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

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.

Recommendations for People who Have or Are Considering Breast Implants

The FDA continues to recommend the following:

• If you areconsidering breast implantsor if you have them, learn more about therisks and benefits of breast implants.

• If you have breast implants, you do not need to change your routine medical care or follow-up.

• Be aware that cases of SCC and various lymphomas (other than BIA-ALCL) in the capsule around the breast implant have been reported.

• Monitor your breast implants for as long as you have them. If you notice any changes in your breasts or implants, promptly talk to your surgeon or health care provider.

• If you do not have symptoms, the FDA does not recommend the removal of breast implants solely due to concern related to the risk of developing SCC or various lymphomas.

• If you have breast implants and experience a problem, the FDA encourages you to file a report throughMedWatch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety.

Currently, these recommendations do not change or affect therecommendationspreviously provided by FDA on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

DON'T STOP NOW! READ THE ENTIRE ARTICLE: https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication