Carcinogenicity of implantable materials: experimental and epidemiological evidence.

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.