The Food and Drug Administration (FDA, for its acronym in English) has received several reports about the detection of certain types of cancer in the scar tissue that forms around breast implants, it said Thursday in a security alert.
"At this time, we don't have enough information to say whether breast implants cause these cancers or whether some have a higher risk than others," the federal agency said.
As of September 1, it had received 10 reports of squamous cell carcinoma, a type of skin cancer, and 12 of lymphomas.
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FDA approved restrictions and warning labels for breast implants in 2021 after receiving reports of women developing anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system, associated with those operations
The FDA said Thursday that the new cases of lymphoma detected were different from those of BIA-ALCL that had already been reported.
He noted in any case that the appearance of cancer in scar tissue around an implant may be rare, although the incidence rate and risk factors are currently unknown.
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Scientists had previously linked an unusual cancer called anaplastic large cell lymphoma to textured implants, whose rough surfaces presumably cause more inflammation than smooth ones.
Lymphoma is a cancer of the immune system.
The FDA confirmed that link more than a decade ago, but the textured implants, made by Allergan, remained on the market until 2019. In some cases, women were diagnosed after years of having breast implants.
Symptoms included swelling, pain, lumps, and skin changes.
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Cases of lymphomas in women with breast implants have been reported in the scientific literature for about a decade, said Mark Clemens, a professor of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston.
They are extremely rare, he said, and the new warning should not be a cause for widespread alarm.
Understanding that this type of cancer is linked to breast implants "allowed us to be more aware that other things could be going on," she added.
"A wound that has been trying to heal for a long time can turn into these things," he said, but in his opinion, the precise nature of the relationship between the implant and the cancer, and whether the implant is causing the cancer, is not yet clear. clear.
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About 400,000 women in the United States get breast implants each year, 300,000 for cosmetic reasons and 100,000 after mastectomies to treat or prevent breast cancer.
This figure fell substantially in the first year of the pandemic, according to the American Society of Plastic Surgeons.
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Last year, the FDA put warning labels on breast implants to alert them that they had been linked to a number of chronic medical conditions, including autoimmune diseases, joint pain, brain fog, muscle aches and chronic fatigue, as well as as with lymphoma.
Among those most at risk of developing later illnesses are breast cancer patients who have had or plan to undergo chemotherapy or radiation treatments, and who represent a large percentage of women who are encouraged to undergo breast reconstruction with implants.
Smokers and women who have lupus or diabetes are also at higher risk for complications, the FDA said.
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One-third of women with breast implants will experience breast pain, breast tenderness or loss of breast sensation, or asymmetry.
Half will experience painful hardening of scar tissue around the implant, and a third will have implants that rupture or leak, the FDA advises.
On Thursday the agency said it was not recommending that women remove breast implants because of the new warning.
But she does advise women to monitor their implants and see a doctor if they notice any abnormal changes.
With information from
NBC News
and
The New York Times
