The FDA has found new clusters of specific types of cancer – including squamous cell carcinoma (SCC) and various lymphomas – linked to the “capsule” of scar tissue that forms around breast implants, as part of its continual post-market review of breast implants and ongoing collaboration with external stakeholders.
The FDA issued the warning in a safety communication on September 8, noting that these cancers are different from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The cases are small in number, but while the FDA believes that occurrences of squamous cell carcinoma and various lymphomas in the capsule around breast implants may be rare, health care providers and people who have or are considering breast implants should be aware of these cases.
The communication states:
After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.
As of September 1, 2022, the FDA has received 10 medical device reports (MDRs) about SCC related to breast implants and 12 MDRs about various lymphomas related to breast implants.
The FDA recognises the limitations of MDR data, including that reports do not necessarily represent unique cases. Reports submitted to the FDA are just one source the FDA uses to monitor the safety of medical devices, in addition to mandated postmarket studies, published literature, and real-world data from registries and claims databases. The FDA will continue to gather and review all available data from these sources to evaluate the occurrence of cancers in the capsule around breast implants.
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Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown. When breast implant information was provided, there have been literature reports of SCC and various lymphomas in the capsule around the breast implants for both textured and smooth breast implants, and for both saline and silicone breast implants. In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps or skin changes.
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.
FDA’s 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, characterise all findings and potential diagnoses.
- Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA.
Currently, these recommendations do not change or affect the recommendations previously provided by the FDA on BIA-ALCL.
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