Get notified of page updates

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:

Take Action Now BECOME AN ADVOCATE 2023 Priorities Advocacy Archive Public Policy Initiatives

News Briefs

12/6/2022 - Joined a broad range of stakeholders to urge Appropriations leaders to pass the FY23 Omnibus spending bill, and to include boosted funding for the National Institutes of Health (NIH) and our nation’s other research agencies.

11/28/2022 - Asked congressional leadership to include the Access to Genetic Counselor Services Act 
(H.R.2144/S.1450) in a year-end legislative package so that Medicare beneficiaries can better access genetic counseling services.

11/21/2022 - Joined the Defense Health Research Consortium in encouraging congressional leaders to enact the FY23 Defense Appropriations Act, to ensure full funding of the Defense Health Research Programs, including the Congressionally Directed Medical Research Programs (CDMRP).