WARNING:
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Some patients have died from BIA-ALCL.
Patients receiving breast implants have reported a variety of systematic symptoms such as joint pain, muscle aches, confusion chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
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 years1. 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 best 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 U.S. 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. Detailed information about the materials found in breast implants is provided in the MemoryGel, MemoryShape and Saline patient educational brochures that are provided in the Patient Educational Brochure section below.
Silicon 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 materials for use in MENTOR® 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.2 The FDA has published a backgrounder on the topic of this type of platinum along with an overview of studies that have been conducted and will continue to review and analyze the literature on the issue of platinum in breast implants, as part of its ongoing assessment of the safety of these devices. They can be found here.
Talk With Your Surgeon
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 surgeon.
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. 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.
Patient Educational Brochures
MENTOR® MemoryGel Breast Augmentation
MENTOR® MemoryGel Breast Reconstruction
MENTOR® MemoryShape® Breast Augmentation
MENTOR® MemoryShape® Breast Reconstruction
MENTOR® Saline Implants: Making an Informed Decision
MENTOR® MemoryGel® Patient Checklist
WARNING:
- Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
- Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Some patients have died from BIA-ALCL.
- Patients receiving breast implants have reported a variety of systematic symptoms such as joint pain, muscle aches, confusion chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel® Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least 18 years old for MENTOR® Saline Breast Implants. MENTOR® Breast Implants are also indicated for breast reconstruction.
Breast implant surgery should not be performed in women:
- With active infection anywhere in their body
- With existing cancer or pre-cancer of their breasts 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. 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.
Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.
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 MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications for breast reconstruction with MENTOR® MemoryGel® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. The most common complications with MENTOR® MemoryShape® Breast Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. 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 incidence of worldwide cases.
Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures for both augmentation and reconstruction:
For Augmentation: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
For Reconstruction: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
Saline-Filled Breast Implants: Making an Informed Decision.
These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA® Breast Tissue Expander and CONTOUR PROFILE® 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 ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® 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 ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com
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