New Clinical Studies Reinforce the LAP-BAND® System is a Safe and Effective Weight-Loss Treatment for Obese Adults with Obesity-Related Comorbid Conditions
IRVINE, Calif., April 13, 2011 /PRNewswire/ — 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.”
About the LAP-BAND® System
Allergan is committed to advancing gastric banding technology, as evidenced by the development of the LAP-BAND AP® System, an evolution of the LAP-BAND® System which features Allergan’s proprietary 360-degree OMNIFORM™ technology. The LAP-BAND AP® System was designed to enhance the proven safety of the LAP-BAND® System and help bariatric surgeons to better accommodate a wider range of patients.
The LAP-BAND® System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In February 2011, the LAP-BAND® System became the first and only FDA-approved device for bariatric surgery for use in obese patients with a BMI of 30-40 with at least one obesity-related comorbid conditions. The LAP-BAND® System does not involve stomach stapling or intestinal re-routing(1)(2)(3) and has non-surgical adjustments that can help patients attain and maintain a healthy satiety level and minimize the potential for weight regain.(4)
Obesity is the second-leading cause of preventable death in the United States, second only to smoking.(5) Sadly, every two minutes a person dies of weight-related causes.(6) Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese.(7) However, not all weight-loss treatments are effective over the long term – as a preponderance of data, published literature and scientific research have found that diet and exercise is unsuccessful in 80-85 percent of overweight and obese patients at one year(8)(9) – underscoring the critical role of the LAP-BAND® System in providing an effective treatment option for the obese patient whose health is impacted by their weight, when more conservative weight-loss therapies, like supervised diet, exercise and behavior modification fail.
Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Precautions: Revision procedures may require the existing staple line to be partially disrupted to avoid having a second point of obstruction below the band. As with any revision procedure, the possibility of complications such as erosion and infection is increased. Any damage to the stomach during the procedure may result in peritonitis and death or in late erosion of the device in to the GI tract.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Gastric banding done as a revision procedure has a greater risk of complications. Prior abdominal surgery is commonly associated with adhesions involving the stomach. In the US study, 42% of the patients undergoing revisions were reported to have developed adhesions involving the stomach. Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.
Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.
CAUTION: Rx only.
This press release contains “forward-looking statements,” including, but not limited to, the statements by Drs. Ren Fielding and Ray, and other statements regarding the studies referred to herein as well as the safety, effectiveness, adverse reactions, product availability and market potential of the LAP-BAND® System. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Allergan’s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2010 Form 10-K. Additional information about Allergan is available on the World Wide Web at www.Allergan.com or you can contact the Allergan
Investor Relations department by calling (714) 246-4636.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have more than 9,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
© 2011 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved.
(1) Chapman A, Game P, O’Brien P, Maddern G, Kiroff G, Foster B, Ham J. Executive summary: Laparoscopic adjustable gastric banding for the treatment of obesity: Update and re-appraisal. Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) Report No. 31, Second Edition. Adelaide, South Australia: ASERNIP-S, June 2002. (Laparoscopic adjustable gastric banding surgery, like the LAP-BAND® surgery, is associated with a mean short-term mortality rate of around 0.05% compared to 0.50% for Gastric Bypass and 0.31% for Vertical Banded Gastroplasty.)
(2) Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Laparoscopic Objective Comparison of Complications Resulting from Laparoscopic Bariatric Procedures. J Am Coll Surg. 2006;202:252–261.
(3) Chapman AE, Kiroff G, Game P, Foster B, O’Brien P, Ham J, Maddern GJ. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery 2004;135:326-351.
(4) Faria SL, Kelly E, Faria OP. Energy Expenditure and Weight Regain in Patients Submitted to Roux-en-Y Gastric Bypass. Obes Surg. Apr 28 2009.
(5) Jia H, Lubetkin E. Trends in quality-adjusted life-years lost contributed by smoking and obesity. Am J Prev Med 2010;38:138-44.
(6) Mokdad AH, et al. Actual Causes of Death in the United States, 2000. JAMA. 2004; 291:1238-1245.
(7) Kuczmarski MD, Prevelance of Overweight and Weight Gain in the United States. Am J Clin Nutr 1992; 55:495S-502S.
(8) Kraschnewski, JL et al. Long-term weight loss maintenance in the United States. International Journal of Obesity 2010; 1-11
(9) Sacks FM, et al, Comparison of Weight-Loss Diets with Different Composition of Fat, Protein, and Carbohydrates. NEJM 2009; 360:859-73.
SOURCE Allergan, Inc.