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

Hanson Zhao; Colby P. Souders; Paige K. Kuhlmann; Kai Dallas; Karyn Eilber; Jennifer T. Anger

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저자정보: Hanson Zhao (Division of Urology Department of Surgery Cedars-Sinai Medical Center) Colby P. Souders (Division of Urology Department of Surgery Cedars-Sinai Medical Center) Paige K. Kuhlmann (Division of Urology Department of Surgery Cedars-Sinai Medical Center) Kai Dallas (Division of Urology Department of Surgery Cedars-Sinai Medical Center) Karyn Eilber (Division of Urology Department of Surgery Cedars-Sinai Medical Center) Jennifer T. Anger (Division of Urology Department of Surgery Cedars-Sinai Medical Center)

저널정보: 대한배뇨장애요실금학회 International Neurourology Journal International Neurourology Journal 제25권

발행연도: 2021.1

수록면: 172 - 176 (5page)

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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.

#Male sling #Mesh #Male stress incontinence #Urethra #Erosion

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