Harth Karem C, Rosen Michael J
University Hospitals Case Medical Center, Case Western Reserve School of Medicine, Cleveland, OH, USA.
Surg Innov. 2009 Dec;16(4):324-9. doi: 10.1177/1553350609353609. Epub 2009 Dec 22.
There is limited research for xenograft biologic mesh performance in the setting of infection despite widespread use and significant associated costs.
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.
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.
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.
尽管异种移植生物补片被广泛使用且相关成本高昂，但关于其在感染情况下性能的研究有限。
作者回顾性分析了美国食品药品监督管理局（FDA）数据库中报告的异种移植不良事件（AE）。所有补片均于1997年至2008年用于腹壁重建。
作者识别出150例不良事件。Permacol和Collamend占报告病例的75%（n = 112）。主要不良事件包括急性机械故障（42%；n = 63）、补片崩解（32%；n = 48）和补片整合不良（13%；n = 20）；80%的病例被描述为感染，近90%的不良事件需要再次手术。
异种移植生物补片的主要并发症已上报至FDA。交联补片向FDA报告的不良事件最多。补片的内在特性及其与感染相关结果的关系尚不清楚。此次FDA数据库审查结果表明需要仔细评估这些产品。
