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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, September 15, 2022
On September 8, 2022, the following statement (an abbreviated version of which appears here) was made by Binita Ashar, MD, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA):
“The U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive 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 clear and understandable information to the public as quickly as possible.
“In some reported cases, patients were diagnosed years after having breast implants and presented with findings such as swelling, pain, lumps, or skin changes. These emerging reports of lymphoma in scar tissue are different from breast implant–associated anaplastic large cell lymphoma which the FDA began communicating about as a potential risk more than a decade ago.
“The FDA’s work in the area of patient-centered risk communication for these devices has accelerated in recent years, including convening stakeholders to share perspectives that have informed the FDA’s regulatory oversight and implementation of new requirements for manufacturers. We continue to engage top 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 data sources, such as the scientific literature and adverse event reports submitted to the agency, and is soliciting information from manufacturers regarding any reports they may have regarding SCC and other lymphomas related to the tissue around an implant.
“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others. For this reason, instances of SCC, lymphoma, and any cancer located in the scar tissue around breast implants should be reported to the FDA. If a patient with breast implants is experiencing a problem, or there is 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 Safety Information and Adverse Event Reporting program. Reporting strengthens our ability to work with manufacturers and others to improve safety.
“As we learn more about these cases, we hope to better understand the patient risk and communicate findings to the public.”
U.S. Food and Drug Administration
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