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Update: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) is providing an update to the March 8, 2023, safety communication to inform health care providers they can submit case reports of squamous cell carcinoma (SCC), various lymphomas and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) Registry. This is a collaborative effort between the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Foundation (PSF), and the FDA. Health care providers can continue to submit case reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) to PROFILE as well.

The FDA continues to recommend that health care providers also report all cases of SCC, various lymphomas, BIA-ALCL, and any other cancers in the capsule around the breast implant to the FDA.

Additional Resources:

• March 8, 2023 Safety Communication - UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication  
• CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
• Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) Registry

 Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).