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Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics.

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Presentation on theme: "Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics."— Presentation transcript:

1 Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics

2 Disclosures None 1/15/20152

3 Impact of Obesity Weight Loss Makes a Difference Surgical Options for Weight Loss Safety and Effectiveness of Adjustable Gastric Banding System vs. Other Surgical Options Adjustable gastric band Is Effective in Obese and Moderately Obese Patients Gradual Weight Reduction With Gastric Band Results in Better Quality of Weight Loss Review of Today’s Topics 3

4 Impact of Obesity 1/15/20154

5 Disease Risk* ―IncreasedHighVery highExtremely high *Disease risk for type 2 diabetes, hypertension, and cardiovascular disease (CVD), relative to normal weight and waist circumference. 1. National Institutes of Health/National Heart, Lung and Blood Institute. NIH Publication , Rockville, MD: September US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity; Rockville, MD: NorNormal 1 Weigh t 1 (BMI 18.5 to 24.9) Overweight 1 (BMI 25 to 29.9) Obese 1 (BMI 30 to 34.9) Class I Obesity Moderate Obesity 1 (BMI 35 to 39.9 ) Class II Obesity Morbid Obesity 1 (BMI 40 or more) Class III Obesity Classification of Overweight and Obesity by Body Mass Index (BMI), Waist Circumference and Associated Disease Risk* Additional Risks: –Large waist circumference (men >40 in; women >35 in) 1 –Weight gain of as little as 11 pounds increases risk of developing type 2 diabetes 2 –Specific races and ethnic groups 1 5

6 Pulmonary disease Abnormal function Obstructive sleep apnea Hypoventilation syndrome Nonalcoholic fatty liver disease Steatosis Steatohepatitis Cirrhosis Coronary heart disease Diabetes Dyslipidemia Hypertension Gynecologic abnormalities Abnormal menses Infertility Polycystic ovarian syndrome Osteoarthritis Skin problems Gall bladder disease Cancer Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate Phlebitis Venous stasis Gout Medical Complications of Obesity 1 Idiopathic intracranial hypertension Stroke Cataracts Severe pancreatitis 1. Bhoyrul S, Lashock J. JMCM. 2008:11(4):

7 Widely Accepted That Obesity Is Associated With Increased Morbidity Nguyen NT et al. J Am Coll Surg. 2008;207(6): HypertensionType 2 DiabetesDyslipidemia Prevalence (%) Weight gain of 11 pounds or more has been shown to increase the risk of developing Type 2 Diabetes.

8 *BMI ≥30 or about 30 lbs overweight for 5’4” person. Includes gestational diabetes. 1. CDC US Obesity Trends. Accessed January 13, 2011; 2. World Health Organization, the Economist Intelligence Unit, BCG Analysis. Behavioral Risk Factor Surveillance System, 1990, 1995, 2000, 2005, and Obesity Trends* Among Adults No Data<10%10%-14%15%-19%20%-24%25%-29%≥30% From 1990 to 2000, morbid obesity (BMI ≥40 kg/m 2 ) nearly tripled from 0.8% to 2.2% 3 Between 2005 and 2015, the US obese population is expected to increase 59% to 140 MM

9 BMI vs. Mortality Relative Mortality Rate per 100,000 BMI (kg/m 2 ) Exponential Increase in Risk High risk Medium risk Low risk Data based on BMI distribution from the Third NHANES (NHANES III)—a 6-year study from Fontaine KR et al. JAMA. 2003;289(2): For adults with a BMI >45, life expectancy decreases by up to 20 years 1 9

10 Costs Associated With Obesity % Impact of Obesity: Social and Economic Effects Social Impact –Getting a job, making a good impression –Dealing with judgmental behavior –Compromising health and premature aging Economic Impact* 1-6 –As weight increases, so does medical spending in the health care system –$139 billion in direct and indirect costs annually –Annual costs for obesity are ~15× greater than those for being overweight –Increased personal spending on prescriptions, weight-loss products –By 2030, health care costs attributable to overweight/obesity could account for 16% to 18% of total US health care costs *Regression approach using data from 1998 Medical Expenditure Panel Survey and the National Health Interview Surveys. N=9867 adults. Percent of increase is significant across all payors (P<.05). † Value of years of life lost measured by the dollar value of a quality-adjusted life year. 1. Dor A et al. September 21, Accessed February 15, 2011; 2. Finkelstein EA et al. Health Aff. 2003; doi /hthaff.w3.219; 3. Finkelstein EA et al. Obes Res. 2004;12(1):18-24; 4. Sturm R. Health Aff. 2002;21(2): ; 5. Warner J. Web MD: November 8, 2004; 6 Wang Y et al. Obesity. 2008;16(10): †

11 Weight Loss Makes a Difference 1/15/201511

12 Plasma Lipids Improve With Weight Loss: Meta-analysis of 70 Clinical Trials 1 *P ≤.05 LDL-C=low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; TG=triglycerides. 1. Dattilo AM et al. Am J Clin Nutr. 1992;56(2): Total Cholesterol LDL-CTG HDL-C (weight stable) HDL-C (actively losing)  mmol/L per kg of Weight Loss  mg/dL per kg of Weight Loss * * * * *

13 Disease Resolution With Weight Loss Weight Loss: Effect on Comorbidities Comorbidity∆Weight∆Effect Type 2 diabetes 1 >13.6 kg >10% A1C by 2.6 A1C by 1.6 High blood pressure kg Diastolic: -7.0 mm Hg Systolic: -5.0 mm Hg Heart disease kg-48% risk factor sum Sleep apnea 4 10% 20% -26% AHI -48% AHI AHI=apnea hypopnea index (apnea events + hypopnea events per hour of sleep) 1. Wing RR et al. Arch Intern Med. 1987;147(10): ; 2. Stevens VJ et al. Ann Intern Med. 2001;134(1):1-11; 3. Wilson PW et al. Arch Intern Med. 1999;159(10): ; 4. Peppard PE et al. JAMA. 2000;284(23): Obesity can lead to resistance against insulin and leptin, which are two hormones that work to regulate metabolism and appetite in the body.

14 Current Obesity Treatment Guide National Institutes of Health. National Heart, Lung and Blood Institute. NIH Publication No October Accessed January 13, BMI Category (kg/m 2 ) Treatment Diet, exercise, behavior therapy With comorbidities ++ Pharmacotherapy With comorbidities ++ Surgery With comorbidities 14

15 Major US Commercial Weight Loss Programs Aren’t Effective Long Term for Most Patients 1. Tsai AG et al. Ann Intern Med. 2005;142(1):56-66; 2. Copeland PM. Nat Clin Pract Endocrinol Metab. 2006;2(12): ; 3. Truby H et al. BMJ. 2006;332(7553) ; 4. Gold BC et al. Obesity. 2007;15(1): TreatmentWeight Change (%)Attrition Rate (%) Short TermLong TermInitialLong Term TOPS ®1 Nutrition and behavior therapy, therapist -2.3 to 0.4 at 12 weeks -3.2 – 1.6 at 1 yearNot given38 to 67 at 1 year Health Management Resources ®1 Very low calorie diet (VLCD) using meal replacements with or without usual foods – 14.1 at 12 weeks -8.4 at 1 year0 – at 1 year Optifast ®1 Group counseling and 12-week VLCD at 26 weeks-9.0 at 1.5 years4557 at 1.5 years Weight Watchers ®1 Weight Watchers, group Self-help with 2 visits and a dietician 5.3 at 26 weeks 1.5 at 26 weeks 3.2 at 2 years 0 at 2 years 18 at 1 year 27 at 2 years Slim-Fast ®2,3 Meal replacement, support pack (self-help) -6.8 at 6 months-11.4 at 1 yearNot given Vtrim ®4 Internet-based behavioral intervention -7.3 at 6 months-5.5 at 1 year18 at 6 months35 at 12 months eDiets ®4 Internet-based, self-help program -3.6 at 6 months-2.8 at 1 year19 at 6 months23 at 12 months 15

16 Why Current FDA-Approved Weight-Loss Drugs May Not Work May not sustain long-term weight loss in most patients 1,2,3 –Average weight loss with medication is only 5% to 10% 1,4 –Obesity is a complex condition with multiple underlying causes –Medication may not be targeting all the mechanisms driving hunger and cravings Hunger is not the only trigger for eating –Other powerful forces drive eating – comfort eating, social eating –Food is not used solely for nutritional reasons –Genetics and impaired metabolism Side effects can interfere with compliance and increase dropout rates –Cause insomnia, drowsiness, irritability, or depression 1 –Fat absorption drugs can cause muscle cramping, diarrhea, flatulence, and intestinal discomfort 1 –Consuming excess amounts of fat while taking those drugs may cause greater intestinal discomfort 1. Abbott Laboratories. Prescribing Information. Meridia Capsules; 2006; 2. Ioannides-Demos LL et al. Pharmacotherapy for obesity. Drugs. 2005;65(10): ; 3. Li Z et al. Ann Intern Med. 2005;142(7): ; 4. Roche Laboratories. Prescribing Information. Xenical Capsules; 2007 Still… benefits may outweigh risks when evaluating weight-loss programs and pharmacotherapy 16

17 Surgical Options for Weight Loss 1/15/201517

18 Trends in Bariatric Surgery Data on file. Allergan, Inc. Total Procedures – ASMBS , AGN Estimates ; Banding – LAP-BAND ® Sales; Total Banding/Bypass/Sleeve Procedures – AGN Estimates , , , , , ,000 Bariatric Procedures (No.) Procedure Share (%) Banding ShareBypass ShareSleeve Share Total Procedures MM surgery candidates… only 1% (177 K) had surgery in 2009/2010.

19 Bariatric Surgical Options: How They Work Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) 1 Laparoscopic Adjustable Gastric Banding (LAGB) 1,2 Laparoscopic Sleeve Gastrectomy 3 1. Needleman BJ. Surg Clin North Am. 2008;88(5): ; 2. Dixon JB et al. Arch Intern Med. 2001;161(1): ; 3. Weiner RA et al. Obes Surg. 2007;17(10):

20 Roux-en-Y Gastric Bypass 1/15/2015 Advantages Rapid initial weight loss No implant required Disadvantages Stomach stapling and intestinal rerouting Non-adjustable and virtually non-reversible Higher complication rates after surgery Dumping syndrome possible Vitamin deficiencies possible

21 1/15/2015 Potential Complications

22 Sleeve Gastrectomy 1/15/2015 Advantages Rapid initial weight loss No implant required Disadvantages Stomach stapling Complications possible Non-adjustable Non-reversible Longer hospital stay and recovery

23 1/15/2015 Potential Complications

24 Laparoscopic Gastric Banding Surgery 1/15/2015 Advantages No stapling of the stomach Gradual, healthy weight loss Long-term weight loss Disadvantages Requires adjustments by your surgeon Lose one to two pounds per week

25 1/15/2015 Potential Complications

26 Overall, Bariatric Surgery Has a Proven Safety and Low Mortality Rate Flum DR et al. N Engl J Med. 2009;361(5): ; 2. DeMaria EJ et al. Ann Surg. 2007;246(4): ; 3. Buchwald H et al. JAMA. 2004;292(14): ; 4. US Department of Health & Human Services. AHRQ. Accessed January 13, Drug Eluding Stent 4 Mortality Rate Lap Cholecystectomy Rate (%) Appendectomy 4 GI Obstruction 4 CABG w/ cath 4 Carotid Stent 4 Hernia 4 Flum 1 DeMaria 2 Buckwald 3 HHS

27 Coronary Heart Disease (CHD) Risk Is Significantly Reduced After Bariatric Surgery 27 Vogel JA et al. Am J Cardiol. 2007;99(2): MenWomen year CHD Risk (%) P<.0001 P=.002 MenWomen Absolute mg/dL Change P<.0001 for all pairwise changes from baseline CholLDL-CHDL-CTG Before SurgeryAfter Surgery Change in mean lipid values for men and women. Chol = total cholesterol; HDL-C = high-density lipoprotein cholesterol; LDL-C = low density lipoprotein cholesterol; TG = triglycerides. 10-year predicted CHD risk before (blue bars) and after (amber bars) bariatric surgery for men and women.

28 Remission or Improvement of Type 2 Diabetes Often Occurs After Bariatric Surgery Pontiroli AE et al. Diabetes Care. 2005;28(11): ; 2. Spivak H et al. Am J Surg. 2005;189(1):27-32; 3. Ponce J et al. Obes Surg. 2004;14(10): ; 4. Dixon JB, O’Brien PE. Diabetes Care. 2002;25(2): ; 5. Torquati A et al. J Gastrointest Surg. 2005;9(8): ; 6. Skroubis G et al. Obes Surg. 2006;16(4): ; 7. Pories WJ et al. Ann Surg. 1995;222(3):

29 Safety and Effectiveness of Surgical Options 1/15/201529

30 14.5% Prospective, multicenter, observational study of 30-day outcomes in patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007 Within 30 days after surgery, 0.3% of the patients died –0%, 0.2%, and 2.2% of patients died after LAGB, laparoscopic RYGB, and open RYGB, respectively The composite end point of death, deep-vein thrombosis or venous thromboembolism, reintervention, or failure to be discharged by 30 days after surgery occurred in 4.1% of patients Low Incidence of Complications With LAGB: Longitudinal Assessment of Bariatric Surgery (LABS) 30 Flum DR et al. N Engl J Med. 2009;361(5):

31 Data based on interim analysis of ongoing LAP-BAND AP ® Experience (APEX) Study. A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP ® System surgery. BMI of at least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight. 52% Mean EWL at 96 Weeks With Adjustable Gastric Banding in Severely Obese Patients 31 34% 46% 52%

32 APEX Trial Average 19% Mean BMI Loss at 96 Weeks With Adjustable Gastric Banding in Severely Obese Patients 32. Data based on interim analysis of ongoing LAP-BAND AP ® Experience (APEX) Study. A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP ® System surgery. BMI of at least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight. Data on file. Allergan, Inc.

33 Obesity-Related Comorbidities Reduced in Severely Obese Patients at 48 Weeks Data based on interim analysis of ongoing LAP-BAND AP ® Experience (APEX) Study. A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP ® System surgery. BMI of at least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight. Data on file. Allergan, Inc. 33 (n= 75)(n=142)(n=112)(n=72)(n=44)(n=54)

34 Adjustable Gastric Banding Is Also Effective in Obese and Moderately Obese Patients 1/15/ Early Intervention Data (LBMI-001)

35 More Than 82% of Patients Achieved at Least 30% EWL at 12 Months 35 Error bars represent the 95% confidence interval. Data on file. Allergan, Inc., LBMI-001. % of Patients Achieving 30% EWL Baseline BMI <35 kg/m 2 n=62 Baseline BMI ≥35 kg/m 2 n=81 Primary Endpoint Threshold

36 Mean 65% EWL at 12 Months 36 Error bars denote 95% CI, which cannot be used to evaluate differences between time points. Data on file. Allergan, Inc. LBMI-001. Mean % EWL N=143 BaselineMonth 2 Month 4 Month 6 Month 8 Month 10 Month 12

37 Weight Loss With LAGB Is Associated With Positive Changes in Cardiovascular Laboratory Values 37 Treatment NScreening Lab Value Change From Screening to Month 12 Lab Test Mean Cholesterol (mg/dL) HDL (mg/dL) LDL (mg/dL) Triglycerides (mg/dL) Fasting glucose (mg/dL) HbA1c (%) SBP (mm Hg) DBP (mm Hg) DFU. Allergan, Inc

38 *P< Weight on IWQOL-lite total score was also improved (P<.0001) at 12 months (62.8 at baseline vs 90.6 at 12 months). DFU. Allergan, Inc Significant Improvement in Quality of Life (QOL) Measures (100-Point Scale) 38 * * * * * (n=142)(n=143) (n=141)(n=139)

39 Weight Loss Sustained Into the Second Year 39 Year 1 N=143* Year 2 N=128 Primary endpoint: % patients achieving 30% EWL Mean % EWL Mean % total weight loss *Evaluable population. Data on file. Allergan, Inc. LBMI-001. Year 2 data is from an interim analysis before all patients had reached their Month 24 visit.

40 Gradual Weight Reduction With LAGB Results in Better Quality of Weight Loss 1/15/201540

41 Comparable Effectiveness Between Banding and Bypass at 3 Years and Thereafter 41 *LAGB using the LAP-BAND ® System and another adjustable gastric band. Comparison was based on pooled data from 43 peer-reviewed reports involving at least 100 patients at entry and providing at least 3 years of postoperative data. 1 The LAP-BAND ® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvements in percent of EWL vs baseline were achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%). DFU. Allergan, Inc O’Brien P et al. Obes Surg. 2006;16;(8)

42 Gradual weight loss with gastric banding Healthy weight loss Similar to diet and exercise Excess fat is lost Gastric Banding Often Enables a Healthy Rate of Weight Loss 42 Chaston TB et al. Int J Obes (Lond). 2007;31(5): Rapid weight loss with gastric bypass Excess fat lost Muscle, bone and necessary fat lost Nutrients and minerals lost Nutrient supplementation is necessary to prevent other health problems

43 Importance of Fat-Free Mass Loss (FFML) Fat-free mass plays an important role in preservation and regulation of the body. –Preserves skeletal integrity and quality of life as the body ages, and maintains resting metabolic rate, as well as regulates core body temperature With significant weight loss, patients may lose fat-free mass such as bone or muscle mass, nutrients or necessary fat. Certain bariatric surgical methods can cause malabsorption and malnutrition, which influence fat-free mass loss. Nondiversionary LAGB surgery generally preserves a favorable amount of fat-free mass. 43 Chaston TB et al. Int J Obes (Lond). 2007;31(5):

44 Gastric Band: Lower FFML Than RYGB * 44 *The mean %FFML was calculated for all male subjects and all female subjects on dietary and behavioral weight loss interventions. Where studies reported a mean of male subjects and female subjects, the cutoff was adjusted in proportion to the ratio of female subjects to male subjects in the study. † Average FFML was defined by the mean %FFML of subjects on dietary and behavioral weight loss interventions. Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5): LAGBRYGB Patients (n=400) lost a median of 17.5% fat-free mass Patients (n=87) lost a median of 31.3% fat-free mass 8% of cohort (n=400) experienced above-average FFML † 100% of cohort (n=87) experienced above-average FFML †

45 LAGB Is More Cost-effective Than LRYGB The modeled cost-effectiveness analysis showed that both operative interventions for morbid obesity, LAGB and LRYGB, were cost-effective at $25,000 and that LAGB was more cost-effective than LRYGB for all base- case scenarios. 45 *2004 US dollars, adjusted for inflation, based on public data sources. Salem L et al. Surg Obes Relat Dis. 2008;4(1): Probabilities and Cost for 3 Years LAGBLRYGB EWL % (range)55 (38-64)71 (59-89) Cost*$16,200$27,560 Adjustments$150NA Perioperative mortality % (range) 0.5 (0-1)1 (0.5-2) Revisions % (range)5 (2-7)5 (1-10) Revision cost$5,000$10,000

46 LAGB Is Cost Effective in the Long-Term Using Claims Analysi s US health care claims data for 7000 LAGB patients were used to quantify the costs and potential cost savings resulting from LAGB Including the related medical payments in the 90 days before and after the procedure, the mean cost of LAGB was approximately $20,000 The net cost of coverage for LAGB was reduced to 0 by approximately 4 years after band placement in the general population For those with diabetes, the net costs resulting from LAGB were reduced to 0 in just 2 years Finkelstein EA et al. Surg Obes Relat Dis In Press.

47 Amanda’s Success Story 47 Accessed January 13, “After years of yo-yo dieting, gaining back even more weight every time I quit, I gave up. At 304 lbs, I thought I was out of weight loss options. Then I learned about the LAP-BAND ® System weight loss surgery and I knew right away it was the best choice for me. Since my surgery in 2003, I've gone from a size 30 dress down to a size 14. I feel so great about my decision, my positive lifestyle changes, and even better about my results. Best of all, I look like a new woman and I'm in control of my life!” BeforeAfter

48 Duane’s Success Story 48 Accessed January 13, “My moment of truth was when I hit 303 pounds. I knew right then I had to do something or I wasn’t going to be around to see my girls grow up. Now I get to have fun and my kids love it. The greatest feeling I ever had was when my kids could come up to me and put their arms completely around me for the first time. A year ago we had a class reunion and nobody knew who I was. That was cool. I had this one girl say “Duane, you look hot.” And I said, “why didn’t you think that 30 years ago?” Getting the LAP-BAND ® System surgery was the greatest decision I ever made in my life.” BeforeAfter

49 The Role of the Primary Care Physician 1/15/201549

50 The Physician’s Role Diagnose –Recognize patients at risk –Calculate BMI, which may be estimated to be lower than actual value Educate about obesity –Inform patients of health risks and medical hazards associated with severe obesity –If lifestyle recommendations are not able to be consistently followed, then one should consider a bariatric procedure –Describe impact of weight loss on comorbidities and mortality –Communicate weight loss results and importance of long-term follow-up 50

51 The Physician’s Role (cont’d) Motivate patients to address obesity –Describe tangible options available to patients –Share success stories Explain surgical options –LAGB has a lower rate of complications compared to other bariatric procedures 1,2 –LAGB is effective for weight loss with data out to 5 years 3 Lower FFML compared with RYGB (17.5% vs 31.3%) 4 1/15/201551

52 The Physician’s Role (cont’d) –Weight loss with LAGB often improves major cardiovascular risk factors as well as other comorbidities 5 Hypertension Hyperlipidemia Type 2 diabetes Asthma GERD Obstructive sleep apnea Parikh MS et al. J Am Coll Surg. 2006;202(2): ; 2. Weiner RA et al. Obes Surg. 2007;17(10): ; 3. O’Brien P et al. Obes Surg. 2006;16;(8) ; 4. Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5): ; 5. Data on file. Allergan, Inc. (APEX Study)

53 The Physician’s Role (cont’d) Refer patient to better understand surgical options –Important to select an experienced surgeon in a comprehensive, weight loss center with competed support staff, able to care for patients afflicted with obesity. Aftercare management –To enhance the transition to life after bariatric surgery and to prevent weight regain and nutritional complications, all patients should receive care from a multidisciplinary team including an experienced primary care physician, endocrinologist or gastroenterologist and consider enrolling postoperatively in a comprehensive program for nutrition and lifestyle management Heber D et al. J Clin Endocrin Metab. 2010;95(11):

54 Bariatric Surgery Guidelines Support Your Referrals Nonsurgical treatments ineffective for most morbidly obese patients 1 The American Academy for Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery have recommended that morbidly obese patients (BMI >40 or BMI >35 with a obesity related comorbidity) should be offered bariatric surgery. 2 –15 million individuals meet the criteria for morbid obesity 3 American Diabetes Association: Bariatric surgery should be considered for adults with BMI of 35 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy Fontaine KR et al. JAMA. 2003;289(2): ; 2. Mechanick JI et al. Endocr Pract. 2008;14(suppl 1):1-83; 3. ASMBS Fact Sheet. Accessed January 13, 2011; 4. American Diabetes Association. Accessed January 13, 2011.

55 Current Selection Criteria for Bariatric Surgery in Adults 1 55 FactorCriteria Weight (adults) BMI ≥40 with no comorbidities BMI ≥35 with one or more severe obesity-associated comorbidity Weight loss history Failure of previous nonsurgical attempts at weight reduction, including nonprofessional programs (for example, WeightWatchers ® ) Commitment Expectation that patient will adhere to postoperative care Follow-up visits with physician(s) and team members Recommended medical management Instructions regarding any recommended procedures or tests Exclusion Reversible endocrine disorders or other disorders that cause obesity Current drug or alcohol abuse Uncontrolled, severe psychiatric illness Unable to comprehend – Risks, benefits, expected outcomes, alternatives, and required lifestyle changes Not a complete list of exclusion criteria for bariatric surgery 1. Mechanick JI et al. Surg Obes Relat Dis. 2008;4(5 suppl):S109-S184.

56 Consider Early Intervention 56 Early intervention with the Band System in obese and moderately obese patients has recently been approved by the FDA. The gastric band has been shown to be safe and effective in individuals with a BMI of 30 to 40 with obesity-related comorbidity. Majority of patients (>80%) achieved >30% EWL –Mean 65% EWL at 1 year Laboratory values improved Quality of life measures were significantly improved New data supports the need for primary care physicians to refer obese and moderately obese individuals who fail other forms of weight loss management for bariatric surgery. DFU. Allergan, Inc

57 Summary Fewer complications compared with gastric bypass reported in 1 study 1 –9% ( LAP-BAND ®, n=480) vs 23% (RYGB, n=235) Comparable weight loss to gastric bypass after 5 years 2 –55% ( LAP-BAND ®, n=640) vs 58% (RYGB, n=176) More cost-effective than gastric bypass 3 –Payers estimated to fully recover the costs of laparoscopic bariatric surgeries after 2 ¼ years in patients with diabetes and after 4 years in the entire surgical population 4 57 The gastric band is a safe and effective option for your obese to morbidly obese patients whose weight is affecting their health 1. Parikh MS et al. J Am. College Surgeons. 2006;202(2): ; 2. O’Brien PE et al. Obes Surg. 2006;16(8): ; 3. Salem L et al. Surg Obes Relat Dis. 2008;4(1):26-32; 4. Finkelstein EA et al. Surg Obes Relat Dis In Press.

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