The U.S. Food and Drug Administration said it received reports of at least nine deaths and more than 350 cases of a rare blood cancer that’s been linked to breast implants. The announcement, made Tuesday, follows a conclusion made years ago by the World Health Organization that anaplastic large cell lymphoma (ALCL) can develop following breast implants.
The agency, which had first raised concerns about a potential link in 2011, said it can’t determine how many cases there are, but that Australia has also reported three deaths. The cases seem to occur more often in patients with textured surfaces on the implants, and are associated with pain and swelling that may occur years after the surgery has healed.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA said in a statement on its website. “Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”
The FDA advised physicians of patients with breast implants to provide routine care and support, and said breast implant removal in patients without symptoms or other abnormality is not recommended. The statement also said patients with breast implants should not change routine medical care and follow up, but should follow doctor’s instructions on how to monitor breast implants.
“If you notice any changes, contact your health care provider promptly to schedule an appointment,” the FDA advised.
The Associated Press contributed to this report.