The revised checklist aims to shorten and clarify the current document to better support shared decision-making between patients and surgeons.
The Breast Surgery Collaborative Community (BSCC), comprised of patient advocates and board-certified plastic surgeons, has posted a proposed update to the US Food and Drug Administration (FDA)’s Breast Implant Patient Decision Checklist to the FDA public docket and opened a public comment period.
Since the checklist was implemented in 2022, patients and clinicians have raised concerns about its length, clarity, and practical usefulness as a patient educational tool. Patient advocates have called for a shorter, more concise document that would supplement existing informed consent for breast implant procedures without duplicating or complicating current processes.
In response, the BSCC convened a consensus-based revision effort that included patients, surgeons, and manufacturers, with the stated goal of making the checklist more patient-friendly, understandable, and practical for real-world clinical use.
A central objective of the revised document is to better support shared decision-making between patients and physicians. By streamlining the checklist and improving clarity, the BSCC says it aims to encourage more effective use of the document during consultations and help ensure its contents are fully discussed and understood.
The group noted that public input is essential to refining the document and is encouraging interested parties and stakeholders to review the proposal and submit feedback.
Public comments may be submitted directly to the FDA public docket Dec 1, 2026. The BSCC asks commenters to include the tracking number mt7-xgl2-2crx so the FDA can identify submissions referring to the BSCC document.
The BSCC follows the framework of FDA collaborative communities and includes patient advocates, board-certified plastic surgeons, and industry representatives. Member organizations represented in the group include the American Society of Plastic Surgeons, The Aesthetic Society, The Plastic Surgery Foundation, The Aesthetic Foundation, Breast Implant Safety Alliance, Young Survival Coalition, and FORCE: Facing Our Risk of Cancer Empowered. Breast implant and breast device manufacturers also participate in the group’s consensus discussions.
The BSCC’s stated mission is to facilitate discussions with the FDA, CMS, medical professional organizations, patients, and the public on issues related to breast medical devices and breast surgery to enhance regulatory and clinical decision-making.
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