| Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction. | |
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MedLine Citation:
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PMID: 20031943 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Karem C Harth; Michael J Rosen |
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Publication Detail:
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Type: Journal Article Date: 2009-12-22 |
Journal Detail:
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Title: Surgical innovation Volume: 16 ISSN: 1553-3514 ISO Abbreviation: Surg Innov Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2010-01-20 Completed Date: 2010-04-01 Revised Date: 2010-09-02 |
Medline Journal Info:
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Nlm Unique ID: 101233809 Medline TA: Surg Innov Country: United States |
Other Details:
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Languages: eng Pagination: 324-9 Citation Subset: IM |
Affiliation:
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University Hospitals Case Medical Center, Case Western Reserve School of Medicine, Cleveland, OH, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abdominal Wall
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surgery* Humans Reconstructive Surgical Procedures* Retrospective Studies Surgical Mesh / adverse effects* Transplantation, Heterologous / adverse effects* |
| Comments/Corrections | |
Comment In:
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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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