Breast Implant Ingredients
The US 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. The list of materials used to make our breast implants can be found in Section V, Table 2, of the US FDA’s Summary of Safety and Effectiveness Documents (SSED) on the US FDA’s website here, and in Section X here.
Silicone Gel
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 material for use in MENTOR™ Breast Implants.
Our adherence to strict quality manufacturing requirements results in silicone shells that have been tested for excellent strength, resilience, and elasticity. Studies have shown that a small quantity of silicone materials may diffuse (“bleed”) through an intact implant shell at some point.4,5 The diffuse through the shell doesn’t represent a significant health risk.
Metals
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.7 The US FDA has published a backgrounder on the topic of this type of platinum along with an overview of studies that have been conducted that affirm this ingredient’s safe use. They can be found here.