New Clinical Studies reinforce that Lap Band is Safe and Effective Weight-Loss Treatment fo

 New Clinical Studies Reinforce the LAP-BAND® System is a Safe and Effective Weight-Loss Treatment for Obese Adults.15 April 2011  

Two new studies published in the current issue of Surgery for Obesity and Related Diseases, a peer-reviewed journal, add to the large body of scientific evidence which supports that the LAP-BAND® Adjustable Gastric Banding System, made by Allergan, Inc., is a safe and effective weight-loss procedure. One study concluded that laparoscopic adjustable gastric banding (LAGB) procedure can be safely performed in a community medical practice, with patients experiencing meaningful excess weight loss. The second study examined patients *****ceived LAGB following the failure of gastric bypass and found they achieved significant weight loss two years post-banding procedure.

While a wealth of data has been published in the literature worldwide, questions have recently been raised about the safety and effectiveness of the LAP-BAND® System, specifically with respect to average weight loss and complications. These two new studies support that the advanced product technology of the LAP-BAND® AP System, combined with surgical technique and patient aftercare result in positive clinical outcomes. The LAP-BAND® System has an 18-year safety and effectiveness record, including almost 10-years in the United States, with more than 650,000 procedures performed worldwide, leading to more than two million patient years of exposure for the device.

Key Study Findings Published in Surgery for Obesity and Related Diseases:

The first study, by James B. Ray, M.D., F.A.C.S. and Shahla Ray, Ph.D., of the Center for Advanced Laparoscopic and Bariatric Surgery, Bloomington, IN, followed one surgeon's practice for five years (March 30, 2004 to December 2, 2009) in which 442 LAGB procedures were performed. The study found that on average patients achieved 48 percent excess weight loss at two years and 60 percent excess weight loss at five years, with no evidence of weight re-gain over the duration of the study. Percent excess weight loss (% EWL) is defined as the percent of "excess weight" – i.e., the weight above ideal weight – that is lost. Follow-up information for 94 percent of patients was available. Patients were seen two weeks postoperatively and then every six weeks for the first year, every three months for the second year and twice yearly thereafter. Adjustments were made according to weight loss, level of satiety and hunger. The perioperative mortality rate was zero percent and the explantation rate (i.e., band removal) was low – less than two percent. Four patients required reoperation within 30 days. Long term complications were band slippage in nine (2.0%), port problems in 14 (3.1%) and band erosion in two (0.4%). The authors concluded, based on their substantial database, that LAGB is safe and effective, produces sustained weight loss, and has a low long-term failure rate.

"In bariatric surgery, surgeon experience and technique is critical to optimizing patient safety and weight-loss outcomes," said Dr. Ray. "In addition, the procedure that is chosen must meet the expectations of the patient in terms of both efficacy and safety. Our study shows that with the use of advanced band technology by trained surgeons and meticulous follow up care, patients can undergo a minimally invasive procedure in a community setting and achieve successful and sustainable weight loss."

The second study by Katayun Irani, M.D., Heekoung A. Youn, R.N., Christine J. Ren-Fielding, M.D., George A. Fielding, M.D. and Marina Kurian, M.D. from the New York University Langone Medical Center, NY, evaluated 43 patients who had received LAGB after failing to achieve satisfactory weight loss following gastric bypass surgery. Failure was defined as persistent morbid obesity or failure to maintain at least 50 percent EWL at 18 months post gastric bypass. For patients in this study, mean body mass index (BMI) before gastric bypass was 50.4, and they still met the definition of morbid obesity (average BMI of 43.3) more than six years on average after the procedure. Two years after receiving LAGB, the average BMI was 35.2. The study re-operation rate for complications related to LAGB was 10 percent and included two band erosions, one band slip, one port flip, and one case of persistent dysphagia. The study re-operation findings are in line with the medical literature, which finds the re-operation rate of LAGB is higher when performed as a secondary procedure versus as a primary procedure. The researchers concluded that LAGB is a safe and effective procedure to help failed gastric bypass patients achieve successful weight loss.

"Our study demonstrated that gastric bypass is not for everyone and many factors can contribute to the failure of gastric bypass, resulting in patients not meeting their weight-loss goals," said Christine J. Ren-Fielding, M.D., Department of General Surgery, New York University Langone Medical Center, NY. "For those who have been unsuccessful in achieving a healthy weight following gastric bypass, the data shows that a gastric banding procedure performed by a skilled bariatric surgeon is an effective way to achieve sustained weight loss due to its low rate of complications and a very low mortality rate. The LAP-BAND® System not only can be a first-line surgical treatment option, but can also potentially be used safely as an adjunct to other bariatric operations when weight loss is not achieved."

Thanks I needed to see this. I have been seeing so many neg posts. I was starting to worry alot again.

In am also glad to see fact based evidence that is not always just the negative! Yes, there are complications, and negative things that happen, but that is the risk we all take, no matter what type of procedure we have had!
I for one feel lots of times the failure of the band may be related to not following the guidelines. I know from personal experience, if I sabatoge my weight loss, by eating slider foods, or having a sugar filled non carbonated drink, that is MY FAULT. Not the band not working!
Same goes for when the band is too tight, and we "live with it".  We get the warning signs of heartburn, and we slip into old habits of eating soft slider foods. That is also not the fault of the band. It is the fault of the patient who does not report this to the surgeon, and go back in for an unfill.
Now, I KNOW there are things that can happen, and to no fault of the patient, and we should be educated to all risks and benefits, but honestly... bashing the lapband or any other surgery does not make someone appear credible, and most readers just become accustomed to the posts almost as a chicken little "the sky is falling" type of message.

Off of the soap box : )

They also lose less weight and have more weight regain that all the other major WLS porcedures (Lap Band, RNY, DS, VSG).  And Allergan, Inc. pays a bundle to OH to push people toward their surgery.  Just the truth...

I know several lapbanders that are all less then two years out. So I can't speak to the regain of lap band.  However, I do know (not by word of mouth I actually work with, go to church with, or am related to) seven people that have had bypass 3 have regained all of there weight, 1 passed away but not from the surgery, 1 gain back a good deal of weight, and 2 kept of the weight but 1 of the 2 is sick all the time. So in my experience that rate of success isn't that great either.

Well they can print all they want but as a person who has a useless band I beg to differ especially when my surgeons say they are finding a different result not just in their practice but in others also. Anyone who has had difficulty with their band will tell you they came in to this expecting the best results but we have been sadly disappointed and in some cases severely physically harmed. So it's all well and good to sit behind a desk and publish figures but they need to talk to we who know better from our own personal experience. I'm more than happy for those who succeed but it is not failproof.

is there a link to this study???  Please post...happy to see some positive irrefutable evidence.

 You could probably find it here, but you have to register to use the site:
http://www.soard.org/

Thanks Bette...I was able to read the abstract.

There is another study on there that included only 100 patients who were banded in 2006...it was a comparison of techniques and produced some interesting results:

www.soard.org/article/S1550-7289%2810%2900691-X/abstract

I cant imagine that Naomi hast posted to this thread yet.

I may be a user since 4/23.. I have lurked for years here and posted heavily on another forum.  I have to say I will never recommend the band to anyone. I have had my band for 3 years. My last fill being a year ago.... The fill was great but 8 months later it got tighter and tighter on its own till I lost 15lbs in one month from not being able to eat even though I was close to goal. I chose to call my surgern only to find out that I had a small slip. I had an unfill immediately. I then had a refill of a small amount only to find out nope its still a slip......... another 60 days then I  will try again or look into my options.

I dont buy what that study is selling. I don't think it works for everyone and at this point I dont think its a long term solution.