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Policy Archive

FDA Issues New Communication RE: Breast Implants and Reports of Cancer

Device Safety & Drug Development

September 8, 2022 - Today, the U.S. Food and Drug Administration (FDA) issued a new safety alert for breast implants. The communication informed patients and healthcare providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants.

Note that these emerging reports of lymphoma in scar tissue are different from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA has alerted the public about in recent years.

In a meeting with concerned stakeholders, Terri Cornelison, Chief Medical Officer and Director of the FDA Health of Women Program in the Center for Devices and Radiological Health (CDRH), emphasized that their understanding of the issue is evolving. The FDA is trying to determine if these cases are related to specific types of breast implants (i.e., textured vs. smooth), if the reported cancers remained limited to the capsule around the implants, and whether this is impacting patients internationally or limited to the U.S.

“After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare. However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.”

The FDA encourages individuals considering breast implants to review its Things to Consider Before Getting Breast Implants webpage. For individuals who already have implants, it’s important to understand the risks and benefits of breast implants. For people with breast implants, the agency is not recommending the removal of implants or changes in routine screening and care. Instead, it is asking patients and their physicians to be aware in the event that an individual develops any changes or symptoms—such as swelling, pain, lumps or skin changes—indicating that there may be a problem.  

Importantly, any instances of SCC, lymphoma or other cancers located in the scar tissue around breast implants should be reported to the FDA through its MedWatch reporting program.

Stay tuned for updates as they become available on this issue as they become available.

For information about previous FDA actions related to breast implants and FORCE engagement in these issues, see our archived advocacy articles:

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3/1/2024 - Provided feedback to CMS on the Medicare Advantage Advanced Notice and accompanying Part D Redesign Program provisions aimed at reducing and managing beneficiary out-of-pocket costs in the Medicare Part D program.