The U.S. Food and Drug Administration (FDA) has issued a safety warning about additional cancers discovered in association with breast implants. The September 9 communication reports that numerous cancers have been detected in tissues surrounding breast implants.
The announcement is targeted at people who have received breast implants as well as healthcare providers who perform breast implantation procedures. The agency states that multiple cancers, including squamous cell carcinoma, have been identified in the scar tissue or connective capsule around breast implants.
At this time, the FDA’s position is that the occurrence of these cancers is rare. Nonetheless, the agency is initiating an extensive review of these events in order to identify any clear risks to public health. Patients in the cases reported have had breast implants for years and presented with initial symptoms of swelling, pain, lumps, or skin changes in the areas around the breast implant.
The agency has also explicitly distinguished these cancers from the years-long investigation into Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is a form of lymphoma that occurs in people with breast implants, usually textured breast implants. BIA-ALCL is often able to be eradicated with the removal of the implants alongside traditional lymphoma treatments.
The FDA has announced that it continues to engage with cancer experts and the agency’s Oncology Center of Excellence in order to coordinate an approach informed by leaders in the field. This approach will be informed by scientific literature, adverse event reports from patients, and information solicited from manufacturers about the occurrence of squamous cell carcinoma and other cancers found in the tissue around the implants.
The FDA announcement states that breast implants are not lifetime devices. The longer that a breast implant is in a patient, the more likely it is that the implant will need to be removed or replaced. The agency is dedicated to understanding the full array of potential side effects that breast implants can cause. The FDA is currently investigating in order to determine whether some breast implants pose a higher risk of developing squamous cell carcinoma or other cancers.
Due to the recency of these events and the evolving nature of the situation, the FDA is asking breast implant patients to speak out about any lymphomas or squamous cell carcinomas they are experiencing. Patients experiencing adverse breast implant side effects should report their adverse event to Medwatch.