A rare type of cancer associated with breast implants has been linked to nine deaths and more than 350 cases of lymphoma, the Food and Drug Administration (FDA) announced on March 22nd.
Six years ago the FDA noted a possible link between breast implants and a rare form of cancer known as anaplastic large cell lymphoma (ALCL), but the scarcity of cases meant that “it was not possible to determine what factors increased risk.”
Now, the FDA has more answers, and the agency believes that evidence it has gathered since 2011 is enough to warrant a new designation for the rare type of T-cell lymphoma that can occur following breast implants — they’re calling it breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
“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,” announced the FDA.
As of February 1, the FDA had received reports on 359 cases of BIA-ALCL and, as the cases continue to trickle in, the agency believes the risk factors are starting to add up. For example, BIA-ALCL “appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants,” noted the agency.
Currently, women can choose from two types of breast implants — those filled with saline or those filled with silicone gel. Both types of implants come with varieties in the thickness of the shell, surface texture and shape.
“Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants,” urges the FDA.
Weighing Other Factors
Despite the warning call, the FDA does not advise women who have had breast implants to make any sudden changes. “If you have breast implants, there is no need to change your routine medical care and follow-up,” said the agency. “BIA-ALCL is rare.”
However, the growing body of evidence behind the implant-associated cancer rates makes precaution a necessary part of the post-surgical period. “If you notice any changes, contact your health care provider promptly to schedule an appointment,” said the FDA. “Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.”
Also, women with silicone-filled implants should hew to their regular monitoring schedule, says the agency. “If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.”
The FDA urges all patients and health care providers who are affected by cancer related to or associated with breast implants to report the incident under the agency’s MedWatch program.
Women who are affected by BIA-ALCL are likely to undergo further procedures and may require additional treatment, notes the FDA. “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.”
And before opting for a procedure, make sure you understand all the risks involved. “Educate yourself about breast implants before agreeing to surgery,” says the agency.