Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration.
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.
Robinson
T N
TN
Department of Surgery, University of Colorado Health Sciences Center, Box C311, 4200 East Ninth Avenue, Denver, CO, 80262, USA. thomas.robinson@UCHSC.edu
Clarke
J H
JH
Schoen
J
J
Walsh
M D
MD
D006801:Humans; D011358:Product Surveillance, Postmarketing; D013526:Surgical Mesh / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration