form of weight loss surgery.  In fact, my sister died of complications from another type of WLS, but I have friends who have had tremendous success with that same surgery.

Hopefully none of us is naive enough to think that any surgery is foolproof or 100% effective.  If I had known about the sleeve before I had my band, I might have done that, and the RNY sure would have helped with my sugar cravings, but I give thanks every day for being fortunate enough to have had some sort of intervention.  

Thanks for the references. I hope folks don't get too crazy with this thread at a time of year when we should be about Thanksgiving and peace.

Judy
            

(deactivated member)
on 11/24/09 11:59 pm - San Jose, CA
You are the one starting a fight where none exists.  Nobody said anything about "my surgery is better than yours" besides you.  This is about DATA and CLINICAL TRIAL RESULTS demonstrating the limitations and failure rates of the lapband, and thus warning PRE-OPS to do their research before selecting it -- rather than relying on the people who profit from selling and installing them for accurate information.

But thank you for your oh-so-helpful comments.
(deactivated member)
on 11/25/09 12:40 am - AZ

I don't think it is always a matter of "My surgery type is better than your surgery type" but instead I just want people to do their research.  Many people get the band believing it is the safest surgery type long term and it isn't.  They are getting a band based on bad info, info they are picking up right here on these boards.  If the truth isn't put out there how will they know?  Many do not know how to read studies they find on line and they do not know how these studies are done.

If someone wants the safest surgery type long term they need to do their research and figure out just what it is.  But it isn't the band.

I have been reading these boards for 3 years now and I can't count the number of people that have taken out loans, dipped into their kids college funds, refinanced their homes, went into debt to get WLS just to lose their band a year or two later.  They don't have the money for revision so now they are out a LOT of money and no resources for other options.

THAT is what I want to prevent.

(deactivated member)
on 11/26/09 3:26 am - Canandaigua, NY
Andrea U.
on 11/25/09 8:53 am - Wilson, NC
Just a note -- the RNY doesn't help with sugar cravings...

Andrea -- who's really, really, really trying to avoid the Krispy Kremes in the kitchen...
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