ARLINGTON HEIGHTS, IL – The Breast Surgery Collaborative Community (BSCC) today announced that it has posted to the FDA public docket and has opened a public comment period on a proposed update to the FDA”s Breast Implant Patient Decision Checklist.
Since the checklist’s implementation in 2022, patients and clinicians have raised concerns about its length, clarity and practical usefulness as a patient educational tool. Over time, patient advocates have expressed a clear desire for a shorter, more concise checklist that would meaningfully supplement existing informed consent for breast implant procedures without duplicating or complicating processes. In response, the BSCC undertook a consensus-based effort to revise the current Patient Decision Checklist with the goal of making it more patient-friendly, understandable and practical for real-world clinical use. This collaborative effort included patients, surgeons and manufacturers, ensuring that multiple perspectives were represented throughout the process.
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 aims to encourage more effective use of the document during consultations and to help ensure that its contents are fully discussed and understood.
The BSCC understands that public input is essential to refining the document. Therefore, the revised checklist has been submitted to the FDA public docket for an open comment period. The BSCC encourages all interested parties and stakeholders to review the document and provide constructive feedback.
The BSCC operates and has chosen to follow the framework of FDA collaborative communities. Its members include patients, healthcare professionals and industry representatives committed to improving patient education and informed consent in breast surgery.
Public comments may be submitted directly to the FDA public docket at https://www.regulations.gov/comment/FDA-2019-D-4467-1386 by December 1, 2026. When providing your comment, please include the key tracking number in your comment so that the FDA knows you are referring to the BSCC document: mt7-xgl2-2crx.
A full list of BSCC members is provided below.
William P. Adams Jr., MD (The Aesthetic Society/The Aesthetic Foundation)
Scot B. Glasberg, MD (ASPS/PSF)
George Chatson, MD (ASPS/PSF)
Jennifer Cook (Patient and Advocate (BISA))
Lynn Damitz, MD (ASPS/PSF)
Melinda Haws, MD (The Aesthetic Society/The Aesthetic Foundation)
Amanda Hynum (Patient Advocate / Oregon Health and Science University)
Cynthia Johnson, RN (Patient Advocate)
Debra Johnson, MD (At Large PS Representative)
Meristacia Kingston, MD (Patient Advocate, Pediatric Hospitalist Fellow)
Patricia McGuire, MD (The Aesthetic Society/The Aesthetic Foundation)
Kimberly Platt, MSN, RN, CAPA (Patient Advocate, Registered Nurse)
*Sheryl Robinson-Collins (Head of Regulatory Affairs, Mentor Worldwide LLC)
*Margie Rose, MPH (Head of Global Regulatory Affairs, Establishment Labs/Motiva)
*Sara Saul, PhD (Head of Medical Affairs, Tiger Aesthetics/Sientra)
Briana Theroux (At Large Patient /Author/Nutrition Psychology)
*Jamil Ahmad, MD (The Aesthetic Society President – Ex-Officio)
*C. Bob Basu, MD, MBA, MPH, FACS (ASPS President – Ex-Officio)
*Non-voting members
About the Breast Surgery Collaborative Community (BSCC)
The BSCC is comprised of patient advocates and board-certified plastic surgeons, many of whom serve as representatives of organizations including 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. The group also welcomes participation from the breast implant/breast device manufacturers to provide consensus on key issues affecting the safe delivery of surgical care related to breast surgery.
The mission of the BSCC is to facilitate discussions and communications with the FDA, CMS, medical professional organizations, patients, media, public and other relevant organizations on key issues related to breast medical devices and related breast surgery matters for the purpose of enhancing regulatory and clinical decision-making. A collaborative community is a continuing forum in which private- and public-sector members, which can include the FDA, work together on medical device challenges to achieve common objectives and outcomes.
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