FDA COMMUNICATION REGARDING BREAST IMPLANTS: Reports of Cancers in Capsule Around Implants
Updated: Sep 12, 2022
The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA learned about these reports through our continual postmarket review of breast implants and ongoing collaboration with external stakeholders.
Our GPAC team hopes that this information will be included in the new FDA labeling requirements and the plastic surgeons' informed consent process. GPAC is committed to continuously working collaboratively with the FDA and the American Society of Plastic Surgeons (ASPS) to improve informed consent and patient safety communications.
If you have questions about this announcement, please comment below and we will bring your concerns to future meetings with stakeholders.