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Rare Complications

Breast implants are widely considered among the most intensely studied and regulated devices in the medical industry. For nearly four decades, Mentor, along with FDA and other regulatory bodies, have closely tracked and monitored patient satisfaction and complications associated with breast implants through clinical studies, registries, and real-world complaint data to better understand the breast implant benefits and safety.

In 2011, FDA identified an association between breast implants and the development of Anaplastic Large Cell Lymphoma (ALCL). Today it is believed that women with breast implants have a very small, but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). More recently some women with breast implants have reported a range of systemic symptoms that they refer to as “breast implant illness.” To date, the overall body of scientific evidence does not support claims that breast implants cause systemic illness, however further research is underway to better understand any possible connection.

Rare Complications Breast Implants

Breast Implant Associated Anaplastic Large Cell-Lymphoma (BIA-ALCL)

Women with breast implants are at a small but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that is highly curable if detected early.13,14 BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system), that affects lymphocytes (immune cells), typically taking between 8-10 years to develop.15 In most cases (>85%), BIA-ALCL is found in the implant effusion (fluid surrounding the implant), which current data suggest may be cured by removal of the implant and capsule.16

Many factors may contribute to the development of BIA-ALCL, including bacterial contamination, genetic predisposition and the surface texture of the implant. Current literature, and real world evidence, concludes that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be very low with MENTOR® Breast Implants.17-26

While MENTOR® Breast Implants have a low rate of BIA-ALCL, it remains a concern we take seriously. We closely monitor the clinical performance of our breast implants through clinical studies, registries and post market surveillance activities and continue to work with industry groups, physicians, scientists and health authorities to better understand 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® Breast 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). Further details about policy can be found here.

Learn more about BIA-ALCL: FDA, ASAPS and ASPS.

Current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates have ranged from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000.14, 16 & 17

There is no set methodology for calculating BIA ALCL rates of occurrence. In general, rate estimations are calculated based on the number of BIA ALCL cases and the number of textured implants implanted.

If you are considering breast implant surgery, you should discuss the risks and benefits with your health care provider. You may also visit the FDA’s Breast Implants website for additional information

For additional information on FDA’s analysis and review of BIA-ALCL, please visit:

“Breast Implant Illness” (BII)

Patients receiving breast implants have reported a variety of systemic 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. While the current body of scientific evidence does not support claims that breast implants cause systemic illness, FDA, in partnership with industry, medical and plastic surgery societies, and researchers are taking steps to better characterize the set of conditions and its risk factors and researchers are working to understand the origins of the symptoms.

We support these efforts and have been partnering with the regulatory authorities around the world and diligently reviewing our long-term implant safety and real-word complaint data seeking to better understand any possible connection.

Following your breast surgery, it’s important that you have regular follow up exams and follow your doctor’s instructions to monitor your breast implants. If you notice any changes to your breast implants or experience any unusual signs or symptoms of health issues, contact your health care provider promptly to schedule an appointment.