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Surgical Endoscopy

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01-12-2005

Major mesh-related complications following hernia repair

Events reported to the Food and Drug Administration

Authors: T. N. Robinson, J. H. Clarke, J. Schoen, M. D. Walsh

Published in: Surgical Endoscopy | Issue 12/2005

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.

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Title: Major mesh-related complications following hernia repair
Events reported to the Food and Drug Administration
Authors: T. N. Robinson
J. H. Clarke
J. Schoen
M. D. Walsh
Publication date: 01-12-2005
Publisher: Springer-Verlag
Published in: Surgical Endoscopy / Issue 12/2005
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-005-0120-y

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