ABC News story on banding, Brussels study

 I'm not going to take the time to investigate how big the European study was, but here's a link to the news video, for anyone interested.


abcnews.go.com/Health/video/risks-lap-band-surgery-weight-loss-treatment-13196012

The following is quoted from Jacques Himpens et. al. Arch Surg/vol 146(No.7) July 2011

 Of the 151 patients who had benefited from LAGB between January 1, 1994, and December 31, 1997, 82 (54.3%) were available for full evaluation as a result of a written or telephone reply to the questionnaire and/or an examination in the office by one of the surgeons at the end of 2009. There were 8 men and 74 women, with a mean (SD) age of 50 (0.95) years (range, 28-73 years). The mean (SD) preoperative weight was 113.57 (18.17) kg (range, 86-180 kg), and the mean (SD) BMI was 41.57 (2.9) (range, 35-57). The operative mortality rate was zero. The median postoperative follow-up period was 13 years. 11-14 Three patients (3.7%) died of causes unrelated to the LAGB: one died of melanoma, one died of lung cancer, and one committed suicide for financial reasons. Forty-eight patients (58.5%) had minor and/or major complications.
MINOR COMPLICATIONS Of the 82 patients, 18 (22.0%) had a total of 29 minor complications: 4 (4.9%) presented with an incisional hernia, 16 (19.5%) experienced 23 port-tubing disconnections, and 2 (2.4%) developed isolated port infection. MAJOR COMPLICATIONS Of the 82 patients, 32 (39.0%) had a total of 33 major complications: 9 (11.0%) had pouch dilatation, 6 of whom had their bands removed and 3 of whom had their bands
repositioned. Twenty-three patients (28.0%) presented with band erosion, which was diagnosed after a mean (SD) time of 4 (2.9) years (range, 1-11 years). Of these 23 patients, 17 had their bands removed, 2 had their bands repositioned, 2 were switched to laparoscopic Roux-en-y gastric bypass (LRYGB), and 2 declined treatment. One patient (1.2%) developed a band infection.

I'm perplexed by that last paragraph about erosion; it states that 2 patients DECLINED TREATMENT. Why on earth would one decline treatment for an erosion?!

That is strange; maybe they did not want to undergo re-operation for some reason.  I saw a paper once that showed an image of an eroded band with contrast media.  The article said that the patients only complaint was no restriction and hunger.  It appeared as though the stomach grew around and sort of walled off the eroded band.  I'll see if I can find the paper again.  It was pretty interesting.

 Maybe so, but I find it hard to believe that their doctor would ok just leaving it there! Who knows. 

A doctor can't force you to have treatment.  My guess is they would have to sign  surgery consent forms for the erosion operation just like any other surgery.

I jus****ched the video, most of it I knew already just from being around these boards for years.

I have a serious questions for band patients. Have you thought about what will happen if the band's ever get recalled all together? I seriously see it as a possibility in the future. I am 8 yrs post op, and had my second band placed 3 yrs ago. I am at a nornal body weight, but I worry all the time not if but when I will have a problem with the band or if the band gets recalled. I SO regret that I did not investigate the VSG further when I had second band placed. My big mistale had been falling off the boards for a while when I had my son in 06, I missed a few good years of learning about other options. Hindsight is 20/20 as usual.

If there is a mass recall what happens? Do we all line up like cattle for band removal and dismissal?

I'm with you SS, mine is empty and I still worry that I'll have some kind of problems from it and I don't tend to be a worry wart but so many things just keep popping up band related in the news that I think a sensible person should be afraid! I'd be thrilled to get this out of me but my insurance doesn't cover it so I just keep treading water. 

DON'T PANIC YET...OR START LOOKING FOR REVISIONS...IF IT AIN'T BROKE DON'T FIX IT...

 I just researched Dr Karen Boyle and she has no background or expertise in Bariatric surgery, however, she IS a genital cosmetic surgeon though...aka she performs vaginal rejuvenation surgeries...  link to her website....http://www.drkarenboyle.com.
 
I will be 7 years post op and I STILL HAVE MY ORIGINAL BAND., I take care of my band and  get yearly checkups and don't keep it too tight and so far so good for me!

Sorry...she has absolutely NO creditability in my view.

Now that said, Allergan has criticized the OUTDATED BRUSSELS STUDY because the STUDY was performed with OLD LAP BAND TECHNOLOGY....NOT WITH THE IMPROVED WAY OF HOW THE BAND IS STITCHED USING THE PARS FLACCIDA METHOD IN THE LAST FEW YEARS......

THE OLD STUDY BELOW:

Published: April 1st, 2011

About six out of every 10 people who undergo gastric Lap-Band surgery may experience complications that require additional surgery and nearly half may have to have the banding removed, according to a recent study by Belgian researchers.

The researchers looked at patients who had received the Allergan Inc. Lap-Band over a period of 12 years and reported their findings last week in the Archives of Surgery. They found that nearly a third of patients who undergo the procedure, known as laparoscopic adjustable gastric banding (LAGB), discovered that their bands had eroded the wall of their stomach over time.

The study used data from 82 patients who underwent LAGB surgery between January 1, 1994 and December 31, 1997. Researchers found that 61% suffered some kind of complications, usually major. Overall, 28% were found to have suffered Lap-Band erosion, and just under 50% had the band removed within 12 years. Overall, the Lap-Band recipients lost about 43% of the excess weight they carried before undergoing to procedure.

The researchers said that the lap band erosion, complications, and an overall lukewarm satisfaction rating by the patients in the study led them to determine that Lap-Band side effects lead to relatively poor long-term outcomes for LAGB.

Allergan has criticized the findings, saying that a 2010 Lap-Band study in Surgical Endoscopy found only a 12% complication rate among nearly 3,000 patients who had the bands implanted in 2001, which was the year the FDA approved the Lap-Band for use in the U.S. The company said that the study focused on the beginning of LAGB surgery, before doctors became experienced with the procedure.

According to Allergan, more than 500,000 people worldwide have received the Lap-Band and said both the band itself and LAGB surgery have changed since the subjects of the Belgian study received their bands.

The new study comes less than a week after the FDA announced that it was expanding the approved use of the Lap-Band to include people who were less obese.

BELOW IS THE NEW AND LATEST STUDY .AND VERY IMPORTANT...THIS STUDY WAS CONDUCTED ON SURGEONS THAT ARE PART OF  THE CENTER OF EXCELLENCE ...THAT IS A BIG DIFFERENCE...

http://www.springerlink.com/content/q7h5605015566218/
 

Abstract

Background

Laparoscopic adjustable gastric banding (LAGB) has become one of the most common weight-loss procedures performed in the United States. The authors’ high-volume academic medical center has gathered a database of almost 3,000 patients who have undergone LAGB since January 2001. The goal of this series, the largest to date on LAGB outcomes at a single institution, was to assess complications associated with LAGB.

Methods

A retrospective analysis was performed using longitudinal data from adult patients who underwent LAGB between 1 January 2001, and 29 February 2008. General and band-related complications were reported for all patients. Death and reoperation for weight gain (LAGB followed by either a second band insertion or a gastric bypass) also were reported.

Results

Of the 2,965 patients *****ceived LAGB during the study period, 2,909 met the criteria for inclusion in this analysis, and 363 (12.2%) experienced one or more complications. The most common complications were band slip (4.5%) and port-related problems (3.3%). Other complications were rare. Only seven patients (0.2%) had band erosion. Eleven patients (0.4%) underwent reoperation for weight gain. A total of 10 deaths (0.34%****urred during the study period. Three patients died within 30 days of surgery. Two of these deaths (0.06%) were related to surgery, and one resulted from a motor vehicle accident. Seven patients died of causes unrelated to surgery during the course of the study.

Conclusions

The LAGB technique is a relatively safe procedure with few early or late complications. Few LAGB patients undergo reoperation for weight gain, and mortality is very rare.

 Naomi this is not exactly telling the whole truth.  True that Karen Boyle is not a bariatric surgeon, but false to imply that she is plastic surgeon who specializes in vajayjay's.  She is micro-surgeon affiliated with Johns Hopkins and it appears as though her work deals with male infertility that is complicated by obesity.  My is guess is that is how she got interested in obesity.  True ABC could have done better and and found a bariatric surgeon to address this publication, but it does not appear to me that Karen Boyle is not well respected as a surgeon, and what she specializes in has absolutely nothing to do with the publication.  

It is also a misrepresentation to not fully disclose that the senior authors on the publication that you referenced here have received research and educational funding from Allergan and they also serve on Allergans advisory board and receive speaker honorariums from Allergan.  

Of course Allergan disputes the Brussels study.  Allergan makes money selling lapbands.  They will lose money if people chose other surgeries.  They will lose even more money if their product gets pulled off the market and still more if they are opened up to lawsuits.  

I think that if you have a lapband and you are problem free it's still a good idea to keep yourself aware of potential problems that may arise.  At the very least it may cause you to get things checked out more often instead of just telling yourself that it's nothing.  Knowledge is power.  We shouldn't try to keep anyone in the dark when it comes to their health or well being.