USA: Reports of squamous cell carcinoma (SCC) in the capsule around breast implants - FDA safety communication

The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on 8 September 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that forms around breast implants.  The various lymphomas are not the same as the lymphomas described previously by the FDA as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).  

This update includes information from the FDA’s review of literature and medical device reports (MDRs). The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature. There have been reports in the literature of deaths from progression of the disease.  While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown. 

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Source: US FDA, 8 March 2023