The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m2 and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events.
MethodsA systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses.
ResultsForty-four studies (n = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3–14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months (p = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = −0.008, p < 0.001) and prosthesis migration (slope = −0.015, p < 0.001). There was no association between BFV and early removal (p = 0.1), gastroesophageal reflux symptom (p = 0.64), or ulcer rates (p = 0.09).
ConclusionsNo association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600–650 mL is recommended.
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Similar content being viewed by others Explore related subjectsDiscover the latest articles and news from researchers in related subjects, suggested using machine learning. AbbreviationsIntragastric balloon
Body mass index
Total body weight loss
BioEnterics Intragastric Balloon
Preservation and Incorporation of Valuable endoscopic Innovations
Gastroesophageal reflux disease
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Department of Gastroenterology, Brigham and Women’s Hospital, Boston, MA, USA
Nitin Kumar & Christopher C. Thompson
Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA
Fateh Bazerbachi, Tarun Rustagi, Christopher J. Gostout & Barham K. Abu Dayyeh
Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
Thomas R. McCarty
Gastro Obese Center, São Paulo, Brazil
Manoel P. Galvao Neto
Department of Surgery, Florida International University, Miami, FL, USA
Natan Zundel
Department of Surgery, University of Texas, Houston, TX, USA
Erik B. Wilson
Correspondence to Barham K. Abu Dayyeh.
Ethics declarations Ethical ApprovalFor this type of study, formal consent is not required.
Grant SupportNone.
Conflict of InterestNitin Kumar, Fateh Bazerbachi, Tarun Rustagi, and Thomas R. McCarty declare that they have no competing interests. Christopher C. Thompson, Manoel P. Galvao Neto, Natan Zundel, Erik B. Wilson, and Barham K. Abu Dayyeh, MD, are consultants for the Apollo Endosurgery, and Christopher J. Gostout is a medical director for the Apollo Endosurgery.
Electronic supplementary materialBelow is the link to the electronic supplementary material.
About this article Cite this articleKumar, N., Bazerbachi, F., Rustagi, T. et al. The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis. OBES SURG 27, 2272–2278 (2017). https://doi.org/10.1007/s11695-017-2636-3
Published: 12 March 2017
Issue Date: September 2017
DOI: https://doi.org/10.1007/s11695-017-2636-3
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