FDA issues safety alert for cancers associated with breast implants
These various lymphomas are not the same as lymphomas that have previously been described as associated with breast implants, according to the FDA’s announcement.
The FDA said that, after a preliminary review of published literature, it is aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas in the capsule around the breast implant.
As of last week, the FDA has received 10 medical device reports about squamous cell carcinoma related to breast implants and 12 medical device reports about various lymphomas related to breast implants, the announcement said.
People with breast implants do not need to change their routine medical care, according to the FDA, but they should be aware that some of the reported signs and symptoms included swelling, pain, lumps or changes in the skin.
The agency said it learned about these reports of squamous cell carcinoma and various lymphomas during an ongoing postmarket review of the safety of breast implants in the United States.
“Reports submitted to the FDA are just one source the FDA uses to monitor the safety of medical devices, in addition to mandated postmarket studies, published literature, and real-world data from registries and claims databases,” the announcement said. “The FDA will continue to gather and review all available data from these sources to evaluate the occurrence of cancers in the capsule around breast implants.”
The exact incidence rate and risk factors for these cancers remain unknown, and “this is an emerging issue and our understanding is evolving.”
A history of health concerns and breast implants
Since then, efforts have been made to better inform breast implant patients about potential health risks.
Last year, the FDA made several changes to breast implant regulations, including new labeling with a boxed warning and a patient checklist that informs people that implants are not a medical device that will last a lifetime.
The older the implants are, the more health risks they pose, and those risks could require additional surgery.
He added that he often discusses benefits and risks with his own patients.
“We do discuss complications. Those range from scarring around the implant, sometimes soreness and discomfort from the implant … to in the last seven years, probably a bit more, we’ve become more acutely aware of a specific type of lymphoma that is associated with breast implants,” he said. “What the general public should appreciate is, as doctors and clinicians, we always want what’s best and safest for our patients. We’re constantly not only educating ourselves but educating our patients.”