According to the U.S. Food and Drug Administration (FDA), by January of 2020, the government agency had received 733 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) diagnoses and treatments.
ALCL first hit the FDA’s radar in 2011. The agency issued a report urging the need to further study the association of the disease with breast implants. In 2016, the World Health Organization confirmed that breast implants could lead to the development of T-cell lymphoma. A lack of breast implant sales data prevented the organization from speculating how many individuals had developed BIA-ALCL from their implants.
In June 2020, the FDA asked Allergan, the manufacturer of breast implants with silicone and polyurethane textures, to recall their textured BIOCELL implants, as well as tissue expanders.
Symptoms of BIA-ALCL
Individuals who develop BIA-ALCL could experience several symptoms, often seven to 10 years after they receive their implants. The FDA urges breast implant recipients to see a medical provider if they detect these symptoms, which could include:
- Continual swelling
- Mass around the breast implant
- Pain in the implant area
- Enlarged lymph nodes
- Skin rash
- Weight loss
A doctor might find that fluid has collected in the area surrounding the breast implant. A thick, obvious scar capsule called a capsular contracture might also be present.
According to the Lymphoma Research Foundation, to diagnose BIA-ALCL, the physician will order imaging tests using ultrasound or magnetic resonance imaging (MRI). If the imaging results show that fluid is collecting close to the implant, the physician would likely gather a sample of the fluid by inserting a thin needle. The sample will be evaluated for a protein called CD30, which manifests in greater amounts on lymphoma cells.
In the event that these tests indicate the presence of CD30, the doctor will then test for another protein, anaplastic lymphoma kinase (ALK), which facilitates cell growth control. In cases of BIA-ALCL, this protein test will come back negative.
Finally, the physician will perform a biopsy. This procedure involves taking a sample of the tissue from the discovered tumor for microscopic evaluation. To determine the extent of spreading and other information, the doctor will perform additional tests, including:
- Computerized tomography (CT) scan
- Blood tests
- Positron emission tomography (PET) scan
- Bone marrow biopsy
- Magnetic resonance imaging (MRI) scan
How BIA-ALCL is Treated
Patients who already have BIOCELL implants but are not experiencing symptoms of BIA-ALCL need not have them removed, as per FDA recommendations. However, the agency has asked plastic surgeons to stop implanting these devices.
However, in the case of a BIA-ALCL diagnosis, physicians would remove the implant, tumor, and any affected surrounding tissue. If the cancer has spread to other areas, additional treatments might be necessary.
- Chemotherapy drugs could be used to control the cancer by attacking cancer cells and stopping their swift growth.
- Radiotherapy could be used in an effort to shrink and wipe out the cancer.