Evaluation of biocompatibility, based on quantitative determination of the vascular response induced by material...

The biocompatibility of nine different materials, including positive and negative references, 4 polyurethane based and 3 latex based materials was investigated by (1) cytotoxic assay using V79 chinese hamster cells, (2) the thickness of inflammatory layer at 3 and 7 days after intramuscular implantation test, and (3) the course of the blood flow in tissue reaction around subcutaneously implanted materials using Laser Doppler Flowmetry (LDF) over 14 days following implantation. In addition, for some materials, different modes of sterilization were compared. Although the three methods explore different reactive systems, the material ranking obtained was highly similar for the three methods, suggesting a relative accuracy between them. For one latex however, an absence of cytotoxic effect in culture and a highly intense response by LDF investigation of the same order of magnitude as for the positive reference implant suggest that bioincompatibility may result from the material itself and cannot be exclusively investigated by the leaching of toxic components.