Arlington Heights, Ill, June 12, 2024 (GLOBE NEWSWIRE) -- A consensus statement on the terminology and management of breast implant capsules issued by the Breast Surgery Collaborative Community (BSCC), a consortium of patient advocates, board-certified plastic surgeons and others with a vested interest in enhancing breast surgery safety, offers clarity for women seeking guidance on removal of breast implants related to health concerns.
In particular, the BSCC, which includes physician representatives of the American Society of Plastic Surgeons (ASPS) and The Aesthetic Society, notes that an en bloc capsulectomy – a lengthy, complex, and expensive procedure – is only necessary for patients with an established or suspected breast implant-associated cancer after appropriate medical workup.
“It’s unfortunate, but there are surgeons who will capitalize on a patient’s trust or fear to urge them toward the more costly and riskier procedure,” says The Plastic Surgery Foundation (PSF) President Scot Bradley Glasberg, MD, who is a co-founder of the BSCC. “In actuality, the en bloc is only necessary in very specific cases, and it can leave patients with significant breast deformities and be prone to complications. Ultimately, it should be the science and clinical data that dictates clinical care and guidelines.”
The BSCC consensus statement points out that it is currently unknown whether the removal of breast implants with or without a capsulectomy will prevent the future development of a breast implant-associated cancer. It also says there is a rare subset of patients who have still developed breast implant-associated cancer after capsulectomy.
The BSCC statement adds that patients who decide to undergo a capsulectomy, particularly those with textured implants, must continue standard clinical monitoring and imaging surveillance after that surgery.
“It’s absolutely vital that patients be made aware of all options and the risks associated with any surgical procedure during the informed consent process,” says William P. Adams Jr., MD, a past-president of The Aesthetic Society, The Aesthetic Foundation, and also a co-founder of BSCC. “It is always a patient’s choice to elect to undergo a procedure such as a capsulectomy, provided the risks of such a surgery are clearly understood. However, it is our responsibility as plastic surgeons to ensure that patients get the best evidence-based information developed through high level science, and right now many patients are being given a lot of misinformation on the internet and social media sites.”
The BSCC consensus statement defines four types of capsulectomy:
- Total intact capsulectomy: Complete removal of the breast implant capsule as a single unit.
- Total capsulectomy (total precise capsulectomy): Complete removal of the breast implant capsule, not necessarily done as a single unit or in one piece.
- Partial capsulectomy: Removal of the breast implant capsule where some capsule is left behind.
- En bloc capsulectomy: Removal of the breast implant capsule with a margin of uninvolved tissue for treatment of suspected or established breast implant-associated cancers after appropriate medical workup.
Further, the BSCC consensus statement explicitly states, “the absolute and only indication for an en bloc capsulectomy is for an established or suspected breast implant-associated cancer after appropriate medical workup.”
The BSCC notes that the informed-consent process for patients considering a capsulectomy should be a shared decision-making process with their surgeon, including a discussion of potential benefits and risks. This should include patient concerns regarding systemic symptoms, often referred to as Breast Implant Illness (BII), the risk of breast implant-associated cancers involving the capsule (such as BIA-ALCL, BIA-SCC, etc.), and any potential future risks, especially resulting from textured implants and tissue expanders. Importantly, the risk of the capsulectomy procedure itself, including the patient's medical history, must also be weighed against those risks noted.
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, Global Patient Advocacy Coalition, Young Survival Coalition and FORCE: Facing Our Risk of Cancer Empowered. The group also welcomes participation from the FDA/CDRH and breast implant/breast device manufacturers and 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. The BSCC is one of 17 collaborative communities in which the FDA currently participates.
About ASPS
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. ASPS comprises more than 92 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada.
About The Aesthetic Society
The Aesthetic Society is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. The Aesthetic Society is comprised of over 3,000 Plastic Surgeons; 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.
Members of the BSCC
William P. Adams Jr., MD, The Aesthetic Society/The Aesthetic Foundation
Amanda Savage Brown PhD, LCSW, Patient Advocate
George Chatson, MD, ASPS/The Aesthetic Society
Lynn Damitz, MD, ASPS/PSF
Terri Diaz, Patient Advocate, Global Patient Advocacy Coalition
Maria Gmitro, Patient Advocate, Breast Implant Safety Alliance
Scot Bradley Glasberg, MD, ASPS/ PSF
Melinda Haws, MD, Immediate Past President, The Aesthetic Society
Amanda Hynum, Patient Advocate, Young Survival Coalition
Debra Johnson, MD, At Large Plastic Surgery Representative
Patricia McGuire, MD, The Aesthetic Foundation
Jennifer Cook, Patient Advocate, Breast Implant Safety Alliance
Briana Theroux, At-Large Patient Advocate
Kiya Movassaghi, MD, DMD, President, The Aesthetic Society – ex officio
Steven Williams, MD, President, ASPS – ex officio
