SIS Recommendations

Senologic International Society presents recommendations about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

August 2019

What we know

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare non-hodgkin peripheral T cell lymphoma. It emerges around prosthesis for either cosmetic or reconstructive patients. In 2016, the World Health Organization recognized and defined specific diagnostic criteria for this rare disease.1 Besides ALCL be considered an aggressive illness, BIA-ALCL clinical behaviour seems to be less threatening than the other three subtypes.2

Actual evidence addresses that BIA-ALCL occurs in the setting of implant-induced chronic inflammation, although its pathogenesis is not yet understood, and no etiologic factors have been distinctly spotted.3-5 Some experts theorized a potential role of textured implants, presence of a subclinical biofilm and a genetic predisposition, though proper studies did not demonstrate these suspicions .6-8

Incidence index over BIA-ALCL is uncertain since most of the data come from clinical reports and case series. However, these studies have shown considerable relation amidst textured implants and BIA-ALCL. United States Food and Drug Administration (FDA) reported that from 457 patients with BIA-ALCL with known prosthesis surface characteristics, 92.9% were associated with textured devices.

A population-based study reported an 18-fold higher rate of ALCL in women with implants when compared to those without (odds ratio 18.2, 95% CI 2.1-156.8). This study also reported that is needed approximately 6920 women with textured implants to cause one BIA-ALCL. Also, reconstructive or cosmetic interventions seems not to influence risk.

According to reported BIA-ALCL cases, the time between implant insertion and disease presentation showed a range from two up to 32 years, with a greater prevalence between 7 to 10 years. Most cases are unilateral, although there has been some bilateral diagnosis, which also is an indicator of aggressiveness.

Examination typically evidences 70% seroma and 30% mass. However, around 60% of patients present only late seroma, 17% present an adjacent mass to the prosthesis, 20% present both effusion and mass, and few rare cases show capsule contracture exclusively. There are other signs generally associated: breast swelling, asymmetry and pain. Axillary adenopathy is identified in almost 20% of patients analyzed.

The morphology is characterized by large pleomorphic cells with abundant cytoplasm. On immunohistochemistry, there is an important CD30 expression and negative presentation to anaplastic lymphoma kinase (ALK).

To our colleagues

The National Comprehensive Cancer Network (NCCN) established a guideline for the diagnosis and management of BIA-ALCL. Suspicious peri-prothesis delayed effusion or mass, or lymphadenopathy must be assessed to exclude BIA-ALCL.

A patient with suspected BIA-ALCL must be submitted to complete breast inspection and palpation, followed by ultrasound imaging to determine the extension of the effusion, identify masses and guide aspiration. It is necessary to collect a representative fluid volume and capsular portions for analysis. Examination of the material should include cytology, flow cytometry, cell block and immunohistochemistry including CD30 and ALK study.

Ultrasound is the exam of choice for suspected BIA-ALCL patients since it is far more sensitive than mammography to identify peri prothesis effusion and suspicious masses.

BIA-ALCL diagnosis requires tumor with enough fluid or mass for analysis, identify large anaplastic lymphoid cells with abundant cytoplasm and pleomorphic nuclei, immunohistochemistry with uniform markers expression of CD30 on T cells and a clonal expanded T-cell population on flow cytometry, and ALK-negative.

BIA-ALCL differential diagnosis: benign implant-associated complications, breast cancer, systemic ALCL, nodal ALCL with breast involvement, primary breast lymphoma and cutaneous ALCL.

Positron emission tomography is indicated for staging BIA-ALCL confirmed cases, and for surveillance.

Staging of BIA-ALCL is determined by the conjunction of pathological and imaging findings. There are two staging systems available: modified Ann Arbor system and Tumour-Node-Metastasis (TNM) system. Currently, experts have given preference to the TNM staging system.

Treatment recommendations for confirmed BIA-ALCL:
§ Localized disease: complete surgical resection of breast implant, capsule and associated mass.
§ Nodal disease, chest wall invasion or unresectable lesion: complete surgical resection of the implant and capsule, and adjuvant treatment with chemotherapy and radiotherapy.

Worse prognosis is associated with the presence of a mass lesion, extracapsular ALCL extension and bilateral disease.

Follow-up periodic clinical visits do not have a determined schedule. For localized disease, we recommend every six months up to five years, for physical examination and annual ultrasound. For extensive disease, the follow-up must be determined according to the patient’s response to adjuvant treatments.

After BIA-ALCL complete treatment, textured implant replacement is not recommended. Insertion of smooth implants are not contraindicated; however, these patients must be carefully monitored.

Recommendations before implant placement:
§ Patients must complete aware of BIA-ALCL existence and its details.
§ BIA-ALCL signs and symptoms should be extensively discussed.
§ Provide educational material explaining the advantages and risks of different types of implants.
§ Informed consent must be signed in the presence of the surgeon.

Every surgeon must report their BIA-ALCL cases and should stimulate research studies over the subject.

To our patients

BIA-ALCL is a rare disease and women with breast implants have a small risk of developing this type of lymphoma. There is an increased risk for textured implants.

More than 95% of patients diagnosed with BIA-ALCL are treated and cured with surgical removal of the implant and capsule.

Women with breast implants must perform a regular assessment with their surgeon.

Asymptomatic women shall not be submitted to screening.

Prophylactic implant removal is not recommended, even for those women with textured surface implants or increased family history for cancer.

Leonardo Dias
SIS Deputy-Secretary

Mauricio Magalhães costa
President