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

Daryl Ramai, Peter Bhandari, Antonio Facciorusso, Mohamed Barakat, Yuriy Pasisnichenko, Syed Saghir, Antonio Ambrosi, Nicola Tartaglia, Saurabh Chandan, Banreet Dhindsa, Amaninder Dhaliwal, Stephanie McDonough, Douglas G. Adler

Research output: Contribution to journalArticlepeer-review

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. Graphical abstract: [Figure not available: see fulltext.].

Original languageEnglish (US)
Pages (from-to)3360-3364
Number of pages5
JournalObesity Surgery
Volume31
Issue number7
DOIs
StatePublished - Jul 2021
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

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