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FOLLOW UP EFFECT
• Unbiased Population based studies => Poor Results of RNY
• Positive Results of RNY reported from RNY centers
• Suffer from “Follow Up Effect”
• Patient Returns to clinic doing well: Greeted Warmly with Great Joy
• Patient Returns to clinic doing poorly: Greeted with anger and disapproval
• Successful pt => Good Follow Up / Failed pt tacitly sent away
• Now; Center reports excellent results; (30%) follow up
• Weight Regain, Band Erosion, Death
• Not Seen, Not Reported
Irrational Fear of Gastric Cancer:
CHOOSING THE BEST WEIGHT LOSS SURGERY
R Rutledge MD,
The Centers for Laparoscopic Obesity Surgery
www.CLOS.net
Email: DrR@clos.net
Dr Rutledge: Training & Background
• Undergrad/Medical School; Teacher
Dr. Lester Dragstedt Pioneer / Inventor of the
Highly Controversial Vagotomy and Pyloroplasty
• 2 Years Cardiac Surgery National Institutes of Health National Heart
Lung Blood Institute
• 20 years University of NC; Professor of Surgery, Associate Chief
of Staff, Director of Section Medical Informatics, Director North
Carolina Trauma Registry
• Author of 93 papers and articles
Dr Rutledge: Training & Background
• Specialty: Trauma, Critical Care, Medical Informatics and Bariatric Surgery
(1978-1998 20 years University NC)
• Experience: Trauma Surgery, Director NC Trauma Registry
• Peptic Ulcer Surgery; Vagotomy & Pyloroplasty;
Antrectomy & Billroth II
• Bariatric Surgery 33 years:
Open RNY & Vertical Banded Gastroplasty
• 1997 one first surgeons laparoscopic RNY
• Mini-Gastric Bypass; 14 years, over 6,000 cases
Dr. Rutledge
USA 001-702-714-0011 DrR@clos.net
CONSIDERING THE MGB?
MGB IS A SUPERB SURGERY BUT…
WARNING:
“THERE ARE “TRICKS AND TRAPS”
OFFER A SAFE & SUCCESSFUL
MGB PROGRAM
• Call / Email: Anytime question or advice on any clinical, technical or
patient MGB question
• USA 001-702-714-0011 DrR@clos.net
• Personal Visit: Dr. Rutledge Visiting Professor: France, Turkey,
Austria & India, Upcoming visits Greece, Istanbul, United Kingdom
Czech Republic, Italy, Germany, UAE, Pakistan,
• Please Use the Knowledge of Others Before You Start;
Experience; over 14 years, over 6,000 patients
• USA 001-702-714-0011 DrR@clos.net
Human Decision Making is Flawed
Need for Decision Making Support
 Research: Human Decision Making
frequently Flawed & driven by Irrational thinking
 Selecting the Best Weight Loss surgery
 Should be based on a rational review of the data
 Avoid Emotional or Irrational Bias
HUMAN DECISION MAKING ERRORS
Recent Research in Psychology and
Neurobiology Shows that:
The Human Brain is a Notoriously
Bad Decision Maker
Human Decision Making Errors
Very Common
• Exaggerate Rare Events,
Downplay Common Events
• Underestimate risks taken Willingly, (car)
Overestimate risks Beyond Control (airplane)
• Overestimate risks Talked About
Irrational Illogical Thinking
Decision-Making Errors
• Confirmation Bias
(favor information that confirms preconceptions)
• Herd Behavior
(group think override rational)
• “Reptilian Brain”
Amygdala is part "impulsive," primitive system that
triggers emotional override rational thinking
PRIMITIVE RESPONSE SYSTEMS
MODIFY RISK ASSESSMENT
THE REPTILIAN BRAIN:
EMOTION & DECISION MAKING
• Rational Logical Thinking:
Frontal Lobe
• Amygdala
Interferes with the Frontal lobe
• Primitive, Impulsive
• Irrational decision-making
IRRATIONAL ILLOGICAL THINKING
CONFIRMATION BIAS
• Contrary Evidence =>
Maintains or strengthens
present beliefs
• Overconfidence
in present beliefs
• Poor Decision Making
• Especially Present in
Organizations, Military, Political & Social Groups
REPTILIAN BRAIN POOR DECISIONS
FEAR LEADS TO JUDGMENT ERRORS
• Errors in Risk Assessment
• Death Airplane Crash
• Death Car Crash
• 1 in 1,000 patient / 20 years risk of
gastric cancer
• Bowel Obstruction from internal
hernia +16% in 5 years
SURGERY
HISTORY OF POOR
DECISIONS
JOSEPH LISTER:
AMERICAN SURGEONS
DELAYED ADOPTION OF
ANTISEPSIS 10 YEARS
REPTILIAN BRAIN
POOR DECISION MAKING
• Lister
published
antisepsis
paper:
• 1867
Dr. Gross; Gross Clinic 1875
HUMAN DECISION MAKING ERRORS:
EXPECTED, NOT RARE
• Realization of Fallibility
Human Decision Making
• Humility
• Socratic Questioning of
Assumptions
• Search for Logical & Rational
Decision Making
THE PROBLEM
• Obesity Epidemic
• History of Failure of Bariatric Surgical
Procedures
• Selecting the “Ideal / BEST”
Bariatric Surgical Procedure
Problem Definition:
Bariatric Surgery: A HISTORY OF FAILURE
Procedure Assessment
Jejuno-ileal Bypass (Failure)
Vertical Banded Gastroplasty (Failure)
Lap Band (Fail?)
RNY Bypass (Fail?)
BPD/DS (Fail?)
Sleeve: 1% Leak, 30% GE Reflux, Irreversible,
Weight regain (Fail?)
1.  Low Risk
2. Major Weight Loss
3. Easily performed
4. Short operative times
5. Outpatient or short hospital stay
6. Minimal Blood Loss
7. No Need for ICU Stay
8. Minimal Pain
9. Very High Patient Satisfaction
10. A Good "Exit Strategy" 
SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
11. Change Behavior & Preferences;  Marked Decrease in Hunger 
and Increased Satiety
12. Minimal Retching and Vomiting 
13. Few adhesions or hernias
14. Minimal impact on Heart and Lung Function
15. Low Failure Rate
16. Low Cost
17. Short Recovery Time
18. Rapid Return to Work
19. Low Risk of Pulmonary Embolus
20. Durable weight loss
SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
21. Low Risk of Ulcer
22. Fat Malabsorption; low cholesterol & CV risk 
23. No Plastic Foreign Body 
24. Easily Verifiable Results; > 10 years of Results
25. Low Risk of Bowel Obstruction
26. Based upon sound surgical principles  
27. Independent confirmation of results
28. Healthy life after surgery
29. Supported by LEVEL I Evidence; RCT (Controlled Prospective 
Randomized Trial)
30. Block “Sweet Eater” Failures
ALTERNATIVES
• RNY
• Band
• Sleeve
• MGB
MINI-GASTRIC BYPASS
• The Mini-Gastric Bypass
1997 – 2011 ; >6,000 pts,
10 yr Data; Multiple Centers,
R.C.Trials
• Vertical Gastric Tube
(Collis Gastroplasty)
• Gastric Bypass
(Billroth II Gastro-jejunostomy)
MINI-GASTRIC BYPASS
BASED SOUND SURGICAL PRACTICE 
• Billroth II Performed 
over 100 years
• 16,000 Billroth II’s
USA in 2007
• Operation of choice: 
Trauma, Ulcers, Cancer 
Stomach etc.
C: Consequences / Results / Outcomes
RNY Band SG MGB
1. Low Risk - + - +
2. Major Weight Loss + - - ++
3. Easily performed - - + + +
4. Short operative times - + + +
5. Short hospital stay - - + + +
6. Minimal Blood Loss - + + +
7. No Need for ICU Stay - + + +
8. Minimal Pain - + + +
9. High Patient Satisfaction - - - +
10. A Good "Exit Strategy" - - - + - - +
C: Consequences / Results / Outcomes
RNY Band Sleeve MGB
11. Decrease Hunger + - + +
12. Min Vomiting + + + +
13. No Internal hernias - + + +
14. Min Heart/Lung - + + +
15. Low Failure Rate - - - +
16. Low Cost - - - +
17. Short Recovery - + + +
18. Return to Work - + + +
19. Low Risk of PE - + + +
20. Durable Weight Loss - - - +
C: Consequences / Results / Outcomes
RNY Band SG MGB
21. Low Risk of Ulcer - + + -
22. Malabsorption of fat + - - +
23. No Foreign Body + - + +
24. Verifiable Results - - - ++
25. Bowel Obstruction - - + + ++
26. Sound Surgical + - + +
27. Independent confirm - - - ++
28. Healthy life - - - ++
29. RCT; LEVEL I Evidence - - - ++
30. Block Sweet Eater + - - ++
• Fear of Gastric Cancer  Bile Reflux
• Rational vs. Reptilian Brain Decision Making
STATISTICAL ILLITERACY; "MANY DOCTORS
MISUNDERSTAND MEDICAL LITERATURE"
• Example:  “In the absence of a Roux limb, 
the long-term effects of chronic alkaline reflux are unknown.”
• REALLY? Rational vs. Reptilian Brain thinking
• Billroth II >100 years and >1,450 papers on Billroth II
• Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW.,  Gastric Bypass; 
Why Roux-en-Y? A Review of Experimental Data, Arch Surg. 2007; 142(10):1000-
1003.
GASTRIC CANCER 
RAPIDLY DECLINING
• The incidence of gastric cancer 
in the United States has 
• Decreased four-fold since
1930 
• Approximately 7 cases per 
100,000 people.  
BARIATRIC SURGEONS FEAR BILLROTH II;
CANCER SURGEONS CHOOSE BILLROTH II
• 1,490 articles on performance of the Billroth II
• General/Trauma/Oncologic surgeons commonly use 
the Billroth II
• Over 16,000 Billroth II operation 
performed in USA 2007
• While Bariatric Surgeons Fear the Billroth II General 
Surgeons use the Billroth II routinely
BARIATRIC SURGEONS FEAR BILLROTH II
WHAT IS MAGNITUDE OF THE PROBLEM
• Mayo Clinic Study (Example)
• 338 Billroth II patients 
• Followed 25-years
• 5,635 person-years
• Only 2 Cancers in 5,000+ pt years of Follow Up
• Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease. N 
Engl J Med. 1983 Nov 17;309
BARIATRIC SURGEONS FEAR BILLROTH II
MAGNITUDE OF THE PROBLEM
• Population based study, 338 Billroth II pts 
• Followed 25-years
• 5,635 person-years
• Only 2 Cancers Found in 5,000 years
• Predicted 2.6 cancers (relative risk 0.8) 
Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease. N Engl J Med. 1983 Nov 
17;309
BARIATRIC SURGEONS FEAR BILLROTH II
MAGNITUDE OF THE PROBLEM
• 338 Billroth II pts, Followed 25-years
• 5,635 person-years
• Only 2 Cancers in 5,000 pt years follow up
• RATE of Gastric Cancer is Declining
• 24 - 50% Expected Decrease from 1983
• Future risk ~1 patient / 5,000 pt years
ULCERS INCREASE RISK CANCER
• Meta-analysis: 
7 studies Small increased risk
 5 studies No Increased Risk
• Studies with increased Risk; Flawed
• Billroth II = Surgery Rx Ulcers
• ULCERS increase risk of Gastric Cancer!
• Ulcers and Gastric Cancer Common Etiology 
=H. Pylori=
ULCERS INCREASE RISK CANCER
•3,078 gastric cancer vs. 89,082 controls
•Ulcer increases risk gastric cancer
=(relative risk 1.53)=
•Same as Increased Risk reported Billroth II 
•Many other studies confirm these findings: 
•Ulcer Increases Risk  Gastric Cancer
•Ulcers & Gastric Cancer:
•Common Etiology =H. Pylori=
BARIATRIC SURGEONS FEAR BILLROTH II
GASTROENTEROLOGISTS IGNORE BILLROTH II
• Hundreds of thousands of people with Billroth II’s
• If cancer IS SUCH  A  BIG RISK…
• Shouldn’t gastroenterologists be looking for these people, 
screening them with endoscopy?
• No, there is no recommendation for BII follow up screening; 
Why? THE RISK IS LOW
• 63,000 yrs Follow up 23 cancers = Gen Pop.
RISK OF GASTRIC CANCER AFTER 
BILLROTH II IS LOW
• Follow-up study of 1000 patients
• 22-30 year follow-up
• 196 endoscopy and biopsy No Cancer of the gastric 
remnant seen
• Endoscopic screening will be “unrewarding”
• Br J Surg. 1983 Sep;70(9):552-4. Risk of gastric cancer after Billroth II resection for 
duodenal ulcer. Fischer AB
WHAT CAUSES GASTRIC CANCER?
ITS NOT BILLROTH II
• Diets rich in fried, salted, smoked or preserved foods
increased cancer risk in many studies.
• Foods contain nitrites and these chemicals can be converted
to more harmful compounds (carcinogens) by bacteria in the
stomach.
• Diets high in fruit and vegetables protects against Cancer
• Stomach cancer is much more common in smokers and in
those with heavy alcohol intake.
• H. Pylori, No H. Pylori No Cancer
DIET AND CANCER PREVENTION
• Avoid ETOH, Tobacco,
Processed & Preserved
Meats, Salt
• RX H. Pylori,
• Eat Fruits and Veggies,
Yogurt and
• Drink Green Tea
•
Gonzalez CA, Cancer Research, Institut Català d'Oncologia, Av. Gran Via s/n, km
2.7, 08907 L'Hospitalet, Barcelona, Spain.
CANCER QUIZ: MORE DEADLY
CANCER CAUSING AGENT? A OR B
AA BB
CANCER QUIZ: MORE DEADLY
Hot Dog or Mini-Gastric Bypass
AA
• American Institute
for Cancer
Research
• Hot Dog / day
• Increase the risk
cancer 21%
UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 1. Gastric Cancer Declining Rapidly, > 50%
• 2. Gastric Cancer Cause:
Environmental Factors / Easily Prevented
Diet, Lifestyle changes and Rx of H. Pylori
(Avoid Etoh, smoking, processed & salted meats and
foods, seek high intake of fruits and vegetables)
UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 3. Some studies Slight Increased Risk of gastric cancer
after 20 – 30 years (RR 1.5):
But: BII to Rx Ulcer =>
Ulcer => Increased Risk
• (Worried? Rx H Pylori, Eat healthy etc.)
• 4. Many Large Studies: No Increased Risk
Thousands of patients followed for Decades
UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 5. Endoscopic screening of Billroth II patients is Not
Recommended. Why? Low Risk!
• 6. General, Trauma and Oncologic surgeons routinely
use the Billroth II (Thousands of publications)
• 7. 2007 ~16,000 BII procedures were performed in the
USA
UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 8. Billroth II and the Mini-Gastric Bypass
Excellent, Safe and Effective
• 9. FEAR Gastric Cancer?
Avoid ETOH, Tobacco, Processed & Preserved Meats,
Rx H. Pylori,
Eat Fruits and Veggies, Yogurt and Drink Green Tea
• A Billroth II probably makes NO difference
• Rational Review of the Data vs.
Fear Gastric Cancer / Bile Reflux
• Rational Thinking vs. Reptilian Brain
Rational Data Analysis vs.
Irrational FEAR Gastric Cancer
• 1. Gastric Cancer Declining Rapidly
• 2. GC Environmental Causes; Easily Prevented
• 3. Some studies show Small Increased Risk
Probably from Ulcers / H. Pylori
• 4. Many large studies: NO increased risk
• 5. Endoscopic Screening: Not Recommended
• 6. General, Trauma & Oncologic Surgeons Use Billroth II
FEAR OF GASTRIC CANCER
• FEAR gastric cancer?
• Avoid: Alcohol, Tobacco, Processed &
Preserved Meats
Rx: H. Pylori,
Eat Fruits & Veggies, Yogurt and
Drink Green Tea
• Billroth II Probably Makes NO DifferenceBillroth II Probably Makes NO Difference
FEAR OF GASTRIC CANCER
A Billroth II Probably
Makes No Difference
FEAR OF GASTRIC CANCER
A Billroth II Probably
Makes No Difference
C: Consequences / Results / Outcomes
RNY Band SG MGB
1. Low Risk - + - +
2. Major Weight Loss + - - ++
3. Easily performed - - + + +
4. Short operative times - + + +
5. Short hospital stay - - + + +
6. Minimal Blood Loss - + + +
7. No Need for ICU Stay - + + +
8. Minimal Pain - + + +
9. High Patient Satisfaction - - - +
10. A Good "Exit Strategy" - - - + - - +
C: Consequences / Results / Outcomes
RNY Band Sleeve MGB
11. Decrease Hunger + - + +
12. Min Vomiting + + + +
13. No Internal hernias - + + +
14. Min Heart/Lung - + + +
15. Low Failure Rate - - - +
16. Low Cost - - - +
17. Short Recovery - + + +
18. Return to Work - + + +
19. Low Risk of PE - + + +
20. Durable Weight Loss - - - +
C: Consequences / Results / Outcomes
RNY Band SG MGB
21. Low Risk of Ulcer - + + -
22. Malabsorption of fat + - - +
23. No Foreign Body + - + +
24. Verifiable Results - - - ++
25. Bowel Obstruction - - + + ++
26. Sound Surgical + - + +
27. Independent confirm - - - ++
28. Healthy life - - - ++
29. RCT; LEVEL I Evidence - - - ++
30. Block Sweet Eater + - - ++
CONCLUSIONS:
Rational Choice: Mini-Gastric Bypass
• Choice of Obesity Surgery?
• Criteria for “Ideal” Weight Loss Surgery
• RNY, Band, Sleeve, MGB
• MGB Best Meets Success Criteria
• Fear of Bile Reflux & Gastric Cancer
Not Supported by the Data
• Rational Decision Making: Best Choice;
Mini-Gastric Bypass
WHY CRITICS ONLY CARE FOR MGB?
• Why do Critics only care about the
Mini-Gastric Bypass?
• 100,000’s of people already have and are living with and
are getting the Billroth II every day
• Why haven’t concerned bariatric surgeons stepped
forward to stop all general, trauma and oncologic
surgeons from performing this Billroth II surgery?
WHY CRITICS ONLY CARE FOR MGB?
•Why do Critics only care about the
Mini-Gastric Bypass?
•Why haven’t concerned bariatric surgeons stepped
forward to start a fund to help suffering Billroth II patients
get needed conversions of their surgery
to Roux-en-Y?
•Why don’t they write letters to the editor calling for the
Billroth II to be declared a operation non-grata?
WHY CRITICS ONLY CARE FOR MGB?
• Why do Critics only care about the
Mini-Gastric Bypass?
• Why haven’t concerned bariatric surgeons stepped
forward to national funding for lifetime endoscopic
screening of Billroth II patients to find dreaded gastric
cancers?
• It seems odd doesn’t it?
• There is a simple reason
WHY CRITICS ONLY CARE FOR MGB?
• There is a simple reason
• The critics of the MGB do not do those things because of
Cognitive Biases
• Such actions are Not supported by the data
• The Billroth II and the MGB are both good operations
• Published data Does Not support the critics misreading of
the medical literature
CRITICS OF THE
MINI-GASTRIC BYPASS
SHOULD BE EMBARRASSED
For Forgetting their
General Surgery
Dr Rutledge; USA 001-702-714-0011 DrR@clos.net
ARE YOU CONSIDERING THE MGB?
WARNING:
THERE ARE “TRICKS AND TRAPS”
OFFER A SAFE AND SUCCESSFUL
MGB PROGRAM
• Please Call / Email: Anytime question or advice on any clinical,
technical or patient MGB question
• USA 001-702-714-0011 DrR@clos.net
• Personal Visit: Dr Rutledge Visiting Prof: Costa Rica, Turkey,
France, Austria & India, Upcoming visits Greece, Istanbul,
Czech Republic, Italy and Germany
• Please Use the Knowledge of Others Before You Start;
Experience; over 14 years, over 6,000 patients
THE TIDE BEGINS TO TURN
TO THE MINI-GASTRIC BYPASS
• “Not too long ago, the bariatric community questioned the
role of the mini-gastric bypass and its appropriateness as a
durable operation for obesity.”
• The experience of Lee et al. with a large cohort suggests
some answers.”
• Michel M. Murr, M.D.
• “The Journal continues to commit to open, spirited, and
balanced discussions that are supported by data and
withstand the test of common sense.”
A CLARION CALL FOR BETTER
BARIATRIC SURGERY
• RNY and VBG FAIL to Lengthen Life!
• Bariatric Surgery; A History of Complications &
Failure
• We Need Better Bariatric Surgery
• We Simpler, Safer, More Powerful, More Durable
and Revisable and Reversible
• We Need the MGB
MGB, 9 YEARS LATER!
OUT PERFORMS RNY
• Stunning new results of the MGB:
• “Of the 1,322 patients, 23 (1.7%) had undergone
revision surgery during a follow-up of 9 years.”
• Excess weight loss at 5 years after MGB was 72.1%
• No patient had surgery for internal hernia
SURVEY: MGB OUT-PERFORMS
BAND & RNY
• Follow up survey of bariatric surgery results in 1,500
patients’ friends, family and acquaintances
• Patient Reported Success in Friends Family:
36% RNY,
24% Band and
93% MGB
EXAMPLE FEAR & DECISION MAKING SBO VS.
GASTRIC CANCER
Which is more Deadly?
• Gastric Cancer or Small
Bowel Obstruction?
• Which is more
fearsome?
11+ RNY STUDIES INTERNAL HERNIA
BOWEL OBSTRUCTION
• 1 - 16% Internal Hernia /Small Bowel Obstruction
• Follow Up 1-10 years
(only 7% F/U at 10 years)
• Note: Dead patients cannot return for follow up
• =15/18 patients, ReOp, failed closure USA=
DEATH AFTER
SMALL BOWEL OBSTRUCTION
• 877 patients who underwent 1,007 operations for
SBO from 1961 to 1995
• Risk of bowel obstruction increases over time
• 52 Deaths 6% Death Rate
• Ann Surg. 2000 April; 231(4), Complications and Death After Surgical Treatment of
Small Bowel Obstruction A 35-Year Institutional Experience Fevang et.al.,
Department of Surgery, University Hospital, University of Bergen, Norway
FEAR AND DECISION MAKING
SBO VS. GASTRIC CANCER
• Which is more Deadly?
• Gastric Cancer or
Small Bowel
Obstruction?
• Which is more
fearsome?
FEAR AND DECISION MAKING
SBO VS. GASTRIC CANCER
• 1,000 RNYs, Estimate 20% SBO => 200 operations for
SBO in 5-10 years (? How many more for 20 years?)
FEAR?
SBO VS. GASTRIC CANCER
• 1,000 RNYs, 20% SBO => 200 operations for SBO in
5-10 years (? How many for 20 years?)
• 6% Death Rate => 12 dead before the end of 10 years
from SBO
FEAR?
SBO VS. GASTRIC CANCER
• 1,000 RNYs, 20% SBO => 200 operations for SBO in
5-10 years (? How many for 20 years?)
• 6% Death Rate => 12 dead before the end of 10 years
from SBO
• 1,000 MGBs After 20 years possibly increased risk of
cancer of 1 / 1,000
FEAR?
SBO VS. GASTRIC CANCER
• 1,000 RNYs, 20% SBO => 200 operations for SBO in
5-10 years (? How many for 20 years?)
• 6% Death Rate => 12 dead before the end of 10 years
from SBO
• 1,000 MGBs After 20 years possibly increased risk of
cancer of 1/1,000
• Deaths at 10 years from Gastric Cancer 0.0
FEAR?
SBO VS. GASTRIC CANCER
• 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10
years (? How many for 20 years?)
• 6% Death Rate => 12 dead before the end of 10 years
from SBO
• 1,000 MGBs After 20 years possibly increased risk of
cancer of 1/1,000
• Death at 10 years from Gastric Cancer 0.0
• Death SBO 12/10 years,
Deaths Gastric Cancer 10-20 years 0-1
WHICH DO YOU FEAR?
SBO VS. GASTRIC CANCER
• 1,000 RNYs = 200 SBO operations
• Death from RNY SBO 12 deaths / 10 years
• 1,000 MGB’s 0-1 Gastric Cancer @ 20 yrs
• Deaths Gastric Cancer 10-20 years 0-1?
FEAR AND DECISION MAKING
SBO VS. GASTRIC CANCER
• Which is more Deadly?
• Gastric Cancer or
Small Bowel
Obstruction?
• Which is more
fearsome?
FOLLOW UP EFFECT
• Unbiased Population based studies => Poor Results of RNY
• Positive Results of RNY reported from RNY centers
• Suffer from “Follow Up Effect”
• Patient Returns to clinic doing well: Greeted Warmly with Great Joy
• Patient Returns to clinic doing poorly: Greeted with anger and disapproval
• Successful pt => Good Follow Up / Failed pt tacitly sent away
• Now; Center reports excellent results; (30%) follow up
• Weight Regain, Band Erosion, Death
• Not Seen, Not Reported

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Irrational Fear of Gastric Cancer:After Billroth II

  • 1. FOLLOW UP EFFECT • Unbiased Population based studies => Poor Results of RNY • Positive Results of RNY reported from RNY centers • Suffer from “Follow Up Effect” • Patient Returns to clinic doing well: Greeted Warmly with Great Joy • Patient Returns to clinic doing poorly: Greeted with anger and disapproval • Successful pt => Good Follow Up / Failed pt tacitly sent away • Now; Center reports excellent results; (30%) follow up • Weight Regain, Band Erosion, Death • Not Seen, Not Reported
  • 2. Irrational Fear of Gastric Cancer: CHOOSING THE BEST WEIGHT LOSS SURGERY R Rutledge MD, The Centers for Laparoscopic Obesity Surgery www.CLOS.net Email: DrR@clos.net
  • 3.
  • 4.
  • 5. Dr Rutledge: Training & Background • Undergrad/Medical School; Teacher Dr. Lester Dragstedt Pioneer / Inventor of the Highly Controversial Vagotomy and Pyloroplasty • 2 Years Cardiac Surgery National Institutes of Health National Heart Lung Blood Institute • 20 years University of NC; Professor of Surgery, Associate Chief of Staff, Director of Section Medical Informatics, Director North Carolina Trauma Registry • Author of 93 papers and articles
  • 6. Dr Rutledge: Training & Background • Specialty: Trauma, Critical Care, Medical Informatics and Bariatric Surgery (1978-1998 20 years University NC) • Experience: Trauma Surgery, Director NC Trauma Registry • Peptic Ulcer Surgery; Vagotomy & Pyloroplasty; Antrectomy & Billroth II • Bariatric Surgery 33 years: Open RNY & Vertical Banded Gastroplasty • 1997 one first surgeons laparoscopic RNY • Mini-Gastric Bypass; 14 years, over 6,000 cases
  • 7. Dr. Rutledge USA 001-702-714-0011 DrR@clos.net CONSIDERING THE MGB? MGB IS A SUPERB SURGERY BUT… WARNING: “THERE ARE “TRICKS AND TRAPS”
  • 8. OFFER A SAFE & SUCCESSFUL MGB PROGRAM • Call / Email: Anytime question or advice on any clinical, technical or patient MGB question • USA 001-702-714-0011 DrR@clos.net • Personal Visit: Dr. Rutledge Visiting Professor: France, Turkey, Austria & India, Upcoming visits Greece, Istanbul, United Kingdom Czech Republic, Italy, Germany, UAE, Pakistan, • Please Use the Knowledge of Others Before You Start; Experience; over 14 years, over 6,000 patients • USA 001-702-714-0011 DrR@clos.net
  • 9. Human Decision Making is Flawed Need for Decision Making Support  Research: Human Decision Making frequently Flawed & driven by Irrational thinking  Selecting the Best Weight Loss surgery  Should be based on a rational review of the data  Avoid Emotional or Irrational Bias
  • 10. HUMAN DECISION MAKING ERRORS Recent Research in Psychology and Neurobiology Shows that: The Human Brain is a Notoriously Bad Decision Maker
  • 11. Human Decision Making Errors Very Common • Exaggerate Rare Events, Downplay Common Events • Underestimate risks taken Willingly, (car) Overestimate risks Beyond Control (airplane) • Overestimate risks Talked About
  • 12. Irrational Illogical Thinking Decision-Making Errors • Confirmation Bias (favor information that confirms preconceptions) • Herd Behavior (group think override rational) • “Reptilian Brain” Amygdala is part "impulsive," primitive system that triggers emotional override rational thinking
  • 14. THE REPTILIAN BRAIN: EMOTION & DECISION MAKING • Rational Logical Thinking: Frontal Lobe • Amygdala Interferes with the Frontal lobe • Primitive, Impulsive • Irrational decision-making
  • 15. IRRATIONAL ILLOGICAL THINKING CONFIRMATION BIAS • Contrary Evidence => Maintains or strengthens present beliefs • Overconfidence in present beliefs • Poor Decision Making • Especially Present in Organizations, Military, Political & Social Groups
  • 16. REPTILIAN BRAIN POOR DECISIONS FEAR LEADS TO JUDGMENT ERRORS • Errors in Risk Assessment • Death Airplane Crash • Death Car Crash • 1 in 1,000 patient / 20 years risk of gastric cancer • Bowel Obstruction from internal hernia +16% in 5 years
  • 17. SURGERY HISTORY OF POOR DECISIONS JOSEPH LISTER: AMERICAN SURGEONS DELAYED ADOPTION OF ANTISEPSIS 10 YEARS
  • 18. REPTILIAN BRAIN POOR DECISION MAKING • Lister published antisepsis paper: • 1867 Dr. Gross; Gross Clinic 1875
  • 19. HUMAN DECISION MAKING ERRORS: EXPECTED, NOT RARE • Realization of Fallibility Human Decision Making • Humility • Socratic Questioning of Assumptions • Search for Logical & Rational Decision Making
  • 20. THE PROBLEM • Obesity Epidemic • History of Failure of Bariatric Surgical Procedures • Selecting the “Ideal / BEST” Bariatric Surgical Procedure
  • 21. Problem Definition: Bariatric Surgery: A HISTORY OF FAILURE Procedure Assessment Jejuno-ileal Bypass (Failure) Vertical Banded Gastroplasty (Failure) Lap Band (Fail?) RNY Bypass (Fail?) BPD/DS (Fail?) Sleeve: 1% Leak, 30% GE Reflux, Irreversible, Weight regain (Fail?)
  • 26. MINI-GASTRIC BYPASS • The Mini-Gastric Bypass 1997 – 2011 ; >6,000 pts, 10 yr Data; Multiple Centers, R.C.Trials • Vertical Gastric Tube (Collis Gastroplasty) • Gastric Bypass (Billroth II Gastro-jejunostomy)
  • 28. C: Consequences / Results / Outcomes RNY Band SG MGB 1. Low Risk - + - + 2. Major Weight Loss + - - ++ 3. Easily performed - - + + + 4. Short operative times - + + + 5. Short hospital stay - - + + + 6. Minimal Blood Loss - + + + 7. No Need for ICU Stay - + + + 8. Minimal Pain - + + + 9. High Patient Satisfaction - - - + 10. A Good "Exit Strategy" - - - + - - +
  • 29. C: Consequences / Results / Outcomes RNY Band Sleeve MGB 11. Decrease Hunger + - + + 12. Min Vomiting + + + + 13. No Internal hernias - + + + 14. Min Heart/Lung - + + + 15. Low Failure Rate - - - + 16. Low Cost - - - + 17. Short Recovery - + + + 18. Return to Work - + + + 19. Low Risk of PE - + + + 20. Durable Weight Loss - - - +
  • 30. C: Consequences / Results / Outcomes RNY Band SG MGB 21. Low Risk of Ulcer - + + - 22. Malabsorption of fat + - - + 23. No Foreign Body + - + + 24. Verifiable Results - - - ++ 25. Bowel Obstruction - - + + ++ 26. Sound Surgical + - + + 27. Independent confirm - - - ++ 28. Healthy life - - - ++ 29. RCT; LEVEL I Evidence - - - ++ 30. Block Sweet Eater + - - ++
  • 31. • Fear of Gastric Cancer Bile Reflux • Rational vs. Reptilian Brain Decision Making
  • 32. STATISTICAL ILLITERACY; "MANY DOCTORS MISUNDERSTAND MEDICAL LITERATURE" • Example:  “In the absence of a Roux limb,  the long-term effects of chronic alkaline reflux are unknown.” • REALLY? Rational vs. Reptilian Brain thinking • Billroth II >100 years and >1,450 papers on Billroth II • Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW.,  Gastric Bypass;  Why Roux-en-Y? A Review of Experimental Data, Arch Surg. 2007; 142(10):1000- 1003.
  • 33. GASTRIC CANCER  RAPIDLY DECLINING • The incidence of gastric cancer  in the United States has  • Decreased four-fold since 1930  • Approximately 7 cases per  100,000 people.  
  • 34. BARIATRIC SURGEONS FEAR BILLROTH II; CANCER SURGEONS CHOOSE BILLROTH II • 1,490 articles on performance of the Billroth II • General/Trauma/Oncologic surgeons commonly use  the Billroth II • Over 16,000 Billroth II operation  performed in USA 2007 • While Bariatric Surgeons Fear the Billroth II General  Surgeons use the Billroth II routinely
  • 35. BARIATRIC SURGEONS FEAR BILLROTH II WHAT IS MAGNITUDE OF THE PROBLEM • Mayo Clinic Study (Example) • 338 Billroth II patients  • Followed 25-years • 5,635 person-years • Only 2 Cancers in 5,000+ pt years of Follow Up • Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease. N  Engl J Med. 1983 Nov 17;309
  • 36. BARIATRIC SURGEONS FEAR BILLROTH II MAGNITUDE OF THE PROBLEM • Population based study, 338 Billroth II pts  • Followed 25-years • 5,635 person-years • Only 2 Cancers Found in 5,000 years • Predicted 2.6 cancers (relative risk 0.8)  Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease. N Engl J Med. 1983 Nov  17;309
  • 37. BARIATRIC SURGEONS FEAR BILLROTH II MAGNITUDE OF THE PROBLEM • 338 Billroth II pts, Followed 25-years • 5,635 person-years • Only 2 Cancers in 5,000 pt years follow up • RATE of Gastric Cancer is Declining • 24 - 50% Expected Decrease from 1983 • Future risk ~1 patient / 5,000 pt years
  • 38. ULCERS INCREASE RISK CANCER • Meta-analysis:  7 studies Small increased risk  5 studies No Increased Risk • Studies with increased Risk; Flawed • Billroth II = Surgery Rx Ulcers • ULCERS increase risk of Gastric Cancer! • Ulcers and Gastric Cancer Common Etiology  =H. Pylori=
  • 39. ULCERS INCREASE RISK CANCER •3,078 gastric cancer vs. 89,082 controls •Ulcer increases risk gastric cancer =(relative risk 1.53)= •Same as Increased Risk reported Billroth II  •Many other studies confirm these findings:  •Ulcer Increases Risk  Gastric Cancer •Ulcers & Gastric Cancer: •Common Etiology =H. Pylori=
  • 40. BARIATRIC SURGEONS FEAR BILLROTH II GASTROENTEROLOGISTS IGNORE BILLROTH II • Hundreds of thousands of people with Billroth II’s • If cancer IS SUCH  A  BIG RISK… • Shouldn’t gastroenterologists be looking for these people,  screening them with endoscopy? • No, there is no recommendation for BII follow up screening;  Why? THE RISK IS LOW • 63,000 yrs Follow up 23 cancers = Gen Pop.
  • 41. RISK OF GASTRIC CANCER AFTER  BILLROTH II IS LOW • Follow-up study of 1000 patients • 22-30 year follow-up • 196 endoscopy and biopsy No Cancer of the gastric  remnant seen • Endoscopic screening will be “unrewarding” • Br J Surg. 1983 Sep;70(9):552-4. Risk of gastric cancer after Billroth II resection for  duodenal ulcer. Fischer AB
  • 42.
  • 43. WHAT CAUSES GASTRIC CANCER? ITS NOT BILLROTH II • Diets rich in fried, salted, smoked or preserved foods increased cancer risk in many studies. • Foods contain nitrites and these chemicals can be converted to more harmful compounds (carcinogens) by bacteria in the stomach. • Diets high in fruit and vegetables protects against Cancer • Stomach cancer is much more common in smokers and in those with heavy alcohol intake. • H. Pylori, No H. Pylori No Cancer
  • 44. DIET AND CANCER PREVENTION • Avoid ETOH, Tobacco, Processed & Preserved Meats, Salt • RX H. Pylori, • Eat Fruits and Veggies, Yogurt and • Drink Green Tea • Gonzalez CA, Cancer Research, Institut Català d'Oncologia, Av. Gran Via s/n, km 2.7, 08907 L'Hospitalet, Barcelona, Spain.
  • 45. CANCER QUIZ: MORE DEADLY CANCER CAUSING AGENT? A OR B AA BB
  • 46. CANCER QUIZ: MORE DEADLY Hot Dog or Mini-Gastric Bypass AA • American Institute for Cancer Research • Hot Dog / day • Increase the risk cancer 21%
  • 47. UNINFORMED FEAR BILLROTH II EDUCATED USE BILLROTH II • 1. Gastric Cancer Declining Rapidly, > 50% • 2. Gastric Cancer Cause: Environmental Factors / Easily Prevented Diet, Lifestyle changes and Rx of H. Pylori (Avoid Etoh, smoking, processed & salted meats and foods, seek high intake of fruits and vegetables)
  • 48. UNINFORMED FEAR BILLROTH II EDUCATED USE BILLROTH II • 3. Some studies Slight Increased Risk of gastric cancer after 20 – 30 years (RR 1.5): But: BII to Rx Ulcer => Ulcer => Increased Risk • (Worried? Rx H Pylori, Eat healthy etc.) • 4. Many Large Studies: No Increased Risk Thousands of patients followed for Decades
  • 49. UNINFORMED FEAR BILLROTH II EDUCATED USE BILLROTH II • 5. Endoscopic screening of Billroth II patients is Not Recommended. Why? Low Risk! • 6. General, Trauma and Oncologic surgeons routinely use the Billroth II (Thousands of publications) • 7. 2007 ~16,000 BII procedures were performed in the USA
  • 50. UNINFORMED FEAR BILLROTH II EDUCATED USE BILLROTH II • 8. Billroth II and the Mini-Gastric Bypass Excellent, Safe and Effective • 9. FEAR Gastric Cancer? Avoid ETOH, Tobacco, Processed & Preserved Meats, Rx H. Pylori, Eat Fruits and Veggies, Yogurt and Drink Green Tea • A Billroth II probably makes NO difference
  • 51. • Rational Review of the Data vs. Fear Gastric Cancer / Bile Reflux • Rational Thinking vs. Reptilian Brain
  • 52. Rational Data Analysis vs. Irrational FEAR Gastric Cancer • 1. Gastric Cancer Declining Rapidly • 2. GC Environmental Causes; Easily Prevented • 3. Some studies show Small Increased Risk Probably from Ulcers / H. Pylori • 4. Many large studies: NO increased risk • 5. Endoscopic Screening: Not Recommended • 6. General, Trauma & Oncologic Surgeons Use Billroth II
  • 53. FEAR OF GASTRIC CANCER • FEAR gastric cancer? • Avoid: Alcohol, Tobacco, Processed & Preserved Meats Rx: H. Pylori, Eat Fruits & Veggies, Yogurt and Drink Green Tea • Billroth II Probably Makes NO DifferenceBillroth II Probably Makes NO Difference
  • 54. FEAR OF GASTRIC CANCER A Billroth II Probably Makes No Difference
  • 55. FEAR OF GASTRIC CANCER A Billroth II Probably Makes No Difference
  • 56. C: Consequences / Results / Outcomes RNY Band SG MGB 1. Low Risk - + - + 2. Major Weight Loss + - - ++ 3. Easily performed - - + + + 4. Short operative times - + + + 5. Short hospital stay - - + + + 6. Minimal Blood Loss - + + + 7. No Need for ICU Stay - + + + 8. Minimal Pain - + + + 9. High Patient Satisfaction - - - + 10. A Good "Exit Strategy" - - - + - - +
  • 57. C: Consequences / Results / Outcomes RNY Band Sleeve MGB 11. Decrease Hunger + - + + 12. Min Vomiting + + + + 13. No Internal hernias - + + + 14. Min Heart/Lung - + + + 15. Low Failure Rate - - - + 16. Low Cost - - - + 17. Short Recovery - + + + 18. Return to Work - + + + 19. Low Risk of PE - + + + 20. Durable Weight Loss - - - +
  • 58. C: Consequences / Results / Outcomes RNY Band SG MGB 21. Low Risk of Ulcer - + + - 22. Malabsorption of fat + - - + 23. No Foreign Body + - + + 24. Verifiable Results - - - ++ 25. Bowel Obstruction - - + + ++ 26. Sound Surgical + - + + 27. Independent confirm - - - ++ 28. Healthy life - - - ++ 29. RCT; LEVEL I Evidence - - - ++ 30. Block Sweet Eater + - - ++
  • 59. CONCLUSIONS: Rational Choice: Mini-Gastric Bypass • Choice of Obesity Surgery? • Criteria for “Ideal” Weight Loss Surgery • RNY, Band, Sleeve, MGB • MGB Best Meets Success Criteria • Fear of Bile Reflux & Gastric Cancer Not Supported by the Data • Rational Decision Making: Best Choice; Mini-Gastric Bypass
  • 60. WHY CRITICS ONLY CARE FOR MGB? • Why do Critics only care about the Mini-Gastric Bypass? • 100,000’s of people already have and are living with and are getting the Billroth II every day • Why haven’t concerned bariatric surgeons stepped forward to stop all general, trauma and oncologic surgeons from performing this Billroth II surgery?
  • 61. WHY CRITICS ONLY CARE FOR MGB? •Why do Critics only care about the Mini-Gastric Bypass? •Why haven’t concerned bariatric surgeons stepped forward to start a fund to help suffering Billroth II patients get needed conversions of their surgery to Roux-en-Y? •Why don’t they write letters to the editor calling for the Billroth II to be declared a operation non-grata?
  • 62. WHY CRITICS ONLY CARE FOR MGB? • Why do Critics only care about the Mini-Gastric Bypass? • Why haven’t concerned bariatric surgeons stepped forward to national funding for lifetime endoscopic screening of Billroth II patients to find dreaded gastric cancers? • It seems odd doesn’t it? • There is a simple reason
  • 63. WHY CRITICS ONLY CARE FOR MGB? • There is a simple reason • The critics of the MGB do not do those things because of Cognitive Biases • Such actions are Not supported by the data • The Billroth II and the MGB are both good operations • Published data Does Not support the critics misreading of the medical literature
  • 64. CRITICS OF THE MINI-GASTRIC BYPASS SHOULD BE EMBARRASSED For Forgetting their General Surgery
  • 65. Dr Rutledge; USA 001-702-714-0011 DrR@clos.net ARE YOU CONSIDERING THE MGB? WARNING: THERE ARE “TRICKS AND TRAPS”
  • 66. OFFER A SAFE AND SUCCESSFUL MGB PROGRAM • Please Call / Email: Anytime question or advice on any clinical, technical or patient MGB question • USA 001-702-714-0011 DrR@clos.net • Personal Visit: Dr Rutledge Visiting Prof: Costa Rica, Turkey, France, Austria & India, Upcoming visits Greece, Istanbul, Czech Republic, Italy and Germany • Please Use the Knowledge of Others Before You Start; Experience; over 14 years, over 6,000 patients
  • 67. THE TIDE BEGINS TO TURN TO THE MINI-GASTRIC BYPASS • “Not too long ago, the bariatric community questioned the role of the mini-gastric bypass and its appropriateness as a durable operation for obesity.” • The experience of Lee et al. with a large cohort suggests some answers.” • Michel M. Murr, M.D. • “The Journal continues to commit to open, spirited, and balanced discussions that are supported by data and withstand the test of common sense.”
  • 68. A CLARION CALL FOR BETTER BARIATRIC SURGERY • RNY and VBG FAIL to Lengthen Life! • Bariatric Surgery; A History of Complications & Failure • We Need Better Bariatric Surgery • We Simpler, Safer, More Powerful, More Durable and Revisable and Reversible • We Need the MGB
  • 69. MGB, 9 YEARS LATER! OUT PERFORMS RNY • Stunning new results of the MGB: • “Of the 1,322 patients, 23 (1.7%) had undergone revision surgery during a follow-up of 9 years.” • Excess weight loss at 5 years after MGB was 72.1% • No patient had surgery for internal hernia
  • 70. SURVEY: MGB OUT-PERFORMS BAND & RNY • Follow up survey of bariatric surgery results in 1,500 patients’ friends, family and acquaintances • Patient Reported Success in Friends Family: 36% RNY, 24% Band and 93% MGB
  • 71. EXAMPLE FEAR & DECISION MAKING SBO VS. GASTRIC CANCER Which is more Deadly? • Gastric Cancer or Small Bowel Obstruction? • Which is more fearsome?
  • 72. 11+ RNY STUDIES INTERNAL HERNIA BOWEL OBSTRUCTION • 1 - 16% Internal Hernia /Small Bowel Obstruction • Follow Up 1-10 years (only 7% F/U at 10 years) • Note: Dead patients cannot return for follow up • =15/18 patients, ReOp, failed closure USA=
  • 73. DEATH AFTER SMALL BOWEL OBSTRUCTION • 877 patients who underwent 1,007 operations for SBO from 1961 to 1995 • Risk of bowel obstruction increases over time • 52 Deaths 6% Death Rate • Ann Surg. 2000 April; 231(4), Complications and Death After Surgical Treatment of Small Bowel Obstruction A 35-Year Institutional Experience Fevang et.al., Department of Surgery, University Hospital, University of Bergen, Norway
  • 74. FEAR AND DECISION MAKING SBO VS. GASTRIC CANCER • Which is more Deadly? • Gastric Cancer or Small Bowel Obstruction? • Which is more fearsome?
  • 75. FEAR AND DECISION MAKING SBO VS. GASTRIC CANCER • 1,000 RNYs, Estimate 20% SBO => 200 operations for SBO in 5-10 years (? How many more for 20 years?)
  • 76. FEAR? SBO VS. GASTRIC CANCER • 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10 years (? How many for 20 years?) • 6% Death Rate => 12 dead before the end of 10 years from SBO
  • 77. FEAR? SBO VS. GASTRIC CANCER • 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10 years (? How many for 20 years?) • 6% Death Rate => 12 dead before the end of 10 years from SBO • 1,000 MGBs After 20 years possibly increased risk of cancer of 1 / 1,000
  • 78. FEAR? SBO VS. GASTRIC CANCER • 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10 years (? How many for 20 years?) • 6% Death Rate => 12 dead before the end of 10 years from SBO • 1,000 MGBs After 20 years possibly increased risk of cancer of 1/1,000 • Deaths at 10 years from Gastric Cancer 0.0
  • 79. FEAR? SBO VS. GASTRIC CANCER • 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10 years (? How many for 20 years?) • 6% Death Rate => 12 dead before the end of 10 years from SBO • 1,000 MGBs After 20 years possibly increased risk of cancer of 1/1,000 • Death at 10 years from Gastric Cancer 0.0 • Death SBO 12/10 years, Deaths Gastric Cancer 10-20 years 0-1
  • 80. WHICH DO YOU FEAR? SBO VS. GASTRIC CANCER • 1,000 RNYs = 200 SBO operations • Death from RNY SBO 12 deaths / 10 years • 1,000 MGB’s 0-1 Gastric Cancer @ 20 yrs • Deaths Gastric Cancer 10-20 years 0-1?
  • 81. FEAR AND DECISION MAKING SBO VS. GASTRIC CANCER • Which is more Deadly? • Gastric Cancer or Small Bowel Obstruction? • Which is more fearsome?
  • 82. FOLLOW UP EFFECT • Unbiased Population based studies => Poor Results of RNY • Positive Results of RNY reported from RNY centers • Suffer from “Follow Up Effect” • Patient Returns to clinic doing well: Greeted Warmly with Great Joy • Patient Returns to clinic doing poorly: Greeted with anger and disapproval • Successful pt => Good Follow Up / Failed pt tacitly sent away • Now; Center reports excellent results; (30%) follow up • Weight Regain, Band Erosion, Death • Not Seen, Not Reported