ASPS Comments on Draft Breast Implant Labeling Guidance

Late last month, the American Society of Plastic Surgeons submitted its comments to the FDA on the Agency's proposed guidance on the labeling of breast implants. In its comments, ASPS detailed recommendations based on current scientific knowledge and understanding of the risks associated with breast implants.

The draft guidance provides recommendations for the content and format of certain patient education and labeling information. ASPS believes any checklist should be a tool, focusing on understandable information. ASPS encouraged the FDA to review the length of the draft checklists, its readability – that is, the grade level at which it's written – as well as choice of wording to ensure plain, consistent language is used. Furthermore, ASPS expressed its belief that the utilization of graphics is also a good idea.

Additionally, ASPS asked the FDA to address the timing for delivery and implementation of the Patient Information Brochure and checklist, how manufacturers might verify a checklist has been signed, how often the checklist will have to be signed and updated, what process the FDA suggests for when unplanned implant exchange occurs during surgery, and how to notify patients when labeling changes. Finally, the FDA guidance suggests recommendations for the breast implant card, rupture screening, and breast implant materials to which ASPS offered suggestions.ASPS has worked through the members of its Health Policy Committee to provide feedback on this proposed breast implant guidance and will continue to advocate for the specialty, ensuring the creation of any guidance documents related to breast implants remains transparent and does not limit access to care.