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FDA Issues Safety Alert Over Possible Link Between Cancer and Breast Implants


The US Food and Drugs Administration (FDA) issued a safety communication informing about reports of squamous cell carcinoma (SCC) and various lymphomas around breast implants.

According to the FDA, SCC and lymphomas were located in the capsule or scar tissue around breast implants.

These emerging reports of lymphoma in scar tissue are different from breast implant associated anaplastic large cell lymphoma (BIA-ALCL), which was identified more than a decade ago. According to the FDA, women with breast implants that have textured surfaces have a slightly increased risk of developing BIA-ALCL.

Recently reported malignancies have been linked to both textured and smooth breast implants and for both saline and silicone breast implants. In some reported cases, patients were diagnosed years after having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps, or skin changes.

As of September 1, 2022, the FDA has received ten medical device reports (MDRs) about SCC related to breast implants and 12 MDRs about various lymphomas related to breast implants.

The FDA says it recognizes the limitations of MDR data, including that reports do not necessarily represent unique cases.

“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 says in a press release.

Resources:

FDA. FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants.

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