Adverse Events Associated With Synthetic Male Slings: An Analysis of the FDA MAUDE Database.

Abstract

Purpose\nWe sought to describe and analyze the adverse events associated with synthetic male slings reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.\n\n\nMethods\nWe 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).\n\n\nResults\nA 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 four 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.\n\n\nConclusions\nThere 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 mid-urethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.