At the behest of the US Food and Drug Administration (FDA), a member of one of its advisory committees coordinated the development of a guideline covering best practices for “the recognition and diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL),” which was published in the Journal of Clinical Oncology.1

A rare form of non-Hodgkin lymphoma, BIA-ALCL is a T-cell lymphoma that has been recognized by the World Health Organization (WHO) as a specific entity.

First reported in 1997, the FDA had received 573 unique BIA-ALCL medical device reports (MDRs), including notice of 33 related deaths, by July 6, 2019.2

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Thus far, BIA-ALCL has mainly been associated with textured implants, rather than implants with a smooth surface. The median time from placement of the implant to manifestation of signs and symptoms of BIA-ALCL — which often arise from fluid collection (ie, an effusion such as a seroma) resulting in persistent swelling of the breast and are less frequently characterized by a mass and/or pain — has been estimated to be 8 to 10 years. There have been case reports of BIA-ALCL diagnoses as early as 4 months and 10 months, however.1

Although many of the patients diagnosed with BIA-ALCL had a previous diagnosis of breast cancer, “when information was available, indications for implant placement were nearly evenly split between cosmetic augmentation and reconstruction,” the study authors commented.

Key elements of the guideline, based on the medical literature and experience of the contributors to the guideline, include the following:

  • Initial evaluation of the patient should involve breast imaging
    • The preferred imaging approach is ultrasound for patients with a signs and symptoms of an effusion, and MRI for those with evidence of a mass, followed in the latter case by incisional, excisional, or core biopsy
  • Ultrasound-guided, fine-needle aspiration should be performed in patients presenting with an effusion and enough material should be collected to prepare/perform:
    • Cytopathology smears
    • A cell block for hematoxylin and eosin staining, as well as a panel of immunohistochemical stains — including CD30 and ALK, as BIA-ALCL is characterized as CD30-positive and ALK1-negative — to identify other lineage-associated markers
    • Polymerase chain reaction (PCR) assays for the detection of clonal T-cell receptor rearrangements, if possible
  • Neither next-generation sequencing or fluorescence in situ hybridization (FISH) testing is currently recommended for the routine evaluation of suspected BIA-ALCL, although flow cytometry and molecular genetic studies could aid detection
  • For confirmed BIA-ALCL, en bloc resection of the intact capsule (ie, capsulectomy), including “the implant, surrounding effusion, and any associated masses” is recommended, followed by orientation of the specimen on a paraffin board, formalin fixation, and pathologic analyses to stage disease
    • Excision of suspicious lymph nodes is recommended at the time of capsulectomy to assess for lymph node metastasis
  • Use of positron emission tomography-computerized tomography (PET-CT) is included as an option for patients with confirmed BIA-ALCL to more accurately stage disease and identify lymph nodes for biopsy.

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Disclosures: Some of the authors of the study declared financial relationships with pharmaceutical and medical device companies or hold patents relevant to the research. For a full list of disclosures, please refer to the original study.


  1. Jaffe ES, Ashar BS, Clemens MW, et al. Best practices guideline for the pathologic diagnosis of breast implant-associated anaplastic large-cell lymphoma [published online February 11, 2020]. J Clin Oncol. doi: 10.1200/JCO.19.02778
  2. US Food and Drug Administration. Medical device reports of breast implant-associated anaplastic large cell lymphoma. Updated July 24, 2019. Accessed February 19, 2019.