The FDA issued a safety communication to inform patients and providers of potential cancers in scar tissue around breast implants.
According to the agency’s notice, it received reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. Some cases included patients diagnosed years after having breast implants. Findings included swelling, pain, lumps or skin changes.
After an initial review, the FDA determined that the risk of SCC and other lymphomas in this situation is rare. However, the agency wanted to provide “clear and understandable” information to the public on the matter. The FDA added that it is engaging “top cancer experts” and consulting with its Oncology Center of Excellence to ensure a coordinated approach.
“We know that breast implants are not lifetime devices, and that the longer a patient has breast implants, the more likely they will need to be removed or replaced,” the FDA notice said. “We also understand that information regarding breast implant risks can be overwhelming for a patient. For this reason, we encourage review of our website with attention to patient labeling, which has easy-to-understand information in the patient brochure.”
The FDA went on to say that there is not enough information at present to say whether the implants cause the cancers or if some implants come with higher risks than others. If a patient with breast implants experiences a problem or observes a case of SCC, lymphoma or any other cancer of the breast implant capsule identified, the FDA encourages reporting this through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Additionally, the FDA will complete a literature review and continue its partnership with the American Society of Plastic Surgeons. It seeks to identify ways to collect more detailed information regarding these patient cases.
“The safety signal issued [Sept. 8] is an emerging issue that will require steadfast, ongoing evaluation and communication with patients, healthcare providers and manufacturers,” the FDA said. “We remain committed to informing the public of important and emerging medical device safety risks and appropriately take action on behalf of patients and public health. “
