- For immediate release:
- Statement by:
Today, the US Food and Drug Administration issued a safety communication informing patients and providers of reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. After extensive initial review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare. However, in this case and when safety risks with medical devices are identified, we wanted to provide the public with clear and understandable information as soon as possible.
In some reported cases, patients were diagnosed years after breast placement and presented with findings such as swelling, pain, lumps, or skin changes. These emerging reports of scar tissue lymphoma are distinct from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which the FDA began communicating as a potential risk more than a decade ago .
FDA’s work on patient-centered risk communication for these devices has accelerated in recent years, including gathering stakeholders to share perspectives that have informed FDA’s regulatory oversight and implementation of new requirements. for manufacturers. We continue to engage senior cancer experts and are consulting with our Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field. Additionally, the agency continues to closely monitor various sources of data, such as the scientific literature, adverse event reports submitted to the agency, and is requesting information from manufacturers regarding any reports they may have regarding with SCC and other lymphomas associated with tissue around an implant.
We know that breast implants are not lifelong devices and that the longer a patient has breast implants, the more likely they are to be removed or replaced. We also understand that information about breast implant risks can be overwhelming for a patient. For this reason, we encourage the review of our website with attention to patient labeling, which has easily understandable information in the patient brochure.
Right now, we don’t have enough information to say whether breast implants cause these cancers or whether some implants pose a higher risk than others. For this reason, cases of SCC, lymphoma, and any cancer located in the scar tissue around breast implants must be reported to the FDA. Our collective understanding has advanced significantly due to efforts to study, communicate and act when necessary. As the agency moves forward in adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is essential.
If a patient with breast implants is experiencing a problem, or has a case of SCC, lymphoma, or any other cancer of the breast implant capsule identified, the FDA strongly encourages reporting this through MedWatch, the FDA’s patient information program. safety and adverse event reporting. Reporting strengthens our ability to work with manufacturers and others to improve safety.
Today’s safety communication underscores our commitment to sharing the information we regularly collect and analyze so that patients can fully consider and carefully discuss the risks of the implant with their doctors. We will continue to collaborate with other regulatory authorities, clinical and scientific experts, breast implant registries and patients as part of our commitment to educate and improve evidence generation on these potential new risks.
Looking forward, the FDA will soon complete a comprehensive review of the literature and will continue our partnership with the American Society of Plastic Surgeons as we work to identify ways to gather more detailed information about patient cases where reported breast implant capsule cancer. As we learn more about these cases, we hope to better understand patient risk and communicate the findings to the public.
The safety alert issued today is an evolving issue that will require consistent and ongoing evaluation and communication with patients, healthcare providers and manufacturers. We remain committed to informing the public about important and emerging medical device safety risks and to taking appropriate action on behalf of patients and public health.
###
Boiler plate
The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.
