The FDA said it had received at least 10 reports about squamous cell carcinoma (SCC) and 12 reports about various lymphomas related to breast implants as of Sept. 1. SCC is a type of skin cancer while lymphoma is defined as cancer of the lymph nodes.
According to the agency's safety alert, 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," read the statement.
Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA's Center for Devices and Radiological Health, said that some patients were only diagnosed years after they had breast implants. The patients were presented with findings like pain, lumps, skin changes or swelling. (Related: Popular plastic surgeon says breast implant illness is real.)
Ashar added that after an initial extensive review, the risk of SCC and other lymphomas occurring in the tissue around breast implants is low. She also acknowledged that the FDA currently doesn't have enough information to determine if breast implants cause these cancers or "if some implants pose higher risk than others."
Breast implants are not lifetime devices and the longer a patient has breast implants, the more likely they will need to be removed or replaced. Ashar also said that information about breast implant risks can be overwhelming for a patient so she encouraged people to review the FDA website to learn more about patient labeling.
The agency's safety alert also explained that the breast implant issue is an emerging one and that their "understanding is evolving." This is why the FDA is asking healthcare providers and people with breast implants to report any cases of lymphomas, SCC or other cancers around the breast implant to the agency.
Ashar commented that the FDA "strongly encourages" reporting the problems to MedWatch, which is the agency's safety information and adverse event reporting program. Reporting can help the FDA's ability to work with manufacturers and others to improve patient safety, added Ashar.
The new safety alert was released after the FDA added new restrictions and warning labels for breast implants back in 2021 following reports that some women with breast implants developed cancer of the immune system or breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Ashar explained that the new lymphoma cases discussed on the Sept. 8 FDA safety alert were different from the BIA-ALCL reported last year.
FDA issues recommendations for people considering to get breast implants
In the safety alert, the FDA issued a running list of current recommendations for people with or considering breast implants:
- If you are considering breast implants or if you have them, read up on the risks and benefits of breast implants.
- If you already have breast implants, there's no need to change your routine medical care or follow-up.
- Be aware that there have been reported cases of SCC and various lymphomas in the capsule or scar tissue around the breast implant.
- Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, check in immediately with your surgeon or health care provider.
- If you don't have symptoms, the FDA doesn't recommend the removal of breast implants because of the safety alert.
- If you have breast implants and experience any issues, the FDA encourages you to file a report through MedWatch.
The FDA explained that the above recommendations don't change or affect those previously provided on BIA-ALCL last year.
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Watch the video below to learn more about breast implant illness.
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