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 an 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.^4-6

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, the FDA, in partnership with industry, medical and plastic surgery societies, and researchers, is taking steps to better characterize the set of conditions and its risk factors. Researchers are also working to understand the origins of the symptoms. We support these efforts and have been partnering with regulatory authorities around the world and diligently reviewing our long-term implant safety and real-world complaint data, seeking to better understand any possible connection.