New guidelines for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provide diagnosis guidance

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon form of ALCL that was first reported in 1996. The U.S. Food and Drug Administration (FDA) first reported a possible link between women with breast implants and ALCL in 2011, based on its investigation of 34 published reports of ALCL.

BIA-ALCL typically develops in the fluid and the capsule around a textured surface breast implant with the most common symptom being swelling around the breast implant. On average, patients experience symptoms eight to 10 years following initial implantation.

Because breast implant-associated anaplastic large cell lymphoma is uncommon, it has historically been difficult to diagnose and treat. But new guidelines published in the Journal of Clinical Oncology provide additional guidance to health care providers. Using a consistent pathological procedure for the clinical evaluation of patients, the guidelines can help providers recognize and diagnose BIA-ALCL.

BIA-ALCL diagnosis guidelines reflect need to inform patients and health care providers

In March 2019, the FDA held a public advisory committee meeting on the safety of breast implants, including the risk of developing BIA-ALCL. Based on discussions from the meeting, it was determined that patients and health care providers may not be informed about BIA-ALCL, including its clinical presentation and diagnosis. 

The FDA requested invited disease experts to prepare best practice guidelines for the diagnosis of BIA-ALCL, as well as a complete review of current literature.

On July 24, 2019, the FDA called for a Class I device recall of all Allergan Biocell textured breast implants and tissue expanders due to risk of BIA-ALCL. While the risk of ALCL is low, women with breast implants, especially textured breast implants, do have a higher risk of the disease.

 New BIA-ALCL diagnosis recommendations

The new BIA-ALCL diagnosis guidelines represent a collaboration between researchers at MD Anderson, the National Institutes of Health and the FDA.  These guidelines complement treatment guidelines established by the National Comprehensive Cancer Network (NCCN).

“Patients should talk to their doctors if they notice breast swelling, asymmetry, or unexplained sensation of fullness,” says Mark Clemens, M.D., associate professor of Plastic Surgery, an author on the paper and NCCN guidelines. “If the physician suspects BIA-ALCL, ultrasound-guided fine needle aspiration of the fluid collection around the implant is important to obtaining a correct diagnosis.”

A larger volume of fluid yields a more accurate diagnosis, but a minimum of 10 to 50 mL is appropriate to provide enough material for preparation of cytopathology smears, cell block with immunohistochemistry for CD30 and other lineage-associated markers and, when possible, flow cytometry and molecular genetic studies.

Once BIA-ALCL in the fluid is confirmed, the patient has surgery with implant removal and complete scar capsulectomy. The surgery includes removal of the tissue capsule that surrounds the breast implant, to remove any cancer cells that may be present.

The capsule should be pinned flat on a paraffin board and submerged overnight in buffered formalin. The entire external surface of the capsule is marked using six different colors for each of the sides of the specimen: at this time is recommended to obtain 2 generous samples from each of the six areas.

“Mapping of the specimen is recommended to determine the extent and tumor distribution of the tumor in the capsule and assess for negative margins,” says Roberto Miranda, M.D., professor of Hematopathology and an author on the paper. “Standardizing the pathology process contributes to thorough evaluation of capsules surrounding implants and hopefully achieve uniform outcomes.”

Standardized BIA-ALCL guidelines will help improve diagnosis and treatment

A standard procedure for handling capsules will allow to better understand the distribution and determine the causes of tumor progression. It is still not understood how BIA-ALCL advances and the natural progression of the disease. More research is needed to identify which patients are at risk of developing BIA-ALCL.

“These guidelines will better inform health care providers about BIA-ALCL and the diagnostic procedures used in the evaluation of patients with suspected BIA-ALCL,” says Clemens. “It is important to standardize the process of diagnosis to better identify women early who need treatment which we have shown improves survival outcomes.”

Refer a patient to MD Anderson online or by calling 1-877-632-6789.