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

doi:10.1007/s11695-021-05324-x

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

Department of Medicine

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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 language	English (US)
Pages (from-to)	3360-3364
Number of pages	5
Journal	Obesity Surgery
Volume	31
Issue number	7
DOIs	https://doi.org/10.1007/s11695-021-05324-x
State	Published - Jul 2021

All Science Journal Classification (ASJC) codes

Surgery
Endocrinology, Diabetes and Metabolism
Nutrition and Dietetics

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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. G. (2021). Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Obesity Surgery, 31(7), 3360-3364. https://doi.org/10.1007/s11695-021-05324-x

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, DG 2021, 'Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database', Obesity Surgery, vol. 31, no. 7, pp. 3360-3364. https://doi.org/10.1007/s11695-021-05324-x

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

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AU - Barakat, Mohamed

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AU - Tartaglia, Nicola

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

Abstract

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