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Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

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Abstract

Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.

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Authors and Affiliations

  1. Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA

    Daryl Ramai, Peter Bhandari & Yuriy Pasisnichenko

  2. Department of Medical Sciences, Section of Gastroenterology, University of Foggia, 71122, Foggia, Italy

    Antonio Facciorusso

  3. Division of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA

    Mohamed Barakat

  4. Department of Medicine, University of Nevada, Las Vegas, NV, USA

    Syed Saghir

  5. Department of Surgery, University of Foggia, 71122, Foggia, Italy

    Antonio Ambrosi & Nicola Tartaglia

  6. Division of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA

    Saurabh Chandan

  7. Gastroenterology & Hepatology, University of Nebraska Medical Center, Omaha, NE, USA

    Banreet Dhindsa

  8. Division of Gastroenterology, Moffitt Cancer Center, University of South Florida, Tampa, FL, USA

    Amaninder Dhaliwal

  9. Division of Gastroenterology and Hepatology, Huntsman Cancer Center, University of Utah School of Medicine, 30N 1900E 4R118, Salt Lake City, UT, USA

    Stephanie McDonough & Douglas G. Adler

Authors
  1. Daryl Ramai
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  2. Peter Bhandari
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  3. Antonio Facciorusso
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  4. Mohamed Barakat
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  5. Yuriy Pasisnichenko
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  6. Syed Saghir
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  7. Antonio Ambrosi
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  8. Nicola Tartaglia
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  9. Saurabh Chandan
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  10. Banreet Dhindsa
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  11. Amaninder Dhaliwal
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  12. Stephanie McDonough
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  13. Douglas G. Adler
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Corresponding author

Correspondence to Douglas G. Adler.

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Ramai, D., Bhandari, P., Facciorusso, A. et al. Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. OBES SURG 31, 3360–3364 (2021). https://doi.org/10.1007/s11695-021-05324-x

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  • DOI: https://doi.org/10.1007/s11695-021-05324-x

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