New Study Finds That Gastric Banding Pays for Itself In Approximately Two Years for Patients With Diabetes and Four Years for Patients Without Diabetes

IRVINE, Calif., June 22, 2011 /PRNewswire/ -- Allergan, Inc. (NYSE: AGN) today announced a new study published in the peer-reviewed journal Surgery for Obesity and Related Diseases that found the cost of a gastric banding weight-loss surgery procedure, such as Allergan's LAP-BAND® Adjustable Gastric Banding System, was offset by reductions in obesity-related medical costs within 2.25 years for surgery eligible patients with diabetes, and within four years of the procedure for all surgery eligible patients.

The study evaluated healthcare claims data from 7,310 patients who had undergone gastric banding compared to claims from a matched control group of 7,306 surgery eligible obese individuals who did not have weight-loss surgery, for the purpose of quantifying the potential savings of gastric banding. The study found that while post-surgery medical costs for the gastric banding group declined slightly, medical costs for the control group continued to rise, thus resulting in significant savings for the banding sample. These findings underscore the critical effect gastric banding has on containing healthcare costs among the target population.  

"Although the gastric banding procedure is associated with upfront costs, our analysis shows that those costs are recovered in a relatively short period of time, particularly for obese patients with diabetes," said study lead author Eric A. Finkelstein, Ph.D., of Duke University and Duke-NUS Graduate Medical School in Singapore. "Although the potential for cost-savings should not drive coverage decisions, some insurance providers are hesitant to cover the costs of bariatric procedures for fear they will break the bank. These results may allay some of those concerns," Finkelstein said.  

Currently, one in three American adults is obese.(1) Due to increased medical expenditures, absenteeism, and presenteeism (reduced on the job productivity due to health reasons), obesity now costs U.S. businesses roughly $70 billion per year.(2) The total medical bill for the nation as a result of obesity is now projected at $147 billion per year, or nearly 10 percent of all medical expenses in the United States.(3) This figure is projected to reach 16-18 percent of all U.S. healthcare costs in the next 20 years.(4) Given its known correlation to life-threatening co-morbid 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. Furthermore, medical research has found that if left untreated those individuals who are currently obese will likely remain obese,(5) highlighting the unmet clinical need among obese patients for the availability of and reimbursement for effective treatment options.

"This study is consistent with the vast findings from the published literature that support gastric banding is an effective and safe weight-loss surgery procedure that can produce sustained weight loss, ultimately resulting in reduction of obesity-related comorbid conditions and medical costs," said Frederick Beddingfield, M.D., Allergan's Vice President of Clinical Research and Development. "Research of this kind is integral in our efforts as a company to ensure appropriate access to and affordability for the LAP-BAND® System procedure for patients across the country."

About the LAP-BAND® System

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 30-35 with at least one obesity-related comorbid conditions. The LAP-BAND® System has been approved internationally since 1993, and over the past 18 years, more than 650,000 procedures have been performed, leading to more than two million patient years of exposure for the device. As such, the LAP-BAND® System has an 18-year safety and effectiveness record.

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.

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.

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.

Forward-Looking Statements

This press release contains "forward-looking statements," including, but not limited to, the statements by Dr. Beddingfield and Mr. Finkelstein, and other statements regarding potential cost-savings and reimbursement coverage 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 and subsequent Quarterly Reports on Form 10-Q. 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.

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(1) CDC: National Center for Health Statistics. NCHS Data on Obesity. Available at http://obesity.procon.org/sourcefiles/NCHSDataOnObesity.pdf. Accessed 3/22/10.

(2) Finkelstein et al. The Costs of Obesity in the Workplace. Journal of Occupational & Environmental Medicine. 2010; 52(10):971-976.

(3) Finkelstein et al.Health Affairs 28, no. 5 (2009): w822–w831.

(4) Wang Y, Beydoun MA, Liang L, et al. Will all Americans become overweight or obese? Estimating the progression and cost of the US obesity. Obesity October 2008;16(10):2323-2330.

(5) Kuczmarski MD, Prevelance of Overweight and Weight Gain in the United States. Am J Clin Nutr 1992; 55:495S-502S.  

SOURCE Allergan, Inc.