Benoit F M
Health and Welfare Canada, Tunney's Pasture, Ottawa.
J Biomed Mater Res. 1993 Oct;27(10):1341-8. doi: 10.1002/jbm.820271014.
The release of toluene diisocyanate derivatives from polyurethane foam covers that were removed from the Même breast implant was studied. The polyurethane foam covers as retrieved from the implants were contaminated on average with 2,4- and 2,6-toluene diamine (TDA), 2,4- and 2,6-toluene diisocyanate (TDI), and toluene isocyanate amine (TIA) at the 1086 ppm level (combined TDA, TDI, and TIA). When cleaned foam was incubated in Ringer's solution at 37 degrees C for periods ranging from 6-35 days, 4.6 ppm/day of TDA, TDI, and TIA (combined) was formed; the projected annual degradation rate of the foam under these conditions was estimated to be about 0.8%. When cleaned foam was incubated dry at 37 degrees C, 1.5 ppm/day of TDA, TDI, and TIA (combined) was produced. Hence, the polyurethane foam covers used in the Même breast implants are susceptible to both thermal and hydrolytic degradation under simulated physiological conditions.
对从Même乳房植入物上取下的聚氨酯泡沫覆盖层中甲苯二异氰酸酯衍生物的释放情况进行了研究。从植入物中取出的聚氨酯泡沫覆盖层平均被2,4-和2,6-甲苯二胺(TDA)、2,4-和2,6-甲苯二异氰酸酯(TDI)以及甲苯异氰酸酯胺(TIA)污染,污染水平为1086 ppm(TDA、TDI和TIA的总和)。当清洁后的泡沫在37摄氏度的林格氏溶液中孵育6至35天不等时,每天会形成4.6 ppm的TDA、TDI和TIA(总和);在这些条件下,泡沫的预计年降解率估计约为0.8%。当清洁后的泡沫在37摄氏度下干燥孵育时,每天会产生1.5 ppm的TDA、TDI和TIA(总和)。因此,Même乳房植入物中使用的聚氨酯泡沫覆盖层在模拟生理条件下易受热降解和水解降解的影响。