WASHINGTON - The US Food and Drug Administration on Thursday warned women who have breast implants or are considering getting them that certain cancers may develop in scar tissue forming around the implants.
The malignancies seem to be rare, but they have been linked to implants of all types, including those with textured and smooth surfaces, and those filled with saline or silicone.
Scientists had already linked an unusual cancer called anaplastic large cell lymphoma primarily to textured implants, whose rough exteriors presumably cause more inflammation than those of smooth implants. Lymphoma is a cancer of the immune system.
The FDA confirmed that link more than a decade ago, but textured implants, made by Allergan, were on the market until 2019. The agency's new warning called attention to another cancer, called squamous cell carcinoma, and also to other types of lymphoma that may be related to the implants.
There are few documented cases. The FDA said it was aware of fewer than 20 cases of carcinoma, and fewer than 30 cases of unexpected lymphomas, in the capsule around the breast implant. The capsule is the scar tissue that builds up around the implant. Given the history of implants and their widespread use, however, federal health officials felt concern was warranted. In some cases, women were diagnosed after years of having breast implants. Among the symptoms were swelling, pain, lumps and changes in the skin.
Although lymphomas and other cancers in the area around the 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 FDA said.
An agency spokesperson, Audra Harrison, said that the new cancers were an "emerging safety signal that we're seeing with implants that we will be communicating about, separate from ALCL," the previously documented cancer.
But cases of lymphomas other than ALCL in women with breast implants have been reported in scientific literature for about a decade, said Dr Mark Clemens, a professor of plastic surgery at the University of Texas MD Anderson Cancer Centre in Houston.
They are rare, he added, and the new warning should not be cause for widespread alarm. The realisation that ALCL was linked to breast implants had already "enabled us to be more cognizant that other things could be happening in that area," Dr Clemens said.
"If ALCL is uncommon, these are very rare," he added. It has long been known that scar tissue, like that resulting from breast implant surgery, can yield squamous cell carcinoma, Clemens added.
"A wound that tries to heal, and tries to heal for a long time, can develop into these things," he said. But the precise nature of the relationship between the implant and the cancer, and whether the implant is causing the cancer, is not yet clear, he said.
In a typical year, some 400,000 women get breast implants in the United States, 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer.
Numbers dropped substantially during the first year of the pandemic, according to the American Society of Plastic Surgeons.
Last year, the FDA placed so-called black-box labels on breast implants, warning that they had been linked to a host of chronic medical conditions, including autoimmune disease, joint pain, mental confusion, muscle aches and chronic fatigue, as well as to lymphoma.
Among those at highest risk for 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 the women who are encouraged to have breast reconstruction with implants.
Smokers and women who have lupus or diabetes are also at greater risk for the complications, the FDA has said.
One-third of women who have breast implants will experience breast pain, sensitivity or loss of sensitivity in the breast, or asymmetry. Half will experience a painful tightening of scar tissue around the implant, and one-third will have implants that rupture or leak, the FDA has said.
Nearly 60 per cent will need another operation to resolve problems with implants.
On Thursday, the FDA said it was not recommending that women remove breast implants because of the new warning. But the agency is advising women to monitor their implants, and to see a surgeon or a health care provider if they notice any abnormal changes.
Textured implants made by Allergan were recalled after nearly 600 cases of cancer were linked to the implants and 33 deaths were attributed to the company's devices. NYTIMES