The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).
Materials approved as Class V and VI can be considered medical grade.
Brittle fracture can occur from defects within sections owing to poor control of vulcanization.
[2] It resulted in high failure rates for breast implants, and much subsequent litigation in the US, as well as elsewhere in the world.
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