The FDA recently released a communication to health care providers and the public about a rare cancer of the immune system termed anaplastic large cell lymphoma (ALCL).
Research indicates that women with breast prostheses may have a very small but increased risk of developing this disease in the scar capsule that develops arround the implant.
Is this common?
The number of cases is small (estimated at 60) compared to the total number of women with breast implants (5 to 10 million) world wide.
For women with implants:
The FDA recommends that women do not need to change their routine medical care.
Monitoring of the implants by a health care provider at regular intervals is recommended.
Among the confirmed cases of ALCL are patients with silicone as well as saline prostheses.
What to look for:
After the breasts have healed from the augmentation surgery, look for any changes in one or both breasts.
There may be new onset of pain, swelling, lumps or firm nodules that develop around the prostheses.
For Health Care Providers:
Because ALCL has generally only been identified in patients with late onset of symptoms such as pain, swelling (seroma) , lumps (capsular masses), the FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
What to test for when suspecting ALCL:
If the decision has been made to remove the prostheses then the following test are recommended by the FDA:
1. Fresh seroma fluid and representative portions of the capsule should be collected and sent for pathology tests to rule out ALCL.
2. Diagnostic evaluation should include:
a) Cytological evaluation of seroma fluid with Wright Giemsa stained smears and
b) Cell block immunohistochemistry testing for cluster of differentiation (CD) and
Anaplastic Lymphoma Kinase (ALK) markers.
3. All cases of ALCL should be reported to the FDA through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
or at 1-800-332-1088.
Do I need to be concerned?
According to the National Cancer Institute, ALCL is rare (estimated 1 in 500,000 women per year in the U.S).
ALCL in the breast is even more rare; approximately 3 in 100 million women per year.
This article aims to provide some perspective and understanding about breast prostheses and ALCL.
The condition is rare, manifests with late onset seroma (inter alia), and is treated by removal of the entire capsule around the implant toghether with the implant (capsulectomy).
Regular visits for monitoring of the prosthese by a health care professional is recommended.
===###===
Bryan J. Michelow, MD., FACS
