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“All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.”1—Arthur Schopenhauer
Consider a patient who presents to your clinic having just heard media reports about the risks of textured surface breast implants and breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).2 She is concerned about developing lymphoma, and wants to minimize her risk as much as possible. Having no symptoms or evidence of disease, neither the FDA nor any national plastic surgery societies recommend prophylactic explantation for this patient.3 Despite this, she wishes to proceed with an implant exchange to smooth surface implants combined with total capsulectomies, recommendations she obtained from social media websites. Plastic surgeons who place breast implants have likely encountered this clinical scenario, and up to this point there was a lack of data on whether risk reduction was possible for this in any specific patient population—that is, until the current manuscript.4
Drs di Pompeo and Sorotos present clear and convincing evidence for the justification of prophylactic explantation of asymptomatic patients with textured surface implants. Through a systematic review of BIA-ALCL world cases, the authors have demonstrated that textured implant removal or replacement with smooth implants decreases the future onset of BIA-ALCL, whereas patients with no exchange or exchange to another textured device maintain their risk. A single implant exchange reduced the number of expected BIA-ALCL cases by 30%, and by nearly 65% if a patient underwent 2 exchanges. Through subcohort analysis, the authors stratify BIA-ALCL risk reduction for asymptomatic patients, and thereby identify patient populations that most benefit from prophylactic explantation. Taking into consideration BRCA status, Li Fraumeni p53 mutation, age greater than 45, etc., the risk factor score introduced by the authors provides a helpful and easy-to-adopt tool to assist in shared decision-making with patients.
A surprising finding of this study was the observed “protective effect” of breast implant ruptures and capsular contracture, although these likely represent surrogates for situations necessitating explantation. Unfortunately, data on capsule management were limited, with less than 10% of the implant exchange reports indicating some form of capsulectomy. Performing a capsulectomy to address silicone or polyurethane particulate shed seems intuitive, but additional studies are warranted to determine whether capsule removal imparts additional risk reduction. For those surgeons who do choose to remove the capsule out of concern for BIA-ALCL, we recommend evaluating the capsule with CD30 immunohistochemistry in a standardized fashion, such that 12 regions of the capsule are sampled to adequately screen for disease.5 National Comprehensive Cancer Network guidelines advise BIA-ALCL patients to remove the contralateral implant combined with total capsulectomy due to incidental bilateral disease.6 Therefore, prophylactic explantation has precedence in previous guidelines, but the current manuscript significantly broadens the indications for asymptomatic patients with textured devices.
Any consideration for a risk-reducing procedure must take into account a risk-benefit analysis based upon the explant surgery itself. Readers should evaluate the current manuscript in tandem with Dr di Pompeo's other recent article on revisional breast surgery and mortality risk.7 In brief, an additional explant procedure performed to mitigate BIA-ALCL risk carried minimal chance of morbidity and a surgery mortality rate of zero in a study of nearly 100,000 oncologic and non-oncologic breast implant patients. Compare this to BIA-ALCL risk, which Cordeiro and colleagues estimate to be as high as 1:100 in breast reconstruction with Biocell devices.8 As each patient's clinical history is different, the final decision for prophylactic explantation must take into account unique surgical risks and comorbidities. Just as important, risk reduction is not absolute, and patients should be aware of the need to continue to monitor and report back to their surgeon with any abnormal breast findings. Disease has still occurred years after total capsulectomy, but these cases are rare, and this does not contradict the possible level of risk reduction.9
It is important to emphasize findings in this paper that corroborate previous studies. No pure smooth implant cases are reported here, nor in any case series or registry worldwide. BIA-ALCL is uncommon but emerging. Standardized informed consents, national prospective implant registries, and mechanisms for education, awareness, and reporting all contribute to geographical discrepancies and case clustering, which do not result from surgeon technique or bacteria, misinformation that is frequently perpetuated by industry proxies.10
Currently, the FDA advocates neither for keeping nor explanting Biocell textured implants. In light of this new evidence, surgeons and patients will question whether the FDA and other national societies will update recommendations for prophylactic explantation for Biocell or any textured surface implant, and whether insurance providers will provide coverage for “risk-reducing” explantations. Precedence on explantation and authority guidance suggests that institutions will likely continue to have no recommendation, reserving the decision for surgeon and patient. A strategic ambivalence accepts and allows for those that perform the procedure without admonishing those that do not. The vast majority of revisional surgeries are covered by insurance for breast cancer patients, however a pressing question, as yet unanswered, is who will pay for these procedures in aesthetic patients.11 Despite the inclusion of a new diagnosis code for BIA-ALCL (C84.7A) in the 2023 ICD-10-CM edition, insurance coverage for treatment of confirmed BIA-ALCL patients is increasingly denied if it follows cosmetic augmentation. Considering that actual oncologic treatments are commonly denied, coverage for prophylactic procedures seems a distant reality. Implant manufacturers and insurance companies are first responsible to their shareholders, whereas physicians bear the responsibility of patient care and advocacy.
I congratulate the authors on an important and much needed study that at once gives actionable data and guidance on the management of asymptomatic patients with textured surface implants. This represents a dramatic evolution in patient management, which seems intuitive and is increasingly performed by surgeons. However, until recently, these management shifts and our understanding of textured implant sequelae seemed unthinkable. This evolution has similarities to Schopenhauer's progression of truth, although, lest we forget, he is considered a foremost pessimist of philosophy because he perceived free will as aimless. Rather let us be optimists, encouraged that risk reduction for BIA-ALCL is possible and reasonable: an important update for our patients at high risk and those who may request the procedure.
Disclosures
MD Anderson Cancer Center participates in FDA clinical trials for Allergan (Irvine, CA), Mentor (Irvine, CA), and Establishment Labs (Alajuela, Costa Rica). Dr Clemens was a consultant to Abbvie Corporation (North Chicago, IL) from 2012 to 2015.
Funding
The author received no financial support for the research, authorship, and publication of this article.
REFERENCES
Author notes
Dr Clemens is associate vice president of perioperative services, MD Anderson Cancer Center, University of Texas, Houston, Texas, USA and is a Breast Surgery section co-editor for Aesthetic Surgery Journal.
