Breast-Implant–Associated Anaplastic Large Cell Lymphoma

Sponsoring Organizations: U.S. Food and Drug Administration and the American Society of Plastic Surgeons

Target Audience: Multidisciplinary women's health and cancer treatment teams, including lymphoma oncologists, general and oncologic surgeons, radiation oncologists, pathologists, radiologists, family practice physicians, gynecologists, and plastic surgeons

Background and Objective

Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging T-cell lymphoma that can arise within a malignant effusion or in the scar tissue surrounding textured-surface breast implants. Surgical removal of the implant and resection of the scar capsule and any associated mass is indicated for most cases of early-stage disease. Systemic treatment with CD30-targeted immune therapy in combination with an anthracycline-based regimen, chest wall radiation, and, in rare cases, stem-cell transplant are reserved for advanced cases (stage IIB and above on a TNM [tumor, nodes, metastases] staging system). Controversy surrounds a standardized approach to achieving a reliable diagnosis for symptomatic patients and for the pathological evaluation of the scar capsule to determine the extent and stage of disease. Recent evidence suggests recommendations for laboratory testing, tissue handling, and proper screening. An author panel comprising content experts and U.S. government authorities has now sought to establish best practice guidelines for the diagnosis of BIA-ALCL.

Key Recommendations

• The most common presentation of BIA-ALCL is swelling of the breast with a rapid-onset fluid collection. Therefore, cytological evaluation of the effusion aspirate surrounding the affected implant is required for an accurate diagnosis.
• An adequate volume (10–50 mL) of fresh, unfixed effusion fluid is required for cytocentrifugation and filtration to produce air-dried smears stained with Giemsa, Wright-Giemsa, or other Romanowsky-type stains.
• A cell block preparation is advisable for hematoxylin and eosin staining, CD30 immunohistochemical analysis, and polymerase chain reaction T-cell receptor gene receptor clonality testing of formalin-fixed, paraffin-embedded histologic sections.
• To assess for microscopic tumor involvement and capsular invasion, fixation and selection of 12 biopsies based on regional mapping of the capsulectomy specimen are recommended. Tissue invasion, mass formation, and lymph node metastasis all portend higher rates of recurrence.