U.S. FDA Investigates Link Between a Rare Cancer Type and Breast Implants
What is anaplastic large cell lymphoma (ALCL)?
A rare type of cancer has been reported in people with breast implants. The cancer, known as anaplastic large cell lymphoma (or ALCL), 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. The cancer is called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). 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, health care providers performed about 4 million breast implant surgeries. Statistics from the U.S. National Cancer Institute reveal that physicians diagnose about one in 500,000 women with ALCL in the United States every year, while ALCL in the breast is even less common. Physicians only diagnose around three out of 100 million women per year in the U.S. with ALCL in the breast. As of September 2017, the FDA had received a total 414 reports of breast-implant associated ALCL (BIA-ALCL), including nine deaths due to the condition. Australia and France also have reported instances of this rare cancer.
What causes breast implant-associated ALCL?
Physicians have described BIA-ALCL 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. Physicians note that the cancer appears 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.
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 doctors treat most lymphomas 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, patients may need chemotherapy and/or radiotherapy.
At this point, because the condition is so rare, researchers have not proved a definite link to the implants as a cause of BIA-ALCL. Health care professionals do not recommend removal of breast implants in women without symptoms or other abnormalities. Doctors also do not recommend changes to routine medical care and follow-up 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 Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)." Mar. 21, 2018.<https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/
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/