Patient Eligibility

A patient should meet certain criteria to be considered eligible for the LAP-BAND^® System surgery.

To be considered eligible for LAP-BAND^® System surgery^4,9 the patient should:

Have failed non-surgical weight loss (diet, pharmaceutical therapy, behavior modification, exercise)
Be at least 30 pounds above their estimated ideal weight, with a BMI of at least 30 kg/m² with one or more obesity related comorbid conditions
Have a BMI of at least 40 kg/m²
Be willing to adhere to post-operative care and follow-up
Be aware of and accept the operative risks

Laparoscopic bariatric surgery is not recommended for patients who:

Are younger than 18 years
Have conditions that may make the risk of surgery greater than the benefits
Are unwilling or unable to comply with the required lifelong dietary, exercise, and medical requirements
Are currently or may become pregnant
More detailed risk information is available in the Directions for Use (DFU)

Reference

National Heart, Lung, and Blood Institute Web site. The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed March 27, 2009.

Chaston TB, Dixon JB, O'Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes 2007;31:743-750.

Dávila-Cervantes A, Borunda D, Domínguez-Cherit G, et al. Open Versus Laparoscopic Vertical Banded Gastroplasty: A Randomized Controlled Double Blind Trial. Obes Surg 2002;12:812-818.

Sears D, Fillmore G, Bui M, et al. Evaluation of Gastric Bypass Patients 1 Year After Surgery: Changes in Quality of Life and Obesity-Related Conditions. Obes Surg 2008;18:1522-1525.

Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient. Surg Obes Relat Dis 2008;4:S109-184.

Data on File. Allergan, Inc. Irvine, CA. November , 2010.

Directions For Use (DFU). LAP-BAND AP^® Adjustable Gastric Banding System with OMNIFORM^® Design. Allergan, Inc. Irvine, CA. 02/11. The LAP-BAND^® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs. baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

LAP-BAND^® Adjustable Gastric Banding System P000008/S017. Gastroenterology and Urology Devices Panel, Food and Drug Administration. Accessed March 25, 2011 at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM237422.ppt.

O'Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg 2006;16:1032-1040.

American Society of Metabolic and Bariatric Surgery Clinical Issues Committee Web site. ASMBS position statement on sleeve gastrectomy as a bariatric procedure.Approved by the ASMBS Executive Council June 2007. Available at: http://www.pugetsoundsurgicalcenter.com/sleeve_statement.pdf. Accessed June 3, 2009.

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Singhal R, Kitchen M, Bridgwater S, et al. Metabolic Outcomes of Obese Diabetic Patients Following Laparoscopic Adjustable Gastric Banding. Obes Surg 2008:18:1400-1405.

50.

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Brancatisano A, Wahlroos S, Brancatisano R. Improvement in comorbid illness after placement of the Swedish Adjustable Gastric Band. Surg Obes Relat Dis 2008;4:S39-46.

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Pontiroli AE, Folli F, Paganelli M, et al. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care 2005;28(11):2703–9.

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Reference

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Patient Eligibility

To be considered eligible for LAP-BAND® System surgery4,9 the patient should:

Laparoscopic bariatric surgery is not recommended for patients who:

To be considered eligible for LAP-BAND^® System surgery^4,9 the patient should: