FDA Issues Safety Alert Regarding Reports of SCC in Scar Tissue Around Surrounding Implants

On September 08, 2022, the Food and Drug Administration (FDA) issued a warning for patients and health specialists after it received reports of individuals with breast implants being diagnosed with multiple types of cancer. 

According to Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, the FDA received reports of squamous cell carcinoma (SCC) and different lymphomas in the capsule or scar tissue around breast implants. 

As per Ashar, FDA reviewed the reports and specified that such occurrences are infrequent, but the agency wanted to provide comprehensible and perspicuous information to the public as promptly as possible. 

In a few reported cases, patients were diagnosed years after having breast implants and presented with findings such as pain, swelling, lumps or skin changes, Ashar said. 

These emerging reports in scar tissue are separate from BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma), which the FDA started communicating about as a potential risk over a 10 years ago.  

Ashar stated that the agency does not have sufficient deets to conclude if the implants are responsible for causing certain cancers or if a few implants pose a greater risk than others. Any instances of squamous cell carcinoma (SCC), lymphoma or any cancer in the scar tissue near the breast implants needs to be reported to the FDA as a finding. 

This safety communication underscores our dedication to sharing the facts and figures that we regularly collect and examine so that patients may completely consider and generously talk over implant risks with their health specialists, she said. “We will carry on collaborating with certain other existing regulatory bodies, clinical as well as scientific analysts, breast implant registries and those as a part of our dedication in order to educate and boost the evidence creation on these potential new risks.” 

Ashar stated the FDA will conduct a literature review and continue its partnership with the American Society of Plastic Surgeons (ASPS) to recognize ways to accumulate more comprehensive details about these cases.

Source:https://www.fda.gov/news-events/press-announcements/fda-issues-safety-alert-squamous-cell-carcinoma-and-various-lymphomas-scar-tissue-around-breast?utm_medium=email&utm_source=govdelivery