FDA UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants -
Updated: Apr 17
Date Issued: March 8, 2023 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 September 8, 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. Health care providers and people who have or are considering breast implants should be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported to the FDA and in the literature. The FDA continues to ask health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants to the FDA. In addition, we continue to collaborate with other regulatory authorities, scientific experts, breast implant manufacturers and registries to gather all available information on cancers in the capsule around breast implants.
To read more: https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication