title: The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis.
abstract: 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/m2and 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.
  
  
  
  A 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.
  
  
  
  Forty-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).
  
  
  
  No 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.
authors.affiliation: Department of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Kumar
authors.affiliation: Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Fateh
authors.initials: F
authors.lastname: Bazerbachi
authors.affiliation: Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Tarun
authors.initials: T
authors.lastname: Rustagi
authors.affiliation: Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: McCarty
authors.affiliation: Department of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Thompson
authors.affiliation: Gastro Obese Center, São Paulo, Brazil.
authors.forename: Manoel P
authors.initials: MP
authors.lastname: Galvao Neto
authors.affiliation: Department of Surgery, Florida International University, Miami, FL, USA.
authors.forename: Natan
authors.initials: N
authors.lastname: Zundel
authors.affiliation: Department of Surgery, University of Texas, Houston, TX, USA.
authors.forename: Erik B
authors.initials: EB
authors.lastname: Wilson
authors.affiliation: Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Gostout
authors.affiliation: Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA. AbuDayyeh.Barham@mayo.edu.
authors.forename: Barham K
authors.initials: BK
authors.lastname: Abu Dayyeh
mesh_terms: D050110:Bariatric Surgery / Q000009:adverse effects / Q000706:statistics & numerical data; D015992:Body Mass Index; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects / Q000706:statistics & numerical data; D006801:Humans; D007441:Intubation, Gastrointestinal / Q000009:adverse effects / Q000706:statistics & numerical data; D008297:Male; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011475:Prosthesis Failure / Q000009:adverse effects / Q000209:etiology; D015431:Weight Loss
keywords: Endoscopic bariatric; Obesity; Weight management