The Plastic Surgery Foundation (The PSF) announces that its PROFILE Registry has been updated to allow all U.S. physicians to report suspected or confirmed cases of breast implant-associated squamous cell carcinoma (BIA-SCC) as well as any lymphoma or other cancer found in the capsule surrounding breast implants beginning March 22, 2023.
“The expansion of PROFILE is vital to improving patient safety and was initiated in direct response to the U.S. FDA’s September 2022 safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that may form around breast implants,” says The PSF President-Elect Scot Glasberg, MD.
ASPS and PSF leaders responded immediately to provide a detailed overview of BIA-SCC and its symptoms to help plastic surgeons and other healthcare providers recognize it as a distinct disease entity, separate from the more widely known breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
“Gaining [Institutional Review Board] approval to expand the monitoring capabilities of PROFILE was the next step,” says Glasberg. “ASPS/PSF has not changed its initial guidance and clinical recommendations regarding BIA-SCC, but we expect to gain greater insights into this disease entity by reviewing each case entered into PROFILE.”
The American Society of Plastic Surgeons (ASPS)/PSF remains in communication with the FDA regarding this emerging issue. Data on BIA-SCC are currently limited, but BIA-SCC appears to be a rare but potentially aggressive epithelial-based tumor that can form in the capsule around breast implants. A March 2023 FDA follow-up communication reported that 19 cases of SCC have been identified in published literature. While the FDA states that occurrences of SCC are rare, the cause, incidence and risk factors remain unknown.
“PROFILE now provides a trusted mechanism for any physician with a patient who has a confirmed or suspected case of BIA-SCC or any lymphoma or other cancer in the breast implant capsule to report the clinical presentation, breast implant history, imaging studies performed, pathology of the capsule tissue, treatments used, and any outcomes,” says PROFILE Principal Investigator Colleen McCarthy, MD. Physicians should also report all cases of any cancer in the breast implant capsule to the FDA.
The PROFILE registry launched in 2011 as a collaborative effort between ASPS/PSF and the FDA to track cases of BIA-ALCL, another uncommon yet distinct type of cancer that can develop around breast implants.
“Expanding PROFILE beyond BIA-ALCL is essential to protecting our patients by identifying potential risk factors as we manage this disease,” says McCarthy. “The PSF has taken an important leadership position in helping all stakeholders to better understand the role of breast implants in the etiology of BIA-SCC or other lymphomas in the breast implant capsule.”