What is BIA-ALCL?
Anaplastic Large Cell Lymphoma (ALCL) is a rare form of cancer of the immune system. Experts now agree that women with breast implants are more likely to develop ALCL.1 Since it will develop in the breast area, it is called Breast Implant Associated-ALCL (BIA-ALCL). Usually, this cancer develops in the scar tissue (capsule) that forms around a breast implant.2 Sometimes this cancer can be found in the lymph nodes. If it’s not treated quickly, it can be fatal.
How can breast implants cause cancer? Why didn’t my doctor mention it?
Scientists are trying to figure out why ALCL forms near breast implants. Some experts believe that cancer may develop in response to chronic inflammation caused by bacteria.3 Most cases of BIA-ALCL have been reported in women with textured implants, which provide a better surface for bacteria to grow.
In July 2019, the US Food and Drug Administration (FDA) requested that Allergan recall their Biocell textured breast implants and tissue expanders. The FDA made this request after concluding that the Biocell textured implants are six times as likely as other textured breast implants to cause BIA-ALCL.
This was just 7 months after these breast implants were taken off the European market. In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma.4
Following the FDA request for a recall in July 2019, Allergan announced a worldwide recall of their BIOCELL textured breast implants and tissue expanders. See a full list of recalled models here. The FDA also published an updated safety notice, informing patients to communicate with their health-care professionals if they have any concerns or symptoms of BIA-ALCL.
The controversy about whether other types of textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL. That is not known, because some women who developed ALCL did not know what brand of breast implants they had. Other types of textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.
The apparent link between ALCL and breast implants was published by cancer experts in 2009. However, it wasn’t until 2011 that the Food and Drug Administration (FDA) warned the public, and it wasn’t until 2013 that cancer researchers published an article in a medical journal stating that breast implants could cause ALCL. As of 2018, BIA-ALCL is widely recognized by cancer experts, but still not all oncologists or plastic surgeons are aware of it. Many breast cancer survivors are upset to realize that their “cautious” choice to have a mastectomy with implants rather than a lumpectomy puts them at risk of developing another type of cancer, ALCL.
Is BIA-ALCL really rare?
At the time of the recall, the FDA reported that 573 cases of BIA-ALCL worldwide had been reported since 2011, and this was increased to 1,130 cases, including 59 reported deaths, in 2022. They say that since millions of women have breast implants, BIA-ALCL must be very rare. However, the most recent U.S. estimates are that the risk of BIA-ALCL in textured implants in the U.S. range from 1.79 per 1,000 (1 woman with BIA-ALCL per 559 implants) to 2.82 per 1,000 (1 woman per 355 implants). Since the FDA’s analysis stated “based on the currently available information, including the newly submitted data…the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.” 5, that suggests that the estimates of risk that were based on all textured implants is an underestimate of the risks for women with BIOCELL textured implants.
Many experts believe that ALCL is underreported and therefore the chance of developing ALCL from breast implants is likely higher than the current estimates. Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.
How will I know if I have BIA-ALCL?
All women with breast implants should be seeing a doctor regularly to check for any problems. If you experience redness or swelling near your implants you should see a doctor immediately. A swollen breast is usually an infection, but the fluid around your implants should be tested for ALCL as well.
Although a swollen breast is the most common symptom of BIA-ALCL, not all women with BIA-ALCL have noticeable swelling. Some women with BIA-ALCL reported feeling a lump near their implant or capsular contracture. If you find a lump, see your doctor immediately to check for breast cancer or ALCL. If you have capsular contracture, keep in mind that it could be a sign of BIA-ALCL, even though it probably isn’t.
How can I prevent BIA-ALCL?
You can’t prevent ALCL if you have breast implants. However, you can watch out for warning signs mentioned and have regular checkups with a doctor who knows about BIA-ALCL and other risks associated with breast implants.
What is the treatment for BIA-ALCL?
ALCL is treated by removing the implant and all of the surrounding scar tissue. This procedure is called a total capsulectomy. This is done to make sure any cancer cells in the tissue are removed.
If any of your lymph nodes are found to have ALCL, they will also be removed.
If the cancer is found later and has spread, you may need to be treated with chemotherapy or radiation therapy.
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
- FDA, Center for Devices and Radiological Health. (2017). Breast Implants – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. ▲
- Swerdlow, S. H., Campo, E., Pileri, S. A., Harris, N. L., Stein, H., Siebert, R., et al. (2016). The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, 127, 2375-2390. doi:10.1182/blood-2016-01-643569. ▲
- Kadin, M. E., Deva, A., Xu, H., Morgan, J., Khare, P., Macleod, R. A., Epstein, A. L., et al. (2016). Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic Surgery Journal, 36(7), 773-781. doi:10.1093/asj/sjw023. ▲
- International Consortium of Investigative Journalists. (2018). Allergan Textured Breast Implants Recalled in Europe Amid Safety Controversy. Retrieved from https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe-pending-safety-review/. ▲
- FDA, Center for Devices and Radiological Health. (2020). The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. ▲