Most people understand that there are risks to having a surgical procedure, but did you know that breast implant surgery is possibly linked to a rare form of cancer? How do you weigh the benefits versus the risks in this scenario? Let's take a look.
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 anaplastic large cell lymphoma (ALCL). 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.
ALCL attacks lymph nodes and skin. The lymphoma is an aggressive form of cancer, and survival varies widely between different varieties of the disease. Chemotherapy is usually the first line of treatment. 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.
But, the number of women with implants who develop ALCL is very, very low. In fact, among the five million to 10 million women worldwide with breast implants, the FDA has identified about only 60 women with ALCL. However, that number is difficult to verify because not all of them were noted in scientific publications and some reports may have been duplicated. 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. Agency experts say the known ALCL cases are too few to say conclusively that breast implants cause the disease. The FDA said on its website: "Based on these data, the FDA believes that women with breast implants may have a very small but increased risk of ALCL." Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.
So 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.
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. The FDA and the American Society of Plastic Surgeons are establishing a registry of ALCL patients who have breast implants to better understand the association of breast implants and lymphoma.
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.
For more information concerning breast implants and lymphoma, visit FDA News Release.
Naeim F, Rao PN, Grody WW. Hematopathology: Morphology, Immunophenotype, Cytogenetics,and Molecular, 1st Edition. Oxford, UK: Academic Press an imprint of Elsevier, Inc. 2008.
Anaplastic Large Cell Lymphoma. Medical Devices. 26 January 2011. United States Food and Drug Administration. Accessed 13 March 2011.
FDA News Release. News Events. 26 January 2011. United States Food and Drug Administration. Accessed 13 March 2011.
FDA Advises Women with Breast Implants. For Consumer. 26 January 2011. United States Food and Drug Administration. Accessed 13 March 2011.