Update on FDA Safety Alert for Skin Cancer in Scar Tissue Around Breast Implants

By: Lauren Velentzas
Posted: Monday, March 13, 2023

In September 2022, the U.S. Food and Drug Administration (FDA) released a statement regarding reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. Binita Ashar, MD, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health of the FDA, said in the statement: “As we learn more about these cases, we hope to better understand the patient risk and communicate findings to the public.” On March 8, 2023, this hope was realized as the FDA released an update on its reports in a new FDA Safety Communication.

The update states that “the FDA is aware of 19 cases of squamous cell carcinoma in the capsule around the breast implant” from its review of the literature and medical device reports. Deaths have been reported from the disease, and though occurrences of squamous cell carcinoma in the capsule around the breast implant continue to be rare, the cause, incidence, and risk factors remain unknown.

The FDA’s recommendations for those who have or are considering breast implants remain the same and do not change or affect the recommendations previously provided by the FDA on breast implant–associated anaplastic large cell lymphoma. The recommendations for health-care providers, however, have been updated to include the following:

• Discuss the possibility of squamous cell carcinoma and various lymphomas in the capsule around the breast implant with those who have or are considering breast implants
• For patients who have been diagnosed with squamous cell carcinoma or various lymphomas in the capsule around the breast implant, develop an individualized treatment plan in coordination with a multidisciplinary team of experts, including surgical oncologists, plastic surgeons, breast surgeons, radiologists, medical oncologists, and pathologists
• Report all cases of squamous cell carcinoma, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

U.S. Food and Drug Administration

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