Adjustable Gastric Banding System is a Safe and Effective Weight-Loss Treatment
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Irvine, CA – 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. (NYSE: AGN), 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 who received 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.”