Silicone implants may be linked to cancer, warns US agency

This Thursday (8), the FDA (the agency that regulates food and drugs in the United States) warned women who have breast implants or are considering getting them that certain types of cancer can develop in the scar tissue that forms around them. .

Malignancies appear to be rare but are associated with implants of all types, including those with textured or smooth surfaces and those filled with saline or silicone.

Scientists have previously linked an unusual cancer called anaplastic large cell lymphoma (ALCL) to mostly textured implants, whose rough exterior is likely to cause more inflammation than smooth implants. Lymphoma is a cancer of the immune system.

The FDA confirmed this link more than a decade ago, but textured implants, made by Allergan, were on the market until 2019. The agency’s new alert has drawn attention to another cancer, called squamous cell carcinoma, as well as other types of lymphoma that may be related to implants.

There are few documented cases. The FDA said it was aware of fewer than 20 cases of carcinoma and less than 30 cases of unexpected lymphomas in the capsule around the breast implant. (The capsule is the scar tissue that accumulates around the product.)

Due to the widespread use of breast implants and their history, however, US health officials deemed the concern justified. In some cases, women were diagnosed years after getting them. Symptoms included swelling, pain, lumps and skin changes.

While lymphomas and other cancers in the area around the implant may be rare, “Health care professionals 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 said.

A spokeswoman, Audra Harrison, said the new cancers are a “new safety signal that we are seeing with implants that we will be reporting separately from ALCL,” the previously documented cancer.

But cases of lymphomas other than ALCL in women with breast implants have been reported in the scientific literature for about a decade, said Mark Clemens, professor of plastic surgery at the MD Anderson Cancer Center at the University of Texas at Houston.

They are rare, he added, and the new warning should not cause widespread alarm. The realization that ALCL was linked to breast implants has already “allowed us to be more aware of what other things could be going on in this area,” Clemens said.

“ALCL is uncommon, very rare,” he added. It has long been known that scar tissue such as that resulting from breast implant surgery can produce squamous cell carcinoma, Clemens added.

“A wound that has been trying to heal for a long time can develop into these things,” he said. But the exact nature of the relationship between the implant and the cancer, and whether the implant is causing the cancer, is still unclear, he said.

In a typical year, about 400,000 women receive 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.

The numbers dropped substantially during the first year of the pandemic, according to the American Society of Plastic Surgeons.

Last year, the FDA put so-called black box labels on breast implants, warning that they are linked to a number of chronic medical conditions, including autoimmune diseases, joint pain, brain fog, muscle pain and chronic fatigue, as well as to lymphoma.

Among the patients most at risk of developing later disease are those with breast cancer who have had or are planning to undergo chemotherapy or radiation treatments — and who represent a large proportion of women who are encouraged to have breast reconstruction with implants.

Smokers and women who have lupus or diabetes are also at increased risk of complications, the FDA said.

One-third of women who have breast implants will have breast pain, tenderness, loss of sensation or asymmetry. Half of them will feel a painful pinch of scar tissue around the implant, and one-third implants will rupture or leak, the agency said.

Nearly 60% will need another operation to resolve implant problems.

On Thursday, the FDA said it is not recommending that women remove breast implants because of the new warning. But the agency advises that they monitor their implants and consult a surgeon or healthcare professional if they notice any abnormal changes.

The textured implants made by Allergan were recalled after nearly 600 cases of cancer related to them and 33 deaths attributed to the company’s devices.

Translated by Luiz Roberto M. Gonçalves