FDA warns of rare cases of cancers possibly linked to breast implants
WASHINGTON - The U.S. Food and Drug Administration issued a recent warning about rare cases of certain cancers linked to breast implants.
The FDA said in a notice posted on Thursday that it has received reports of cancers, including squamous cell carcinoma and various lymphomas, in the scar tissue that forms around breast implants.
These cancers are different from a previous warning from the FDA about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which was first identified over a decade ago.
BIA-ALCL is not breast cancer, but rather a type of non-Hodgkin's lymphoma — a cancer of the immune system. While rare, the risk is higher for textured implants over smooth implants, according to the FDA.
In the agency’s new warning, it says the cases of squamous cell carcinoma and various lymphomas still seem to be rare but have been linked to both textured and smooth breast implants, and for those filled with both saline and silicone.
The FDA said it’s aware of less than 20 cases of squamous cell carcinoma and less than 30 cases of various lymphomas in the capsule around the breast implant.
"While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature," the agency’s notice states.
Breast implants are used to increase breast size or to replace breast tissue that has been removed due to cancer or trauma. Sometimes they are used in revision surgeries, which seek to correct or improve the result of an original surgery.
There are two types of implants approved in the United States — saline-filled and silicone-filled — while both types have a silicone outer shell, the FDA says. They vary in size, shell thickness, shell surface texture, and shape.
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Generally, the longer a person has breast implants, the more likely they’ll need to have them removed or replaced, the agency said.
Neither saline nor silicone breast implants appear to be linked to an increased risk of breast cancer, according to the Susan G. Komen Foundation, citing several findings from cohort studies. It noted how a few studies have found a decreased risk of breast cancer among women with breast implants, but said this is "likely due to traits of women who tend to choose breast implants (such as being lean), rather than the implants themselves."
What to know if you have breast implants or are considering them
The FDA said those considering breast implants or patients who already have them should learn more about the risks and benefits.
Those with breast implants should be aware of these rare reports of certain cancers but do not need to change their routine medical care or follow-up, the agency added.
"Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider," the FDA said.
"If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication," it added.
Anyone with breast implants who experiences a problem is asked to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program, which helps to improve patient safety.
The agency said it is continuing to work with other regulatory authorities, clinical and scientific experts, manufacturers, and breast implant registries to evaluate the safety of approved breast implants and any associated risks.
This story was reported from Cincinnati.