Williams David F
Wake Forest Institute of Regenerative Medicine, Winston Salem, NC, USA,
Int Urogynecol J. 2014 May;25(5):577-80. doi: 10.1007/s00192-014-2346-5. Epub 2014 Mar 11.
Recent product-liability litigation concerning polypropylene meshes has been associated with a number of claims about the suitability of these meshes for conditions such as pelvic organ prolapse (POP) surgery. It has been stated, for example, that they pose a risk for tumor formation on the basis of some animal studies that have appeared in the literature and on a few suggestions of circumstantial evidence. However, it is clear that studies of biomaterial-related tumors in animals have no relevance to clinical performance in humans. If anything, these studies predict that smooth, flat, implant surfaces are more at risk, which places polypropylene meshes in the least-risk category. Attempts to demonstrate implant-induced carcinogenicity from population studies in humans with many types of devices have routinely failed to do so.
最近关于聚丙烯网片的产品责任诉讼涉及许多有关这些网片适用于盆腔器官脱垂(POP)手术等情况的索赔。例如,根据文献中出现的一些动物研究以及一些间接证据的暗示,有人声称它们会带来肿瘤形成的风险。然而,很明显动物体内与生物材料相关肿瘤的研究与人类的临床表现并无关联。如果有什么关系的话,这些研究预测光滑、平坦的植入物表面风险更高,而聚丙烯网片属于风险最低的类别。试图通过对使用多种类型器械的人类群体研究来证明植入物诱发的致癌性,通常都未能成功。