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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
  • 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 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
  • For more information: visit 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.
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.