Our Commitment to Safety
Nothing is more important to MENTOR® than the health and satisfaction of the patients who choose our breast implants. At MENTOR®, all products manufactured meet required standards of design and testing.
Quality and safety are of paramount importance to us here at MENTOR®. Silicone gel breast implants, such as MENTOR® MemoryGel® Breast Implants, are one of the most studied medical devices. MENTOR® has patient data covering over 200,000 patients.1-10Because of this we stand behind our product with a Lifetime Replacement Policy.*
Our products are sold around the world because of our commitment to provide objective, clinical information about breast implant safety to help drive an informed choice and give women results they seek.
At MENTOR® we are confident in the performance of our products and, in turn, offer a comprehensive warranty for your peace of mind.
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 Manufacturing
MENTOR® Breast Implants adhere to strict US and EU manufacturing standards.11
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
MENTOR® MemoryGel® Breast Implant's shell physical properties are designed to exceed industry strength standard.12
MENTOR® MemoryGel® Breast Implants have been shown to have low gel bleed (gel diffusion).13 The overall body of available evidence supports that the extremely low level of gel bleed (gel diffusion) for MENTOR® MemoryGel® Breast Implants is of no presently known clinical consequence.13
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 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.14
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.
* Breast Implants are not a lifetime device and may require replacement during your lifetime. Explore our warranty further here.
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. MemoryGel® Post Approval Study Seventh Annual Report, November 5, 2013.
3. Adjunct Study Final Report for Mentor’s MemoryGel® Silicone Gel‐Filled Breast Implants, 02 November 2012.
4. Mentor Worldwide, LLC. MemoryShape™ Post‐Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.
5. Mentor Becker Expander/Breast Implant Clinical Trial 2013 Annual Report.
6. Adjunct Study Annual Report for Mentor's Becker Adjustable Breast Implants: Year 18 (September 1992‐ November 2010) October 3, 2011.
7. CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 2015.
8. MemoryShape™ Post‐Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study). 2014.
9. Athena Study annual report (Sept 2018): A Study of the Safety and Effectiveness of the Mentor® Smooth and Textured Larger Size MemoryGel® Ultra High Profile (UHP‐L) Breast Implants in Subjects who are Undergoing Primary Breast Reconstruction or Revision Reconstruction.
10. Glow Study annual report (Feb 2018): Memory Gel and Shape Combined Cohort Post Approval Study.
11. ISO Standard 14385
12. ISO: Non‐active surgical implants — Mammary implants — Particular requirements. 14607. Second edition. 2007‐ 02‐15
13. "FDA: Summary of Safety and Effectiveness Data: MENTOR MemoryGel® Silicone Gel‐Filled Breast Implants. P030053. Recommended April 13, 2005. Notice of Approval November 17, 2006. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm? id=p030053, Accessed 04/12/2018."
14. R. Wixtrom. Silicone breast implants and platinum. Plast Reconstr Surg., December 2007; PMID: 18090821
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