Autologous plasma coating - a new approach for improvement of the biocompatibility of mesh implants

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Two recent warnings by the US Food and Drug Administration (FDA) relating to severe side-effects led to discussions concerning the biocompatibility requirements of surgical meshes. There are currently no standardized tools for the comparison of surgical meshes.Our aim was to develop a standardized and manufacturer-independent in vitrotest system for the adherence performance of tissue clusters (fibroblasts, endothelial cells and muscle-derived cells) as a marker for the biocompatibility of commercially available meshes. In this test system, we could establish a repeatable ranking of meshes with regard to their biocompatibility. The adherence behavior was independent of the individual patient features, suggesting that the biological behavior of a mesh is probably conditioned by the structure of the biomaterial or/and its chemical composition rather than by individual host characteristics/features. This in vitrotest system has been shown to be a feasible pattern for the investigation of different mesh coating strategies. The coating of meshes prior to cultivation, e.g.with peripheral blood mononuclear cells (PBMCs), did not affect the adherence score, whereas coating with platelets and blood plasma increased the score, suggesting improved biocompatibility in vitro. Plasma coating exhibited the greatest potential to improve the in vitroadherence score. The previous ranking of native meshes remained consistent after coating, but established at a higher level.In order to explore the predictive value and validityof the test system and also newly tested coating strategies, we translated the preliminary in vitroresults into in vivo circumstances and conducted a large-animal experiment on sheep. The entire experimental approach followed the recently developed recommendations of the IDEAL (Innovation, Development Exploration, Assessment and Long-term) studyfor surgical innovations. In this long-term animal study, we demonstrated that our recently developed in vitrotest system may predict the in vivo performances of the meshes. This effect was independent of the location of the mesh in the body, although its particular extent varies with the site of implantation. The coating of meshes with autologous plasma prior to implantation had positive effects on the biocompatibility of meshes in vivo. Investigation of the ultra-short-term determinants of the foreign body reaction (FBR) at the implant site in vivo revealed that the local inflammatory reaction is an early and susceptible event after mesh implantation. It cannot be influenced by prior plasma coating and does not depend on the localization of implantation. The project is continuing, the method currently being implemented in humans.

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