Cases of squamous cell carcinoma (SCC) and various lymphomas related to scar tissue around breast implants have been reported to the Food and Drug Administration (FDA), according to a new safety communication.

Following an initial extensive review, the Agency identified less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant. These cases were associated with both saline and silicone breast implants. Breast implant medical device reports submitted to the FDA also showed 10 linked to SCC and 12 related to various lymphomas, though the Agency noted that these reports may not represent unique cases. In some reported cases, patients presented with swelling, pain, lumps or skin changes and were diagnosed years after having breast implants.

While believed to be rare, the incidence rate for SCC and various lymphomas in the capsule around breast implants is currently unknown. Health care providers are urged to report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. These recommendations do not change or affect the previous recommendations provided by the FDA on breast implant-associated anaplastic large cell lymphoma.

Commenting on the new safety alert, Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said, “Looking ahead, the FDA will soon complete a thorough literature review and continue our partnership with the American Society of Plastic Surgeons as we work to identify ways to collect more detailed information regarding patient cases where cancer in the breast implant capsule has been reported. As we learn more about these cases, we hope to better understand the patient risk and communicate findings to the public.”

References

FDA: Cases of Breast Implant-Related SCC, Various Lymphomas Reported

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