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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 safety

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.

Breast implant silicone gel

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.

Platinum metal in breast implants

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.

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.

 

Breast implant doctor

In addition to what is included in the documents, it’s important that you know the following safety updates: 

  1. Patients who undergo breast implant surgery with connective tissue diseases (CTD) may experience an increased risk of wound dehiscence, infection and bleeding (likely due to their ongoing medical management) that may require further treatment. 

  2. Some patients with breast implants have reported experiences of neurological and/or rheumatological diseases. Mentor is currently collecting data to further understand these potential risks and their possible association with breast implants. 

  3. Based on information reported to global regulatory agencies and found in medical literature, an association has been identified between breast implants and the development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin’s lymphoma. Women with breast implants have a very small but increased risk of developing Breast Implant Associated ALCL (BIA-ALCL) in the fluid or scar capsule adjacent to the implant, with documented potential for local, regional, and distant spread of the cancer with mortality reported in rare cases. BIA-ALCL has been reported globally in patients with an implant history that includes Mentor’s and other manufacturers’ breast implants with various surface properties, styles, and shapes. Most of the cases in the literature reports describe a history of the use of textured implants. Several journal articles explore the risk factors for BIA-ALCL, including the varied methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.

    You should consider the possibility of BIA-ALCL when a patient presents with a late onset seroma (at least 1 year and on average 7 to 10 years following implantation), breast mass adjacent to the implant capsule or lymphadenopathy. Work-up of delayed enlargement of a previously implanted breast includes an ultrasound or MRI to look for the presence of seroma or lymphoma, Diagnosis starts at presentation, with needle aspiration of as much of the fluid as possible (minimum 50 mL), using ultrasound for implant displacement and protection. A suspicious mass requires needle or open tissue biopsy. Specimens should be sent for cell morphology by cytology, CD30 immunohistochemistry and ALK (anaplastic lymphoma kinase), and flow cytometry for evaluation, quantification, and characterization of T cells within the specimen. Hematopathology consultation at a tertiary cancer center is strongly encouraged to establish or exclude a diagnosis of BIA-ALCL. Once the diagnosis of BIA-ALCL has been established, physicians are strongly encouraged to consult with a multidisciplinary team including oncologists, pathologists, surgical oncologists, and plastic surgeons. The United States National Comprehensive Cancer Network (NCCN) guidelines for treatment of established BIA ALCL includes the removal of the implant and the entire surrounding implant capsule in addition to associated masses and lymph node involvement.

    FDA provides additional information regarding questions and answers for BIA-ALCL, please visit:

    http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
    ImplantsandProsthetics/BreastImplants/ucm239995.htm

    Please note for latest diagnostic and treatment options refer The National Comprehensive Cancer Network (NCCN) guidelines

References

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 (SpectrumTM) 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
https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053b.pdf

6. Institute of Medicine, National Academy of Medicine 2007. Information for women about safety of silicone breast implants (full article https://www.ncbi.nlm.nih.gov/books/NBK44792/)

7.  R. Wixtrom. Silicone breast implants and platinum. Plast Reconstr Surg., December 2007; PMID: 18090821

References

All links to external website links are being provided as a convenience and for informational purposes only, Johnson & Johnson Medical Devices bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

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