Women with saline or silicone gel-filled breast implants may be at risk for developing anaplastic large cell lymphoma (ALCL), a very rare type of cancer, the Food and Drug Administration (FDA) announced.
The agency reviewed data in which there were 60 cases of ALCL in women with breast implants worldwide. An estimated 5 million to 10 million women worldwide have breast implants. ALCL is a type of non-Hodgkin lymphoma that appears in different parts of the body including the lymph nodes and skin. In women with breast implants, ALCL has been found in the scar capsule adjacent to the implant.
Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 of every 100 million women nationwide without breast implants.
It is not yet possible for researchers to identify a type of implant – silicone versus saline – or a reason for implant – reconstruction versus aesthetic augmentation–associated with a smaller or greater risk.
The exact number of cases of ALCL in women with breast implants is hard to pinpoint because not all cases were published in scientific literature and some may be duplicate reports. Based on the data available, the FDA has identified the risk as “very small but significant.”
Breast implant manufacturers will be required to update their product labeling materials for patients and health care professionals so that patients receiving breast implants are aware of the possible risk.
The FDA does not advise women with breast implants to have them removed if they are not experiencing symptoms or other abnormalities.
Health care professionals are asked to report any confirmed cases of ALCL in women with breast implants to the FDA. Patients may also report any adverse reactions or side effects related to their breast implants to the FDA’s MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.