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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.

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

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma(a cancer of a type of cell of the immune system)typically occurring in a delayed fluid collection around a textured implant or surrounding scar capsule.1

Breast implants are associated with increased risk of BIA-ALCL, but the absolute risk remains small.2

BIA-ALCL patients most commonly present with a spontaneous peri-prosthetic fluid collection or capsular mass at an average of eight to ten years following implantation with a breast implant for either cosmetic or reconstructive indication.1

Many factors may contribute to the development of BIA-ALCL, including biofilm organisms, possible rare genetic predisposition and the surface texture of the implant.3

Current literature indicates that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR™ SILTEX™ Breast Implants.4-5

While MENTOR™ SILTEX™ 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.

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.