BSCC Issues Consensus Statement on Breast Implant Capsulectomy Definitions and Management

Written By Breast Implant Safety Alliance

Members of BISA recently worked on a consensus document as part of the Breast Surgery Collaborative Community (BSCC) in regards to breast implant removal terminology. The consensus document is titled Consensus Statement from the Breast Surgery Collaborative Community (BSCC) on Capsulectomy Terminology and Management. This consensus document is only the first part of what we hope will be a series of documents from the BSCC addressing related topics in more depth. These documents will help BISA create balanced educational tools and materials for individuals considering explant surgery.

Why is this important?

This is important because many surgeons have varying opinions on implant and surrounding scar tissue removal which can be confusing to patients. It can be important for patients to know and communicate to their doctors the precise type of capsulectomy they had (1) when undergoing future imaging and (2) when seeking evaluation of post explant symptoms.

What is explant surgery?

Explant surgery is the process of removing breast implants. According to the ASPS, “the goal of breast implant removal surgery is to remove breast implants from breast augmentation or breast reconstruction patients. During these procedures, the surgeon may also remove silicone material from implant leaks and the breast capsule, which is the scar tissue that forms after the placement of a breast implant.”

What is a capsulectomy?

Those unfamiliar with breast implant removal need to understand that scar tissue forms around the breast implants and begins as soon as they are implanted into the body. The scar tissue is also referred to as breast implant capsule and the removal of this capsule is called a capsulectomy. When patients are considering breast implant removal, explant surgery is not one size fits all. BISA believes the patient should be informed of the various types of removal as well as the risks and benefits of each.

What is the Breast Surgery Collaborative Community (BSCC) and why was it created?

According to a recent press release by The Aesthetic Society, “The FDA recently created a strategic priority for the creation of collaborative communities to bring together stakeholders in the medical device realm to solve challenges and achieve a collective betterment for patients, physicians, industry, as well as the medical community at large.  In the cases of breast implants and symptoms associated with having breast implants in some patients, a Breast Surgery Collaborative Community (BSCC) was created due to issues where managing breast implant-related issues were quite complicated.

The Breast Surgery Collaborative Community (BSCC), a consortium of patient advocates, board-certified plastic surgeons, the medical device industry, and others with a vested interest in enhancing breast surgery safety, was assembled to offer clarity for women seeking guidance on removal of breast implants related to health concerns.”

Breast Surgery Collaborative Community (BSCC) Capsulectomy Terminology and Management Consensus Document

Breast Surgery Collaborative Community (BSCC) Capsulectomy Terminology and Management Consensus Document PDF

 

Why the need for consensus?

The purpose of the consensus document was to create consensus on terminology. Patients and surgeons often use capsulectomy-related terms loosely with different intended meanings. This creates confusion for patients when making explant-related decisions. The BSCC consensus document defines the different types of capsulectomy in hopes that patients and surgeons will begin to use the terms in the same way to avoid confusion. It can be important for patients to accurately inform their doctors of the specific type of capsulectomy they underwent, both when undergoing future imaging and when seeking evaluation of symptoms after explantation.

“BISA believes the patient should be informed of the various types of removals as well as the risks and benefits of each. It is not BISA’s position to tell patients what type of implant/capsule removal patients should choose but rather to provide balanced information from credible sources for the purpose of balanced, informed shared-decision making. ”
— Breast Implant Safety Alliance (BISA)
 

Risks & Benefits

Information relevant to the risks and benefits for various types of capsulectomies are complex and evolving and patients should stay up to date on what is known and unknown from diverse and reliable sources. Staying informed will help individuals seeking explant surgery ask the right questions for purposes of choosing the best surgeon for them and the best course of action for their situation. The risks and benefits of the different explant procedures vary from individual to individual and can be impacted by many factors. These factors include individual anatomy, whether the patient’s implants are ruptured, whether the patient’s implants have been recalled for safety, and/or whether the patient has an increased risk of a breast implant-associated cancer. For the latest information on breast implant-associated cancers, read BISA’s most recent blog article of highlights from the 5th BIA-ALCL World Consensus Conference.


According to the BSCC, “The informed consent 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 or 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.”


The BSCC additionally states, “It is currently unknown whether capsulectomy prevents the future development of a breast implant-associated cancer. There is a rare subset of patients who have still developed a breast implant-associated cancer after capsulectomy. Patients who do decide to undergo a capsulectomy, particularly those with textured implants, must continue standard clinical monitoring and imaging surveillance. 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.”

As stated earlier, BISA believes the patient should be informed of the various types of removals as well as the risks and benefits of each. It is not BISA’s position to tell patients what type of implant/capsule removal patients should choose but rather to provide balanced information from credible sources for the purpose of balanced and informed, shared-decision making. 


Like other plastic surgery leaders, BISA is also concerned that there are surgeons that will capitalize on a patient’s trust and engage in practices dictated by something other than the science and clinical data. BISA’s concern, however, is not limited to surgeons that may perform oncologic procedures when there is no concern for a malignancy. Our concerns extend to all aspects of care that plastic surgeons provide including the informed consent process, the presurgical evaluation, and the postoperative pathology.

“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. 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. Unfortunately not all patients say they are receiving proper informed consent or clearly understand the risks and benefits. However, it is our responsibility as patient advocates to ensure that patients get the best evidence-based, balanced information. And right now, many patients are concerned that they are getting biased and untrustworthy information from their plastic surgeons.”
— Maria Gmitro, BISA president & BSCC founding member
 

Differentiating the Work Product of the BSCC from the Joint Press Releases by Two Plastic Surgery Societies

We feel it is important to provide a bit more clarification on the BSCC consensus document and the joint statements from the American Society of Plastic Surgeons (ASPS) and The Aesthetic Society (ASAPS).

  1. The work product of the BSCC discussed in this blog is the document titled Consensus Statement from the Breast Surgery Collaborative Community (BSCC) on Capsulectomy Terminology and Management. The BSCC charter does not require 100% consensus of all members for document approval and in this instance, unanimous approval was not achieved.


  2. Members of BISA do serve on the BSCC and collaborated on the verbiage of this document and did vote to approve Consensus Statement from the Breast Surgery Collaborative Community (BSCC) on Capsulectomy Terminology and Management. As members of the BSCC, we participate as individuals, as stakeholders, and as members of an organization. As stated in the BSCC charter, as members we may present BSCC recommendations to our respective groups/organizations, however, we or our organization are not under any obligation to endorse BSCC proposals. BISA’s Board of Directors voted to endorse the consensus document on July 3, 2024.


  3. On Wednesday, June 14, 2024, two plastic surgery societies, the American Society of Plastic Surgeons (ASPS) and The Aesthetic Society (ASPAS) released statements discussing the BSCC work product. The societies titled their joint statement/press release about the BSCC deliverable to mirror the title of the document itself; however, the ASPS and the ASAPS joint statement/press releases are not a product of the BSCC and BISA members had no role in the drafting or publishing.

 

BISA’s History with Collaborative Communities and the Breast Surgery Collaborative Community (BSCC)

Collaboration with the medical community has always been a large part of our mission. Since 2019, members of Breast Implant Safety Alliance (BISA) have been involved in multiple collaborative groups related to consumer and patient safety for informed decision making in regards to breast surgery including breast implants.

Maria Gmitro, BISA’s president and founder, has served on the National Center for Health Research’s Breast Implant Working Group, the Breast Implant Collaborative Council (BICC) with the American Society of Plastic Surgeons (ASPS), the Breast Device Collaborative Community (BDCC) with The Aesthetic Society (ASAPS), and now as a founding member of the Breast Surgery Collaborative Community (BSCC).

Jennifer Cook, BISA’s Director of BIA-ALCL Advocacy and Amanda Savage Brown Ph.D., LCSW, Licensed Psychotherapist, BISA’s Mental Health Advisor, are also members serving on the BSCC.

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. Members from the FDA/CDRH and breast implant/breast device manufacturers are also asked to join BSCC meetings.

BSCC Vision, Mission & Responsibilities

The BSCC was created with a vision to bring all stakeholders, including patients, surgeons, manufacturers, and the FDA, within the breast surgery and device marketplace together to provide consensus on key issues affecting the safe delivery of surgical care. 

The mission of the BSCC is to facilitate discussions and communications with relevant entities, including the FDA, CMS, medical professional organizations, patients, the media, the public, and/or other relevant organizations, on key issues related to breast medical devices and related breast surgery matters to enhance regulatory and clinical decision-making.

The responsibilities of the BSCC are to identify issues involving breast devices and work to develop solutions. As members of the BSCC, we participate as individuals, as stakeholders, and as members of an organization. As stated in the BSCC charter, as members we may present BSCC recommendations to our respective groups/organizations, however, we or our organization are not under any obligation to endorse BSCC proposals.

Typically, the BSCC has been meeting virtually once a month and supplements communication and discussions via email.

About Breast Implant Safety Alliance (BISA)

The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority focused on providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.

Current Members of the BSCC

*As of July 3. 2024, the following are the current members of the BSCC. Three patient advocates resigned from the collaborative earlier this year and open spots are in the process of being filled.

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
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

 
 
 

Questions, comments or concerns? Email our team at contact@bisanonprofit.org

About Breast Implant Safety Alliance: BISA is a 501(c)3 women-owned nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, medical professionals, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization not funded by implant manufacturers.

Breast Implant Safety Alliance https://bisanonprofit.org
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