Study on Histocompatibility and Carcinogenicity of Silicone Gel-Filled Breast Implants after Radiation Sterilization
Objective: To evaluate the histocompatibility and carcinogenic toxicity of silicone gel-filled breast implants after irradiation sterilization and promote the application of irradiation sterilization in the polymer biomaterials. Methods: The initial contaminating bacteria of silicone gel-breast implants were detected in accordance with ISO11737 standard, and the dose of irradiation sterilization was set according to ISO11137 standard. After irradiation sterilization, a series of tests included cytotoxicity, sensitization, intracutaneous irritation and implantation tests were performed to evaluate the histocompatibility of silicone gel-breast implants. Results: No cytotoxicity and carcinogenicity were observed in irradiation sterilized silicone gel-filled breast implants, silicone gel-filled breast implants after irradiation sterilization did not induce local reactions, sensitization, intracutaneous irritation. Conclusion: After the dose of irradiation sterilization, silicone gel-filled breast implants had a good histocompatibility and no carcinogenicity, radiation sterilization is a good method for medical polymer biological material, which deserves further promotion and application.
Y. Yang et al., "Study on Histocompatibility and Carcinogenicity of Silicone Gel-Filled Breast Implants after Radiation Sterilization", Advanced Materials Research, Vol. 590, pp. 525-530, 2012