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FDA finds at least 19 cases of skin cancer in breast implant data, including 3 deaths

Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and tracked by the regulator since 2011—the agency has only recently begun warning about other cancer risks linked to the implants.

The FDA first issued a safety alert last September about the possibility of other lymphomas and squamous cell carcinoma (SCC) developing in the scar tissue that forms around breast implants. This week, it shared the results of its analysis of literature about SCC cases in people with breast implants and updated its recommendations for healthcare providers accordingly.

After reviewing a range of abstracts and full scientific articles published through January of this year, the FDA found 19 reported cases of SCC developing in the capsule around breast implants. Of those identified patients, three died from the carcinoma.

For the most part, the skin cancer was discovered after the appearance of symptoms that included swelling and pain in the breast—found in 90% of the reviewed cases—as well as the development of lumps, skin discoloration and more.

And while they had some symptoms in common, the cases spanned a range of patients: They were aged between 40 and 81 when the cancer was diagnosed, and the diagnosis came between seven and 42 years after the breast implants had been put in place. The type of implant varied, too—the cases reviewed by the FDA included both silicone gel- and saline-filled implants, and implants with textured, smooth and foam-covered surfaces.

The FDA noted in Wednesday’s safety communication that while cases of SCC linked to breast implants are rare, “the cause, incidence and risk factors remain unknown.”

In addition to reviewing published literature about SCC cases, the FDA also analyzed the medical device reports (MDRs) it has so far received regarding the condition in people with breast implants.

As of mid-January, the agency has received 24 such reports—up from the 10 it mentioned in last September’s safety notice. However, due to the limitations of its reporting system, the FDA has stopped short of counting them as unique cases; not only could there be overlaps between the reported diagnoses and those detailed in the scientific literature, but injuries and deaths detailed in MDRs also typically can’t be definitively linked to a specific cause.

Despite those limitations, the FDA noted that the 24 cases entered into its database featured similar symptoms and a range of patient data and implant types comparable to those described in the literature.

In the wake of its review of the scientific articles, the FDA has now updated its recommendations for healthcare providers with patients who are considering or have already received breast implants. For one thing, doctors should mention the risk of developing SCC and various lymphomas in the capsule around breast implants during discussions with those patients.

Additionally, if they discover any cases of cancer in that scar tissue, doctors should immediately report them to the FDA, including information about the symptoms and pathology of the cancer, the patient’s breast implant history, the results of any scans performed and their treatment plans and outcomes.

The FDA also suggested that those treatment plans be developed on a case-by-case basis, “in coordination with a multidisciplinary team of experts including surgical oncology, plastic surgery, breast surgery, radiology, oncology and pathology.”

Meanwhile, the agency didn’t alter its previously issued recommendations that people who already have breast implants continue their routine medical care and follow-up schedules as usual. It has also recommended against having the implants removed based solely on concerns about the risk of developing cancer as long as no symptoms have cropped up.