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Hidalgo and Weinstein1 report a retrospective study of 100 women treated for capsular contracture using capsulectomies and Strattice (AbbVie Inc., North Chicago, IL), a porcine acellular dermal matrix (ADM). This important study makes the case for a major and costly intervention, justified by the notion that it is “cheaper than failure.”1 Is it time for plastic surgeons to adopt this method to treat the most common complication of breast augmentation? If so, this treatment would become the new standard, employed in thousands of patients. Caution is needed. This publication does not evaluate the efficacy of this product, which is not approved by the US Food and Drug Administration (FDA) for this indication. Complications are given little description. Important ethical issues include a belated institutional review board (IRB) approval. No mention is made of a safe and effective minimalist treatment alternative.2–4 The discussion of limitations consists of one sentence—retrospective nature and limited follow-up. These issues merit our close consideration. SUPPORTIVE LITERATURE In their 2020 publication, evaluating the first 32 patients treated with ADM, Hidalgo and Weinstein5 reported that capsular contracture recurred in 1 patient among 32 patients (3%) who received ADM. By comparison, 26 patients (among 185 total patients) who did not receive ADM required surgery for recurrence (14%). The control patients were treated before ADM was adopted in 2014, so that these patients had more time to develop and be diagnosed with a capsular contracture. Despite this advantage for the more recently treated cohort, a χ2 test yielded a nonsignificant difference.3 The study period, originally 2014-2018, has been extended 6 years; the authors have now implanted ADM in 100 patients.1 In the new study, the mean follow-up time was 2.3 years,1 compared with 1.25 years for the previous study.5 The recurrence rate has climbed from 3%5 to 10%.1 A comparison of recurrence rates between capsulectomies without ADM (26/185)5 and capsulectomies with ADM (10/100)1 reveals no significant difference. A χ2 test produces a P value of 0.32.6 Consequently, any benefit from incorporating ADM is not supported by the authors’ data. This finding in itself should temper enthusiasm for the insertion of this expensive, biological, non-FDA-approved product. Moreover, a 2024 systematic review concluded that there is insufficient evidence that concurrent insertion of ADM affects recurrence rates.7 No further discussion is needed without reliable evidence of efficacy. A 2009 chart review by Maxwell and Gabriel is referenced in support of ADM insertion to treat capsular contractures.8 These authors reported treating 56 patients with capsular contracture and no recurrences at 1-year follow-up. Only charts with available operative reports were reviewed. In addition to this early report, Hidalgo and Weinstein1 reference a 2012 article published by Hester et al9 These authors reported 3 cases of recurrent capsular contracture among 80 patients (3.75%) treated with Strattice. There are some important caveats. Hester et al did not include 4 additional capsular contractures in this group because they were judged to be clinically insignificant. The authors cautioned that the average follow-up time was only 1.3 years (range, 3 mo to 3.5 y). The historical control patients were treated before the authors started inserting ADM, so that the minimum follow-up time for control patients was >3.5 years. The eligibility criteria were dissimilar. Unlike the historical control group, the more recent group included 49 patients who were treated with ADM prophylactically. These patients had no history of capsular contracture, making them at lower risk than patients who have already developed this complication.4 Also referenced is a second comparative study by Wagner and Mirhhaidari.10 These authors reported 2 recurrences of capsular contracture among 43 women (4.7%), comparing favorably with a cohort of 24 women treated without Strattice (6 recurrences, 25%). The authors excluded 3 recurrences that occurred in 4 patients immediately before the study period, in whom the Strattice was placed posteriorly in the pocket, as opposed to anteriorly. This omission creates selection bias. If these patients are included, there is no significant benefit for ADM utilization (P = 0.08).4 Although a 2023 systematic review and meta-analysis found in favor of ADM in treating capsular contracture, based on only 3 publications comparing methods,11 these sources of bias undermine the conclusion.4 A 2024 review that included 8 studies using ADM to manage capsular contracture concluded that, despite a growing body of literature supporting ADM to treat capsular contracture, data are lacking to definitively determine whether using this product concurrently with implant site change or capsulectomy lowers the rate of capsular contracture recurrence.7 It is possible that most patients do not redevelop capsular contracture in spite of the presence of this implanted allograft (AlloDerm, AbbVie) or xenograft (Strattice) rather than because of it. A limitation of retrospective studies is that the investigator is, by definition, looking back rather than forward. The authors have already implemented their new method and replaced their previous one. There is pressure to find a new treatment superior to the old treatment. Otherwise, it is difficult to justify the increased expense incurred by patients. It is difficult to retract previous representations to patients regarding treatment superiority. By contrast, if a prospective study is undertaken, the investigators have an opportunity to be surprised by the results. The comparison is likely to be a fairer one, avoiding the confirmation bias that affects retrospective reviews.12 Sterility The authors reassure the reader that no patient objected to Strattice based on its (porcine) origin.1 Perhaps this is not surprising. The word “Strattice” reveals no information regarding the origin of the material.4 Most patients are likely to be unaware that this material is processed pigskin. Women receiving ADM may not be aware that they are receiving foreign nuclear material. In fact, the term “acellular dermal matrix” is not accurate.4 Cellular elements, including donor DNA, remain. The material cannot be autoclaved. AlloDerm is packed with nuclei and donor DNA.4 The authors subscribe to the 14-point plan13 to reduce the risk of capsular contracture. This plan, which lacks a scientific foundation,14 calls for antibiotic irrigation and the use of an introduction sleeve. The authors irrigate the implant pocket with Betadine solution and use a Keller funnel (AbbVie).15 Betadine solution is nonsterile and is not recommended for irrigation of an open wound (its intended use is topical).16 It is also cytotoxic.17 The evidence supporting the “no touch” technique and the Keller funnel is weak and heavily affected by financial conflicts.18 The authors also administer 2 doses of intravenous antibiotics.1,15 Any value from prophylactic intravenous antibiotics is unclear.19–21 A recent meta-analysis failed to demonstrate a benefit in either infection rate or capsular contracture rate after breast augmentation.21 Sophisticated microbiological studies have been unable to link capsular contracture to a specific microbe.14 Although inflammation is clearly involved in the pathogenesis of capsular contracture, there is presently no reliable evidence of a bacterial etiology.14 The authors leave drains in for 1 week to reduce the risk of a seroma,1,15 which violates one of the 14 points by allowing a possible entry site for bacteria.13 Complications The authors’ 2020 publication was unusual in that there was no reporting of complications apart from the recurrence of capsular contracture.5 This new publication also does not provide the authors’ complication rate,1 although they do report 3 seromas and 2 hematomas. The ADM borders are frequently palpable, especially in thin patients.15 Five patients complained of palpable edges. The authors comment that their incidence of complications is very low and these complications are largely inconsequential.1 The revision rate is also unreported. The authors do not discuss infra-areolar contour depression deformities that commonly require revision.15 The authors do not mention the radiographic artifact caused by ADM and the need to provide patients with a letter to give to the radiologist at the time of future mammograms.15 Capsulectomy, even without ADM insertion, is often not an easy procedure. Inserting ADM through a short incision is especially difficult. An incision length of at least 7 to 8 cm is needed for most surgeons,10,22 to allow enough access to insert the ADM, which is secured by external bolster sutures that are removed a week later.1,15 One surgeon describes the surgery as “like working through a mail slot.”22 In contrast to capsulotomies, capsulectomies are known to carry much more morbidity and additional complications, including nerve injury, possible necrosis of overlying skin, protracted discomfort, increased bleeding, and pneumothorax.2,23 With removal of the capsular lining, control of the pocket is compromised, which may lead to implant malposition, asymmetry, and contour deformities. The authors caution that inferior periareolar deformities are common when a periareolar incision is reused.15 In fact, the patient in the authors’ video underwent a procedure to treat this deformity. In a follow-up publication,24 Hidalgo and Chadab describe their method of treating this problem in over 25 patients by inserting a rolled piece of Strattice, which remains palpable. “Cheaper Than Failure” The authors believe that this operation, while admittedly expensive, is “always cheaper than failure.”1,5,15 The authors report that inserting ADM requires an additional 1.5 hours of operating time (2 hours for a bilateral case), plus the cost of the material.1,15 This extra operating time and cost are in addition to the time and cost to perform capsulectomies. Hidalgo reports that the operating time for a bilateral capsulectomy is 3 to 3.5 hours. Adding ADM increases the operating time to 5 to 5.5 hours.25 The authors report that an occasional patient declined treatment due to cost concerns.1 It would be interesting to know how these patients were managed and their outcome. The authors make a case for treating both sides with Strattice in patients with a recurrent unilateral capsular contracture.1 The rationale is that the contralateral implant may be replaced at the same time, and treating both sides the same way would ensure similar quality aesthetic results.1 My patients with capsular contracture are told up front that they have a 22.7% risk of recurrence.2 A second treatment, like the first, has minimal morbidity, cost, and downtime. Patients often return to work in a few days. Patients readily accept the possibility that they may require another operation. I also discuss capsulectomy and the fact that many surgeons routinely perform capsulectomies, and some insert ADM. I explain my reasons for not performing capsulectomies routinely and never inserting ADM. Capsulectomy is reserved for a pathologic capsule, such as one that is calcified.2,23 Over a 20-year period, I performed 15 secondary open capsulotomies.2 I have yet to perform a third capsulotomy on the same breast.4 There is no never-ending cycle of treatment.26 A leaking silicone breast implant does increase the risk of recurrence.1,2,27 An open capsulotomy leaves all other options available and avoids creating a deformity that will require revision. The first line of treatment is the simplest rather than the most complex—the bottom rung of the reconstructive ladder rather than the top rung.28,29 Treatment Alternatives Weinstein emphasizes the importance of patient selection and shared decision-making.15 It is not clear what alternative treatments were offered to patients since the authors adopted ADM in 2014. One treatment option is a simple open capsulotomy.2–4,7 The authors do not recognize this treatment alternative.1,5,15 Over the last decade, many publications2–4,7,26,28–31 have challenged the presumed need for ADM to treat capsular contracture, but none are referenced. Scientifically, one can accept or reject contradictory evidence but not ignore it.32 A 2016 survey by Hidalgo and Sinno did not include open capsulotomy as an option for treating capsular contracture.33 However, a 2024 review found that 9 of 17 publications on surgical management of capsular contracture reported using open capsulotomy routinely.7 Two additional studies favored capsulotomy in almost half of affected patients. None of these 11 publications using open capsulotomy are referenced by Hidalgo and Weinstein.1 In fact, their manuscript does not contain the word “capsulotomy.”1 If this popular alternative is not mentioned in the authors’ publications and presentations,1,5,15 it is unlikely that patients are being informed either. The same is true of complications and regulatory status. In their 2024 review, Boyd et al7 concluded that there was no evidence of a different recurrence rate comparing capsulotomy with capsulectomy. The authors also determined that there is insufficient evidence to conclude that concurrent use of ADM affects recurrence rates. Surgeons are ethically bound to inform patients of treatment alternatives. When informed of the pros and cons of each treatment, some patients, indeed a majority, may elect to undergo a simple open capsulotomy.7 The treatments are compared in Table 1. For many women, the steep cost differential will make it the only financially viable option. Generally, the lesser surgical procedure is preferred over the more invasive one if there is no significant difference in outcome. TABLE 1 - Comparison of Surgical Treatments for Capsular Contracture Parameters Open Capsulotomy Capsulectomy and ADM Recurrence risk (%) 22.7 10 Biological product No Yes Foreign DNA No Yes Operative difficulty Low High Scar length Same Longer Need for drains No Yes External bolsters No Yes Patient morbidity Minimal Moderate Recovery time Days Weeks Seromas, n (%) 1 (1.3) 3 (3) Hematomas, n (%) 2 (2.7) 2 (2) Infra-areolar indentation No Common Causes asymmetry No 30 mL increment Palpable edges None Yes Radiographic artifact None Yes Surgical time 30-50 min 2.5-5.5 h Bilateral surgery Adds 20 min Adds 2 h Cost to the patient Low* High FDA approval Not required No Pathology exam None Yes IRB approval Exempt Poststudy approval May be (easily) repeated Yes No Alternatives discussed Yes No Patient expectations Low High Ultrasound treatments None For failures ADM indicates acellular dermal matrix. IRB, institutional review board. FDA, US Food and Drug Administration.*May be covered by the manufacturer's warranty. Informing patients of alternative treatments is not just good practice. The American Society of Plastic Surgeons Code of Ethics mandates that members inform patients of “potential risks and adverse outcomes with their probability and severity, alternatives to the procedure being considered, and their benefits, risks, and consequences, outcome anticipated, and whether the operation is experimental or being applied in a manner not approved by the relevant regulatory authorities.”34 Similar requirements are contained in the regulations of state medical boards.35 Surgeons must have a “backup plan” if their recommended treatment proves unsuccessful. Few patients are willing to endure another round of capsulectomies and ADM insertion. The authors believe that “the likelihood of success by an identical second effort using ADM is only hopeful and without data to support efficacy.”1 Such a second operation (including a second or third capsulectomy) would further traumatize the breasts, and the complication rate would be unacceptable. As a practical matter, few patients would be able to afford it. CONCLUSIONS Not surprisingly, surgeons tend to champion their techniques. Caution is needed when an especially invasive and costly procedure is recommended over a much simpler, but also effective and safe, alternative. Plastic surgeons who are trying to determine the best treatment plan for this common complication deserve to be informed of both sides of the debate. Presenting one side and not the other is analogous to listening to the prosecution make its case without hearing from the defense, or vice versa. Such debate is the only way to advance medical knowledge and ensure that we make the best evidence-based treatment recommendations to our patients.