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.
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.
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.
Talk to Your Doctor
As with any medical procedure, there are risks involved with breast implant surgery. It is important for you to have a discussion about these risks with your doctor and/or surgeon so that you have a full understanding of both benefits and risks before undergoing surgery for breast implants. It’s also important for you to know that breast implants aren’t expected to last a lifetime, and the longer you have your breast implants, the more likely it will be for you to have them removed, with or without replacement, for any reason.
Ask your doctor to provide you with the MENTOR® informational booklets at least two weeks prior to surgery to give yourself enough time to read and think about the information before deciding whether to have the surgery. Electronic versions of these booklets can be accessed below. Once you’ve decided that breast implant surgery is right for you, you will be asked to sign an “Acknowledgement of Informed Decision” statement that confirms you have read and understood the information, and that you have been informed of the benefits and risks of breast implants. Make sure all your questions have been answered and you understand the information provided to you before you sign this statement.
Learn more about breast implant safety: US FDA
The information we provide here should not replace the important conversations you have with your doctor.
- Important Information for Woman Considering Breast Implants
- Making an informed decision
- Breast Augmentation - Patient Information Brochure
- MENTORPromise Warranty
Instructions For Use
- Gel Breast Implants (Applicable to Round Gel and CPG):
- CPX™4 Breast Tissue Expander:
- Becker Breast Implants:
- Gel Sizers:
- 1000696624 Rev 3 (13157-03) (EN, DE, FR, IT, ES, ES Mexico, PT EU, PT Brazil, NL, SE, DK, NO, GR, CZ, HU, PL, SK, SI, RO, LT, LV, JP, KR, TH, CN, TR, BG, EE, FI, RU, UA, HR, RS)