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.¹¹

Breast implants are associated with increased risk of BIA-ALCL, but the absolute risk remains small.¹²

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.¹¹

Many factors may contribute to the development of BIA-ALCL, including biofilm organisms, possible rare genetic predisposition and the surface texture of the implant.¹⁴

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^15,16

While MENTOR™ SILTEX™ Breast Implants have a low rate of BIA-ALCL¹⁶, 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

Some patients with breast implants have reported a range of systemic symptoms which they refer to as breast implant illness. Some reported symptoms include fatigue, chronic pain, rash, anxiety, muscle pain, recurring infections and swollen lymph nodes.

To date there have not been any concrete or evidence-based studies or peer-reviewed data concerning the formation of a new syndrome: silicone implant illness,¹³ however globally there is ongoing work across industry, medical and plastic surgery societies, and researchers, 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.