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.
Caution: US law restricts this device to sale by or on the order of a physician.
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.
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 best warranty programs in the industry.
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.
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. This information can also be found in Section V, Table 2, of the FDA’s Summary of Safety and Effectiveness Documents (SSED) on the FDA’s website here and here, and in Section X here.
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.
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 amount is less than what is absorbed from daily consumer products containing silicone,6 and scientific evidence supports that the extremely low level that may diffuse through the shell doesn’t represent a significant health risk.
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 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.
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: FDA.