Breast Implant Ingredients
The U.S. Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR® Breast Implants and determined that the implants are safe and effective. Detailed information about the materials found in breast implants is provided in the MemoryGel, MemoryShape and Saline patient educational brochures that are provided in the Patient Educational Brochure section below.
The shells of all MENTOR® Breast Implants and Tissue Expanders are constructed from medical-grade silicone elastomer. The shells are then filled with either our medical-grade, cohesive silicone gel during the manufacturing process or saline at the time of surgery by the surgeon. Toxicology testing has confirmed the safety of these silicone materials for use in MENTOR® Breast Implants.
Platinum is the only metal added during the manufacturing process for the silicone gel and shells of breast implants and tissue expanders. Scientific evidence supports that the extremely low level of the specific type of platinum used in breast implants that may diffuse through the shell doesn’t represent a significant health risk.2 The FDA has published a backgrounder on the topic of this type of platinum along with an overview of studies that have been conducted and will continue to review and analyze the literature on the issue of platinum in breast implants, as part of its ongoing assessment of the safety of these devices. They can be found here.