Document Detail


Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction.
MedLine Citation:
PMID:  20031943     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: There is limited research for xenograft biologic mesh performance in the setting of infection despite widespread use and significant associated costs. DESIGN: The authors retrospectively reviewed an FDA database for reported xenograft adverse events (AEs). All meshes were used in the setting of abdominal wall reconstruction from 1997 to 2008. RESULTS: The authors identified 150 AEs. Permacol and Collamend comprised 75% (n = 112) of reported cases. Main AEs included acute mechanical failure (42%; n = 63), mesh disintegration (32%; n = 48), and poor mesh integration (13%; n = 20); 80% of cases were described as infected, and nearly 90% of AEs required reoperation. CONCLUSIONS: Major complications are reported to the FDA for xenograft biologic meshes. Cross-linked meshes had the most AE reports to the FDA. The intrinsic properties of meshes and how they relate to infection-related outcomes are poorly understood. The findings from this FDA database review point toward a need to carefully evaluate these products.
Authors:
Karem C Harth; Michael J Rosen
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Publication Detail:
Type:  Journal Article     Date:  2009-12-22
Journal Detail:
Title:  Surgical innovation     Volume:  16     ISSN:  1553-3514     ISO Abbreviation:  Surg Innov     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2010-01-20     Completed Date:  2010-04-01     Revised Date:  2010-09-02    
Medline Journal Info:
Nlm Unique ID:  101233809     Medline TA:  Surg Innov     Country:  United States    
Other Details:
Languages:  eng     Pagination:  324-9     Citation Subset:  IM    
Affiliation:
University Hospitals Case Medical Center, Case Western Reserve School of Medicine, Cleveland, OH, USA.
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MeSH Terms
Descriptor/Qualifier:
Abdominal Wall / surgery*
Humans
Reconstructive Surgical Procedures*
Retrospective Studies
Surgical Mesh / adverse effects*
Transplantation, Heterologous / adverse effects*
Comments/Corrections
Comment In:
Surg Innov. 2010 Jun;17(2):170; author reply 171   [PMID:  20504796 ]
Surg Innov. 2010 Sep;17(3):273-5; author reply 276   [PMID:  20513724 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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