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Our Highest Priority: You

Our Commitment to Product Safety

Nothing is more important to Mentor than the health of the patients who choose our breast implants. Mentor adheres 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, 10-year, prospective clinical trials.1-3 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. At Mentor, we’re proud of the long-standing safety of our implants and, in turn, offer the best warranty program in the industry.

Our Safety Assurance Process

Our process is stringent and thorough for every product we make – and the process never stops. We’re constantly evaluating materials based on the latest research and your feedback.

Learn more about the Mentor Safety Assurance Process

Our Continued Research

For more than a decade, we have closely evaluated the safety and clinical performance of MENTOR® Breast Implants in completed and ongoing studies involving more than 200,000 women. We closely monitor reports of and information about adverse events, and we partner with health authorities and the medical community to identify more ways to further the understanding of breast implant safety.

Our Accreditation

Both MENTOR® MemoryGel® Breast Implants and MENTOR®MemoryShape® Breast Implants are FDA approved for breast augmentation. The Institute of Medicine, in a highly respected study, concluded that: “There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives.”

Our Latest Generation of Silicone

Both MENTOR® MemoryGel® Breast Implants and MENTOR®MemoryShape® Breast Implants are FDA approved for breast augmentation. The Institute of Medicine, in a highly respected study, concluded that: “There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives.”

Talk With 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. Ask your doctor to provide you with the Mentor informational booklets at least two weeks prior to surgery – you’ll find more important details about your upcoming journey with Mentor.

What Are the Risks?

The most common adverse events associated with breast implants are capsular contracture, reoperation, implant removal and rupture or deflation of the implant.

Patients with breast implants are also at a small, but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). A range of systemic symptoms, referred to as “Breast Implant Illness,” have also been reported by women with breast implants.

Considerations Before Surgery

In rare cases, complications associated with breast implants can occur. Prior to surgery, learn more about implant types and any possible complications with the help of our online brochures:

Rare Complications

BIA-ALCL

Women with breast implants are at a small but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). It is not breast cancer, it is a type of non-Hodgkin’s lymphoma (cancer of the immune system) that is highly curable if detected early. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Health authorities state that BIA-ALCL has occurred in only a very small number of the millions of people who have breast implants globally.[2] Many factors may contribute to the development of BIA-ALCL, including bacterial contamination, genetic predisposition and the surface texture of the implant.

Current literature concludes that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR® Breast Implants. 4-12

While MENTOR® Breast Implants have a low rate of BIA-ALCL, it remains a concern we take seriously. Mentor closely monitors reports of BIA-ALCL through clinical studies, registries and post market surveillance activities and continues to work with industry groups, physicians, scientists and health authorities to enhance our understanding of the associated risks and causes of this type of lymphoma.

In March 2018, Mentor began contributing to an industry-funded BIA-ALCL Patient Assistance Fund for uninsured patients diagnosed with ALCL.

Patients with Mentor implants diagnosed with BIA-ALCL as of January 1, 2019 are covered even if their implant surgery was prior to that date (based on diagnosis date, not original implant date).

  • Up to $7500 in financial assistance towards treatment and diagnosis
  • Replacement implants of choice for affected and contralateral breast
  • Last known device implanted is a Mentor device

Learn More About BIA AL

BII - Breast Implant Illness

Some patients with breast implants report a range of systemic symptoms, referred to as “Breast Implant Illness.” “Breast Implant Illness” is a general term describing a broad range of signs and symptoms that some believe are associated with breast implants.

To date, the overall body of scientific evidence doesn’t support claims that silicone gel breast implants cause systemic illness, but Mentor believes in furthering the scientific understanding of BII with continued clinical evidence generation through the use of registries. Mentor actively reviews long-term implant safety, seeking to better understand these symptoms, their etiology, and incidence. We continue to track and monitor symptoms through our post-market clinical studies and surveillance.

Learn More About BII

Questions? Connect with Your Mentor® Breast Implants Team Directly

Mailing Address:

Mentor Worldwide LLC
31 Technology Drive, Suite 200
Irvine, CA 92618

For general inquiries:

Toll Free 800.636.8678
Monday-Friday 5:30am – 4:30pm PDT

Warranty Information:

1-800-MENTOR8 or 1-800-636-8678
Email: askmentor@mentorcorp.com
Monday-Friday 8:00 a.m. – 5:00 p.m. PST

  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 Post-operatively Adjustable Mammary Prosthesis (Spectrum TM) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.
  4. de Boer, M., et al., Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncology, 2018. 4(3): p. 335-341
  5. Brody, G.S., et al., Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases. Plastic and Reconstructive Surgery, 2015. 135(3): p. 695-705.
  6. Gidengil, C.A., et al., Breast Implant–Associated Anaplastic Large Cell Lymphoma: A Systematic Review. Plastic and Reconstructive Surgery, 2015. 135(3): p. 713-720.
  7. Loch-Wilkinson, A., et al., Breast implant associated Anaplastic Large Cell Lymphoma in Australia and New Zealand - high surface area textured implants are associated with increased risk. Plastic and Reconstructive Surgery, 2017. 140(4): p. 645-654.
  8. Doren, E.L., et al., U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 2017. 139(5): p. 1042-1050
  9. Srinivasa, D.R., et al., Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases. Plast Reconstr Surg, 2017. 139(5): p. 1029-1039
  10. Johnson, L., et al., Breast implant associated anaplastic large cell lymphoma: The UK experience. Recommendations on its management and implications for informed consent. Eur J Surg Oncol, 2017. 43(8): p. 1393-1401.
  11. Deva, A.K. “BIA-ALCL: Translating Science Into Practice.” The Aesthetic Meeting of ASAPS, April 29, 2018, Javits Center, New York, NY. Lecture in Panel: Hot Topics in Breast Surgery—ALCL, Texture, Biofilms
  12. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). US Food & Drug Administration. March 2018 [accessed 12DEC2018]. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm