Sept. 17, 2022 -- The U.S. Food and Drug Administration is warning the public that a small number of cancer cases, including squamous cell carcinoma and other lymphomas, have been linked to scar tissue around breast implants.

These cases are not the same as the cases of anaplastic large cell lymphoma linked to breast implants a decade ago, the FDA said in a safety communication.

A preliminary review of published literature found fewer than 20 cases of SCC and fewer than 30 cases of various lymphomas in the capsule, or scar tissue around the implant, the FDA said. Since Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 medical device reports about various lymphomas related to breast implants.

“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 said in a safety communication.

Women who have had implants don’t need to change their routine but should be aware of symptoms of cancer, which include swelling, pain, lumps or skin changes, the FDA said, noting that some cases emerged years after women received breast implants. The SCC cases were linked to both textured and smooth implants, and saline and silicone implants.

“This is an emerging issue and our understanding is evolving,” the FDA said in the Sept. 8 communication. “For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA.”

The FDA said it became aware of the SCC cases through medical device reports, post-market studies, published literature, and data from registries and claims databases.

The New York Times reports that about 400,000 women in the United States get breast implants a year – 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies.

In 2019, the pharmaceutical company Allergan issued a worldwide recall of Biocell textured breast implants that had been linked to breast implant-associated anaplastic large cell lymphoma.

FDA: “Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication”

The New York Times: “Breast Implants May Be Linked to Additional Cancers, F.D.A. Warns”

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