Guidelines for BIA-ALCL Provide Additional Guidance for Recognition and Diagnosis

The new guidelines provide additional guidance for healthcare providers to better recognize and diagnose breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Guidelines published in the Journal of Clinical Oncology provide additional guidance for health care providers to recognize and diagnose breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).1

The new diagnosis guidelines, created by The University of Texas MD Anderson Cancer Center, the National Institutes of Health, and the FDA, complement already established recommendations from the National Comprehensive Cancer Network (NCCN). The creation of the guidelines was deemed necessary in March 2019 after the FDA held a public advisory committee meeting on the safety of breast implants, including the risk of developing BIA-ALCL, and found that patients and health care providers may not be well informed about the disease.

“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,” Mark Clemens, MD, author on the paper and NCCN guidelines and associate professor of Plastic Surgery at MD Anderson, said in a press release.2 “It is important to standardize the process of diagnosis to better identify women early who need treatment which we have shown improves survival outcomes.” 

The recommendations focused on the processing of seroma fluid and effusion surrounding the implant, the handling of capsulectomy specimens following the removal of implants, and the preoperative evaluation of a patient with suspected BIA-ALCL. The researchers’ guidelines were based on already published literature and personal experiences.

The most common clinical presentation of patients with BIA-ALCL, according to the authors, is the onset of periprosthetic fluid collection surrounding an implant, which generally occurs at least 1 year after the initial implantation. This could be manifested as breast swelling, asymmetry, or a sensation of fullness, sometimes accompanied by pain.

“Patients should talk to their doctors if they notice breast swelling, asymmetry, or unexplained sensation of fullness,” Clemens explained. “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.”

Ultrasound-guided aspiration of the effusion is then essential to obtaining an accurate diagnosis, with a larger volume of fluid yielding a more accurate diagnosis; however a minimum of 10 to 50 mL is suitable 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. 

Should BIA-ALCL in the fluid be confirmed, the patient’s implant should be surgically removed with complete scar capsulectomy. This should include removal of the tissue capsule that surrounds the breast implant in order to remove any cancer cells present. The capsule should then be pinned flat on a paraffin board and submerged overnight in buffered formalin. Following the overnight fixation, the external surface of the capsule should be marked using 6 different colors for each of the sides of the specimen and 2 generous samples should be obtained from each of the 6 areas, for a total of 12 sections. 

“Mapping of the specimen is recommended to determine the extent and tumor distribution of the tumor in the capsule and assess for negative margins,” Roberto Miranda, MD, author on the paper and professor of Hematopathology at MD Anderson, said in a press release. “Standardizing the pathology process contributes to thorough evaluation of capsules and surrounding implants and hopefully achieve uniform outcomes.” 

However, there is still a lack of understanding as to the natural history of BIA-ALCL, specifically in regard to precursor lesions. The authors also noted that the end of the disease spectrum could also benefit from better definition. Additionally, the connection of BIA-ALCL to other forms of ALK-negative ALCL has not been fully determined, and instances of the disease have been reported in patients with other types of surgical implants that may provoke a chronic inflammatory response.


1. Jaffe ES, Ashar BS, Clemens MW, et al. Best Practices Guideline for the Pathologic Diagnosis of Breast Implant-Associated Anaplastic Large-Cell Lymphoma. Journal of Clinical Oncology; 2020. doi:10.1200/JCO.19.02778.

2. New guidelines for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provide diagnosis guidance [news release]. MD Anderson Cancer Center. Published February 12, 2020. Accessed March 3, 2020.