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Our Highest Priority: You
Our Commitment to Safety
Nothing is more important to MENTOR® than the health and satisfaction of the patients who choose our breast implants. We adhere to the highest standards of quality, and the safety and clinical performance of MENTOR® Breast Implants is supported by long-term clinical data, including three prospective clinical trials that followed patients for 10 years.1,2,3 Our products are sold around the world because of our persisting commitment to provide objective, clinical information about breast implant safety to help drive an informed choice and give women results they seek.
We’re proud of the long-standing safety of our implants and, in turn, offer one of the most comprehensive warranty programs in the industry.
Our Safety Assurance Process
Each MENTOR® product undergoes a stringent inspection and rigorous testing to ensure quality and performance. Our process is robust for every product we make – and the process never stops. We closely monitor the clinical performance of MENTOR® Breast Implants through clinical studies, registries and post-market surveillance activities. And we’re constantly evaluating materials and implementing manufacturing innovation based on the latest research and feedback.
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.
Product Safety Information
- MENTOR® MemoryGelTM Breast Implants Product Insert Data Sheet
- MENTOR® MemoryGelTM Resterilizable Gel Sizer Product Insert Data Sheet
- MENTOR® Saline Breast Implant Product Insert Data Sheet
- Single Use Sterile Saline Sizer Product Insert Data Sheet
- Smooth Tissue Expander Product Insert Data Sheet
- MENTOR® MEMORYGEL SILTEX BECKER EXPANDER/BREAST IMPLANTS
- MENTOR® CPX4 Breast Tissue Expanders
1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013.
2. Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.
3. Bielefeld, B. A Prospective Clinical Study of Mentor Corporation Saline-filled Mammary Prosthesis, Siltex® Saline-filled Mammary Prosthesis, and Siltex® Saline-filled Postoperatively Adjustable Mammary Prosthesis (Spectrum TM) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.
4. Bondurant, S., V.L. Ernster and R. Herdman, Eds. 2000. Safety of silicone breast implants. Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, D.C.: National Academy Press
5. FDA’s Summary of Safety and Effectiveness Document. https://www.accessdata.fda.gov/cdrh_docs/pdf6/p060028b.pdf and
7. R. Wixtrom. Silicone breast implants and platinum. Plast Reconstr Surg., December 2007; PMID: 18090821