Genotoxicity Assessment of Advanced Composite Material – Silicone Gel-Filled Breast Implant after Radiation Sterilization


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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.



Edited by:

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

Online since:

October 2012




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