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Major mesh-related complications following hernia repair

Events reported to the Food and Drug Administration
  • T. N. RobinsonEmail author
  • J. H. Clarke
  • J. Schoen
  • M. D. Walsh
Article

Abstract

Mesh material affects complications following hernia repair. Medical device reports on the use of surgical mesh for hernia repair were reviewed from the Food and Drug Administration’s (FDA) Manufacturer User Facility Device Experience Database from January 1996 to September 2004. We analyzed 252 adverse event reports related to the use of surgical mesh for hernia repair. Adverse events included infection (42%, 107 reports), mechanical failure (18%, 46), pain (9%, 23), reaction (8%, 20), intestinal complications (7%, 18), adhesions (6%, 14), seroma (4%, 9), erosion (2%, 6), and other (4%, 9). Compared to all other mesh types, Sepra/polypropylene mesh had more mechanical failures (80 vs 14%, p < 0.05), biomaterial mesh had more reactions (57 vs 7%, p < 0.05), polytetrafluoroethylene (PTFE)/polypropylene mesh had more intestinal complications (14 vs 7%, p < 0.05), and PTFE mesh tended to have more infections (75 vs 41% all other, p = 0.07). Death occurred in 2% (5). We conclude that specific mesh materials are related to specific complications.

Keywords

Mesh Complications Hernia repair FDA database review 

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Copyright information

© Springer Science+Business Media, Inc. 2005

Authors and Affiliations

  • T. N. Robinson
    • 1
    Email author
  • J. H. Clarke
    • 1
  • J. Schoen
    • 1
  • M. D. Walsh
    • 1
  1. 1.Department of SurgeryUniversity of Colorado Health Sciences CenterDenverUSA

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