FDA Issues Warning Over Additional Cancers Linked to Breast Implants

The U.S. Food and Drug Administration is alerting the public that scar tissue around breast implants has been associated to a limited number of cancer occurrences, including squamous cell carcinoma and various lymphomas.

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

Less than 20 cases of SCC and less than 30 cases of different lymphomas were discovered in the capsule, or scar tissue, surrounding the implant, according to a preliminary examination of published literature, the FDA reported. The FDA has received 12 medical device reports concerning different lymphomas related to breast implants and 10 medical device reports about SCC related to breast implants since September 1.

“While the FDA believes that SCC or various lymphomas in the capsule around the breast implant may be uncommon,” the agency stated in a safety communication. “Healthcare 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 advised women who had implants not to adjust their routine but to be alert for cancer symptoms, which might include swelling, discomfort, lumps, or changes in the skin. It also noted that some cases were discovered years after women had breast implants. Both textured and smooth implants, as well as saline and silicone implants, were associated with SCC cases.

The FDA stated in the message dated Sept. 8 that “this is an emerging concern and our understanding is evolving.” Because of this, the FDA is requesting reports of SCC, lymphomas, or any other cancers around breast implants from medical professionals and patients.

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

According to The New York Times, around 400,000 women in the United States have breast implants each year, 100,000 of whom need them for reconstruction following mastectomies and 300,000 for cosmetic reasons.

Biocell textured breast implants were voluntarily recalled globally in 2019 by the pharmaceutical company Allergan due to an increased risk of breast implant-associated anaplastic large cell lymphoma.

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