The Food and Drug Administration (FDA) issued a safety alert after reviewing some reports of patients who had been diagnosed with cancer after receiving breast implants.
Binita Ashar, the director of the Office of Surgical and Infection Control Devices at the FDA, noted the reports of “squamous cell carcinoma and various lymphomas” in scar tissue implants.
“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,” Ashar stated. “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 alert also clarified that the findings were sometimes diagnosed years after receiving implants. The new safety alert also involves a different issue of lymphoma in scar tissue than in a similar risk reported more than a decade ago.
The agency currently states that it does not have enough information to conclude if the implants cause certain cancers or whether some types of implants present higher risks than others. The alert urged any instances of cancer near the scar tissues around breast implants to be reported to the FDA through MedWatch, the agency’s Safety Information and Adverse Event Reporting program.
The agency plans to conduct further studies in cooperation with the American Society of Plastic Surgeons. The research hopes to identify more details regarding such cases to better address the issue in the future.
“We also understand that information regarding breast implant risks can be overwhelming for a patient,” the alert also noted. “For this reason, we encourage review of our website with attention to patient labeling, which has easy to understand information in the patient brochure.”
Approximately 400,000 women get breast implants in the U.S. in a typical year, according to a report by The New York Times. Of the number, 300,000 are for cosmetic reasons, and 100,000 are for reconstruction after mastectomies to treat or prevent breast cancer.
Those who have received breast implants following breast cancer are already at higher risk of future illness. Other factors, including nicotine usage, can also increase the risk of lymphoma.
The FDA is not recommending that women remove breast implants due to its warning. Instead, any concerns should be reported to a healthcare provider for additional consideration.
In October 2021, the FDA took several steps to improve risk communications regarding breast implants. The changes included orders restricting who can sell implants, new box label warnings, and a patient decision checklist, among other updates.
“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,” Asher said at the time. “As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”