Women with saline or silicone gel-filled breast implants may have a small but significant risk for developing anaplastic large cell lymphoma (ALCL), a rare type of cancer that affects the lymph nodes and skin, the FDA announced today.
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, said in a press release.
The agency identified 34 unique cases of ALCL in women with breast implants in a scientific literature review of information published between January 1997 and May 2010, and is aware of about 60 cases worldwide.
ALCL diagnosis occurred when the women sought medical treatment for implant-related symptoms including pain, lumps, swelling or asymmetry that developed after initial surgical sites were fully healed.
The FDA urges health care professionals treating women with breast implants to consider ALCL if a patient has late onset, persistent fluid around the implant and to send fresh seroma fluid for pathology tests to rule out the cancer. Confirmed ALCL cases should be reported to Medwatch.
“There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants,” the agency wrote in the press release.
However, the FDA encouraged women to monitor their breast implants and contact their doctor if they notice any changes.
Currently, the agency is working with breast implant manufactures to update product labeling materials to reflect the possible risk of ALCL, as well as with the American Society of Plastic Surgeons to establish a breast implant patient registry.
The FDA will publish an update with interim findings from ongoing silicone gel-filled breast implant post-approval studies, adverse event reports and additional literature reviews in the spring of 2011.