BIA-ALCL Summary and Quick Facts
The following provides a summary of what is currently known about BIA-ALCL.
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself.
- BIA‐ALCL should continue to be discussed with any patient considering breast implants as part of the informed-consent process.1
- The lag time between implant insertion to diagnosis of BIA-ALCL has been from 2 to 28 years, with a median of 8 years.
- No cases of BIA-ALCL have been definitively associated with patients who have only had smooth implants. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time.
- The association of BIA‐ALCL textured implants may be related to the increased surface area of the texturing; however, this has not yet been definitively proven. The variation in surface texturing among manufacturers may mean there are variable risks for the development of BIA-ALCL, although the number of cases to date remain too low to make any significant distinctions between the various forms of texturing.
- The disease has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.
- The majority of patients present as a delayed seroma. Diagnosis is based on ultrasound‐guided fine needle aspiration of the peri-implant fluid, which is assessed with immunohistochemistry for CD 30-positive and ALK-negative T-cell lymphocytes.
- PET‐CT and MRI scans are investigations performed following a positive diagnosis. Mammograms are not helpful.
- Consideration should be given to a multidisciplinary approach including, when required, an oncological breast surgeon and an oncologist specializing in lymphoma.
- Incomplete capsular resection has been associated with both recurrence and significantly lower survival.
- The majority of patients can be cured of their disease by bilateral total capsulectomy and implant removal. Rare patients will present with a mass and have an increased risk of requiring radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL, available at nccn.org.
- Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally.2
- The FDA recommends that any suspected or confirmed cases of BIA‐ALCL be reported to the PROFILE registry, the MAUDE database, and the device manufacturer. To submit a case to PROFILE, go to ThePSF.org/PROFILE. To submit a case to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which collects medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions, visit www.accessdata.fda.gov.
- For more information: visit www.plasticsurgery.org/alcl or search "ALCL" on RADAR.
1. Clemens, M. W., Miranda, R. N., & Butler, C. E. (2016). Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 137(4), 1117–1122. doi.org/10.1097/01.prs.0000481103.45976.b1
2. Clemens, M. W., Medeiros, L. J., Butler, C. E., Hunt, K. K., Fanale, M. A., Horwitz, S., et al. (2016). Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant‐Associated Anaplastic Large‐Cell Lymphoma. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 34(2), 160–168. doi.org/10.1200/JCO.2015.63.3412