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

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 Facil...

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Bibliographic Details
Published in:Obesity surgery 2021-07, Vol.31 (7), p.3360-3364
Main Authors: Ramai, Daryl, Bhandari, Peter, Facciorusso, Antonio, Barakat, Mohamed, Pasisnichenko, Yuriy, Saghir, Syed, Ambrosi, Antonio, Tartaglia, Nicola, Chandan, Saurabh, Dhindsa, Banreet, Dhaliwal, Amaninder, McDonough, Stephanie, Adler, Douglas G.
Format: Article
Language:English
Subjects:
Abdomen
Brief Communication
Endoscopy
FDA approval
Gastroenterology
Gastrointestinal surgery
Hepatology
Intensive care
Medical equipment
Medicine
Medicine & Public Health
Nausea
Obesity
Pain
Patients
Surgery
Surgical outcomes
Vomiting
Weight control
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Summary: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
ISSN:0960-8923
1708-0428
DOI:10.1007/s11695-021-05324-x