Genotoxicity Assessment of Advanced Composite Material – Silicone Gel-Filled Breast Implant after Radiation Sterilization
The purpose of this study was to evaluate the genotoxicity of advanced composed material—silicone gel-filled breast implant after irradiation sterilization, which will provide basis for the safety of such medical material in clinical application. The irradiation dose for sterilization was set according to ISO11137-2 standard. Ames test, micronucleus test and chromosome aberration test were performed to detect the genotoxicity of silicone gel-filled breast implant. No genotoxicity, no mutagenicity and no significant increase in micronucleus rate in polychromatic erythrocytes of bone marrow were observed in the samples of silicone gel-filled breast implant after irradiation sterilization. Therefore, irradiation sterilization is recommendable to be widely applied to biomedical polymer materials.
B. Xu and H.Y. Li
W. Liu et al., "Genotoxicity Assessment of Advanced Composite Material – Silicone Gel-Filled Breast Implant after Radiation Sterilization", Advanced Materials Research, Vol. 583, pp. 95-99, 2012