疝修补术后主要的补片相关并发症：向美国食品药品监督管理局报告的事件
Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration.
作者信息
Robinson T N, Clarke J H, Schoen J, Walsh M D
机构信息
Department of Surgery, University of Colorado Health Sciences Center, Box C311, 4200 East Ninth Avenue, Denver, CO, 80262, USA.
出版信息
Surg Endosc. 2005 Dec;19(12):1556-60. doi: 10.1007/s00464-005-0120-y. Epub 2005 Oct 5.
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.
补片材料会影响疝气修补术后的并发症。我们回顾了1996年1月至2004年9月期间美国食品药品监督管理局（FDA）制造商用户设施设备经验数据库中关于使用外科补片进行疝气修补的医疗器械报告。我们分析了252份与使用外科补片进行疝气修补相关的不良事件报告。不良事件包括感染（42%，107份报告）、机械故障（18%，46份）、疼痛（9%，23份）、反应（8%，20份）、肠道并发症（7%，18份）、粘连（6%，14份）、血清肿（4%，9份）、侵蚀（2%，6份）以及其他（4%，9份）。与所有其他类型的补片相比，Sepra/聚丙烯补片有更多的机械故障（80%对14%，p<0.05），生物材料补片有更多的反应（57%对7%，p<0.05），聚四氟乙烯（PTFE）/聚丙烯补片有更多的肠道并发症（14%对7%，p<0.05），并且PTFE补片往往有更多的感染（75%对其他所有补片的41%，p = 0.07）。2%（5例）发生了死亡。我们得出结论，特定的补片材料与特定的并发症相关。
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