On Tuesday, March 21, 2017, the FDA released an update regarding BIA-ALCL and their association with Silicone Prostheses.
Anaplastic Large Cell Lymphoma-
The first reported case of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) was reported in 1997. Silicone breast implants were cleared by cleared for use by the FDA. In recent years there has been a worldwide effort to collect data on cases because it is so rare in an effort to better understand, treat, and avoid the disease. Because information is typically incomplete and retrospective (review of past cases) a new and very specific database that collects exact information has been started.
Information regarding BIA-ALCL:
- ALCL is a rare type of non-Hodgkin’s lymphoma, which can present in many forms. The cutaneous (skin) presentation has a 90% 5 year survival, and a more aggressive type that presents as a mass has a 5 year survival rate of 40-60%. When found around implants the survival rate is even better than the primary skin type. Those presenting with a breast mass have a worse prognosis.
- ALCL of the breast without implants is estimated at .03 per million person years.
- ALCL of the breast with implants is estimated at 2.03 per million patient years.
- Worldwide approximately 1.5 million breast implants are placed each year.
- To date there have been 375 cases Of BIA-ALCL reported, of which 258 were confirmed. There have been 9 deaths attributed to ALCL.
- To give you some perspective, nearly 1.7 million women are diagnosed with breast cancer every year, and over 40,000 will die this year alone.
- Implant information is only known in less than half of the cases, but in patients where information is available, all had textured at some point in their lifetime.
- Outside of the U.S. textured implants are used in 90% of the cases. Inside the U.S. the vast majority of breast cancer patients reconstructed with implants have textured tissue expanders, and in more recent years the number of textured implants used has increased dramatically with the availability of anatomic implants.
- Textured implants are often used to maintain implant position over time, orientation of anatomic implants, and reduce capsular contracture.
- It is felt that the lymphoma is a result of chronic inflammation from the implant surface and bacterial biofilms around the implant.
- It is estimated that one case will develop out of 50,000 women with textured implants when followed for 10 years.
- Most presented with a late seroma or fluid around the implant. More rarely patients presented with a mass (which carries a poor prognosis). Some cases were incidental findings at surgery.
- The average time of presentation was around 10 years (ranging from 1 to 40 years).
- If patients develop swelling of the breast due to fluid, it is aspirated and sent for cytology to determine the diagnosis.
- Treatment typically includes removal of the implant and surrounding scar tissue. Chemotherapy and radiation may be indicated for advanced or aggressive cases.
- The overall prognosis for BIA-ALCL is excellent when the disease is limited to fluid and the surrounding capsule, which is the majority of the cases.