The new FDA approved Gastric Balloon is a modern day version of the Garren-Edwards Balloon. See how it is perched to re-invent obesity treatment for the BMI 30-40.

1. Unlocking the Thin
gastric balloon the answerMatthew R. brackman, md, facs
Person Within: Is
www.tummybubble.com

2. 338% of U.S. Adults are obese
95% of people fail diet and exercise alone
In July 2015 the FDA approved the Intragastric Balloon for BMI 30-40
Why will it be any more successful than the Garren-Edwards Balloon of 1985?

3. Garren-Edwards Balloon
Smaller fill volumes
Less durable material
Uncontrolled providers
Cylindrical shape (?ulcers)
Withdrawn from market by 1990

4. ReShape Balloon Orbera Balloon
Dual Balloon (900 total cc) Single (400-700cc)
Spherical Spherical
Acid resistant silicone Selected providers
Improved valve mechanism Multidisciplinary program

5. Specializing in
Obesity treatment
Surgical
Medical
Endoscopic
New York
30 Central Park S
Manhattan
Massachusetts
1515 Allen St
Springfield
Multidisciplinary
Nutrition
Psych
Education
Support Groups
CERTIFIED
Healthcare
Financing
Partners
Post Procedural
Care
Maintenence
complication management
Body Contouring

6. balloon placement
balloon removal
pREOP SURGEON VISIT
pREOP NUTRITION VISIT
eDUCATION
STEPS
surgeon visits
support groups
nutrition visits
support groups
surgeon follow up
nutrition visits

7. RESULTS
Balloons
Obesity Surgery 2008
meta-analysis
3608 pts
32.1% excess wt. lost
Early balloons showed no
difference compared to pla-
cebo.
Orbera Baloon
9.3-21.3% TBWL at 6mo
10 prospective studies- 11-51% at 12mo
%EWL
2 studies at 36mo showed 6%TBWL
Orbera vs sham 4 studies: -7% to 33 %EWL
ORBERA U.S. Pivotal Trial- multicenter,
prospective, non blinded, control trial.
255 pts
Orbera group- 40%EWL at 6mo
72% achieved at least 25%EWL
Mean TBWL treatment/control at 6 mo=
10.54/4.71
ReShape Dual Balloon
REDUCE Pivotal Trial
262 pts
randomized, control,
week 24 %EWL
treatment/control =
25.1/11.3
48.8% achieved at least
25%EWL

8. COMPLICATIONS
EARLY LATE
Nausea, vomitting, spasm, heavy Ulceration (rare, usually superficial)
feeling, epigastric pain
Deflation (3-23%)
Intolerance (voluntary removal 4.2%)
Intestinal Obstruction (rarer with dual
Hemorrhage, perforation (mortality balloon (0 events in pivotal trial)
0.07%)
Dehydration

9. CONTRAINDICATIONS
Pregnancy or breast feeding Hiatal hernia > 5cm
Inflammatory bowel disease Uncontrolled psychologic disorder
Prior stomach surgery Active ulceration or gastritis
Bleeding disorder, varices Esophageal disorders (achalasia, stricture)
Anticoagulation therapy Gastric mass
Alcohol or drug abuse Hepatic insufficiency, cirrhosis
Noncompliant

10. Implantation of Intragastric Balloons can result in significant weight loss
Appears intragastric balloons have additional weight loss benefit vs diet
and exercise alone. An experienced, multi-disciplinary team is necessary
to achieve these benefits.
Safety profile is very good with rare serious complications.
Early troublesome symptoms are common but short lived.
Can be used as a pre-operative adjunct for high risk bariatric surgery patients

11. Dr. Brackman is the first physician certified to
perform the Reshape Procedure in Massachusetts
and New York.
Contact info@tummybubble.com for more information
www.tummybubble.com