Breast Implant-Associated Anaplastic
What is BIA-ALCL? Is BIA-ALCL Breast Cancer?
Breast Implant Associated Lymphoma (BIA-ALCL) is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. An individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treatment with chemotherapy and radiation therapy.
The FDA classifies breast implant-associated ALCL as an uncommon cancer. The organization believes that women with textured breast implants have a small but increased risk of developing this disease in the tissue capsule the body forms around an implant over time. ALCL may also be found in the lymph nodes and the skin.
At this time, data indicates that the incidence of ALCL is very low, even among breast implant patients. Between one in 1,000 to one in 30,000 of these individuals develop the disease, according to recent studies. Currently, there does not seem to be a greater cancer risk based on the type of implant (silicone or saline) or the type of surgery (breast augmentation or reconstruction).
Overall, lymphomas of any type that occur in the breast are rare, accounting for only 1% to 2% of all non-Hodgkin lymphomas. Most breast lymphomas involve B cells. However, in breast implant-associated ALCL the diseased cells are T cells. While they play different roles, both are cells of the immune system.
Most of the patients who have developed BIA-ALCL receive an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.
Patients undergoing plastic surgery procedures, aesthetic or reconstructive, should be thoroughly informed of the potential risks and possible complications known to be associated with the procedure, and any device used in that procedure. In the cases where a diagnosis of BIA-ALCL is made, surgical treatment is essential for the management of the disease.
Implant-Associated ALCL Symptoms
Diseases and cancers of the breast can cause similar symptoms, which is why implant-associated ALCL is often a difficult diagnosis. Symptoms can vary from person to person.
Common symptoms include:
- A spontaneous fluid collection in the breast, developing many months or years after receiving a breast implant
- Redness and swelling of the breast around an implant that is not from an infection
Less common symptom: Contraction of the scar tissue capsule surrounding the breast implant
Experienced Doctors Matter
If you have a fluid collection or unexplained swelling many months or years after receiving a breast implant, it is imperative that you see a doctor who has experience in ALCL. If you have been diagnosed with implant-associated ALCL, it is very important that a doctor experienced in ALCL reviews your tests.
Where in the breast has BIA-ALCL been found?
In the case studies reported in the literature, BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule.
FDA Update
The FDA website update as of July 24, 2019 acknowledges that while it remains difficult to determine the exact number of BIA-ALCL cases, after thorough review there have now been 573 unique confirmed cases worldwide which included 33 known deaths. The majority of these cases involved a textured device at the time of BIA-ALCL diagnosis or demonstrate a clinical history of a textured device at some time prior. This update confirms that both saline and silicone gel implants have been reported in cases of BIA-ALCL. The FDA noted that a majority (481 reports) of cases were associated with Allergan breast implants and therefore requested a voluntary recall of Allergan Biocell surface devices within the US. Allergan subsequently responded with a worldwide recall of their Allergan Biocell textured implants and expanders.
As of December 6, 2019, 303 suspected/confirmed U.S. cases of BIA-ALCL have been reported to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma Etiology and Epidemiology (PROFILE) Registry, a joint collaboration between ASPS, PSF and the FDA.
For More Information
The FDA recommends that all cases of BIA-ALCL be reported to the FDA and to the PROFILE Registry.
Organizations’ websites for additional information: