Do Breast Implants Cause Cancer?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rare

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When considering whether to get breast implants, there is one risk that you should keep in mind: cancer

In 2011, the U.S. Food and Drug Administration, commonly known as the FDA, discovered a possible link between saline and silicone-gel breast implants and a very rare form of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

What Is Anaplastic Large Cell Lymphoma?

BIA-ALCL is not a breast cancer.

It involves cells of the immune system found in the fluid surrounding breast implants or in the capsule (scar tissue) surrounding the breast.

BIA-ALCL attacks lymph nodes and skin. The lymphoma is an aggressive form of cancer, and survival varies widely between different varieties of the disease. Treatment has progressed in recent years and most commonly includes implant removal and total resection of the tumor, including capsule, mass, and involved lymph nodes.  Individuals with complete remission have gone on to live long, healthy lives. Bone marrow transplant is reserved for those who relapse. These individuals have a much lower survival rate.

How Considered Should You Be?

The number of women with implants who develop BIA-ALCL is very, very low. As of 2016, among the five million to 10 million women worldwide with breast implants, almost 200 women worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma.

This type of lymphoma in the breast is seen in just three of every 100 million women without breast implants. Though the numbers are not big, this difference is a marked difference.

FDA experts say the known BIA-ALCL cases are too few to say conclusively that breast implants cause the disease. However, the unique location and specific lymphoma type strongly suggest a link between breast implants and BIA-ALCL.

But even then, the incidence of this occurring is small.

Even though researchers are trying to pinpoint how BIA-ALCL develops, there are some theories that suggest it is a tangled relationship between genes and missteps in the immune system. There have been studies examining some of these ideas; however, no clear-cut mechanism has been uncovered yet.

Despite not knowing a definite reason why BIA-ALCL occurs, the FDA believes that women with breast implants may have a very small but increased risk of ALCL. 

What Should Women with Implants Do?

The FDA is not recommending implant removal in women who have no problems. If however, a woman with breast implants has swelling or pain around the implant, they should see their plastic surgeon for evaluation. "Women should monitor their breast implants and contact their doctor if they notice any changes," the agency said in a statement. Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.

Additionally, the FDA has requested that health care professionals report any confirmed cases of ALCL in women with breast implants through the FDA's MedWatch Program or in the PROFILE database.

For those interested in breast augmentation, breast implants are not expected to be removed from the market. At present, breast implant manufacturers do not warn of the risk of ALCL. However, in an effort to ensure that patients receiving breast implants are informed of this risk, the FDA will be working with manufacturers to update their product labeling materials to reflect the possibilities of this cancer.


Anaplastic Large Cell Lymphoma. Medical Devices. 20 January 2016. United States Food and Drug Administration. 

Clemens MW, Miranda RN. Coming of Age: Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation. Clin Plast Surg. 2015 Oct;42(4):605-13. doi: 10.1016/j.cps.2015.06.006.

FDA News Release. News Events. 26 January 2011. United States Food and Drug Administration. 

FDA Advises Women with Breast Implants. For Consumer. 26 January 2011. United States Food and Drug Administration. 

Joint ASPS & ASAPS Advisory to Members on FDA's Update regarding Breast Implant-Associated ALCL. 15 January 2016. American Society of Plastic Surgeons (ASPS) and The American Society for Aesthetic Plastic Surgery (ASAPS). 

Kadin ME, Deva A, Xu H, Morgan J, Khare P, MacLeod RA, Van Natta BW, Adams WP Jr, Brody GS, Epstein AL. Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthet Surg J. 2016 Mar 15. pii: sjw023. [Epub ahead of print].

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