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					The Weight Is Over
 Weight Loss Surgery Options



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Presentation Outline


   • History and Trends in Obesity
   • Current Surgical Options
      – Advantages and Disadvantages
   • Why Choose the LAP-BAND® System?
   • Cost of Obesity Versus Affordability of
     Surgery
   • The Decision to Undergo Surgery
   • Conclusion


                                               2
Changing Perceptions of the Seriously Overweight

   Past
   • Obesity seen as a weakness or failure of individual
   • Diet and exercise were prescribed treatments
   • Weight loss surgery viewed as dangerous and
     extreme
   Present
   • Obesity is considered a disease and the cause of
     many serious health conditions
   • Surgery has gained acceptance as a proven method
     to treat this disease
   • But surgical treatment is not for all obese patients
      – Eligibility must be determined
                                                            3
 Who Qualifies for Weight Loss Surgery?

Clinical Terms Used to Describe Various Levels of Body Fat1

              Normal Weight                         Overweight                            Obese                               Obese                       Extremely Obese
             (BMI* 18.5 to 24.9)                   (BMI 25 to 29.9)                        (Class I)                           (Class II)                      (Class III)
                                                                                    (BMI 30 to 34.9)                    (BMI 35 to 39.9 )                  (BMI 40 or more)




* BMI (Body Mass Index): A measurement of an individual’s weight in relation to height (kg/m 2).
                                                                                                                                                                              4
1. National Institutes of Health/National Heart, Lung and Blood Institute Clinical Guidelines Evidence Report. NIH Publication 98-4083, September 1998.
   Sizing Up Your Level of Body Fat

      Using the Body Mass Index (BMI)*1-3
      • Used to determine if
                                                                                                                                                   Height (ft/in)
                                                                                                                                 4’9”   4’11”   5’1”   5’3”   5’5”   5’7”   5’9”   5’11”   6’1”   6’3”
                                                                                                                           154   33      31     29     27     26     24     23      22     20     19
        you qualify for surgery                                                                                            165   36      33     31     29     28     26     24      23     22     21
                                                                                                                           176   38      36     33     31     29     28     26      25     23     22
      • Measures obesity                                                                                                   187   40      38     35     33     31     29     28      26     25     24
        based on weight                                                                                                    198   43      40     37     35     33     31     29      28     26     25




                                                                                                            Weight (lbs)
                                                                                                                           209   45      42     40     37     35     33     31      29     28     26
        and height                                                                                                         220   48      44     42     39     37     35     33      31     29     28
                                                                                                                           231   50      47     44     41     39     36     34      32     31     29
                    Weight Category                                   BMI (kg/m2)                                          243   52      49     46     43     40     38     36      34     32     30
           Healthy Weight                                               18.5-24.9                                          254   55      51     48     45     42     40     38      35     34     32
                                                                                                                           265   57      53     50     47     44     42     39      37     35     33
           Overweight                                                    25-29.9
                                                                                                                           276   59      56     52     49     46     43     41      39     37     35
           Obese                                                         30-34.9                                           287   62      58     54     51     48     45     42      40     38     36
           Severely Obese                                                35-39.9                                           298   64      60     56     53     50     47     44      42     39     37
                                                                                                                           309   67      62     58     55     51     48     46      43     41     39
           Morbidly Obese                                                    ≥40
                                                                                                                           320   69      64     60     57     53     50     47      45     42     40
* Please note BMI does not distinguish between fat and muscle. A heavily muscled person could have a BMI in excess of 25 without having any increased health risks.


References: 1. National Institutes of Health/National Heart, Lung and Blood Institute Clinical Guidelines Evidence Report. NIH Publication 98-4083, September 1998. 2. Weight-control Information
Network (WIN); an information service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Statistics related to overweight and obesity. October 2006. Available at:
                                                                                                                                                                                                     5
http://win.niddk.nih.gov/statistics/index.htm#table,2003-2004. Accessed May 2, 2007. P3, 1-2. 3. del Negro A. It's time to treat obesity. Program and abstract presented at: the 73rd Scientific Sessions of
the American Heart Association; November 12-15, 2000; New Orleans, LA.
 Health Risks and Increased Risk of Mortality


                                                                                                                                                    • Diabetes
                                                                                                                                                    • Hypertension
                                                                                                                                                    • Sleep apnea
                                                                                                                                                    • Depression
                                                                                                                                                    • Joint pain
                                                                                                                                                    • Infertility
                                                                                                                                                    • Cancer
                                                                                                                                                    • GERD
                                                                                                                                                    • Asthma




                                                                                                                                                                     6
Calle EE, Michael MJ, Petrelli JM, et al. Body-mass index and mortality in a prospective cohort of US adults. N Eng J Med. 1999;341(15):1097-105.
Impacts of Obesity

 • Social Impact
           – Still an acceptable form of
             social discrimination
 • Annual Economic Impact
           – Personal
                    • $700 in additional pharmacy
                      costs1
           – Business
                    • More than $12 billion for
                      employee care2
                    • 5% of total healthcare
                      expenditures2
           – National
                    • Direct Cost – $61 billion3
                    • Indirect Cost – $56 billion3
                    • Total Costs – $117 billion3


References: 1. Mayo Clinic News Release; November 7, 2004. Accessible at www.mayoclinic.org/news2004-rst/2501.html. 2. Smith AM, Lopez-Jimenez F, McMahon MM, et al. Action on
                                                                                                                                                                                       7
Obesity: Report of a Mayo Clinic National Summit. Mayo Clin Proc. 2005;80(4):527-532. 3. US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent and
Decrease Overweight and Obesity;2001.
Diseases Attributable to Obesity
        Relative Risk of Developing Certain Diseases Over the Next
                      Decade For Men With BMI >351




                                                                                                                                                                              8
Reference: 1. Lopes HF, Egan BM. Autonomic dysregulation and the metabolic syndrome: Pathologic partners in an emerging global pandemic. Arq Bras Cardiol. 2006;87:489-498.
   Weight Loss Strategies

           • Dietary Intervention
                     – About 10% of body weight can be healthfully lost in 6 months,1 but
                       diets are prone to failure for many reasons2
           • Physical Activity1
                     – Increased activity can improve general health but may have little
                       impact on total body weight in morbid obesity
           • Behavior Modification1
                     – Can contribute to overall weight loss program, but requires
                       ongoing professional contact and failure rate can be high
           • Drug Treatments1
                     – Short-term use not recommended since weight is typically regained
                       when treatment ends and there is modest difference from placebo
                       long-term
           • Weight Loss Surgery in the Severely Obese1
                     – The most effective approach for long-term weight loss

References: 1. American Gastroenterological Association medical position statement on obesity. Gastroenterology. 2002 Sep;123(3):882-932. 2. Report of the Michigan Surgeon General.   9
Accessible at www.michigan.gov/surgeongeneral/0,1607,7-216-33084_33097---,00.html.
Most Common Surgical Options

      Gastric Bypass     The LAP-BAND® System
         (GBP)          Adjustable Gastric Banding




      Restrictive and         Restrictive and
      Malabsorptive             Adjustable
                                                     10
Gastric Bypass
                                                                                       Advantages
                                                                                       •   Rapid initial weight loss
                                                                                       •   Less frequent follow-up required
                                                                                       •   No implant required
                                                                                       •   Laparoscopic approach is possible
                                                                                       •   Longer experience in the United States

                                                                                       Disadvantages
                                                                                       • Stomach cutting, stapling, and intestinal rerouting
                                                                                         required
                                                                                       • Higher perioperative complication rates than the
                                                                                         LAP-BAND® System1
                                                                                       • Higher short-term mortality rates than the
                                                                                         LAP-BAND® System2
                                                                                       • Portion of digestive tract is bypassed, which may
                                                                                         result in nutritional deficiencies3
                                                                                       • “Dumping syndrome” can occur4
                                                                                       • Nonadjustable5
                                                                                       • Difficult to reverse5
                                                                                       • Longer mean hospital stay and recovery6

References: 1. Parikh SM, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic banding procedures. J Am Coll Surg. 2006;202:252-
261. 2. O’Brien PE, Dixon J. Lap-Band®: Outcomes and results. J Laparoendosc Adv Surg Tech A. 2003;13:265-270. 3. Ferraro DR. Management of the bariatric surgical patient. Clin Rev.
2004;14:73-79. 4. 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.     11
Adelaide, South Australia. ASERNIP-S, June 2002. 5. Data on File, Allergan, Inc. 6. Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: A
systematic literature review. Surgery. 2004;135(3):326-351.
Gastric Bypass (Roux-en-Y)




                  FPO




                             12
The LAP-BAND® System

Advantages                                      Disadvantages
• No stomach stapling, cutting, or intestinal   • Slower initial weight loss than gastric
  rerouting                                       bypass
• Low perioperative complication rates          • Regular follow-up critical for optimal
• Low malnutrition risk                           results
• Free of “dumping syndrome”                    • Requires implanted medical device
• Adjustable–customized per patient             • Less experience in the United States
• Reversible
• One-tenth the short-term mortality rates of
  open Roux-en-Y gastric bypass
• Minimally invasive
• Satiety-inducing procedure
• Average patient does not need an
  overnight stay


  For detailed risk information,
 please visit www.lapband.com


                                                                                            13
The LAP-BAND® System Procedure


    • Performed
      laparoscopically1
                                                                                                                         FPO Animation
    • Band is placed around
      the upper part of the
      stomach1
    • Small pouch is created1
    • Your stomach holds less
      food2
    • You eat less but feel full2

                                                                                                                                                                                14
References: 1. BioEnterics® LAP-BAND® Adjustable Gastric Banding System. System Usage Manual–PN 94163; INAMED Health. 2. University of California, San Diego Medical Center –
Center for the Treatment of Obesity. Accessible at http://health.ucsd.edu/specialties/lapband/faq/.
Benefits of an Adjustable Procedure*

      • Gradual, healthy weight
        loss1
      • Customized rate of weight                                                                                           FPO Animation

        loss1
      • Prolonged sense of
        fullness after small meals1
      • Long-term mean excess
        weight loss of
        62.0% ± 20.9% 36 months
        after surgery (N=68)2+
* Individual results may vary.
+ Based  on a chart review of 1,014 consecutive cases of patients undergoing the LAP-BAND® System surgery at a single center. Follow-up data were
available for relatively few patients at 36 months (68 of 77) and at 48 months (12 of 14).
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
excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).                                     15
References: 1. Data on file, Allergan, Inc. 2. Ponce J, Paynter S, Fromm R. Laparoscopic Adjustable Gastric Banding: 1,014 Consecutive Cases. J Am Coll Surg. 2005;201(4):529-35.
Possible Risks and Complications

            • Risks associated with any surgery, including death
                      – 0.05% short-term mortality1
            • Infection
            • Nausea and vomiting
            • Band Slippage
            • Erosion
            • Obstruction
            • Reoperation
                              For detailed risk information, please visit
                                         www.lapband.com

                                                                                                                                                                                        16
  Reference: 1. 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.
Data on File, Allergan, Inc.
Possible Risks and Complications

Remember: There are risks associated with any surgery

           Categories                                                            LAP-BAND® System                                          Gastric Bypass
           Total                                                                                                                                        23%1
                                                                                                          9%1
           Complications*
           Major (Grade III/IV)
                                                                                                       0.2%1                                              2%1
           Complications *
           Short-term
                                                                                                       0.05%2                                          0.5%2
           Mortality Rate
 Background: Several surgical treatment options for morbid obesity exist. Since no studies have objectively compared complication rates after laparoscopic bariatric operations, a retrospective
 review of all patients (n=780) undergoing these surgeries at a single institution from September 2000 to July 2003 was performed. Complications were categorized according to a standard
 classification system for surgical procedures. Grading based on the classifications set by Clavien and colleagues:
           Grade I      Events carrying minor risks

           Grade II     Events requiring intervention, eg, drug therapy, TPN, blood transfusions, therapeutic imaging, or reoperation

           Grade III    Events with residual and lasting disability and/or requiring organ resection

           Grade IV     Death as a result of any complication
*Published complication rates vary depending upon the institution and how the surgeon diagnoses and defines a particular complication.

1. Parikh MS, Laker S, Weiner M, et al. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg. 2006;202(2):252-61. 2. 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, 17
June 2002.
 Comparison of Average Recovery Time1



                                                           The LAP-BAND®                                            Open
                                                                                                                                                   Lap. Bypass
                                                               System                                              Bypass
                                                                                                                                                      n=19
                                                                n=21                                                n=20
                Length of
               Hospital Stay                                                1.3                                         3.5                                   2.5
                  (Days)
                      Days to
                      Normal                                                7.2                                       17.6                                   18.2
                      Activity

                    Recovery
                                                                          15.8                                        29.1                                   21.7
                     (Days)

                                                                                                                                                                       18
Reference: 1. Fisher BL. Comparison of recovery time after open and laparoscopic gastric bypass and laparoscopic adjustable banding. Obesity Surgery. 2004;14;67-72.
 Comparing Weight Loss Results
                   Laparoscopic adjustable gastric banding (LAGB)
                   provides effective weight loss after 3 years, comparable
                   to that seen with standard gastric bypass1




                                 *LAGB using the LAP-BAND® System and another adjustable gastric band. Comparison is based
                                 on pooled data from 43 peer-reviewed reports involving at least 100 patients at entry and
                                 providing at least 3 years postoperative data.                                                                              19
Reference: 1. O’Brien P, McPhail T, Chaston T, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006:16;1032-40.
Significant Excess Weight Loss Observed
Over Time With the LAP-BAND® System
     In a recent study, 62.0% ± 20.9% mean excess weight loss
     with the LAP-BAND® System at 36 months (n=68)*1




* Based on a chart review of 1,014 consecutive cases of patients undergoing LAP-BAND® System surgery at a single center. Follow-up data were available
for relatively few patients at 36 months (68 of 77) and 48 months (12 of 14). These data were collected prior to the development and launch of the LAP-BAND
AP™ System.

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
excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%)                                       20
Reference: 1. Ponce J, Paynter S, Fromm R. Laparoscopic Adjustable Gastric Banding: 1,014 Consecutive Cases. J Am Coll Surg. 2005;201(4):529-35.
    Your Decision

         The LAP-BAND® System                                                                       Gastric Bypass
         • Minimally invasive1                                                                      • More invasive1
         • 55% average excess weight loss 5 years                                                   • 58% average excess weight loss 5 years
           after LAGB surgery2*+                                                                      after surgery2*
         • Lower short-term mortality (up to 10                                                     • Higher short-term mortality and
           times) and perioperative complication                                                      perioperative complication rates3,4
           rates3,4                                                                                 • Nonadjustable1
         • Adjustable long-term satiety1                                                            • Difficult to reverse1
         • Reversible1                                                                              • Does not require implanted medical
         • Requires implanted medical device                                                          device
         • Shorter hospital stay and recovery5                                                      • Longer hospital stay and recovery5
         • Long track record worldwide, 6 years                                                     • Longer track record in the United States
           experience in United States1                                                             • Less frequent follow-up required
         • Regular follow-up required

* LAGB using the LAP-BAND® System and another adjustable gastric band. Comparison is based on pooled data from 43 peer-reviewed reports involving at
least 100 patients at entry and providing at least 3 years postoperative data.

+   Individual results may vary.

1. Data on File, Allergan, Inc. 2. O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16:1032-1040. 3.
O’Brien PE, Dixon JB. Lap-Band®: Outcomes and Results. J Lap Adv Surg Tech. 2003;13(4):265-70. 4. Parikh MS, Laker S, Weiner M, et al. Objective comparison of complications resulting from
                                                                                                                                                                                            21
laparoscopic bariatric procedures. J Am Coll Surg. 2006;202:252-261. 5. Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: A systematic
literature review. Surgery. 2004;135(3):326-51.
The LAP-BAND® System Candidates

  • Meet the BMI criteria
    – Your BMI is at least 40, or
    – Your BMI is at least 35 and you are suffering
      from one or more severe obesity-related
      health problems, or
    – You are at least 100 lbs. overweight
  • Are at least 18 years old
  • Have been overweight for more than 5 years
  • Are prepared to attend regular follow-up
    sessions and make lifestyle changes
                                                      22
 The LAP-BAND® System Patient: Robin


             “Here’s what my life
             was like: Pick up
             three 50-pound bags
             of dog food and strap
             them to your body.
             Then try walking.
             It was difficult to even
             bend down and pick
             up my little girl.”
                                        Before
                                                 23
Data on file, Allergan, Inc.
 The LAP-BAND® System Patient: Robin


                     “Now, I have the
                     energy to play with
                     my children and
                     am comforted
                     knowing I’ll be
                     around when they
                     grow up.”

                                                            After
                                                                    24
Individual results may vary. Data on file, Allergan, Inc.
 The LAP-BAND® System Patient: Amanda (Before)


                   “With each diet, I
                   would lose weight, but
                   I’d always gain
                   it back—plus more.
                   After years of yo-yo
                   dieting, I topped the
                   scales at 304 lbs and
                   had given up on losing
                   weight.”
                                            Before

                                                     25
  Data file, Allergan, Inc.
Data on on file, Allergan, Inc.
 The LAP-BAND® System Patient: Amanda (After)


                  “Because of my nursing
                  experience, I knew the
                  LAP-BAND® System
                  was the right choice for
                  me.
                  Since surgery, I’ve gone
                  from a size 30 to a size
                  14. I’ve lost the weight,
                  and I’m keeping it off this
                  time!”
                                                            After
                                                                    26
Individual results may vary. Data on file, Allergan, Inc.
The Personal Cost of Obesity

   Weight loss surgery has the potential to dramatically
   reduce annual costs of living
   Items                                                                                                        Estimated Annual Costs
   Mean medical/drug costs (BMI 35)1                                                                                             $ 7337
   Out-of-pocket healthcare expenses2                                                                                             $ 2664
   Inactivity costs3                                                                                                              $ 1125
   Commercial weight loss program fees4                                                                                           $ 678
   Prescription co-pays (5 meds at $10)                                                                                          $ 738
   Food2                                                                                                                         $ 5931
   TOTAL                                                                                                                         $18,473
References: 1. Health Management Research Center, University of Michigan, 2001. 2. US Bureau of Labor Statistics, Consumer Expenditures in 2005. Accessible at
http://www.bls.gov/cex/csxann05.pdf. 3. Texas A&M University System Health Science Center School of Rural Public Health. “Active for Life” web site accessible at
http://www.activeforlife.info/resources/january_05.html. 4. Market Data Enterprises, Inc., October 2002.                                                            27
The LAP-BAND® System Affordability


  • Pursue insurance coverage
     – Review the coverage in your insurance policy
     – Understand the appeal process and coverage
       possibility
     – Speak with our office




                                                      28
The LAP-BAND® System Financing Options



   • The LAP-BAND® System Patient
     Financing Program
     – Check to see if your doctor is a participant
     – Physician enrollment is possible through any
       LAP-BAND® System Territory Manager
   • Loans
     – Some specific companies offer financing
       packages for medical procedures


                                                      29
Why [insert practice name]?

   • [insert advantages of your LAP-BAND®
     System program, such as experience, patient
     weight loss results, articles published,
     patients on staff, etc]




                                                   30
Results Speak for Themselves!

 • Please welcome our special LAP-BAND® System
   patients!
   – [insert name]
   – [insert name]




                                                 31
Next Steps

  • Question and answers
  • Please fill out seminar evaluation forms
  • If you would like to schedule a consultation to
    see if the LAP-BAND® System is appropriate
    for you:
     – Speak with [insert name] after the Q&A, or
     – Contact [insert name of contact and phone
       number]


           [insert practice or hospital logo]
                                                      32
  Testimonial from a LAP-BAND® System Patient

     “At 291 pounds, I feared my young
     son would soon be embarrassed to
     have a severely overweight mom,
     and I didn’t have the energy to keep
     up with him. I looked into the gastric
     bypass, but was uncomfortable with
     the idea of having my insides
     rearranged. I chose the LAP-BAND®
     System because it can be adjusted
     to fit my specific needs. I’ve lost 115
     pounds, and I can enjoy an active
     life with my son. I feel like such a
     success, thanks to the LAP-BAND®                          Cyndi,
     System.”                                                  LAP-BAND® System patient since 2003



                                                                                                     33
* Individual results may vary. Data on file, Allergan, Inc.
   Individual results may vary. Data on file, Allergan, Inc.
This Presentation is Brought to You by:




                                               ®         TM
                                                                                                                                       34
     ©2007 Allergan, Inc., Irvine, CA 92612.       and        Marks owned by Allergan, Inc. All rights reserved. M1508-01 10/07 RCW.

				
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