Product Description

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The LAP-BAND^® System

The LAP-BAND^® System is a safe, effective, and well-established surgical option for obese patients that helps them to lose weight and maintain that weight loss over time.

Over 650,000 LAP-BAND^® Systems have been sold worldwide, with data supported by more than 1,850 publications and references with up to 10 years of follow-up.²⁴

Unlike gastric bypass surgery, the LAP-BAND^® System is minimally invasive, adjustable and reversible. The adjustable gastric band, which is placed around the upper part of the stomach, is a silicone ring comprised of soft, pre-curved individual sections, filled with saline to allow adjustability of the band and increased or decreased restriction. This creates a new, smaller stomach pouch and reduces the amount of food that the patient's stomach can hold. The LAP-BAND AP^® System has the highest available fill volume (0-14 cc) for greater flexibility and more precise adjustments. The LAP-BAND^® System and Access Port are available in 2 sizes for an optimal fit.

No cutting or stapling of the stomach is required, and because the stomach and intestines are not bypassed, there is less risk of vitamin or mineral deficiencies.

Comparable weight loss with the LAP-BAND^® System and open gastric bypass surgery is observed at three years post-surgery and beyond.^8,25

To date, the LAP-BAND^® System is the only FDA-approved gastric banding system for people with a BMI of at least 30 kg/m² with one or more obesity related comorbid conditions. For patients who are 30 or more pounds above their ideal weight with a BMI of at least 30 kg/m² with one or more obesity related comorbid conditions, or a BMI of at least 40 kg/m², the LAP-BAND^® System could be their answer for long-term weight loss.

The LAP-BAND AP^® System is available in 2 sizes to address patient's needs:^*

AP Standard (APS)-considered the standard size
AP Large (APL)-intended for the largest anatomical situations

The LAP-BAND AP^® System

Band Features

The only FDA-approved gastric banding system for people with a BMI of at least 30 kg/m² with one or more obesity related comorbid conditions, or a BMI ≥40 kg/m²
360^o OMNIFORM^® technology — soft, precurved individual sections minimize potential for crease-fold failure and leaks
Concentric shape at any inflation volume
Wide balloon with minimal lateral exposure — limits the risk of puncture during surgery
Thickest shell available — reduces the risk of balloon fatigue and failure (.043 inch average shell thickness).

Flexibility

	The only system available in 2 sizes to address every patient's needs^*
	Access Port available in 2 sizes — to meet the needs of different patients Port placement with either manual sutures or mesh

Proven Results

Post-Operative Health Improvements from Surgically-Induced Weight Loss Include:

In separate studies each evaluating one obesity-related health condition, weight loss with the LAP-BAND^® System was shown to help improve and resolve obesity related comorbid conditions in the large majority of patients studied, such as asthma (93%; N=32), Type 2 diabetes (90%; N=50), sleep apnea (93%; N=123), gastroesophageal reflux (90%; N=48), and hypertension (79%; N=34).^{26,27,28,29 ‡}
Reduction in medication usage for obesity-related conditions³
Surgically-induced weight loss, in general, is also associated with resolved or improved:¹⁸
- Urinary incontinence^{19,30,31,32,33}
- Infertility^21,22,30
- Complications of pregnancy and delivery²²
- Degenerative joint disease^{19,20,21,23,34}
- Venous stasis disease³⁵
- Quality of life^19,21,36

For those with a Body Mass Index (BMI) between 30 and 40, a new study (N=149) shows that the LAP-BAND^® System provides significant results.^6,7

In the first 12 months (N=143):

The mean Excess Weight Loss (EWL) was 64.5%⁶
The mean reduction in Body Mass Index (BMI) was 6.5 points⁶
The mean reduction in waist circumference (in inches) for men was 6.1 inches; women 5.9 inches⁷

Weight loss results were maintained at year 2⁷

*The LAP-BAND AP^® System family of products consists of 5 bands. LAP-BAND^® Access Port I and II are not shown at actual size.

The Realize^™ Band-C

Band Features

Balloon is 1 long silicone tube that creases at placement
Triangular shape when inflated
Wide balloon with broad lateral exposure
Thin shell (.022 inch average shell thickness)

Flexibility

	Band-C available in only 1 size^†
	Only 1 port size— can be difficult to palpate in heavier patients Port placement with mechanical applier — manual suture if appropriate fixation cannot be accomplished by integrated fastening hooks

†The Realize^™ family of products consists of 2 bands. Realize^™ Band-C port is not shown at actual size.

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.

10.

Chapman A, Game P, O'Brien P. Laparoscopic adjustable gastric banding for the treatment of obesity: update and re-appraisal. ASERNIP-S Report No.31, Second Edition. Adelaide, South Australia. ASERNIP-S, June 2002.

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The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Perioperative Safety in the Longitudinal Assessment of Bariatric Surgery. New Eng J Med 2009;361(5)445-454.

12.

Lalor PF, Tucker O, Szomstein S, Rosenthal RJ. Complications after laparoscopic sleeve gastrectomy. Surge Obes Relat Dis. 2008;4:33-38.

13.

LAP-BAND^® Adjustable Gastric Banding System [directions for use]. Irvine, CA:Allergan, Inc, 2008.

14.

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Aggarwal S, Kini SU, Herron DM. Laparoscopic sleeve gastrectomy for morbid obesity: a review. Surg Obes Relat Dis. 2007;3:189-194.

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Elder KA and Wolfe BM. Bariatric Surgery: A Review of Procedures and Outcomes. Gastroent 2007;132:2253-2271.

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Spivak H, Hewitt MF, Onn A, Half EE. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg 2005;189:27-32.

19.

Ahroni JH, Montgomery KF, Watkins BM. Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year. Obes Surg 2005;15:641-647.

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Kleinman NL, Melkonian A, Borden S, et al. The Impace of Morbid Obesity and Bariatric Surgery on Comorbid Conditions: A Comprehensive Examination of Comorbidities in an Employed Population. JOEM 2009;51(2)170-179.

21.

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22.

Dixon J, O’Brien P. Changes in comorbidities and improvements in quality of life after LAP-BAND placement. Am J Surg 2002;184:S51-4.

23.

Korenkov M, Shah S, Sauerland S, et al. Impact of Laparoscopic Adjustable Gastric Banding on Obesity Co-morbidities in the Medium- and Long-Term. Obes Surg 2007;17:679-83.

24.

Data on file, Allergan, Inc. June 2010.

25.

Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 2005;201:529-535.

26.

Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after LAP-BAND^® surgery for morbid obesity. Obes Surg 1999;9:385-389.

27.

Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care 2002;25(2)358-363.

28.

Dixon JB, Schachter LM, O'Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med 2001;161:102-106.

29.

Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of Lap-Band placement. Obes Surg 1999;9:527-531.

30.

Sugerman HJ. The pathophysiology of severe obesity and the effects of surgically induced weight loss. Surg Obes Relat Dis 2005;109-119.

31.

Kuruba R, Almahmeed T, Martinez F, et al. Bariatric surgery improves urinary incontinence in morbidly obese individuals. Surg Obes Relat Dis 2007;3:586-90.

32.

Burgio K, Richter H, Clements R, et al. Chances in urinary and fecal incontinence symptoms with weight loss surgery in morbidly obese women. Obstet Gynecol 2007;110:1034-40.

33.

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34.

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35.

Sugerman HJ, Sugerman EL, Wolfe L, et al. Risks and Benefits of Gastric Bypass in Morbidly Obese Patients With Severe Venous Stasis Disease. Ann Surg 2001;234(1)41-46.

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38.

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39.

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40.

O'Brien PE, Dixon JB, Brown W, et al. The laparoscopic adjustable gastric band (Lap-Band^®): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg. 2002;12:652-660.

41.

Maniscalco M, Zedda A, Faraone S, et al. Weight loss and asthma control in severely obese asthmatic females. Resp Med 2008;102:102-8.

42.

Ponce J, Haynes B, Paynter S, et al. Effect of LAP-BAND® Induced Weight Loss on Type 2 Diabetes Mellitus and Hypertension. Obes Surg 2004:14:1335-1342.

43.

Buchwald H, Avidor Y, Braunwald E, et al. Bariatric Surgery: A Systematic Review and Meta-analysis. JAMA 2004;292:1724-37.

44.

Taylor CJ, Layani L. Laparoscopic Adjustable Gastric Banding in Patients >=60 Years Old: Is it Worthwhile?. Obes Surg 2006:16:1579-1583.

45.

Edwards MA, Grinbaum R, Schneider BE, et al. Benchmarking hospital outcomes for laparoscopic adjustable gastric banding. Surg Endosc 2007:21:1950-1956.

46.

Frigg A, Peterli, R, Peters T, et al. Reduction in Co-morbidities 4 Years after Laparoscopic Adjustable Gastric Banding. Obes Surg 2004:14:216-223.

47.

Pontiroli AE, Folli F, Paganelli N, 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. Diab Care 2005;28(11)2703-2709.

48.

Shen R, Dugay G, Rajaram K, et al. Impact of Patient Follow-up on Weight Loss after Bariatric Surgery. Obes Surg 2004;14:514-519.

49.

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.

Cunneen SA, Phillips E, Fielding G, et al. Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis. Surg Obes Relat Dis 2008;4:174-185.

51.

Spanakis E, Gragnoli C. Bariatric Surgery, Safety and Type 2 Diabetes. Obes Surg 2009;19:363-368.

52.

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54.

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55.

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56.

Mittermair R, Weiss H, Nehoda H, et al. Laparoscopic Swedish adjustable gastric banding: 6-year follow-up and comparison to other laparoscopic bariatric procedures. Obes Surg 2003;13:412-7.

57.

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.

58.

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.

59.

Dixon JB, Dixon ME, O'Brien PE. Pregnancy after Lap-Band(R) Surgery: Management of the Band to Achieve Healthy Weight Outcomes. Obes Surg 2008:11:59-65.

60.

Martin LF, Finigan KM, Nolan TE. Pregnancy After Adjustable Gastric Banding. Obstet Gynecol 2000;95(6):927-930.

61.

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62.

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63.

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Reference

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Product Description

The LAP-BAND® System

The LAP-BAND AP® System

Band Features

Flexibility

Proven Results

The Realize™ Band-C

Band Features

Flexibility

The LAP-BAND^® System

The LAP-BAND AP^® System

The Realize^™ Band-C