U.S. FDA Investigates Link Between a Rare Cancer Type and Breast Implants
What is anaplastic large cell lymphoma (ALCL)?
In March 2017, the U.S. Food and Drug Administration issued an update about a rare type of cancer that has been reported in people with breast implants. The cancer is called anaplastic large cell lymphoma, or ALCL, and is a rare type of non-Hodgkin's lymphoma (cancer of the cells that make up the immune system). ALCL itself is a rare cancer that can affect both men and women. When it is not associated with breast implants, ALCL can develop in the skin, in the lymph nodes, or in organs throughout the body. ALCL is not a type of breast cancer. Women with breast implants appear to have a very small increased risk for developing this rare tumor in the breast tissues surrounding the implant.
Statistics on breast implant-associated ALCL
To understand just how rare this type of cancer is, it is important to look at some statistics. In the U.S., between 1998 and 2009, about 4 million breast implant surgeries were performed. Statistics from the US National Cancer Institute reveal that about one in 500,000 women is diagnosed with ALCL in the United States every year, while ALCL in the breast is even less common. Only around three out of 100 million women per year in the U.S. are diagnosed with ALCL in the breast. As of February 2017, the FDA had received a total 359 reports of breast-implant associated ALCL (BIA-ALCL), including nine deaths due to the condition.
What causes breast implant-associated ALCL?
BIA-ALCL has been described in women who underwent breast implantation for both reconstruction after cancer surgery and augmentation (cosmetic enlargement). ALCL is a cancer of the T lymphocytes of the immune system, whereas most lymphomas that arise in the breast in people without implants are of the B lymphocyte type. The exact reason for the slight increase in this rare cancer in women with breast implants is still not understood. The cancer has been reported more often in those with implants that have a textured outer shell than in those with implants that have a smooth outer shell, but the meaning of this association is not clear.
Quick GuideSigns of Cancer in Women: Symptoms You Can't Ignore
Breast cancer vs. breast implant-associated ALCL symptoms
- a breast lump or mass,
- a lump or mass in the armpit,
- a change in appearance of the breast, or
- changes in the skin overlying the breast mass, such as dimpling or puckering.
The rare cases of BIA-ALCL have led to similar symptoms in women with breast implants, including problems with the implants, like breast pain, lumps, swelling, or a change in appearance around the breast implants. Most cases described so far have been found in women undergoing repeat operations for fluid collections around the implants.
Treatment of breast implant-associated ALCL
A study published in 2015 showed that treating BIA-ALCL with surgery only led to a good outcome in most patients. Although most lymphomas are treated with chemotherapy without surgery, in the rare case of BIA-ALCL lymphoma, surgical removal of the implants and surrounding tissues is the most important for treatment and cure. Rarely, chemotherapy and/or radiotherapy may be needed.
At this point, because the condition is so rare, a definite link to the implants as a cause of BIA-ALCL has not been proven. Removal of breast implants in women without symptoms or other abnormalities is not recommended. Changes to routine medical care and follow-up are also not recommended at this time. If you are considering getting breast implants, you can discuss the risks and benefits of the procedure with your surgeon. The FDA states that currently available FDA-approved breast implants are safe and that the possible link should not discourage women from considering breast reconstruction.
United States. U.S. Food & Drug Administration (FDA). "Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)." Mar. 21, 2017. <https://www.fda.gov/Safety/MedWatch/SafetyInformation/
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