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Background: Interfaces continue to be used in prepectoral breast reconstruction to refine breast appearance, but more clinical data are required to assess their effectiveness. This study compares the rates of capsular contracture, breast esthetics, and patient satisfaction between two commonly used interface materials, acellular dermal matrix (ADM) and polyurethane (PU) foam., Methods: A cross-sectional assessment was conducted on all patients who underwent prepectoral direct-to-implant reconstruction with an interface material between June 2018 and June 2022. We compared capsular contracture rates (assessed in-person), esthetic outcomes (evaluated by a three-member panel using a specially designed scale), and patient satisfaction (measured using the Breast-Q questionnaire) among the members of the interface groups., Results: Among the 79 reconstructed breasts (20 bilateral cases), 35 were reconstructed using ADM and 44 using PU implants. The ADM group had a significantly higher frequency of Baker III/IV capsular contracture compared with the PU group (14.3% vs. 0%, p = 0.014) and lower ratings from the panel in terms of capsular contracture (median 3.7 vs. 4.0, p < 0.001). PU reconstructions scored worse in implant visibility (median 2.3 vs. 3.3, p < 0.001) and rippling (median 3.0 vs. 3.7, p < 0.001). However, after appropriate adjustment for confounders, no significant differences in overall appearance and patient satisfaction were found., Conclusions: ADM reconstructions are prone to capsular contracture with all their related esthetic issues, but PU implants have certain cosmetic flaws, such as implant visibility and malposition. Since each technique has its own limitations, neither the experienced surgeons nor patients exhibited a clear preference for either approach., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest and have no financial disclosures to make., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Introduction: Despite a lack of data demonstrating causation, there is growing concern over breast implants and systemic illness. This study examines the impact of rising public interest in breast implant illness (BII) and its implications on breast implant removals (BIR)., Methods: A Google Trends (GT) analysis of each year between 2010 and 2022 was performed globally, and then separately for the United States alone (US), using the search terms "capsular contracture," "breast implant illness," and "breast implant(s) removal". Linear regression was performed to determine significant correlations. Data on BII-related Facebook advocacy groups, relevant pop culture events, numbers of BIR surgeries, and number of BII-related publications were collected and analyzed alongside GT data to determine relevance., Results: For global GT, there was a significant relationship between "breast implant illness" and "breast implant(s) removal" in 2016 (R 2 =0.62, β =0.33, p<0.01), 2020 (R 2 =0.53, β =0.23, p=0.01), and 2022 (R 2 =0.60, β =0.44, p=0.01). In the US, 2016 (R 2 =0.53, β =1.75, p=0.01) 2018 (R 2 =0.61, β =1.93, p<0.01) and 2020 (R 2 =0.72, β=0.91, p<0.01) were significant. In 2020, "capsular contracture" and "breast implant(s) removal" was significant in the US (R 2 =0.58, β=0.4, p=0.01). In 2016, Facebook was the platform for the largest BII advocacy group and in 2020 YouTube was the platform for the first BII documentary and TEDx talk. From 2010 to 2020, PubMed publications containing "ASIA" and "BII" increased 24-fold and ASPS reports on BIR rose 70%., Conclusion: This study suggests that BII is a topic of global concern and has implications on both academic medicine and clinical practice., Level of Evidence V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2023. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

As prepectoral implant placement becomes widely adopted, recent studies investigating the use of acellular dermal matrix (ADM) during tissue expander placement have demonstrated no major benefit with regard to postoperative outcomes. We sought to evaluate second-stage outcomes 1 year after tissue expander exchange to implant with and without ADM. Consecutive patients who underwent prepectoral tissue expander-based breast reconstruction with and without ADM were identified. Patients were followed up for 1 year after tissue expander exchange to implant. Second-stage outcomes of interest including implant rippling, capsular contracture, implant explantation, additional revision surgeries, and patient-reported outcomes were collected and compared. Sixty-eight breasts in the ADM cohort and sixty-one breasts in the no ADM cohort underwent tissue expander exchange to implant. Second-stage outcomes of interest were similar between the ADM and no ADM cohorts with no statistically significant differences identified regarding incidences of implant rippling (24.6% vs. 12.1%, p = 0.08), capsular contracture (4.5% vs. 3.3%, p = 1.00), and explantation (6.6% vs. 1.7%, p = 0.67) between the two cohorts. BREAST-Q scores were similar between the two cohorts with the exception of physical wellbeing and satisfaction in terms of implant rippling, as can be seen, which improved in the no ADM cohort (p = 0.04). Our study reports no major benefit for the inclusion of ADM with respect to implant rippling, capsular contracture, explantation, need for additional revision surgeries, and patient-reported satisfaction in prepectoral second-stage implant-based breast reconstruction., (Copyright © 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Implant-based breast reconstruction is the most common reconstructive approach after mastectomy. Prepectoral implants offer advantages over submuscular implants, such as less animation deformity, pain, weakness, and postradiation capsular contracture. However, clinical outcomes after prepectoral reconstruction are debated. The authors performed a matched-cohort analysis of outcomes after prepectoral and submuscular reconstruction at a large academic medical center., Methods: Patients treated with implant-based breast reconstruction after mastectomy from January of 2018 through October of 2021 were retrospectively reviewed. Patients were propensity score exact matched to control demographic, preoperative, intraoperative, and postoperative differences. Outcomes assessed included surgical-site occurrences, capsular contracture, and explantation of either expander or implant. Subanalysis was done on infections and secondary reconstructions., Results: A total of 634 breasts were included (prepectoral, 197; submuscular, 437). A total of 292 breasts were matched (146 prepectoral:146 submuscular) and analyzed for clinical outcomes. Prepectoral reconstructions were associated with greater rates of SSI (prepectoral, 15.8%; submuscular, 3.4%; P < 0.001), seroma (prepectoral, 26.0%; submuscular, 10.3%; P < 0.001), and explantation (prepectoral, 23.3%; submuscular, 4.8%; P < 0.001). Subanalysis of infections revealed that prepectoral implants have shorter time to infection, deeper infections, and more Gram-negative infections, and are more often treated surgically (all P < 0.05). There have been no failures of secondary reconstructions after explantation in the entire population at a mean follow-up of 20.1 months., Conclusions: Prepectoral implant-based breast reconstruction is associated with higher rates of infection, seroma, and explantation compared with submuscular reconstructions. Infections of prepectoral implants may need different antibiotic management to avoid explantation. Secondary reconstruction after explantation can result in long-term success., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Capsular contracture is one of the most frequent indications for revision following breast augmentation. Management goals focus on restoring breast aesthetics and minimizing subsequent recurrence of capsular contracture. As new data emerge, close review of the data are merited to build evidence-based clinical guidelines to inform surgical practice and management of capsular contracture., Methods: A systematic review of the MEDLINE, Embase, and Cochrane Database of Systematic Reviews databases was conducted to characterize the surgical management of capsular contracture in revision breast augmentations. The primary endpoint was capsular contracture recurrence rate., Results: The review was conducted in November of 2021. Primary search revealed 14,163 results. Initial screening by title left 1223 articles. Abstract review left 90 articles for full-text review, of which 34 were ultimately included and were all observational in nature., Conclusions: Capsular contracture management remains an important topic, with limited high-level evidence for establishing clear evidence-based treatment guidelines. Although more evidence is required to assess the effects of capsulectomy, implant exchange, and plane change, these appear to be useful mechanisms for reducing recurrent capsular contracture. There is more evidence regarding the use of acellular dermal matrix, although this still requires long-term follow-up studies. New developments regarding textured implants limit the revision breast augmentation surgeon to smooth devices., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Rates of capsular contracture have reduced significantly since the use of insertion funnels to place breast implants became routine. However, due to financial constraints, the same funnel is usually used for implantation of both sides., Objectives: The aim of this study was to determine whether the risk of capsular contracture is higher for the second breast when the same insertion funnel is used for both breasts., Methods: The authors collected a sample of the insertion funnel tip immediately after removing the funnel from its sterile packaging and another tip sample after the funnel had been used to insert the first implant. These samples were sent for microbiological culture evaluations. Capsular contracture rates in the first implanted breast vs the second implanted breast were then retrospectively analyzed., Results: All samples taken from the funnel before the first implantation showed no bacterial growth. All 10 samples taken from the funnel after the first implantation showed organism growth (8 were positive for Staphylococcus epidermidis and 2 for Cutibacterium acnes). Retrospective analysis of the results revealed that the overall capsular contracture rate had reduced after the authors began to use insertion funnels. However, this complication was still more common on the second implanted breast., Conclusions: Surgeons should consider the use of separate insertion funnels for each breast. This might help to slightly reduce the incidence of capsular contracture.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, and Chinese (Simplified and Traditional) online here: https://doi.org/10.1093/asj/sjad288., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Implant-based breast reconstruction has evolved over time. However, the effects of prepectoral breast reconstruction (PBR) compared with those of subpectoral breast reconstruction (SBR) have not been clearly defined. Therefore, this study aimed to compare the occurrence of surgical complications between PBR and SBR to determine the procedure that is effective and relatively safe., Methods: The PubMed, Cochrane Library, and EMBASE databases were searched for studies published until April of 2021 comparing PBR and SBR following mastectomy. Two authors independently assessed the risk of bias. General information on the studies and surgical outcomes were extracted. Among 857 studies, 34 and 29 were included in the systematic review and meta-analysis, respectively. Subgroup analysis was performed to clearly compare the results of patients who underwent postmastectomy radiation therapy., Results: Pooled results showed that prevention of capsular contracture (OR, 0.57; 95% CI, 0.41 to 0.79) and infection control (OR, 0.73; 95% CI, 0.58 to 0.92) were better with PBR than with SBR. Rates of hematoma, implant loss, seroma, skin-flap necrosis, and wound dehiscence were not significantly different between PBR and SBR. PBR considerably improved postoperative pain, BREAST-Q score, and upper arm function compared with SBR. Among postmastectomy radiation therapy patients, the incidence rates of capsular contracture were significantly lower in the PBR group than in the SBR group (OR, 0.14; 95% CI, 0.05 to 0.35)., Conclusions: The results showed that PBR had fewer postoperative complications than SBR. The authors' meta-analysis suggests that PBR could be used as an alternative technique for breast reconstruction in appropriate patients., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Breast implants are the most commonly used medical devices in plastic surgery, and capsular contracture (CC) is one of the most common complications. However, our assessment of CC is based largely on Baker grade, which is problematically subjective and affords only four possible values., Methods: The authors performed a systematic review concluding in September of 2021 in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. It identified 19 articles that propose approaches to measuring CC., Results: In addition to Baker grade, the authors identified several modalities reported to measure CC. These included magnetic resonance imaging, ultrasonography, sonoelastography, mammacompliance measuring devices, applanation tonometry, histologic evaluation, and serology. Capsule thickness and other measures of CC inconsistently correlated with Baker grade, whereas the presence of synovial metaplasia was consistently associated with Baker grade I and II, but not III and IV capsules., Conclusions: There remains no particular method to reliably and specifically measure the contracture of capsules that form around breast implants. As such, we would recommend that research investigators use more than one modality to measure CC. Other variables that can impact breast implant stiffness and associated discomfort beyond CC need to be considered when evaluating patient outcomes. Given the value placed on CC outcomes in assessing breast implant safety, and the prevalence of breast implants overall, the need for a more reliable approach to measuring this outcome persists., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Background: Simultaneous breast reshaping and abdominoplasty offer patients the opportunity to undergo body reshaping in a single surgical session involving one anesthesia induction and one incision. In Latin America, abdominal implant placement is an infrequently used technique, likely because there is little evidence on its efficacy and safety. This study aimed to evaluate the efficacy and safety of implant placement through the abdominal route., Methods: A retrospective cohort was analyzed, including 350 records of patients who underwent abdominal breast implants from 2013 to 2021 with a minimum follow-up of 1 year. The procedure was performed under epidural anesthesia., Results: No intraoperative complications were reported. After a minimum 12-month follow-up, complications were detected in 5% of cases; the most frequent was asymmetry (4.6%), followed by abdominal migration and one case of symmastia. During the follow-up period, no capsular contracture was detected in any case. A satisfaction percentage of 98.1% was obtained. The only independent factor associated with complications was distance from the sternal notch to the nipple-areola complex greater than 21 cm., Conclusion: In this case series, mammaplasty with abdominal implant placement was an effective and safe procedure, with reduced risk of infection or capsular contracture and no scarring in or near the breasts for patients with properly selected comorbidities., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Breast augmentation mammaplasty (BAM) remains the most popular cosmetic procedure done worldwide. Bleeding in this procedure increases the chance of capsular contracture. Tranexamic acid (TXA), an antifibrinolytic, has been widely used by other surgical specialties to reduce bleeding., Objectives: We aimed to evaluate the use of TXA in BAM surgery., Methods: This was a single-surgeon case series of all patients who underwent primary BAM from March 2017 to March 2018 and received topical TXA spray to the implant pocket before implant insertion. Early postoperative complications and long-term outcomes, such as capsular contracture and revisional surgery, were recorded and described., Results: Two hundred and eighty-eight patients were included in the study with an overall complication rate of 2.8% over 5 years. No patients had postoperative bleeding or hematoma formation. One patient had a seroma, managed with ultrasound drainage. Complications requiring reoperation included rippling (3, 1.0%), pocket revision (2, 0.7%), capsule contracture (1, 0.3%) and rupture (1, 0.3%)., Conclusions: This study highlights the safety and potential benefits of the use of topical TXA in breast augmentation, with low bleeding and capsular contracture rates., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Capsular contracture is a known complication of breast augmentation and is among the top reasons for revisional breast augmentation procedures. The use of acellular dermal matrix (ADM) has been shown to reduce the rate of capsular contracture in breast reconstruction and augmentation, theorizing that it acts as a protective barrier between the implant capsule and inflammatory process responsible for capsular contracture. The role of ADM in treatment of capsular contracture has been investigated in numerous studies, with a variety of ADMs., Objectives: The aim of this study was to perform a systematic review of existing literature on the use of ADM for treatment of capsular contracture in aesthetic breast augmentation patients to investigate differences in efficacy of ADM types., Methods: The PubMed, Embase, and CINAHL databases were systematically reviewed for articles pertaining to capsular contracture, acellular dermal matrices, and breast augmentation. Number of patients, type of ADM, Baker grade, follow-up time, complication rate, and capsular contracture rate were recorded from identified articles. Data was pooled from studies to calculate a capsular contracture rate for each ADM type, with a chi-squared test performed for analysis. Identified studies with a comparative group were included in a meta-analysis utilizing risk ratio (RR) to assess the efficacy of ADM., Results: Nine articles including ADM for treatment of capsular contracture in breast augmentation met criteria for inclusion, with a total of 481 breasts. Strattice was the most commonly utilized ADM (n = 391), followed by AlloDerm (n = 57). There was a statistically significant difference in efficacy of ADM among the studied ADM types (P < .001). AlloDerm, FlexHD, and DermaMatrix had the lowest capsular contracture rates (0%). NeoForm and SurgiMend had the highest capsular contracture rates (each 25%, but with n = 4 and n = 8, respectively). Strattice had a capsular contracture rate of 1.53% in the pooled data, and meta-analysis showed that Strattice reduced the risk of capsular contracture (RR 0.14 [95% CI 0.06, 0.31]) compared with conventional treatment., Conclusions: Acellular dermal matrices appear to be effective at treating capsular contracture after breast augmentation while maintaining a low complication rate. Overall capsular contracture rates are low with the use of ADM. There is a statistically significant difference in efficacy among ADM types. Meta-analysis shows that Strattice is effective at reducing the risk of capsular contracture in breast augmentation patients when compared to conventional treatment. Future research, especially in the form of randomized controlled trials, is needed to further investigate the efficacy of various ADMs in the treatment of capsular contracture., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Breast implant surgery is one of the most frequently performed procedures by plastic surgeons worldwide. However, the relationship between silicone leakage and the most common complication, capsular contracture, is far from understood. This study aimed to compare Baker grade I with Baker grade IV capsules regarding their silicone content in an intradonor setting, using two previously validated imaging techniques., Methods: Twenty-two donor-matched capsules from 11 patients experiencing unilateral complaints were included after bilateral explantation surgery. All capsules were examined using both stimulated Raman scattering (SRS) imaging and staining with modified oil red O (MORO). Evaluation was done visually for qualitative and semiquantitative assessment and automated for quantitative analysis., Results: Using both SRS and MORO techniques, silicone was found in more Baker grade IV capsules (eight of 11 and 11 of 11, respectively) than in Baker grade I capsules (three of 11 and five of 11, respectively). Baker grade IV capsules also showed significantly more silicone content compared with the Baker grade I capsules. This was true for semiquantitative assessment for both SRS and MORO techniques ( P = 0.019 and P = 0.006, respectively), whereas quantitative analysis proved to be significant for MORO alone ( P = 0.026 versus P = 0.248 for SRS, respectively)., Conclusions: In this study, a significant correlation between capsule silicone content and capsular contracture is shown. An extensive and continued foreign body response to silicone particles is likely to be responsible. Considering the widespread use of silicone breast implants, these results affect many women worldwide and warrant a more focused research effort., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Capsular contracture (CC) is one of the most common complications of implant-based breast reconstruction or augmentation surgery. Common risk factors of CC include biofilm, surgical site infections, history of prior CC or fibrosis, history of radiation therapy, and implant characteristics. Though bacterial contamination of breast protheses is associated with adverse sequelae, there are not universally accepted guidelines and limited best practice recommendations for antimicrobial breast pocket irrigation. Despite advanced molecular biology, the exact mechanism of this complication is not fully understood. Interventions that decrease the rate of CC include antibiotic prophylaxis or irrigation, acellular dermal matrix, leukotriene inhibitors, surgical techniques, and others. However, there is inconsistent evidence supporting these risk factors, and the current data was based on broad heterogeneous studies. The objective of this review was to provide a summary of the current data of contributing risk factors as well as preventative and treatment measures for CC.Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266., (© 2023. The Author(s).)

Background: Although there are many acellular dermal matrix (ADM) products, the sterilization process varies for each product. We compared the clinical outcomes of immediate prepectoral direct-to-implant (DTI) breast reconstruction with and without sterilization products., Methods: This was a retrospective study of immediate prepectoral DTI breast reconstructions performed between 2018 and 2020. We classified patients depending on whether the used ADM products had undergone radiation sterilization and compared the patient demographics and surgical outcomes, including seroma, infection, mastectomy flap necrosis, capsular contracture, and implant failure., Results: The study included 357 patients, 182 in the no-sterilization group and 179 in the sterilization group. The ADM size differed significantly between the no-sterilization and sterilization groups (122.7 cm 2 vs. 145.4 cm 2 , respectively, P = 0.01). There were no significant differences in overall rates of complications between the two groups, including seroma (P = 0.28), infection (P = 0.63), mastectomy flap necrosis (P = 0.76), and capsular contracture (P = 0.76). However, implant failure from infection (0% vs. 3.4%, P = 0.01) and drainage amount (690.3 mL vs. 779.36 mL, P = 0.04) with similar removal days were significantly higher in the sterilization group., Conclusion: The authors demonstrated similar complication rates for seroma, infection, mastectomy flap necrosis, and capsular contracture. Whereas a bigger size of ADM was needed to cover a similar implant volume, and drain amount was higher in the sterilization group, the salvage rate from infection was higher in the no-sterilization group with a significant difference., Competing Interests: Declaration of Competing Interest The authors have no conflict of interests to disclose., (Copyright © 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Introduction: Capsular contracture remains the most common complication following device-based breast reconstruction, occurring in up to 50% of women who also undergo adjuvant radiotherapy either before or after device-based reconstruction. While certain risk factors for capsular contracture have been identified, there remains no clinically effective method of prevention. The purpose of the present study is to determine the effect of coating the implant with the novel small molecule Met-Z2-Y12, with and without delayed, targeted radiotherapy, on capsule thickness and morphologic change around smooth silicone implants placed under the latissimus dorsi in a rodent model., Methods: Twenty-four female Sprague Dawley rats each had 2 mL smooth round silicone breast implants implanted bilaterally under the latissimus dorsi muscle. Twelve received uncoated implants and twelve received implants coated with Met-Z2-Y12. Half of the animals from each group received targeted radiotherapy (20 Gray) on postoperative day ten. At three and 6 months after implantation, the tissue surrounding the implants was harvested for analysis of capsular histology including capsule thickness. Additionally, microCT scans were qualitatively analyzed for morphologic change., Results: Capsules surrounding Met-Z2-Y12-coated implants were significantly thinner (P = 0.006). The greatest difference in capsule thickness was seen in the irradiated 6-month groups, where mean capsule thickness was 79.1 ± 27.3 μm for uncoated versus 50.9 ± 9.6 μm for Met-Z2-Y12-coated implants (P = 0.038). At the time of explant, there were no capsular morphologic differences between the groups either grossly or per microCT., Conclusions: Met-Z2-Y12 coating of smooth silicone breast implants significantly reduces capsule thickness in a rodent model of submuscular breast reconstruction with delayed radiotherapy., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Capsular contracture is the most common complication following breast implant surgery, and the implant shell characteristics are important in preventing this complication., Objectives: The aim of this study was to evaluate the capsular contracture rate for SmoothSilk Motiva implants (Establishment Labs Holdings Inc., New York, NY) in females who underwent primary and revisional breast augmentation over a 3-year period., Methods: A total of 1324 cases that took place from 2017 to 2020 were retrospectively analyzed, with 1027 being primary surgeries and 297 being revisional surgeries., Results: In the 1324 cases of augmentation mammoplasty with SmoothSilk Motiva implants, the overall capsular contracture rate was 1.8% (n = 24). The capsular contracture rate in the 1027 primary surgery cases was 1.07% (n = 11), and the capsular contracture rate in the 297 revisional surgery cases was significantly different at 4.39% (n = 13, P = .0001). More specifically, the capsular contracture rate in 182 revisional surgery for cases without capsular contracture was 1.12% (n = 2), and it showed no statistically significant difference from the rate in primary surgery cases (P = .965). However, the rate in 115 revisional surgery for cases with capsular contracture was 9.57% (n = 11), and it showed a statistically significant difference from the rate in primary surgery cases (P = .000) and the rate in revisional surgery for cases without capsular contracture (P = .001)., Conclusions: Augmentation mammoplasty with SmoothSilk Motiva implants demonstrated a lower rate of capsular contracture than traditional smooth or textured implants. Revisional surgery for cases without capsular contracture showed a similar rate of capsular contracture to primary surgery cases, but the rates were higher in revisional surgery for cases with capsular contracture., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Postmastectomy radiotherapy (PMRT) on immediate breast reconstruction historically involved a marked increase in complication rate (up to 50%). Prepectoral breast reconstruction (PPBR) has shown promising early postoperative results. This study aims to evaluate PPBR long-term results in PMRT setting., Materials and Methods: This is a retrospective monocentric analysis of 485 PPBR (439 patients) undergoing Acellular-Dermal-Matrix assisted direct-to-implant reconstruction (46 bilateral procedures) between January 2015 and December 2020 (mean FU:35.6 months). Group 1 comprised 401 PPBR not submitted to PMRT, and 84 reconstructions receiving PMRT in Group 2. Patients' characteristics, postoperative complication and revisional surgery rate were examined. PMRT characteristics and subcutaneous tissue thickness, measured in Group 2 by CT scan, were also evaluated., Results: Long-term complication rate was 11.2% in Group 1 vs. 21.4% in Group 2 (P-value = .019). Capsular contracture represented the only complication associated to a statistically significant difference between the 2 groups (P-value < .001). In Group 2, only 4.8% implant loss and 8.3% severe capsular contracture rate was found. In patients who underwent PMRT, 38.9% of complications settled with no consequences, and only 4.8% of patients needed revisional surgery in the long-term FU. According to multivariate analysis, drug intake and PMRT were significantly associated with postoperative complications. In Group 2, a thinner subcutaneous tissue was linked to a higher complication risk., Conclusion: In our series, patients treated with PPBR who underwent PMRT, presented a low complication rate and minimal need for revisional surgery in the long-term follow-up, suggesting that this technique is feasible and safe also in PMRT context., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2023. Published by Elsevier Inc.)

Background: Breast implant capsule development and behavior are mainly determined by implant surface combined with other external factors such as intraoperative contamination, radiation or concomitant pharmacologic treatment. Thus, there are several diseases: capsular contracture, breast implant illness or Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), that have been correlated with the specific type of implant placed. This is the first study to compare all major implant and texture models available in the market on the development and behave of the capsules. Through a histopathological analysis, we compared the behavior of different implant surfaces and how different cellular and histological properties give rise to different susceptibilities to develop capsular contracture among these devices., Methods: A total of 48 Wistar female rats were used to implant 6 different types of breast implants. Mentor®, McGhan®, Polytech polyurethane®, Xtralane®, Motiva® and Natrelle Smooth® implants were employed; 20 rats received Motiva®, Xtralane® and Polytech polyurethane®, and 28 rats received Mentor®, McGhan® and Natrelle Smooth® implants. The capsules were removed five weeks after the implants placement. Further histological analysis compared capsule composition, collagen density and cellularity., Results: High texturization implants showed the highest levels of collagen and cellularity along the capsule. However, polyurethane implants capsules behaved differently regarding capsule composition, with the thickest capsules but fewer collagen and myofibroblasts than expected, despite being generally considered as a macrotexturized implant. Nanotextured implants and microtextured implants histological findings showed similar characteristics and less susceptibility to develop a capsular contracture compared with smooth implants., Conclusions: This study shows the relevance of the breast implant surface on the definitive capsules' development, since this is one of the most differentiated factors that determine the incidence of capsular contracture and probably other diseases like BIA-ALCL. A correlation of these findings with clinical cases will help to unify implant classification criteria based on their shell and their estimated incidence of capsule-associated pathologies. Up to this point, the establishment of additional groups is recommended as nanotexturized implants seem to behave differently to pure smooth surfaces and polyurethane implants present diverse features from macro- or microtextured implants., No Level Assigned: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2023. The Author(s).)

Background: Capsular contracture is the most common complication of breast augmentation and reconstruction. It occurs in up to 45% of patients and is theorized to occur secondary to an immune reaction. It can lead to pain, dissatisfaction with aesthetic outcomes, and reoperation. The gold standard for management is capsulectomy. Prior similar studies are limited by narrow inclusion criteria, single-surgeon analysis, small sample size, or univariate analysis. The goal of the following study is to prospectively identify possible risk factors for capsular contracture using a national database., Methods: A retrospective review was conducted utilizing the National Surgical Quality Improvement Program (NSQIP) Database of prospectively collected data of patients undergoing periprosthetic and/or total capsulectomy for capsular contracture from 2013 to 2016. Odds ratios (OR) with 95% confidence intervals (CI) were calculated for variables using a multivariable binary logistic regression model., Results: A total of 6547 patients underwent reconstructive or augmentation mammaplasty with a prosthetic implant, out of which 2543 (39%) underwent capsulectomy. Capsular contracture was more likely in older (OR: 1.10, 95% CI: 1.09-1.10, p<.001), overweight (OR: 1.12, 95% CI: 1.10-1.13, p<.001), and cancer patients (OR: 7.71, 95% CI: 2.22-28.8, p=0.001). Wound infection was associated with capsulectomy (OR: 6.69, 95% CI: 1.74-25.8, p<.001)., Conclusion: These identified risk factors should be comprehensively addressed with patients during the informed consent process before breast augmentation or reconstruction with implants., Level of Evidence Iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Hybrid breast reconstruction (HBR) combines silicone implants with fat grafting to improve implant coverage, treating local tissue deficiencies and leading to a more natural breast appearance. Recent data also indicated less capsular contracture after HBR. The authors developed a novel technique and animal model of cell-assisted (CA) HBR to illuminate its effects on capsular contracture., Methods: Animals received silicone implants in a dorsal submuscular pocket. Although animals of the HBR group received fat grafting around the implant without stem cell enrichment, rats of the CA-HBR1 and the CA-HBR2 groups received stem cell-enriched fat grafting with 2 × 10 6 and 4 × 10 6 adipose-derived stem cells immediately after implant insertion. On day 60, animals underwent sonography and elastography imaging and were euthanized, and outcome analysis was performed by means of histology, immunohistochemistry, chemical collagen quantification, and gene expression analysis., Results: With this novel technique, long-term survival of adipose-derived stem cells within the implant pocket was demonstrated after 60 days after implant insertion. CA-HBR led to significantly reduced thickness and collagen density of capsular contractures. In addition, CA-HBR resulted in reduced fibrotic responses with less occurrence of collagen type I and transforming growth factor-β in capsule tissue. Moreover, the addition of stem cells suppressed fibrotic and inflammatory responses on a genetic level with significant underexpression of collagen type I and transforming growth factor-β1., Conclusions: With this new technique and animal model, the authors observed a preventive effect on capsular contracture substantiating the basis of clinical outcomes of HBR. The authors propose that the addition of stem cells to HBR might booster its beneficial results., Clinical Relevance Statement: Stem cell-enriched fat grafting around silicone implants may reduce the risk for capsular contracture after silicone breast implantation. While fat grafting alone already shows beneficial effects, the addition of stem cells to the fat graft can potentiate this effect., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection., Methods: This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials., Results: Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation., Conclusion: Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Background: Implant-based breast reconstruction remains the most often used method following mastectomy, but data are lacking regarding differences in complications and long-term patient-reported outcomes for two-stage subpectoral versus prepectoral reconstruction. This study sought to better understand the risks and impact of these reconstructive approaches on overall satisfaction., Methods: Patients who underwent unilateral or bilateral nipple-sparing mastectomy and two-stage implant-based reconstruction from 2014 to 2019 were identified from the electronic medical records and contacted via email to complete the BREAST-Q survey. Overall satisfaction was measured by the question, "How happy are you with the outcome of your breast reconstruction?" using a six-point Likert scale. Patients were grouped into subpectoral or prepectoral cohorts. Complications were evaluated retrospectively. Only patients who were at least 6 months from their final reconstruction were included in the analysis., Results: Of the 582 patients contacted, 206 (35%) responded. The subpectoral ( n = 114) and prepectoral ( n = 38) groups did not differ significantly by demographic or treatment characteristics. BREAST-Q scores were also comparable. Complication rates were similar, but prepectoral patients had a significantly higher rate of capsular contracture (16% versus 4%, P < 0.05). Bivariate ordered logistic regression identified prepectoral implant placement, having any postoperative complication, and capsular contracture as predictors of less overall happiness., Conclusions: The authors' study suggests that prepectoral patients may have slightly higher complication rates but are as satisfied as subpectoral patients after at least a year of follow-up. Further studies should investigate risk factors for capsular contracture, how the risk changes over time, and how the risk affects patient satisfaction., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: There is a paucity of evidence comparing the safety of prepectoral and partial subpectoral implant-based breast reconstruction using acellular dermal matrices (ADM). We performed a meta-analysis to evaluate the postoperative complications of the two approaches., Methods: PubMed, EMBASE, Web of Science and Cochrane Library were searched to retrieve relevant articles. The rates of the complications were, respectively, pooled, and relative risk (RR) was estimated with 95% confidence intervals (CIs) to compare the incidence between the two cohorts., Results: Ten articles reporting on 2667 breast reconstructions were eligible. The hematoma rate was lower in the prepectoral group (RR  =  0.590, 95% CI 0.351-0.992). No significant difference was observed in terms of seroma (RR = 1.079, 95% CI 0.489-2.381), skin flap necrosis (RR = 0.936, 95% CI 0.587-1.493), infection (RR = 0.985, 95% CI 0.706-1.375), tissue expander/implant explantation (RR  =  0.741, 95% CI 0.506-1.085), wound dehiscence (RR = 1.272, 95% CI 0.605-2.673), capsular contracture (RR = 0.939, 95% CI 0.678-1.300) and rippling (RR = 2.485, 95% CI 0.986-6.261). The RR of animation deformity for the prepectoral group compared with the subpectoral group was 0.040 (95% CI, 0.002-0.853)., Conclusions: This systematic review suggested that with appropriate patient selection, prepectoral breast reconstruction could avoid animation deformity without incurring higher risk of early wound complications, capsular contracture or rippling than partial subpectoral breast reconstruction. Plastic surgeons should complete a comprehensive assessment of the patients before choosing appropriate surgical approaches in clinical practice., Level of Evidence Iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2023. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Over half of immediate implant-based breast reconstructions (IBBR) are performed with an acellular dermal matrix, despite limited long-term outcome data., Methods: The Breast Reconstruction Outcomes with and without Strattice, or BROWSE, study was a retrospective multicenter cohort study comparing consecutive patients who had undergone immediate Strattice IBBR with those who had undergone immediate IBBR with a submuscular technique between January of 2009 and December of 2015., Results: This study compared 553 Strattice reconstructions with 242 submuscular reconstructions, with a median follow-up of 4.3 years (range, 2 to 9.3 years) and 5.7 years (range, 2 to 8.1 years), respectively, demonstrating an equivalent total complication rate [Strattice, n = 204 (36.9%); submuscular, n = 77 (31.8%); P = 0.17] and implant loss rate (8.5% versus 5.4%, respectively; P = 0.12). Infection rates and wound dehiscence rates were higher in the Strattice cohort [ n = 114 (20.6%) versus n = 31 (12.8%), P = 0.009; and n = 90 (16.3%) versus n = 25 (10.4%), P = 0.03, respectively]. Overall revision rates were comparable [ n = 226 (46.7%) versus n = 79 (41.1%); P = 0.2], but significantly fewer Strattice reconstructions required revision surgery for capsular contracture (5.3% versus 15.6%; P < 0.001)., Conclusion: Although the risk of complications associated with Strattice reconstruction is numerically higher than that for submuscular coverage, the difference is small and not statistically significant, and likely outweighed by the clear reduced rate of revision surgery because of capsular contracture when Strattice is used., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Introduction: Capsular contracture is a common complication after 2-stage breast reconstruction. The relationships between native breast size, the rate of tissue expander expansion, and capsule formation have not been elucidated. This study aims to evaluate how these factors contribute to capsular contracture and establish cutoff values for increased risk., Methods: A data set consisting of 229 patients who underwent 2-stage breast reconstruction between 2012 and 2021 was included in the study. The rate of expansion is estimated as the final expanded volume subtracted by the initial filling volume of the tissue expander over time elapsed. The native breast size was estimated using various preoperative breast measurements and the weight of mastectomy specimen (grams). Further stratified analysis evaluated patients separately based on postoperative radiation status., Results: Greater nipple-inframammary fold distance and faster tissue expander enlargement rate conferred decreased odds of developing capsular contracture ( P < 0.05). On stratified analysis, faster tissue expansion rate was not significant in the nonradiated cohort but remained a significant negative predictor in the radiation group (odds ratio, 0.996; P < 0.05). Cut-point analysis showed an expansion rate of <240 mL/mo and a nipple-inframammary fold value of <10.5 cm as conferring a greater risk of capsular contracture., Conclusion: Smaller inframammary fold distance may be associated with a higher risk of capsular contracture. Slower expansion rates correlate with increased odds of contracture in patients undergoing adjuvant radiation. Breast geometry should be considered when risk stratifying various reconstruction approaches (implant vs autologous). In addition, longer delays between implant exchange and initial tissue expansion should be avoided if clinically feasible., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Acellular dermal matrices (ADMs) have shown promise for use in reconstructive breast surgery as they improve aesthetic outcomes and decrease capsular contracture rates. However, concerns about their use remain because of the higher cost and complication profile. We report a single institution's implant-based-reconstruction (IBR) experience between 2007 and 2021, including cases performed by 51 plastic surgeons. For each stage of IBR, data on age, comorbidities, type of mesh used, and acute complications were collected. Of 1379 patients who underwent subpectoral IBR, 937 received an ADM or synthetic mesh as part of their reconstruction. 256 patients out of 264 treated with prepectoral IBR received an ADM or mesh. Infection and wound dehiscence rates were highest for patients who underwent prepectoral IBR with ADM. Both subpectoral and prepectoral IBR with ADM were associated with higher rates of infection and wound complications compared to without ADM or mesh, but only the difference among the subpectoral cohort reached statistical significance. Prepectoral IBR with ADM or mesh had the lowest rates of capsular contracture and aesthetic reoperations. Although the use of Vicryl® mesh in subpectoral IBR was associated with a higher risk of capsular contracture and skin flap necrosis compared to reconstruction with ADMs (10.53% versus 3.29%; p < 0.05), Vicryl® was associated with fewer aesthetic revisions. Our study demonstrated that prepectoral IBR with ADM or mesh resulted in the fewest aesthetic reoperations and the lowest rates of capsular contracture. Infection and wound dehiscence rates were notably higher for patients who had reconstruction with ADM., Competing Interests: Conflict of interest None., (Copyright © 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: There remains a lack of clarity surrounding the benefits, risks, and outcomes between two-stage expander/implant reconstruction and single-stage direct-to-implant (DTI) reconstruction. This study used a national data set to examine real-world outcomes of two-stage and DTI reconstructions., Methods: A cohort study was conducted examining patients in the Australian Breast Device Registry (ABDR) from 2015 to 2018 who underwent prosthetic breast reconstruction following mastectomy. DTI and two-stage cohorts after definitive implant insertion were compared. Rate of revision surgery, reasons for revision, and patient-reported outcome measures were recorded. Statistical analysis was undertaken using Fisher exact or chi-square, Wilcoxon rank sum, or t tests; Nelson-Aalen cumulative incidence estimates; and Cox proportional hazards regression., Results: A total of 5152 breast reconstructions were recorded, including 3093 two-stage and 2059 DTI reconstructions. Overall revision surgery rates were 15.6% for DTI (median follow-up, 24.7 months), compared with 9.7% in the two-stage cohort (median follow-up, 26.5 months; P < 0.001). The most common reasons for revision for DTI and two-stage reconstruction were capsular contracture (25.2% versus 26.7%; P = 0.714) and implant malposition (26.7% versus 34.3%; P = 0.045). Multivariate analysis found acellular dermal matrix use ( P = 0.028) was significantly associated with a higher risk of revision. The influence of radiotherapy on revision rates was unable to be studied. Patient satisfaction levels were similar between reconstructive groups; however, patient experience was better in the DTI cohort than in the two-stage cohort., Conclusions: The ABDR data set demonstrated that DTI reconstruction had a higher revision rate than two-stage, but with comparable patient satisfaction and better patient experience. Capsular contracture and device malposition were leading causes of revision in both cohorts., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: A significant number of patients with a previous submuscular breast augmentation require a revision surgical procedure during their long-term follow-up period that involves changing the implant pocket from submuscular to subglandular. Reduced soft tissue thickness represents a major concern, discouraging surgeons from undertaking this approach., Objectives: The aim of this study was to determine whether a synthetic resorbable mesh used as a supplemental covering device was safe and yielded improved soft tissue thickness and protection against capsular contracture in patients undergoing implant plane shift to subglandular., Methods: A retrospective review of 34 patients who underwent revision of a previous breast augmentation involving implant change in a subglandular pocket and upper pole GalaFLEX (Galatea Surgical, BD; Franklin Lakes, NJ) mesh coverage was conducted. Onset of minor and major complications was recorded during short- and medium-term follow-up. Patient satisfaction was assessed via an anonymous questionnaire administered 6 months postoperatively., Results: During the follow-up period, which ranged from a minimum of 6 months to a maximum of 28 months, no minor or major complications were reported. In particular, no wrinkling/rippling or significant capsular contracture onset was observed. High levels of patient satisfaction were determined, according to self-reporting questionnaires., Conclusions: The initial results of this preliminary report from this case series demonstrate the safety of GalaFLEX as a supplemental device in terms of improved soft tissue coverage of the implant for complex revisional cases in breast augmentation., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Breast augmentation remains the commonest cosmetic surgical procedure worldwide, in spite of recent regulatory action., Objectives: The aim of this study was to evaluate women with breast implants attending a breast implant assessment clinic and to capture clinical and implant data in women presenting to the service., Methods: Patients were enrolled prospectively between January 2018 and December 2021. Clinical, implant, and practitioner data were recorded. Patients reported satisfaction on size, shape, and overall outcome as well as the presence or pain. Radiological evaluation, where indicated, was performed and data were included on these findings., Results: A total of 603 patients were assessed. Their mean age was 42.7 years and mean age at implantation was 29.1 years. The most common complications were capsular contracture followed by pain, waterfall deformity, and double bubble, with rupture/contracture rates increasing after the 10-year mark. The risk of double bubble was significantly lower if patients were operated on by certified practitioners (odds ratio = 0.49, P = 0.011). There was almost universally poor awareness of the risks of breast implants in patients presenting for evaluation., Conclusions: This study has shown benefit in a breast implant assessment clinic to gather information on adverse events and patient-reported outcomes following breast implant surgery. Having appropriately trained and certified practitioners perform cosmetic augmentation significantly lowers the risk of implant malposition and deformity. Any adverse event occurring within 5 years of initial surgery should be flagged as a mandatory reportable clinical indicator and trigger further investigation., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Round nano-surface Ergonomix (Motiva, Establishment Labs; Alajuela, Costa Rica) implants were developed to address concerns regarding capsular contracture and textured anatomical breasts implants., Objectives: The authors describe their early experience with Ergonomix implants in breast reconstruction., Methods: The authors retrospectively reviewed the charts of 212 patients (321 breasts) who underwent breast reconstruction employing round nano-surface Ergonomix implants between June 2017 and December 2020. Patients were followed for at least 12 months postoperatively. Demographics, surgical data, and postoperative surgical outcomes were recorded. Postoperative physical well-being and satisfaction with the breasts and implant were evaluated with Breast-Q questionnaires., Results: Of 211 patients, 75.4% had surgery due to cancer, and 24.6% underwent prophylactic surgery. Major complications occurred in 21 breasts (6.5%), of which 20 underwent revision operations. Reconstruction failed in 1 case (0.3%). Eleven breasts (3.4%) had minor complications. Immediate breast reconstruction, irradiated breasts, and smokers had higher rates of complications (P = 0.009, 0.02, 0.022, respectively). Rippling was more common in the pre-pectoral implant plane compared with sub-pectoral reconstruction (9% vs 1.2%, P = 0.001). Capsular contracture rate was 0.9% and occurred only in irradiated breasts. Implant malposition (inferiorly and laterally) occurred in 6.5% of the breasts, with no association between implant malposition and implant plane. Early follow-up demonstrated high patient satisfaction with the implant and breasts, and high scores in terms of patients' physical well-being., Conclusions: Breast reconstruction employing the round nano-surface Ergonomix implant yielded low complication rates and high patient satisfaction. The transition from macro-textured to nano-surface implants has operative implications requiring a learning curve and surgical adjustments., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Capsular contracture is a common complication associated with breast implants following reconstructive or aesthetic surgery in which a tight or constricting scar tissue capsule forms around the implant, often distorting the breast shape and resulting in chronic pain. Capsulectomy (involving full removal of the capsule surrounding the implant) and capsulotomy (where the capsule is released and/or partly removed to create more space for the implant) are the most common surgical procedures used to treat capsular contracture. Various structural modifications of the implant device (including use of textured implants, submuscular placement of the implant, and the use of polyurethane-coated implants) and surgical strategies (including pre-operative skin washing and irrigation of the implant pocket with antibiotics) have been and/or are currently used to help reduce the incidence of capsular contracture. In this article, we review the pharmacological approaches-both commonly practiced in the clinic and experimental-reported in the scientific and clinical literature aimed at either preventing or treating capsular contracture, including (i) pre- and post-operative intravenous administration of drug substances, (ii) systemic (usually oral) administration of drugs before and after surgery, (iii) modification of the implant surface with grafted drug substances, (iv) irrigation of the implant or peri-implant tissue with drugs prior to implantation, and (v) incorporation of drugs into the implant shell or filler prior to surgery followed by drug release in situ after implantation., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Plastic surgeons commonly use one of three access incisions to place breast implants during vertical augmentation mastopexy, including inframammary, vertical, and periareolar. It is not known whether there is a correlation between capsular contracture and access incision location. The purpose of this study was to investigate in a single-surgeon series the incidence of capsular contracture associated with access incision locations in silicone vertical augmentation mastopexy., Methods: Patients undergoing a vertical augmentation mastopexy between 2013 and 2017 were studied retrospectively. All patients underwent a standardized, dual-plane breast augmentation with smooth surface silicone gel implants. Patients were evaluated 1 year postoperatively by the Baker scale., Results: A total of 322 patients met study criteria. Eighty-four had periareolar access, 86 had vertical access, and 152 had inframammary access. There were no differences in patient age or mean implant size between the groups. The capsular contracture rate of the periareolar group was 5.36 percent; in the vertical access group, 3.48 percent; and in the inframammary access group, 1.64 percent. Capsular contracture rates correlated inversely to the distance to the nipple-areola complex, with the periareolar access rates the highest, the vertical access rates intermediate, and the inframammary access rates the lowest. Inframammary incisions were associated with lower capsular contracture rates than periareolar incisions when performed in conjunction with vertical augmentation mastopexy ( p = 0.043). Vertical access capsular contracture rates were intermediate between periareolar and inframammary groups., Conclusion: Surgeons should take into consideration the capsular contracture rates associated with access incision location when planning or performing vertical augmentation mastopexy., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 The Author. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.)

Purpose: Our purpose is to explore the effect of postmastectomy radiation therapy (PMRT) modality and timing on complication rates in breast cancer patients receiving immediate 2-stages expander/implant., Methods and Materials: We reviewed the charts of 661 patients who underwent immediate 2-stages expander/implant with/without PMRT at our institution from 2000 to 2019. Patients were divided into 3 cohorts: no radiation, PMRT to expanders (RTE), and PMRT to implants after expander exchange (RTI). PMRT was delivered either with 3-dimensional conformal photon with or without chest wall boost (CWB) or proton therapy. Reconstruction complications were defined as infection/necrosis requiring debridement, capsular-contracture requiring capsulotomy, and reconstruction failure requiring prothesis removal. Logistic regression and Cox models were used to assess the effect of different radiation therapy modalities on complication rates and local control., Results: Among 661 patients, 309 (46.7%) received PMRT, 220 of the 309 (71.2%) received RTE before exchange, and 89 (28.8%) received RTI after exchange. Seventeen out of 309 (5.5%) patients received proton therapy. The complications among RTE versus RTI cohorts were 22.7% versus 15.7% for infection/necrosis, 13.6% versus 19.1% for capsular-contracture, and 39.5% versus 31.5% for overall reconstruction failure, respectively. Among proton patients, 8/17 (47%) developed capsular contracture compared with 16.4% (24/146) and 10.3% (15/146) in CWB and non-CWB groups, respectively. Adjusted multivariable analysis showed no significant difference between RTI and RTE in terms of infection/necrosis and capsular contracture. Yet, RTE significantly increased overall reconstruction failure compared with RTI (39.5% vs 31.5%; odds ratio [OR], 2.11; P = .02). Protons significantly increased capsular contracture compared with both CWB and non-CWB groups (OR, 5.4; P = .01 and OR, 10.9; P < .001, respectively). Moreover, proton significantly increased overall reconstruction failure. The 5-year local control rates were 95.3% and 97.7% for RTE and RTI, respectively (hazard ratio, 1.2; P = .7)., Conclusions: Early radiation to the expander before the exchange to implant significantly increased overall reconstruction failure without improving local control. Protons significantly increased capsular contracture rates and overall reconstruction failure leading to more revision surgeries., (Copyright © 2022 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure:The author has no financial interest or conflict of interest to report with respect to this Discussion or the associated article. No funding was received for this work.

The most frequent complications of post-mastectomy reconstructions are breast implant (BI) infection and capsular contracture (CC). The diagnosis of BI colonization is based on cultures from the sonicated BI and from the capsule tissue. Therefore, we first aimed to assess the yield of conventional culture and molecular techniques in periprosthetic fluid, in addition to BI and capsular tissue. Moreover, we compare colonization and biofilm production between patients with and without CC. During 19 months, we prospectively included patients whose BIs had been removed and divided them into two groups: A (CC, Baker III-IV) and B (no CC). Samples were obtained for conventional culture, 16 s rRNA PCR, and MALDI-TOF. Biofilm production was also evaluated. We included 81 BIs from 69 patients with CC (22) and without CC (53). Forty-three (53.1%) of the 81 BIs had ≥1 positive culture. The culture was positive in 57.1% and 50.9% in groups A and B, respectively (p = 0.645). The highest 16 s rRNA PCR positivity rate was detected in capsular tissue (40.5%). MALDI-TOF was unable to detect colonization in any of the samples. High biofilm production was the following: high biomass: A, 29.8%; B, 39.7% (p = 0.293); high metabolic activity: A, 36.2%; B, 34.5% (p = 0.857). We confirm that cultures from different sites are mandatory to ensure a proper diagnosis of BI colonization. Our study is the first to demonstrate that CC was not associated with BI colonization or high biofilm production. The application of molecular techniques in BI samples was not substantially useful for predicting colonization., Competing Interests: Declaration of Competing Interests The authors declare that they have no conflicts of interest., (Copyright © 2022 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Capsular contracture (CC) represents one of the most common complications in breast reconstruction surgery, impairing final result and patients' well-being. The role of acellular dermal matrixes (ADM) has been widely described for the treatment and prevention of contracture. The aim of the study was to evaluate the efficacy and safety of complete implant coverage with porcine-derived ADM in preventing CC limiting complications. In addition, patients' reported outcomes were evaluated in order to define the role of ADM in improving sexual, physical and psychosocial well-being and satisfaction., Methods: 42 patients who underwent surgical treatment of 46 contracted reconstructed breasts from May 2018th to May 2019th were collected in the two groups (ADM group vs. Control group)., Results: The ADM group showed lower rate of CC recurrence and a higher rate of implant losses and minor complications. A significant difference was observed in red breast syndrome (27.3% in the ADM group vs. absent in control the group) and skin ulceration rates (18.2% in the ADM group vs. 4.18% in the control group). As for patients' perceived outcomes, the ADM group showed a statistically significant higher postoperative Satisfaction of Breast Scale score compared to the control group. In addition, a significant difference was observed in the improvement of Physical Well-Being of the Chest Scale and the Satisfaction of Breast Scale after surgery, in favor to the ADM group., Conclusion: Complete implant coverage with ADM may reduce the risk of CC recurrence in breast reconstruction. An accurate patient selection allows minimizing complications improving patient well-being and satisfaction., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2022. The Author(s).)

Background: Prepectoral direct-to-implant reconstruction has become an alternative to staged subpectoral expander-based reconstruction. Although the surgical safety of this technique has been shown, aesthetic limitations have not been well-described. This article reports aesthetic limitations and elucidates risk factors that may predispose patients toward developing unfavorable outcomes following direct-to-implant prepectoral breast reconstruction., Methods: A retrospective chart review was performed, identifying patients who underwent prepectoral, direct-to-implant breast reconstruction from June of 2016 to June of 2019. Aesthetic limitations assessed included capsular contracture, rippling, implant malposition, and implant flipping., Results: Two hundred twenty-four consecutive women representing 334 breasts underwent immediate reconstruction performed by a single plastic surgeon. A midlateral incision was used in 185 breasts (55.4 percent) and the Wise pattern in 95 breasts (28.8 percent). The mean follow-up time was 30.5 months (45.3 to 18.3 months). Significant capsular contracture (grade 3 to 4) was noted in 27 breasts (8.1 percent), implant flipping in four breasts (1.2 percent), implant displacement in five breasts (1.5 percent), major rippling in nine breasts (2.7 percent), and minor rippling in 17 breasts (5.1 percent). The use of acellular dermal matrix had no significant effect on the aesthetic outcomes. In comparing breasts with postmastectomy radiation, there was a significant difference in the presence of minor rippling and capsular contracture ( p < 0.05)., Conclusions: This cohort represents the largest, single-surgeon, direct-to-implant prepectoral database in the literature. This report shows that aesthetic limitations were comparable to those seen with other forms of reconstruction. Complications did not differ in terms of acellular dermal matrix use. Certain factors can predispose patients to developing unfavorable aesthetic outcomes., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Radiation therapy is increasingly used after breast cancer surgery, which may impact patients' postoperative quality of life. This study assessed differences in long-term patient satisfaction and health-related quality of life after radiation therapy administered at different stages of implant-based breast reconstruction or with no radiation after surgery., Methods: In this observational study, long-term outcomes were evaluated for four cohorts of women who completed breast reconstruction and received (1) no radiation, (2) radiation before tissue expander placement, (3) radiation after tissue expander placement, or (4) radiation after permanent implant between 2010 and 2017 at Memorial Sloan Kettering. Satisfaction and health-related quality of life were assessed using the prospectively collected Satisfaction with Breasts and Physical Well-Being of Chest BREAST-Q subscales. Score distributions were examined by radiation exposure status for 3 years after surgery using nonparametric analyses and regression models., Results: Of 2932 patients who met the inclusion criteria, 25.8 percent received radiation during breast cancer treatment, including before tissue expander placement ( n = 239; 8.2 percent), after tissue expander placement ( n = 290; 9.9 percent), and after implant placement ( n = 228; 7.8 percent). Radiotherapy patients had average scores 7 to 9 points lower at all postoperative time points for Satisfaction with Breasts and Physical Well-Being of Chest subscales ( p < 0.001). Although patient-reported outcomes did not differ by radiation timing, there were higher rates of severe capsular contracture with postimplant radiotherapy ( p < 0.001)., Conclusions: Radiation therapy significantly affected patient satisfaction and health-related quality of life following implant breast reconstruction through 3 years postoperatively. Patient perception of outcome was unaffected by radiotherapy timing; however, capsular contracture was higher after postimplant radiotherapy, suggesting there may be an advantage to performing radiotherapy before placement of the final reconstruction., Clinical Question/level of Evidence: Therapeutic, III., Competing Interests: Disclosure : Dr. Pusic is a codeveloper of the BREAST-Q, which is owned by Memorial Sloan Kettering Cancer Center. She receives a portion of the licensing fees (royalty payments) when the BREAST-Q is used in industry-sponsored clinical trials. Dr. Mehrara is a consultant for PureTech Corporation. The remaining authors have no financial conflicts of interest to declare., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: To achieve long-term improvement in health care of transgender women, it is necessary to analyze all aspects of gender-confirming surgery, especially the relation of risks and benefits occurring in these procedures. While there are many studies presenting data on the urologic part of the surgery, there are just few data about complications and satisfaction with breast augmentation., Methods: This is a retrospective study using parts of the BREAST-Q Augmentation Questionnaire and additional questions for symptoms of capsular contracture and re-operations and analyzing archived patient records of all transwomen which were operated at University Hospital Essen from 2007 to 2020., Results: 99 of these 159 patients (62%) completed the questionnaire after a median time of 4 years after surgery. Breast augmentation led to re-operations due to complications in 5%. The rate of capsular contracture (Baker Grad III-IV) in this population was 3%. Most patients (75%) rated high scores of satisfaction with outcome (more than 70 points) and denied to have restrictions due to their implants in their everyday life. All patients reported an improvement in their quality of life owing to breast augmentation., Conclusion: Breast augmentation by inserting silicon implants is a safe surgical procedure which takes an important part in reducing gender dysphoria., (© 2022. The Author(s).)

Background: Reoperative augmentation mammoplasty (RAM) is a challenging procedure, with the highest rates of complications and revision. Complications include implant malposition, lateral displacement, bottoming out, and rotation. These deformities can be addressed with various procedures, but the pocket control and stability of the new smooth implant surface may present limitations., Objectives: This study revisits a previously described predictable approach in primary breast augmentation and defines a surgical treatment algorithm for RAM technique selection., Methods: Between 2017 and 2021, 72 patients (144 breasts) underwent RAM with composite reverse inferior muscle sling (CRIMS) technique and its technical variations (types I-IV). CRIMS technique involves placing a silicone gel implant into the submuscular (SM) pocket with an inferior sling of the pectoralis major muscle based on the dimensions of the implant, in combination with support points/dermal bridge sutures to stabilize the implant and glandular tissue at the lower breast pole (LBP). Reasons for surgery were ptosis (92%), implant and malposition (59.6%). Patients were followed for at least 6 months in 5 cases (6.9%), at least 12 months in 50 cases (69.4%), for at least 36 months in 10 cases (13.8%), and more than 36 months in 7 cases (9.7%) (mean 34 months; range 6-48 months). Patients were evaluated in terms of resolution of symptoms, satisfaction, and complications. Three-dimensional imaging (3DI) obtained from the Divina scanner system was used and followed up for 1 year to evaluate breast position, lower pole stretch (LPS), and intermammary distance (IMD)., Results: Eleven cases of minor complications were observed in 9 patients (12.5%): hypertrophic scarring in 4 (5.5%), wound dehiscence in 4 (5.5%), Baker II/III capsular contracture in 1 (1.3%). SmoothSilk surface silicone implants were used in all cases, with an average volume decrease of 120 cc. Sixty-eight patients (94.4%) were either very satisfied/satisfied with their aesthetic result. Breast images were performed in a group of 65 patients (90.2%), and in 7 breasts (10.7%), localized oil cysts were observed. The value for LPS was 7.87% (p &lt;0.0001) between 10 days and 1 year, with the majority occurring early in the first 3 months, indicating that the LBP/implant remains steady during the last months of follow-up. No cases of fat necrosis/seroma were observed. There were no signs of intra/extracapsular ruptures, capsular contracture. There were 2 cases (3%) of minimal implant displacement and no cases of rotation., Conclusions: CRIMS and its variations can be performed successfully in RAM. An algorithmic approach can facilitate the pre- and intraoperative decision-making process and provide the new pocket control and implant stability with acceptable complication rates. Further accurate evaluation is recommended to understand the benefits or disadvantages of CRIMS compared to other RAM techniques., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Capsular contracture (CC) is the most common long-term complication of breast surgery with prosthesis. Leukotriene receptor antagonists (LRAs) have been tested as a potential treatment; however, mixed results have been observed., Objectives: The aim of this study was to undertake a meta-analysis to clarify the treatment and prophylactic capabilities of LRAs in the management of CC., Methods: A systematic literature search of the most popular English-language databases was performed to identify relevant primary publications. We included all studies that used the Baker scale to evaluate the treatment and preventive capabilities of LRAs., Results: Six eligible studies were included based on predefined inclusion and exclusion criteria, totalling 2276 breasts, of which 775 did not receive LRAs and 1501 did. Final pooled results showed that LRAs could help manage CC with a risk difference (RD) of -0.38 with a corresponding 95% CI of -0.69 to -0.08, showing statistical significance at a Z value of 2.48, P = 0.01. Subgroup analysis based on the type of drug showed that only montelukast yielded statistical significance (RD = -0.27, 95% CI = -0.51 to -0.03, Z = 2.20, P = 0.03). Zafirlukast did not seem to influence CC. Further subgroup analysis based on treatment timing showed that prophylaxis was ineffective and only treatment for ongoing CC yielded statistically significant improvements., Conclusions: The current meta-analysis proved that LRAs could be used in the management of CC. Only treatment for ongoing CC showed statistically significant improvements. Montelukast seemed to be more efficient with a safer profile for adverse effects, whereas zafirlukast yielded no statistically significant results., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Background: We conducted this study to explore the value of the capsule thickness as an indicator of the severity of capsular contracture (CC) alternatively to the Baker classification system in patients who were treated with an implant-based augmentation mammaplasty., Methods: A total of 117 eligible patients (202 breasts) were included in the current study. We measured the capsule thickness using ultrasound and histologic examination in association with the Baker grades I, II, III and IV. Then, we analysed agreement of the capsule thickness between the two methods using an intra-correlation coefficient (ICC 2,1) with 95% confidence intervals (CIs). The CC of Baker grades II, III and IV (105 breasts), for which the capsule thickness could be measured using US, served as Model 1. Moreover, Model 1 including the CC of Baker grades I (97 breasts) served as Model 2., Results: The capsule thickness was measured as 0.58 ± 0.11 (0.4-0.8) mm, 1.07 ± 0.16 (0.8-1.31) mm and 1.89 ± 0.55 (1-4.1) mm on ultrasound in association with Baker grades II, III and IV, respectively. In addition, it was also measured as 0.28 ± 0.07 (0.09-0.41) mm, 0.58 ± 0.08 (0.42-0.75) mm, 1.06 ± 0.14 (0.79-1.34) mm and 2.13 ± 1.14 (1.38-6.98) mm on histologic examination in association with Baker grades I, II, III and IV, respectively. In Model 1 and 2, the ICC was calculated as 0.942 (95%CI 0.914-0.961) and 0.955 (95%CI 0.940-0.966), respectively. The cut-off values between the Baker grades I-II, II-III and III-IV were calculated as 0. mm, 0.8 mm and 1.2 mm, respectively., Conclusions: In conclusion, the capsule thickness might be used as an indicator of the severity of CC alternatively to the Baker classification system. But further studies are warranted to establish our results., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background and Aim: Capsular contracture is the most common complication with smooth-type silicone implants. We investigated the preventive effect of an active metabolite of tamoxifen, 4-hydroxytamoxifen (4-OH TAM), on capsular contracture., Methods: A silicone sheet was implanted into the back of 28 female ICR mice. Mixtures of gel with 0.2% 4-OH TAM and 0.1% 4-OH TAM were administered transdermally once a day for 4 weeks. Saline was administered to the control. After killing the mice, capsular thickness was measured in H&E-stained specimens. Estrogen receptor (ER), α-smooth muscle actin (α-SMA), and transforming growth factor-β (TGF-β) expressions were immunohistochemically investigated in the capsules., Results: The capsule was thinner in the 0.2% 4-OH TAM gel group than in the control group (control, 0.1% 4-OH TAM gel, 0.2% 4-OH TAM gel: 52.8 ± 3.4 µm, 54.2 ± 6.8 µm, 46.4 ± 3.3 µm, respectively). ER was found in most fibroblasts of all samples. α-SMA expression in the capsule was significantly lower in the 4-OH TAM gel groups than in the control group (control = 70.0 ± 3.4%, 0.1% 4-OH TAM = 57.0 ± 3.4%, 0.2% 4-OH TAM = 49.4 ± 4.9%). TGF-β expression was significantly reduced by the 4-OH TAM gel injections dose-dependently (control = 67.3 ± 2.2%, 0.1% 4-OH TAM = 52.4 ± 3.1%, 0.2% 4-OH TAM = 45.1 ± 2.4%)., Conclusions: The transdermal administration of 0.1% and 0.2% 4-OH TAM gels inhibited capsule development. The inhibition of TGF-β expression is a mechanism by which 4-OH TAM suppresses fibroblast growth, preventing capsular formation., (© 2022. The Author(s), under exclusive licence to The Japanese Breast Cancer Society.)