The US Food and Drug Administration has issued a safety communication 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, it believes 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, the FDA said it wanted to provide clear information to the public quickly.
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 (BIA-ALCL), which the FDA began communicating about as a potential risk more than a decade ago.
Work of the FDA
The FDA’s work in patient-centred 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.
The FDA said it is continuing to engage with top cancer experts and is consulting with its Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field.
Additionally, the agency continues to monitor various data sources, including scientific literature, adverse event reports submitted to the agency and is soliciting information from manufacturers regarding reports they may have regarding SCC and other lymphomas related to the tissue around an implant.
Binita Ashar MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health said: “We know 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.
“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 labelling, which has easy to understand information in the patient brochure.
“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.
“Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed.
“As the agency moves further into adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is crucial.”
