Title
Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database
Document Type
Article
Publication Date
3-9-2021
Publication Title
Obesity Surgery
First page number:
1
Last page number:
5
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.].
Keywords
Adverse events; Intragastric balloons; Obesity
Disciplines
Health and Medical Administration
Language
English
Repository Citation
Ramai, D.,
Bhandari, P.,
Facciorusso, A.,
Barakat, M.,
Pasisnichenko, Y.,
Saghir, S.,
Ambrosi, A.,
Tartaglia, N.,
Chandan, S.,
Dhindsa, B.,
Dhaliwal, A.,
McDonough, S.,
Adler, D.
(2021).
Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
Obesity Surgery
1-5.
http://dx.doi.org/10.1007/s11695-021-05324-x