Public comment is open until December 23 on new draft guidance for labeling of breast implants from the US Food and Drug Administration (FDA). The agency issued the guidance—which contains a sample “black box” warning, and patient decision checklist—in response to concerns that some women are not receiving and/or understanding information about the risks and benefits of the devices.
Detailing the rationale for the changes in the Federal Register, FDA noted recent information on risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms that some women attribute to their implants. In March, the agency convened a meeting of its General and Plastic Surgery Devices Advisory Panel to discuss long-term benefits and risks of breast implants. The panel’s recommendations included a requirement for a “black box” warning, a checklist for informed consent, revised screening recommendations for silent ruptures of silicone implants, and a patient device card.
The warning, the FDA guidance says, should inform patients that:
- Breast implants are not lifetime devices
- Likelihood of complications with implants increases over time
- Some complications require surgery
- Breast implants have been associated with risk of developing BIA-ALCL and may be associated with systemic symptoms
According to FDA, the patient checklist should appear at the end of the manufacturer’s patient information booklet/brochure and inform women about:
- Situations in which the implant should not be used
- Considerations for a successful breast implant candidate
- Risks of implant surgery
- Importance of appropriate physician education, training and experience
- Risk of BIA-ALCL and systemic symptoms, to be updated based on post-market data
- Options other than breast implants
FDA is also recommending screening for rupture between years 5 and 6 post-surgery and every 2 to 3 years thereafter in asymptomatic women with ultrasound or magnetic resonance imaging (MRI). An MRI is recommended at any time for women with implants who have symptoms or equivocal ultrasound results for rupture.