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Consensus Statement on Breast Implant Capsulectomy Definitions and Management Created by Breast Surgery Collaborative Community

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. 

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. 

Perhaps one of the most important notations from the BSCC consensus statement is the language around what is defined as an “En bloc capsulectomy.”  The statement explicitly declares, “the absolute and only indication for an en bloc capsulectomy is for an established or suspected breast implant-associated cancer after appropriate medical workup.”  This decision for surgery is clearly a part of the informed consent process, and any decisions should be shared between the patient and surgeon in a formal discussion around risk assessment, benefits, and alternatives, as well as the expected outcomes.  Clear discussions to clarify any confusion and obfuscation around the separate and distinct entities of Systemic Symptoms associated with Breast Implants and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) should be had when they exist.  Any choices made from that discussion would result from a question-and-answer process for informed consent with decision making shared among the doctor and the patient. 

The result of this consensus statement stems in large part due to the significant efforts of the surgeon scientist members of The Aesthetic Society and The Aesthetic Foundation.  Several notable manuscripts have contributed heavily to the canon of literature for which these guidelines are supported:

  1. Glicksman C, McGuire P, Kadin M, Lawrence M, Haws M, Newby J, Ferenz S, Sung J, Wixtrom R. Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1. Aesthet Surg J. 2022 Jun 20;42(7):809-819. doi: 10.1093/asj/sjab417. PMID: 34915566; PMCID: PMC9208825.
     
  2. Wixtrom R, Glicksman C, Kadin M, Lawrence M, Haws M, Ferenz S, Sung J, McGuire P. Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2. Aesthet Surg J. 2022 Aug 24;42(9):1067-1076. doi: 10.1093/asj/sjac106. PMID: 35474526; PMCID: PMC9400612.
     
  3. McGuire P, Glicksman C, Wixtrom R, Sung CJ, Hamilton R, Lawrence M, Haws M, Ferenz S, Kadin M. Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 3. Aesthet Surg J. 2023 Feb 3;43(2):230-244. doi: 10.1093/asj/sjac225. PMID: 35980942; PMCID: PMC9896138.
     
  4. Glicksman C, McGuire P, Kadin M, Barnes K, Wixtrom R, Lawrence M, Haws M, Ferenz S, Sung CJ, Hamilton RG, Faasse K. Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 4. Aesthet Surg J. 2023 Sep 14;43(10):1194-1204. doi: 10.1093/asj/sjad098. PMID: 37040435; PMCID: PMC10501748.
     
  5. Afshari A, Nguyen L, Glassman GE, Perdikis G, Grotting JC, Higdon KK. Incidence and Preoperative Risk Factors for Major Complications After Capsulectomy: Analysis of 3048 Patients. Aesthet Surg J. 2022 May 18;42(6):603-612. doi: 10.1093/asj/sjac004. PMID: 35022655.
     
  6. Newby JM, et al. Understanding Breast Implant Illness. Aesthetic Surg J. 2020 Dec;41(12):1367-1379.
     
  7. Tang S, et al. A Qualitative Study on the Experiences of Women With Breast Implant Illness. Aesthetic Surg J. 2021 Apr;42(4):381-393.

“We are grateful to share out the efforts of our Surgeon-Scientist Leaders in The Aesthetic Society and The Aesthetic Foundation, whose groundbreaking research has shown a path for safety and understanding for our patients with implants. This is a win for all parties involved and a great benefit for our member plastic surgeons and the patients for whom they provide the highest level of care.”  Dr. Kiya Movassaghi, President of The Aesthetic Society.