The U.S. Food and Drug Administration on Tuesday issued a final warning label and new guidance to inform patients of the potential risks associated with breast implants.
The breast implant guidance includes a boxed warning, also known as a black box warning, to call attention to the serious or life-threatening side effects linked to breast implants. The warning applies to saline or silicone gel implants used in “breast augmentation or breast reconstruction,” which accounts for most, if not all, breast implants.
The consumer warning was part of a 22-page breast implant guidance report that was heavily based on draft guidelines released last October.
The FDA’s warning label aims to raise awareness of breast implant-associated anaplastic large-cell lymphoma, a cancer that exclusively occurs in individuals with breast implants. BIA-ALCL, which is more common in patients with textured breast implants, has been the subject of a mass recall of breast implants in the past.
The labeling also carries the following warnings:
- Breast implants aren’t designed for permanent use
- Risks increase the longer the patient has the implant
- Breast implant complications may require revision or follow-up surgeries
- Patients with implants have reported “systemic symptoms” that can affect the entire body
“It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions," said Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA's Center for Devices and Radiological Health, in a statement.
The new guidance also helps patients weighing whether to get implants, with a patient information brochure and seven-page patient decision checklist.
Part of the informed consent process, patient decision checklists are documents describing the risks and possible complications of a procedure or device. Patients must review and acknowledge the checklist when deciding if a device or procedure is right for them.
By creating a standardized checklist for breast implants, the FDA hopes that patients will have more opportunity to educate themselves about the risks of breast implants and lessen the risks associated with the devices.
FDA guidance references breast implant illness but doesn’t go as far as giving the illness a diagnostic code, a development that patient advocates have pushed for. The agency called the connection between BII and breast implants “unclear at this time.”