MP40-01 ADVERSE EVENTS ASSOCIATED WITH SYNTHETIC MALE SLINGS: AN ANALYSIS OF THE FDA MAUDE DATABASE

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Male Incontinence: Therapy I (MP40)1 Apr 2020MP40-01 ADVERSE EVENTS ASSOCIATED WITH SYNTHETIC MALE SLINGS: AN ANALYSIS OF THE FDA MAUDE DATABASE Hanson Zhao*, Colby P. Souders, Kai Dallas, Paige Kuhlmann, Karyn Eilber, and Jennifer T. Anger Hanson Zhao*Hanson Zhao* More articles by this author , Colby P. SoudersColby P. Souders More articles by this author , Kai DallasKai Dallas More articles by this author , Paige KuhlmannPaige Kuhlmann More articles by this author , Karyn EilberKaryn Eilber More articles by this author , and Jennifer T. AngerJennifer T. Anger More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000889.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The controversy and scrutiny towards polypropylene transvaginal mesh for pelvic organ prolapse has had significant repercussions towards the usage and perception of mid-urethral slings for stress urinary incontinence in women. We aim to explore whether there has been a similar effect for synthetic polypropylene male slings by analyzing the adverse events associated with male slings reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries with the brand name “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, manufacturer, and event description text. Duplicate entries were removed. RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified on the MAUDE database as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths reported. The slings involved were the Advance or Advance XP (69.8%), Invance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). There was no increase in medical device reports (MDRs) from 2011 and 2012 after the FDA safety communication. On review of the event description texts, a total of 232 (47%) events were related to urinary incontinence after sling placement. Other events included sling erosion (9%), mechanical malfunction (8%), pain or numbness (8%), infection (7%), urinary retention (5%), bladder or urethral injury (3%), or were unknown (13%). The report source was from a manufacturer for 490 (98.6%) reports. The rest were from a user facility (n=4) or voluntary (n=3). The source type was reported to be from a health care professional for 428 (86%) reports, consumer for 33 (7%) reports, or other for 36 (7%) reports. There were no reports generated by attorneys. CONCLUSIONS: There are a modest number of MDRs related to male slings and almost half of them describe persistent urinary incontinence. The reporting of adverse events for male slings does not seem to be affected by the controversy toward transvaginal mesh and mid-urethral slings. Further work needs to investigate the safety of polypropylene slings for urinary incontinence. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e585-e585 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hanson Zhao* More articles by this author Colby P. Souders More articles by this author Kai Dallas More articles by this author Paige Kuhlmann More articles by this author Karyn Eilber More articles by this author Jennifer T. Anger More articles by this author Expand All Advertisement PDF downloadLoading ...