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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants - FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, that have developed in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in the previous FDA Communications as Breast Implant - Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). 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 FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA.

This safety communication provides:

• Recommendations for people who have or are considering breast implants.
• Recommendations for health care providers.
• FDA actions
• Instructions for reporting problems related to breast implants.

Questions?

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