An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh

Jason M Sandberg; Ian Gray; Amy Pearlman; Ryan P Terlecki

doi:10.4111/icu.2018.59.2.126

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An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh

Journal article

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Peer reviewed

An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh

Jason M Sandberg, Ian Gray, Amy Pearlman and Ryan P Terlecki

Investigative and clinical urology, Vol.59(2), pp.126-132

03/2018

DOI: 10.4111/icu.2018.59.2.126

PMCID: PMC5840117

PMID: 29520389

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https://doi.org/10.4111/icu.2018.59.2.126View

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Abstract

To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.

Registries

Surgical mesh

United States Food and Drug Administration

Equipment safety

Details

Title: Subtitle: An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh
Creators: Jason M Sandberg - Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC, USA
Ian Gray - Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC, USA
Amy Pearlman - Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC, USA
Ryan P Terlecki - Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC, USA
Resource Type: Journal article
Publication Details: Investigative and clinical urology, Vol.59(2), pp.126-132
DOI: 10.4111/icu.2018.59.2.126
PMID: 29520389
PMCID: PMC5840117
NLM abbreviation: Investig Clin Urol
ISSN: 2466-0493
eISSN: 2466-054X
Publisher: Korea (South)
Language: English
Date published: 03/2018
Academic Unit: Urology
Record Identifier: 9984051558802771

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