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Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

PURPOSE: We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries including the terms “M...

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Autores principales: Zhao, Hanson, Souders, Colby P., Kuhlmann, Paige K., Dallas, Kai, Eilber, Karyn, Anger, Jennifer T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Continence Society 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255823/
https://www.ncbi.nlm.nih.gov/pubmed/33957719
http://dx.doi.org/10.5213/inj.2040294.147
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author Zhao, Hanson
Souders, Colby P.
Kuhlmann, Paige K.
Dallas, Kai
Eilber, Karyn
Anger, Jennifer T.
author_facet Zhao, Hanson
Souders, Colby P.
Kuhlmann, Paige K.
Dallas, Kai
Eilber, Karyn
Anger, Jennifer T.
author_sort Zhao, Hanson
collection PubMed
description PURPOSE: We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries including the terms “Male Sling,” “InVance,” “Virtue,” or “Advance” from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR). RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh. CONCLUSIONS: There was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.
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spelling pubmed-82558232021-07-16 Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database Zhao, Hanson Souders, Colby P. Kuhlmann, Paige K. Dallas, Kai Eilber, Karyn Anger, Jennifer T. Int Neurourol J Original Article PURPOSE: We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries including the terms “Male Sling,” “InVance,” “Virtue,” or “Advance” from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR). RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh. CONCLUSIONS: There was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings. Korean Continence Society 2021-06 2021-05-05 /pmc/articles/PMC8255823/ /pubmed/33957719 http://dx.doi.org/10.5213/inj.2040294.147 Text en Copyright © 2021 Korean Continence Society https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Zhao, Hanson
Souders, Colby P.
Kuhlmann, Paige K.
Dallas, Kai
Eilber, Karyn
Anger, Jennifer T.
Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title_full Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title_fullStr Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title_full_unstemmed Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title_short Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database
title_sort adverse events associated with synthetic male slings: an analysis of the food and drug administration manufacturer and user facility device experience database
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255823/
https://www.ncbi.nlm.nih.gov/pubmed/33957719
http://dx.doi.org/10.5213/inj.2040294.147
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