What is BIA-ALCL?
Breast Implant-Associated Anaplastic Large Cell Lymphoma, BIA-ALCL is a rare Non-Hodgkin T-cell lymphoma that is found in patients who have undergone breast augmentation or breast reconstruction with breast implants. It can occur with either saline or silicone gel-filled breast implants but is significantly more common with textured implants.
In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant. It can spread throughout the body. When it is caught early, it is usually curable. BIA-ALCL is not a cancer of the breast tissue.
What are its causes?
Bacteriologic contamination, long-term allergic inflammation, implant texturing, and genetic factors have been theorized and are undergoing further study.
Symptoms of BIA-ALCL
BIA-ALCL usually develops as a delayed swelling of the breast. The average time of onset is 8 years, range 2 to 28 years, after the insertion of the saline or silicone gel breast implants. It presents as a fluid collection around the implant or marked breast asymmetry. Breast Implant-Associated Anaplastic Large Cell Lymphoma can also present as a lump in the breast or armpit.
Risks of developing BIA-ALCL
Currently 573 cases of BIA-ALCL have been diagnosed worldwide. For a frame of reference, both ASAPS (American Society for Aesthetic Plastic Surgery) and ASPS (American Society of Plastic Surgeons) data report that approximately 300,000 breast augmentations and 150,000 breast reconstructions are performed annually with approximately 10% receiving textured implants in the US. The lifetime risk for BIA-ALCL in previous epidemiological studies ranges from 1:1000 to 1:30,000 for those with textured implants based on implant sales data from the U.S., Canada, the Netherlands and Australia. Currently the lifetime risk of developing BIA-ALCL for a smooth-only implant is less than 2%. The risk for different types of textured implants has not been determined.
What patients are at a greater risk for developing it?
It is not possible to predict who will develop BIA-ALCL. It has occurred in women who have a history of textured breast devices for both cosmetic and reconstructive purposes and has occurred in women with both saline and silicone implants.
The following are the current risk factors for BIA-ALCL:
Textured surface devices. There have been no reported pure smooth-walled device cases at this time.
There has been one published report that there may be a genetic predisposition (germ line mutations in JAK1 and STAT3 genes). Further investigation is required.
Chronic inflammation either triggered by bacteria or another factor, has been implicated.
BIA-ALCL mean presentation is 8–9 years post-operative.
Could certain textured tissue expanders increase the risk of BIA-ALCL?
The FDA believes tissue expanders with a certain textured surface may be of concern. These tissue expanders should not be used and FDA issued new recommendations for patients who have or have had these products. Tissue expanders are indicated to be used for only 6 months, and to date, there is limited information on whether temporary exposure may be associated with the risk of BIA-ALCL. A tissue expander is used to stretch skin and other tissues before breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. It is a temporary implant, placed under the breast skin or muscles of the chest to stretch skin and other tissues, and is intended to be replaced with a breast implant at a later time.
Is BIA-ALCL a major concern?
Although the incidence is rare, any procedure that may lead to the death of a patient must be considered a major concern, and something that patients should be made aware of prior to undergoing breast implant surgery. They should be advised of that risk, as well as the risks that surgery itself poses including additional financial costs. As of December 1, 2017, the PROFILE registry has received 183 unique cases of BIA-ALCL in the U.S., 56% had a history of cosmetic breast augmentation; 44% had a history of post-mastectomy reconstruction. Worldwide 573 unique cases have been reported which includes 17 disease-related deaths.
Latest FDA statement with regards to BIA-ALCL
BIA-ALCL is a rare and highly treatable condition that can develop around textured breast implants. The FDA advocated for surgical management in the majority of patients as well as specifically recommended all confirmed BIA-ALCL cases be reported to the PROFILE registry for detailed tracking of cases.
In October 2017, the European Commission’s Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) released a scientific advisory report on BIA-ALCL and also stressed the importance of future research and reporting to prospective patient registries.
What is the significance of the latest FDA statement?
The 2017 FDA statement emphasized that this disease was predominantly associated with textured implants. The FDA acknowledged and agreed with the World Health Organization classification of BIA-ALCL as a Non-Hodgkin lymphoma and treatment guidelines established by the National Comprehensive Cancer Network (NCCN). Both ASAPS and ASPS fund research to ascertain what might be the underlying issues causing this cancer, and are trying to find a solution so that the disease may be eradicated.
Differences in implant texture and its role in the research
Although it is rare, BIA-ALCL appears to currently develop in women with textured implants. Proposed theories of the primary potentiator of BIA-ALCL include textured implant particulate, mechanical friction, and/or bacteria and biofilm formation.
What about those considering breast implants?
Physicians should include BIA-ALCL in breast implant patient education materials and informed consent so that patients can determine the right procedure for them.
Should women with breast implants be screened for BIA-ALCL?
The FDA states that asymptomatic women without breast changes do not require more than routine follow-up. If a patient experiences a change in her breasts, especially if there is swelling or a lump, she should undergo examination and appropriate imaging, including ultrasound, MRI and fine-needle aspiration of any peri-implant fluid.
Where is it found in the breast?
BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not
in the breast tissue itself. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule.
Does the fill of the breast implant, silicone versus saline, increase an individual’s risk of developing BIA-ALCL?
Based on the currently available data, the type of implant fill does not appear to be a risk factor for BIA-ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. To date, there has not been sufficient data to determine whether ALCL may be found more or less frequently in individuals with silicone-filled breast implants compared to individuals with saline-filled breast implants.
How is BIA-ALCL diagnosed?
Diagnosis should be made by fluid aspiration in a clinic or by interventional radiology prior to any surgical intervention.
Diagnosing the symptoms attributable to it
A swollen breast should be evaluated with ultrasound for either a fluid collection, capsular mass, or lymph node swelling. Fluid collections should be aspirated percutaneously.
The aspirate and/or mass should be sent for:
- CD30 immunohistochemistry
- Cell block cytology evaluation with CD30 testing.
Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases, PET/CT scans are performed to help stage the disease, evaluate for associated capsule masses (20–40% of cases), lymph node metastasis (5–15%) or organ metastasis (1–3%). Confirmation of diagnosis allows for oncologist consultation and oncology workup prior to surgical intervention.
If you have no symptoms, the FDA does not recommend the removal of the implants and tissue expanders or other types of breast implants due to the risk of developing BIA-ALCL.
The treatment of BIA-ALCL is bilateral removal of the capsules i.e. total capsulectomy and removal of the breast implants. All cases of BIA-ALCL with disease confined to the capsule that has been diagnosed and treated with total capsulectomy have been cured to date. In the 17 known deaths from the disease, all patients either received chemotherapy/XRT alone, died of the treatment itself, had incomplete resection/partial capsule removal, or distant metastasis. The majority of early-stage patients treated with total capsulectomy require no additional treatment. Chemotherapy is required for unresectable disease and lymph node and organ metastasis.
For More Information
If you have developed swelling or a mass in one of your breasts after breast augmentation or breast reconstruction, or feel you are having symptoms of BIA-ALCL, please do not hesitate to contact Dr. DeConti to schedule a consultation to discuss your symptoms and options. Call DeConti Plastic Surgery at 804 673-8000.