TY - JOUR
T1 - Real-World Experience of Intragastric Balloons for Obesity
T2 - Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database
AU - Ramai, Daryl
AU - Bhandari, Peter
AU - Facciorusso, Antonio
AU - Barakat, Mohamed
AU - Pasisnichenko, Yuriy
AU - Saghir, Syed
AU - Ambrosi, Antonio
AU - Tartaglia, Nicola
AU - Chandan, Saurabh
AU - Dhindsa, Banreet
AU - Dhaliwal, Amaninder
AU - McDonough, Stephanie
AU - Adler, Douglas G.
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/7
Y1 - 2021/7
N2 - 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.].
AB - 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.].
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U2 - 10.1007/s11695-021-05324-x
DO - 10.1007/s11695-021-05324-x
M3 - Article
C2 - 33687626
AN - SCOPUS:85102307714
VL - 31
SP - 3360
EP - 3364
JO - Obesity Surgery
JF - Obesity Surgery
SN - 0960-8923
IS - 7
ER -