FOR IMMEDIATE RELEASE
Breast Surgery Collaborative Community Invites Public Comment on Updated FDA Patient Decision Checklist
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 Aesthetic Society
The American Society for Aesthetic Plastic Surgery is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and aesthetic medicine of the face and body. The Aesthetic Society is comprised of over 4,000 members; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
About the American Society of Plastic Surgeons
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. Representing more than 11,000 physician members worldwide, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. Founded in 1931, the society represents physicians who have been certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada.
