Grand Rounds- Intragastric Balloon

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Garren-Edwards Balloon Smaller fill volumes Less durable material Uncontrolled providers Cylindrical shape (?ulcers)Withdrawn from market by 1990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 info@tummybubble.com for more information

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