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 “Mal...
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| Format: | Article |
| Language: | English |
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Korean Continence Society
2021-06-01
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| Series: | International Neurourology Journal |
| Subjects: | |
| Online Access: | http://www.einj.org/upload/pdf/inj-2040294-147.pdf |
| _version_ | 1819150498840707072 |
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| author | Hanson Zhao Colby P. Souders Paige K. Kuhlmann Kai Dallas Karyn Eilber Jennifer T. Anger |
| author_facet | Hanson Zhao Colby P. Souders Paige K. Kuhlmann Kai Dallas Karyn Eilber Jennifer T. Anger |
| author_sort | Hanson Zhao |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-22T14:18:28Z |
| format | Article |
| id | doaj.art-70e4613e9a9d4e24977993445d9b8399 |
| institution | Directory Open Access Journal |
| issn | 2093-4777 2093-6931 |
| language | English |
| last_indexed | 2024-12-22T14:18:28Z |
| publishDate | 2021-06-01 |
| publisher | Korean Continence Society |
| record_format | Article |
| series | International Neurourology Journal |
| spelling | doaj.art-70e4613e9a9d4e24977993445d9b83992022-12-21T18:23:02ZengKorean Continence SocietyInternational Neurourology Journal2093-47772093-69312021-06-0125217217610.5213/inj.2040294.147937Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience DatabaseHanson Zhao0Colby P. Souders1Paige K. Kuhlmann2Kai Dallas3Karyn Eilber4Jennifer T. Anger5 Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USAPurpose 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.http://www.einj.org/upload/pdf/inj-2040294-147.pdfmale slingmeshmale stress incontinenceurethraerosion |
| spellingShingle | Hanson Zhao Colby P. Souders Paige K. Kuhlmann Kai Dallas Karyn Eilber Jennifer T. Anger Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database International Neurourology Journal male sling mesh male stress incontinence urethra erosion |
| 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 | male sling mesh male stress incontinence urethra erosion |
| url | http://www.einj.org/upload/pdf/inj-2040294-147.pdf |
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