Cancers Reported in Scar Tissue Around Breast Implants: FDA Safety Alert

Silicone breast implants in a file photo. Miguel Medina/AFP via Getty Images

The U.S. Food and Drug Administration on Sept. 8 issued a safety alert about reports of cancers found in the capsule or scar tissue around breast implants.

The agency stated that it had received 10 reports about squamous cell carcinoma (SCC) and 12 reports about various lymphomas related to breast implants as of Sept. 1 this year. SCC is a type of skin cancer, and lymphoma is defined as cancer of the lymph nodes.

The FDA said it learned about the reports through its “continual postmarket review of breast implants” and “ongoing collaboration with external stakeholders.”

“The FDA recognizes the limitations of [medical device report] data, including that reports do not necessarily represent unique cases,” it noted.

In some of the reported cases, patients “were diagnosed years after having breast implants and presented with findings such as swelling, pain, lumps or skin changes,” Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a release on Sept. 8.

“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 said.

She acknowledged that right now, the FDA does not have “enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others.”

In a separate paragraph, she noted: “We know that breast implants are not lifetime devices, and that the longer a patient has breast implants, the more likely they will need to be removed or replaced. We also understand that information regarding breast implant risks can be overwhelming for a patient. For this reason, we encourage review of our website with attention to patient labeling, which has easy to understand information in the patient brochure.”

The agency stated in the safety alert: “This is an emerging issue and our understanding is evolving. For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA.”

Ashar said the agency “strongly encourages” reporting the problems to MedWatch, which is the FDA Safety Information and Adverse Event Reporting program. “Reporting strengthens our ability to work with manufacturers and others to improve safety,” she said.

The new safety alert comes after the FDA added new restrictions and warning labels for breast implants in 2021 after reports that said some women with breast implants had developed a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The new lymphoma cases the FDA notified about on Sept. 8 differ from the BIA-ALCL reported earlier, Ashar noted.

FDA Recommendations

In its safety alert, the FDA issued a running list of current recommendations for people with or considering breast implants. They are as follows:

• If you are considering breast implants or if you have them, learn more about the risks and benefits of breast implants.
• If you have breast implants, you do not need to change your routine medical care or follow-up.
• Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
• Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider.
• If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication.
• If you have breast implants and experience a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety.

The agency noted that the above recommendations do not change or affect those previously provided on BIA-ALCL.

The FDA also issued a list of recommendations for health care providers:

• Continue to provide routine care and support to your patients with breast implants.
• Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
• When examining breast implant specimens (for example, seroma, capsule, devices) for diagnostic evaluation, characterize all findings and potential diagnoses.
• Report cases of SCC, 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.