The Weight Is Over
Weight Loss Surgery Options
Presented by
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.