Updated Safety Alert on Breast Implant Cancer

An FDA safety update indicates that it has received reports about squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The update provides more information following a 9/2022 safety communication about reports of cancers, including SCC and various lymphomas that are not the same as the lymphomas described previously by FDA as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the agency says.

FDA says it recently conducted a published literature review and became aware of 19 cases of SCC in the capsule around breast implants. The majority of cases involved swelling and/or pain of the breast as symptoms. “Other reported symptoms included lumps and skin discoloration,” it says, adding that breast reconstruction and augmentation was the reason indicated for having an implant. “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,” the update says.