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Unlocking the Thin
gastric balloon the answerMatthew R. brackman, md, facs
Person Within: Is www.tummybubble.com
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?
Garren-Edwards Balloon Smaller fill volumes Less durable material Uncontrolled providers Cylindrical shape (?ulcers)Withdrawn from market by 1990
ReShape Balloon Orbera Balloon Dual Balloon (900 total cc) Single (400-700cc) Spherical Spherical Acid resistant silicone Selected providers Improved valve mechanism Multidisciplinary program
Specializing in Obesity treatment
SurgicalMedical
Endoscopic
New York30 Central Park S
Manhattan
Massachusetts1515 Allen St
Springfield
MultidisciplinaryNutrition
PsychEducation
Support Groups
CERTIFIED
HealthcareFinancingPartners
Post Procedural Care
Maintenencecomplication management
Body Contouring
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
RESULTSBalloons
Obesity Surgery 2008 meta-analysis 3608 pts 32.1% excess wt. lost
Early balloons showed no di�erence compared to pla-cebo.
Orbera Baloon
9.3-21.3% TBWL at 6mo10 prospective studies- 11-51% at 12mo %EWL2 studies at 36mo showed 6%TBWLOrbera vs sham 4 studies: -7% to 33 %EWL
ORBERA U.S. Pivotal Trial- multicenter, prospective, non blinded, control trial.255 ptsOrbera group- 40%EWL at 6mo72% achieved at least 25%EWLMean TBWL treatment/control at 6 mo= 10.54/4.71
ReShape Dual Balloon
REDUCE Pivotal Trial262 ptsrandomized, control, week 24 %EWL treatment/control = 25.1/11.348.8% achieved at least 25%EWL
COMPLICATIONS
EARLY LATE Nausea, vomitting, spasm, heavy Ulceration (rare, usually super�cial) feeling, epigastric pain De�ation (3-23%) Intolerance (voluntary removal 4.2%) Intestinal Obstruction (rarer with dual Hemorrhage, perforation (mortality balloon (0 events in pivotal trial) 0.07%)
Dehydration
CONTRAINDICATIONS Pregnancy or breast feeding Hiatal hernia > 5cm
In�ammatory 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 insu�ciency, cirrhosis
Noncompliant
Implantation of Intragastric Balloons can result in signi�cant weight loss
Appears intragastric balloons have additional weight loss bene�t vs dietand exercise alone. An experienced, multi-disciplinary team is necessary to achieve these bene�ts.
Safety pro�le 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
Dr. Brackman is the first physician certified to perform the Reshape Procedure in Massachusetts
and New York.
Contact [email protected] for more information
www.tummybubble.com