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* 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.

Mentor® Breast Implants are backed by a highly comprehensive warranty to ensure that you are supported long after your surgery.2

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.3 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.3

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.4 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.5

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.6

Our adherence to strict quality manufacturing requirements results in silicone shells that have been tested for excellent strength, resilience, and elasticity. 7

Platinum metal in breast implants

Metals

Scientific evidence supports that the extremely low level of the specific form of platinum used in breast implants and that may diffuse through the shell does not pose a significant health risk. The US FDA has published a backgrounder on the topic along with an overview of studies on the topic and has concluded that the risk of platinum toxicity from current generation implants is low.8

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

Helpful Links

References

*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. Mentor Worldwide, LLC. MemoryShape™ Post‐Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015. 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™) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.

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. 1.2. Mentor Worldwide, LLC. MemoryShape™ Post‐Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015. 1.3. 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™) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.

2. MENTORPROMISE PROTECTION PLAN FOR MENTOR® BREAST IMPLANTS, Legal Document, 2021.

3. Implant Testing and the "Strain Energy" Concept. David A. Caplin, MD. 2018. 3.2. Smooth and SILTEX™ Round Xtra Gel Breast Implants (Project Goldilocks Breast Implants OUS, ADAPTIV # 100502574) 100525323 Design Requirements. May 2018.

4. 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.

5. FDA’s Summary of Safety and Effectiveness Document: https://www.accessdata.fda.gov/cdrh_docs/pdf6/p060028b.pdf
https://www.accessdata.fda.gov/cdrh_docs/pdf/P990075B.pdf

6. Cosmetic. Breast Implants Engineering and Performance. Khashayar Mohebali et al, 2018. 6.2. Institute of Medicine, 2000. Information for women about safety of silicone breast implants (full article https://www.ncbi.nlm.nih.gov/books/NBK44792/) Access date: 21/07/2020

7. Biocompatibility Risk Assessment Report for MemoryGel Breast Implant Product Family 100501884, Rev. 4, 1/4/2020.

8. Wixtrom, R. Silicone Breast Implants and Platinum. American Society of Plastic Surgeons. 2007; Volume 120, Number 7 Supplement 1: 121, para.4. 8.2. FDA, FDA Backgrounder on Platinum in Silicone Breast, 2018. Available from: Implants.https://www.fda.gov/medical‐ devices/breast‐implants/fda‐ backgrounder‐platinum‐silicone‐breast‐ implants [Accessed 04 January 2021].

9. FDA, Breast Implants. Available from: https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants Accessed on: 2nd July 2021.

References

Important Safety Information:

The MENTOR® Collection of Breast Implants are indicated for breast reconstruction and breast augmentation - in women who are at least 18 years old for MENTOR® MemoryGel® Breast Implants, MENTOR® CPGTM Breast Implants, or MENTOR® Saline Breast Implants.

Breast implant surgery should not be performed in women:

  • With active infection anywhere in their body
  • With existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions
  • Who are currently pregnant or nursing

Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The chance of developing complications increases over time. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.

Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with CPGTM Breast Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual's risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the data currently available on the incidence of worldwide cases.

Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures, including the ‘Important Information for Woman Considering Breast Implants’ brochure, and the ‘Making an Informed Decision’ brochure. These brochures are available from your surgeon or visit https://breastimplantsbymentor.net/safety/mentor-safety. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.

MENTOR® CONTOUR PROFILETM Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. These expanders are intended for temporary subcutaneous or submuscular implantation; they should be used within a time frame determined by the physician to achieve the clinically desired degree of tissue expansion.

DO NOT use the MENTOR® CONTOUR PROFILETM Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with the MENTOR® CONTOUR PROFILETM Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of MENTOR® CONTOUR PROFILETM Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.eu

The third-party trademarks used herein are the trademarks of the respective owners.
This publication is not intended for distribution outside of the EMEA region.

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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