FDA Issues Update On Rare Cancer Linked To Breast Implants

Recently, the U.S. Food and Drug Administration (FDA) has shared an update addressing reports of squamous cell carcinoma (SCC), a relatively rare cancer form, found in the scar tissue (capsule) developing around breast implants. This important update follows a safety communication in September 2022, which initially alerted the public to the presence of SCC and various lymphomas in the tissue around breast implants, raising concerns among patients and healthcare providers alike.

Breast implants, not intended to be permanent fixtures, function as medical devices implanted beneath the breast tissue or chest muscle for the purpose of enlarging the breast size (augmentation) or replacing breast tissue (reconstruction) lost due to cancer, injury, or congenital anomalies. In the United States, there are two primary categories of breast implants available: those filled with saline solution and those filled with silicone gel. Both types feature a silicone outer shell and differ in various aspects, such as size, shell thickness, shell surface texture, and shape. It is essential for individuals considering breast implants to be aware of these differences and consult with their healthcare providers to make informed decisions.

In the published literature, the FDA has identified 19 instances of SCC in the tissue surrounding breast implants. While the precise cause, frequency, and contributing factors remain uncertain, the FDA considers the presence of SCC in the scar tissue surrounding breast implants to be a relatively rare occurrence. The agency is committed to ongoing research and investigation to better understand this emerging issue and provide accurate information to the public.

It is crucial for healthcare providers and individuals who have or are contemplating breast implants to be aware of these reported cases. The FDA encourages healthcare professionals and individuals with breast implants to report cases of SCC, lymphomas, or other cancers near breast implants to the agency. This information will contribute to a better understanding of the risks associated with breast implants and help improve patient safety.

The FDA suggests that individuals with or considering breast implants should educate themselves about the potential risks and benefits, continue with routine medical care and follow-ups, and closely monitor their implants for any changes. If any changes are observed, patients should immediately contact their surgeon or healthcare provider for further evaluation. It is important to note that the FDA does not recommend the removal of breast implants solely based on concerns regarding the risk of developing SCC or various lymphomas if no symptoms are present.

Healthcare providers play a vital role in addressing this issue and should remain informed about these cases. They should offer regular care and support to patients with breast implants, ensuring that they receive accurate information and guidance. Additionally, healthcare providers should incorporate information about SCC and various lymphomas in the capsule around the breast implant in their conversations with patients who have or are considering breast implants, facilitating informed decision-making.

The FDA has expressed their commitment to collecting and examining all obtainable information on SCC, lymphomas, and other cancers in the capsule surrounding breast implants. By working closely with regulatory agencies, clinical and scientific professionals, industry associations, manufacturers, and breast implant registries, the FDA seeks to enhance public awareness of SCC in the capsule surrounding breast implants. As new findings and insights emerge, the FDA will continue to share important updates with the public, promoting transparency and prioritizing patient safety.