FDA Alert On Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)

The U.S. Food and Drug Administration recently released an alert regarding breast implant associated squamous cell carcinoma (BIA-SCC) as a result of ongoing reports. The FDA is maintaining that these reports of BIA-SCC in the outer capsule of breast implants are rare, but the number of cases is increasing. Our plastic surgeon Christine Petti, MD, wanted to share this information with her community and patients so that everyone can stay up to date and remain informed. It should be again noted that these cases of BIA-SCC the FDA is referencing are rare. Nonetheless, Dr. Petti wanted to spread the word to raise awareness about this current alert.

The FDA notes that BIA-SCC is known to occur in various types of breast implants, including smooth, textured, silicone, and saline implants. The organization further notes that, based on the literature, this form of carcinoma may be linked to chronic inflammation from a device-associated infection. The current cases involve patients who have had their breast implants for years. According to the FDA’s statement, the current BIA-SCC cases included patients presenting abnormal symptoms such as swelling, pain, lumps, or changes within the skin. It is important to note that the FDA advisory is not new information regarding breast implants or other types of implants where malignancies (though rare) have been reported, including dental implants, orthopedic implants, and pacemakers. With that in mind, it is still imperative for patients who are experiencing implant symptoms such as those mentioned above, or any other signs of irregularities or abnormalities, to notify their plastic surgeon.

In addition to regular self-evaluations and annual follow-up care with their doctor, breast implant patients should also be sure to have an MRI or breast ultrasound exam at least once every 3 to 5 years to monitor the implants. It is also important to note that the FDA is not recommending breast implant removal for patients who are not experiencing symptoms.

If you have additional questions, please reach out to our practice today.