Search

Background: Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants., Objectives: The authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts., Methods: The Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture., Results: A total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up)., Discussion: Motiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change., Conclusions: Three-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Cosmetic breast surgeries such as augmentation, mastopexy, and reduction are common aesthetic medical procedures for enhancing physical appearance. Despite their popularity, the influence of these surgeries on subsequent breast reconstruction for cancer patients remains underexplored., Objectives: In this study we sought to investigate the effects of previous cosmetic breast surgeries on the outcomes of breast reconstruction., Methods: A retrospective chart review was conducted from January 2011 to May 2023. This analysis compared patients with histories of implant augmentation, breast reduction, mastopexy, and augmentation mastopexy with those receiving reconstruction without any cosmetic surgery history. Demographics, comorbidities, complications, revisions, and BREAST-Q surveys were collected. Statistical analysis was performed with SPSS, with significance set at P < .05., Results: The study included 124 patients (50 autologous, 74 implant) with a history of cosmetic breast surgery (102 implant augmentations, 17 breast reductions, 5 mastopexies, and 9 augmentation mastopexies). They were analyzed in comparison with 1307 patients (683 autologous, 624 implant) without previous cosmetic breast surgery. Patients with previous cosmetic surgeries showed a higher incidence of hematoma with tissue expander placement. A preference for implant-based reconstruction was more common among patients with an augmentation history (P < .001), whereas autologous reconstruction was more common in those with a history of breast reduction (P = .047). Patients with a history of breast augmentation had on average significantly more breast revisions (P < .05)., Conclusions: In this study we demonstrate a significantly higher hematoma rate and number of revisions in patients with previous cosmetic breast surgery when compared to patients without a history of cosmetic surgery. Furthermore, we suggest that types of cosmetic breast surgery influence the decision-making process regarding implant vs autologous reconstruction., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Capsular contracture after implant-based breast reconstruction is not an uncommon problem and affects reconstruction outcomes. It can be influenced by various factors, such as the plane of implant placement, implant surface and implant type. This systematic review and meta-analysis aimed to evaluate how the abovementioned risk factors can affect capsular contracture rates., Methods: A systematic review and meta-analysis was performed. PubMed MEDLINE, EMBASE (OvidSP) and Cochrane Library were searched. Comparison groups included subpectoral versus prepectoral implant placement, smooth versus textured implants and saline versus silicone implants. Odds ratios (ORs) were calculated for capsular contracture for each group. The level of evidence was evaluated using the Oxford Centre for Evidence-Based Medicine., Results: Twenty-three studies met the inclusion criteria. Sixteen studies compared subpectoral versus prepectoral implant placement, with no statistically significant differences in capsular contracture rates [OR, 1.21; 95% confidence interval (95% CI), 0.75-1.95; P = 0.44]. Five studies compared smooth versus textured implants, with no statistically significant differences in capsular contracture rates (OR, 0.99; 95% CI, 0.50-1.93; P = 0.97). Two studies compared saline versus silicone implants for capsular contracture. Patients receiving saline implants had significantly lower capsular contracture rates than silicone implants (OR, 0.19; 95% CI, 0.08-0.43; P < 0.0001)., Conclusions: Implant-based breast reconstruction using saline implants demonstrated reduced capsular contracture rates compared to silicone implants. However, no significant differences were observed in capsular contracture rates between subpectoral versus prepectoral implant placement and smooth versus textured implants., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Purpose: Implant-based breast reconstruction (IBR) is being increasingly performed with implant placed above the pectoral muscle (pre-pectoral), instead of below the pectoral muscle (sub-pectoral). Currently, there is a lack of comparative data on clinical and patient-perceived outcomes between pre- vs. sub-pectoral IBR. We investigated whether this difference in surgical approach influenced clinical or patient-perceived outcomes., Methods: This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery., Results: Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4)., Conclusions: This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option., (© 2024. Crown.)

Background: This study explored the surgical management and reconstruction options for augmented breasts in the context of breast conservation therapy (BCT) for breast cancer. The authors hypothesized that there would be no difference in the rates of complications, revisions, or patient satisfaction in patients who maintained their breast augmentation versus those who had their implants removed in the context of BCT., Methods: The authors conducted a retrospective review of 142 patients who underwent BCT at a single center from March of 2016 to March of 2022. The study included patients who had a preexistent cosmetic augmentation at the time of breast cancer diagnosis and BCT. Patient demographics, clinical and treatment characteristics, breast implant details, reconstructive technique, complications, and revisions were recorded. Patient-reported outcomes were assessed using the BREAST-Q BCT module., Results: Ninety-three patients (65.5%) chose to maintain their implants, whereas 49 (34.5%) elected to have them removed during BCT. Patients with submuscular implants were more likely to maintain their implants. Oncoplastic mastopexy was associated with higher complication rates, particularly in patients opting for implant downsizing. However, multivariate logistic regression did not identify implant management strategy as an independent predictor for complications or revisions. Surgical-site infection was the only predictor of implant explantation. Patient-reported outcomes did not differ significantly between the different implant management cohorts., Conclusions: This study demonstrates that maintaining breast implants during BCT does not increase the risk of complications or revisions. Overall, BCT in augmented women was found to be a safe approach, with high patient satisfaction., Clinical Question/level of Evidence: Risk, III., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Background: The difficulty in obtaining long-term data with the use of breast implants is well known. The majority of available data are from multicenter studies with different surgical techniques, and different implants., Methods: The authors provide retrospective 10-year study data (2001 to 2011) with Mentor Contour Profile Gel implants after a mean of 13 years of follow-up, in the first single-center study of such size and length. This study included 835 patients with 1674 Mentor implants across 6 surgery types, all of them performed with a consistent surgical technique developed by the senior author (J.L.M.Y.). Long-term complication rates were analyzed. For the safety analysis, Kaplan-Meier risk rates were calculated., Results: A total of 85% of the patients had long-term follow-up data (at least 7 years). The overall complication rate was 13.2%. The reoperation rate was 12.3%, being just 6.2% caused by complications. The 21-year Kaplan Meier cumulative incidence rate was 1.7% for capsular contracture and 5.1% for implant rupture. The periareolar approach and having a previous capsular contracture were found to be risk factors to develop a new capsular contracture. Low-height, high-projected implants had a significant higher risk of implant rotation. No breast implant-associated anaplastic large cell lymphoma or breast implant illness cases were found; 89.2% of the patients reported being satisfied or very satisfied with the surgery and the implant., Conclusion: With a consistent surgical technique, these 21-year follow-up data of the Mentor Contour Profile Gel implants reaffirm the very strong safety profile of these implants, and continued patient satisfaction with them., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Background: Ptosis recurrence often leads to unsatisfactory results after mastopexy, even more so when additional stress is provided by implants on compromised native tissue. The poly-4-hydroxybutyrate(P4HB) scaffold (GalaFLEX) with its favorable safety profile and proven long-term mechanical strength represents a preferred option for soft tissue support., Objectives: The primary endpoint was assessment of lower pole stretch from the early postoperative period up to 3 years., Methods: Out of 151 patients who underwent surgery by G.B. from March 2020 to December 2023, a total of 72 with a 12-month-mininum follow-up who had primary (46) or secondary (26) augmentation mastopexy with subfascial round smooth implants and P4HB scaffold support were included in the study. Three-dimensional artificial intelligence software was utilized for all measurements. Further analysis included evaluation of ptosis recurrence and all complications., Results: No recurrent ptosis, bottoming out, implant displacement, or capsular contracture was reported during follow-up (mean, 24.8 months). The lower pole arch's elongation was 8.04% and 9.44% at 1 and 3 years respectively, comparing favorably with previous reports. Statistically significant correlation (P < .05) between implant size and lower pole stretch was noted, this being greater for larger implants (> 400 cc; P = .0011) and primary cases (P = .1376). Progressive volume redistribution from upper to lower pole was observed in the first year, with substantial stability thereafter., Conclusions: This is the largest published series reporting long-term results (up to 45 months) in mastopexy augmentation with GalaFLEX, suggesting its supportive role in lower pole stability even in the setting of concurrent breast augmentation with smooth implants in a subfascial plane., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Silicone implants are by far the most widely used implant globally for breast augmentation. Despite technological advancements, complications persist, with silicone lymphadenopathy (siliconoma) being a noteworthy concern. This phenomenon has been inadequately addressed in the existing literature., Objectives: The aim of this study was to characterize axillary siliconomas and identify potential risk factors to help reduce their occurrence., Methods: The authors conducted a retrospective observational cross-sectional study spanning between 2011 and 2021 at the Shamir Assaf Harofeh Medical Center, Israel. Preoperative ultrasound examination was conducted, categorizing patients into those with siliconomas and those without., Results: A total of 614 women (1209 breasts) met the inclusion criteria. The incidence of siliconomas was 13.6% (165 breasts). In univariate analysis, older age (47 years vs 43 years, P < .001), older implant age (12.2 years vs 11 years, P = .026), ruptured implants (59.4% vs 17.7%, P < .001), subpectoral placement (P = .019), severe capsular contracture, and the use of Mentor implants (Irvine, CA; P = .007) and Poly Implant Prothèse implants (PIP; La Seyne-sur-Mer, France; P = .001) correlated significantly with the presence of siliconomas. In a multivariate analysis, implant rupture (odds ratio [OR] = 6.342), and implant manufacturer-Mentor (OR = 3.047) and PIP (OR = 3.475)-were identified as independent risk factors associated with a higher incidence of siliconomas. Severe capsular contracture was also associated with a higher incidence of siliconomas (OR = 1.65)., Conclusions: Surgeons should inform candidates about the potential risk of silicone migration. Patients with ruptured implants, significant capsular contracture, and Mentor and PIP implants face an increased risk for developing siliconomas. Closer monitoring for the detection of siliconomas in the axilla for these patients is advisable, and potential prophylactic replacement or removal of implants may be warranted to mitigate siliconoma risk., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The goals of mastopexy differ significantly from those of augmentation mammoplasty. Mastopexy is designed to lift and reshape the breasts, while augmentation mammoplasty is designed to increase the volume of the breasts. This conflict causes that one-stage augmentation mastopexies showed a revision rate from 8.7 to 23.2%. The aim of our study is to present some technical refinements for reducing the risk of implant exposure and reoperation., Methods: We designed a retrospective matched cohort study, including 216 consecutive patients, undergone augmentation mastopexy between January 2013 and December 2022. We divided them in two groups: Group A undergone an inverted-T superomedial pedicled augmentation mastopexy and Group B undergone our inverted-T modified augmentation mastopexy. The groups were matched for clinical and surgical variables, with the surgical technique the only difference between the two., Results: Complications were registered in ten patients (9.3%) in Group A (two wound breakdowns at T with implant exposure and eight wound dehiscences), six of which required surgical revision. In contrast, only three patients (2.8%) in Group B reported a complication, which was wound dehiscence without implant exposure in all cases. None of the dehiscence required surgical revision. The difference between complication and revision rates was statistically significant., Conclusions: Separating the implant and the mastopexy dissection planes reduces the implant exposure and the reoperation rate in one-stage augmentation mastopexy., 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 https://link.springer.com/journal/00266 ., (© 2024. The Author(s).)

Purpose: The Area Deprivation Index (ADI) ranks neighborhoods by deprivation based on US Census data. This study utilizes ADI scores to investigate the impact of neighborhood deprivation on complication rates following breast reconstruction., Patients and Methods: Patients who received implant-based reconstruction from 2019 to 2023 were identified at a single institution in New York. Patients were linked to a state-specific ADI score and categorized into groups: "High ADI" (6-10) and "Low ADI" (1-5). Patient characteristics and complication rates were compared between the ADI groups with Chi-Square analysis and t-tests. The predictive value of ADI scores on complication rates was assessed using logistic regression models., Results: In total, 471 patients were included, of which 16% (n = 73) were in the High ADI group, and 84% (n = 398) were in the Low ADI group. There were no baseline differences between the 2 groups, except that there were more patients of Hispanic descent in the High ADI group (30% vs. 15%, P < .01). The High ADI group had a higher overall complication rate than the Low ADI group (34% vs. 21%, P < .01), as well as higher individual rates of hematoma (12% vs. 3%, P < .01) and unexpected reoperations (18% vs. 7%, P < .01). After adjusting for differences in race, High ADI scores predicted hematoma, reoperations, and any complication (P < .05)., Conclusion: Patients living in neighborhoods with high ADI had a higher incidence of postoperative complications, independent of comorbidities and race. This measure of disparity should be considered when counselling patients about their risk of complications following procedures like implant-based breast reconstruction., Competing Interests: Disclosure The authors have no other potential conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Several acellular dermal matrices (ADMs) are used for soft-tissue support in prosthetic breast reconstruction. Little high-level evidence supports the use of one ADM over another. The authors sought to compare Cortiva 1-mm Allograft Dermis with AlloDerm RTU (ready to use), the most studied ADM in the literature., Methods: A single-blinded randomized controlled trial comparing Cortiva with AlloDerm in prepectoral and subpectoral immediate prosthetic breast reconstruction was performed at 2 academic hospitals from March of 2017 to December of 2021. Reconstructions were direct to implant (DTI) or tissue expander (TE). Primary outcome was reconstructive failure, defined as TE explantation before planned further reconstruction, or explantation of DTI reconstructions before 3 months postoperatively. Secondary outcomes were additional complications, patient-reported outcomes (PROs), and cost., Results: There were 302 patients included: 151 AlloDerm (280 breasts), 151 Cortiva (277 breasts). The majority of reconstructions in both cohorts consisted of TE (62% versus 38% DTI), smooth device (68% versus 32% textured), and prepectoral (80% versus 20% subpectoral). Reconstructive failure was no different between ADMs (AlloDerm 9.3% versus Cortiva 8.3%; P = 0.68). There were no additional differences in any complications or PROs between ADMs. Seromas occurred in 7.6% of Cortiva but 12% of AlloDerm cases, in which the odds of seroma formation were two-fold higher (odds ratio, 1.93 [95% CI, 1.01 to 3.67]; P = 0.047). AlloDerm variable cost was 10% to 15% more than Cortiva, and there were no additional cost differences., Conclusion: When assessing safety, clinical performance, PROs, and cost, Cortiva is noninferior to AlloDerm in immediate prosthetic breast reconstruction, and may be less expensive, with lower risk of seroma formation., Clinical Question/level of Evidence: Therapeutic, I., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Introduction: Post-mastectomy radiation therapy is an important component of adjuvant therapy for high-risk patients. However, radiation to reconstructed breasts can cause various complications. Recently, hypofractionated (HF) protocols have been adopted in several countries. Here, we aimed to assess the impact of HF protocols on implant-reconstructed breasts through a meta-analysis and systematic review of the currently available literature., Methods: Records published until August 2023 were systematically searched in PubMed, Cochrane Library, and EMBASE databases. Keywords included hypofractionation radiotherapy, mastectomy, and breast reconstruction. Studies that utilized HF and conventional fractionation (CF) after prosthetic reconstruction were selected. Due to the rarity of events in outcomes, Mantel-Haenszel's odds ratios were calculated using a fixed-effect model to compare the complication rates between HF and CF groups. For analysis with high heterogeneity, a random effect model was used., Results: Seven articles with 924 implant reconstructions, in which 506 (54.8 %) underwent HF were included. HF patients received 43.8 Gy on average, while CF patients received 51.2 Gy. Mean follow-up ranged from 10.6 to 35 months. Seven studies were included in the meta-analysis. HF groups had a significantly lower risk of capsular contracture (OR 0.25, 95 % CI 0.11-0.55), major revision surgery (OR 0.19, 95 % CI 0.05-0.80), and wound dehiscence (OR 0.24, 95 % CI 0.07-0.78) compared to CF groups. The risks of other complications were not statistically significant., Conclusion: This study indicates that HF protocols are associated with fewer complications than CF protocols in implant-reconstructed patients. These findings suggest that the application of HF PMRT in implant-reconstructed patients with breast cancer is plausible., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Breast cancer is the most common malignancy among women in the UK. Reconstruction - of which implant-based breast reconstruction (IBBR) is the most common - forms a core part of surgical management of breast cancer. More recently, pre-pectoral IBBR has become common as technology and operative techniques have evolved. Many surgeons use acellular dermal matrix (ADM) in reconstruction however there is little evidence in literature that this improves surgical outcomes. This review will assess available evidence for surgical outcomes for breast reconstructions using ADM versus non-use of ADM., Methods: A database search was performed of Ovid Medline, Embase, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (2012-2022). Studies were screened using inclusion and exclusion criteria. Risk of Bias was assessed using the Newcastle Ottawa scale and ROBIS tools. Analysis and meta-analysis were performed., Results: This review included 22 studies (3822 breast reconstructions). No significant difference between overall complications and failure rates between ADM and non-ADM use was demonstrated. Capsular contracture, wound dehiscence and implant rippling had significant differences however these results demonstrated high heterogeneity thus wider generalisation may be inaccurate. Patient quality of life scores were not recorded consistently or comparably between papers., Conclusions: This review suggests a lack of significant differences in most complications between ADM use and non-use for pre-pectoral IBBR. If no increase in complications exists between groups, this has significant implications for surgical and legislative decision-making. There is, however, inadequate evidence available on the topic and further research is required., (© 2024. The Author(s).)

Background: Anxiety disorders, both with and without comorbid depression, are widespread globally. In this study we investigate the intersection of anxiety, depression, and self-reported breast implant illness (BII) in females undergoing aesthetic breast surgery., Objectives: The objective of our research was to enhance understanding about mental health history, psychotropic medication use, and its relation to BII symptoms., Methods: A cohort of 240 consecutive female patients undergoing elective breast surgery was studied. In the study we categorized patients by groups based on the presence of self-reported BII symptoms and the type of breast surgery performed. Mental health history, psychotropic medication use, and time spent in treatment for mental illness were scrutinized. Statistical analyses were conducted, including multiple regression analysis., Results: Results revealed that patients with self-reported BII symptoms often had a preexisting anxiety/depression disorder treated medically before obtaining breast implants, and this disorder predicted the occurrence of BII symptoms. These patients tended to be diagnosed with anxiety and depression at a younger age, initiate medication therapy earlier, take more medications for their condition, and spend more time in therapy compared with others undergoing elective breast surgery., Conclusions: Implications of this study highlight the need for comprehensive counseling between plastic surgeons and patients with self-reported BII symptoms. Understanding the role of anxiety/depression in the pathogenesis of self-reported BII is crucial, and collaboration with psychiatrists and other mental health professionals can ensure improved supportive care. The findings contribute to a better understanding of the psychological aspects surrounding breast implant surgery and self-reported BII and emphasize the importance of preoperative mental health assessments in appropriate patient selection for elective breast surgery., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Implant malposition is a well-recognized complication of prosthetic breast implants. However, to date, no objective classification system has been described., Objectives: The aim of this study was to perform a prospective trial of an objective and reproducible classification system for implant malposition formulated by analyzing retrospective data from a large cohort of patients with implant malposition., Methods: The authors retrospectively analyzed the degree of medial/lateral and inferior/superior implant malposition relative to their optimal position within the breast footprint in a series of 189 breasts (n = 100 patients). An objective classification system for implant malposition was devised and then applied to a prospective cohort of 53 breasts in 28 patients with implant malposition., Results: The degree of malposition in a single or combination of axes was categorized according to the distance (measured in centimeters) from the ideal breast footprint. The classification system incorporated the axis of malposition and distance to generate a treatment decision-making guide. Cases of Grade 1 malposition did not warrant surgical intervention, whereas surgical correction was warranted in all Grade 3 cases. In the combined patient cohort (n = 242 breasts, 128 patients), lateral, inferior, medial, and superior displacement ranged between Grades 1 and 3. There was no interobserver variability in the grades assigned to 9 out of 10 patients in the prospective group., Conclusions: A simple and reproducible classification system for implant malposition has been created that allows surgeons to objectively record the extent of malposition, guides surgical decision-making, and can be used to document the results of any intervention., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: In 2021, the US FDA issued a new checklist, labeling, and rupture-screening recommendations for breast implants to improve the decision-making process., Objectives: The aim of this study was to understand plastic surgeons' perspective on these changes and their perceived impact on clinical practice., Methods: In September 2023, a 27-question multiple-choice cross-sectional survey was distributed to 4352 active members of the American Society of Plastic Surgeons to evaluate attitudes on the FDA's black-box warning, informed decision checklist, and updated rupture-screening recommendations., Results: A total of 591 responses were collected (13.6%). The majority of respondents were between the ages of 45 and 64 years (58%) and had been in practice for more than 20 years (52%). Surgeons felt that some additions were appropriate; however, the majority (57%) stated that the informed decision checklist did not have a positive impact on workflow; 66% were also neutral or disagreed with the reported incidence rates related to complications and cancer. Nearly half of respondents (47%) did not feel the black-box warning improved their patients' understanding of the risks and benefits. Additionally, 47% of respondents also believed these requirements, in combination, did not improve the overall patient experience with implants., Conclusions: Respondents had an overall positive response towards the addition of risk information provided by the FDA-issued guidance and updates to rupture-screening recommendations. However, they remained divided as to whether the black-box warning and patient decision checklist had an overall positive impact on clinical practice patterns., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Capsular contracture is a significant complication following mammaplasty, with varying incidence rates and symptoms. The etiology of capsular contracture is multifactorial, with postoperative hematoma recognized as a potential contributing factor., Objectives: In this study we aimed to investigate the impact of postoperative hematoma on capsular contracture following mammaplasty, utilizing pig models and modified biomechanical testing. We sought to compare the severity of capsular contracture between smooth and textured implants in the presence of hematoma, assess the biomechanical properties of the capsules, and explore the histological and molecular changes associated with the condition., Methods: The study involved 5 female miniature pigs, implanted with both smooth and textured implants. Hematoma models were established, and various methods were employed to evaluate the impact of the prosthesis surface and hematoma on capsular contracture, including ultrasound assessment, biomechanical tests, scanning electron microscopy, histological analysis, and transcriptome sequencing., Results: Capsules in hematoma groups were classified as Baker III/IV, with significantly unfavorable thickness, elastic modulus, and relaxation and creep amounts compared to nonhematoma groups. Smooth implants under hematoma conditions exhibited increased muscle content and biomechanical strength of the capsule. Transcriptomic analysis highlighted differential gene expression related to muscle development and contraction in smooth implants with hematomas., Conclusions: Hematomas increase the risk of capsular contracture, with smooth implants exacerbating this effect by enhancing pathways related to muscle development and contraction. This underscores the importance of hematoma prevention and treatment strategies, particularly when placing smooth implants, to minimize the occurrence of capsular contracture. The study provides insights into the mechanisms underlying capsular contracture and offers evidence to guide surgical and postoperative management strategies., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Introduction: There has been a rising trend in the use of silicone breast implants for breast reconstructions after breast cancer treatment, as well as in the aesthetic breast procedures. A cluster of non-specific symptoms related to the presence of silicone implant has been called breast implant illness (BII). However, there are no strict criteria of BII which would specifically define this term. The increasing interest in BII among patients and physicians urges verifying own cases of "on-demand" explantations., Material and Methods: In this paper, we discussed a case of a patient with initial BII diagnosis, after breast reconstruction, and reviewed the literature on the BII symptoms and aetiology. A decision for aesthetic revision, not explantation, was made as the diagnosis of BII was questioned, and somatisation due to dissatisfaction with the aesthetic result of breast reconstruction was diagnosed., Results: Improving aesthetics by implant exchange and contralateral mastopexy caused a full recovery from patient's symptoms., Conclusion: Based on our case, we point on the fact that BII diagnosis in patients after breast reconstruction is challenging. We suggest that while considering such a diagnosis and further proceedings, e.g. explantation, especially in patients after breast reconstruction, some exclusion criteria should be considered. Dissatisfaction with the result of the surgery can also lead to somatisation and the presence of real clinical symptoms, which should not be confused with the possible autoimmune reaction to silicone particles., 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 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Breast augmentation procedures using silicone implants have become increasingly popular over the past six decades. This article addresses the concerns of patients regarding implant strength by providing clinicians with valuable information in addition to video and pictorial evidence to share, fostering reassurance. The article focuses on the structural integrity and stability of breast implants, which play a critical role in their long-term performance and patient satisfaction. Specifically, it examines the industry standards outlined by the International Organization for Standardization (ISO), with a particular emphasis on ISO14607-2018, which encompasses a range of mechanical and physio-mechanical tests, including the assessment of silicone gel-fill firmness, evaluation of shell integrity, and examination of the impact of environmental conditions on implant performance. Breast implants are not static devices and are subject to aging and fatigue-based degradation. This emphasizes the need for ongoing monitoring and evaluation to ensure the long-term safety and satisfaction of patients. By providing a comprehensive examination of breast implant structure and industry standards, this article equips clinicians with the necessary knowledge to address patient concerns and foster confidence in the safety and longevity of breast augmentation procedures using silicone 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 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Although mesh-based implant breast reconstruction surgery is emerging as the primary surgical procedure for breast reconstruction, mesh use remains controversial in implant breast reconstruction surgery, especially in terms of how to select the ideal mesh. Our aim is to elaborate relevant prognosis in the mesh-based implant breast reconstruction surgery., Methods: Relevant studies were identified from PubMed, Web of Science, EMBASE, and Cochrane library searches. Extracted data included study type, basic characteristics, mesh information, complications, etc. We analyzed the included cohort studies and randomized controlled trials that reported mesh-related implant breast reconstruction complications and breast quality scale scores., Results: A total of 32 studies including 7475 subjects were included. The results showed that the overall complication rate was 2.07 times higher in the biological mesh group than in the synthetic mesh group (risk ratio [RR]: 2.07, 95% CI 1.14-3.78). The risk of seroma was 4.50 times higher in the biological mesh group than in the synthetic mesh group (RR: 4.50, 95% CI 2.27-8.95). In terms of comparing breast quality scale scores, the mesh group had scores that were 1.49 (95% CI 0.19-2.78) higher than the non-mesh group for "physical well-being" and 2.05 (95% CI 0.08-4.02) higher for "sexual well-being.", Conclusions: Our study found that the risk of total complications was higher with biological mesh than with synthetic mesh in implant breast reconstruction surgery. Based on short-term cost, healthcare burden, and healthcare benefits, synthetic meshes are superior to biological meshes., 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 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: The authors performed a retrospective review to analyze operative outcomes of breast mound reconstruction after robot-assisted mastectomy., Methods: Patients who underwent nipple-sparing mastectomy (NSM) with a robotic device (Da Vinci Xi) and immediate prepectoral prosthetic reconstruction by lateral incision from June of 2018 to July of 2019 were enrolled. Patient characteristics, complications, and satisfaction rates as assessed by BREAST-Q were analyzed. The surgical technique was described in detail., Results: Thirty-nine cases, including 7 bilateral cases (total 46 breasts), underwent robot-assisted NSM followed by immediate prepectoral prosthetic implant reconstruction. The median patient age was 46.63 years (range, 21 to 63 years). The mean operation time for each prepectoral breast mound reconstruction using the direct-to-implant technique was 126.55 minutes. Robot-assisted reconstruction resulted in superior BREAST-Q scores compared with the conventional reconstruction method. Major infection occurred in 7 cases (15.2%), and complete nipple loss occurred in 3 cases (6.6%). Severe complications requiring breast implant removal occurred in 4 breasts (8.7%). Two cases were due to the coexistence of infection and skin necrosis; in 1 case, the skin flap became congested on postoperative day 3 and required additional surgery to change the expander. Other complications were resolved with conservative care or minor revision., Conclusions: This report is the first concerning robot-assisted NSM followed by prepectoral acellular dermal matrix-wrapped prosthetic reconstruction. This procedure was not inferior to other methods. Further prospective research to evaluate oncologic outcomes is warranted., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Transumbilical breast augmentation (TUBA) with saline implants has been considered a safe and efficient technique for decades. However, because silicone implants are more popular than saline ones, TUBA with saline implants is not widely performed. In 2014, we published a report on transumbilical breast augmentation using silicone cohesive gel implants. As we have performed transumbilical silicone breast augmentation (TUSBA) for 13 years with slight modifications, this study aimed to describe this novel technique and present accompanying patient outcomes over 5 years., Methods: We enrolled patients desiring breast augmentation at a single center. The preoperative design was initially determined with the patients in standing positions before they underwent surgery under general anesthesia in a supine position., Results: Between January 2018 and December 2022, 69 women and one man underwent TUSBA at a single center. All patients underwent cohesive gel silicone implantation in the subpectoral pocket. The implant size varied from 225 to 300 mL (average 272 mL) because two patients underwent surgery with implants of different sizes due to breast asymmetry. All patients were satisfied with the surgery outcome except one who was dissatisfied because of abdominal bulging., Conclusions: TUSBA offers advantages such as minimal scarring and unrestricted arm movement; thus, it can be an alternative option for patients seeking breast augmentation., 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 https://www.springer.com/00266 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Despite high complication rates, patients persistently present for single-stage augmentation mastopexy. In empty, deflated breasts, we perform one-stage augmentation mastopexy; however, in heavy ptotic breasts, our preference is to stage the procedure with mastopexy and fat graft first. With volume from fat grafting focussing on the upper pole and cleavage areas, many of our patients avoid implants altogether. This reduces subsequent risks of waterfall deformity, implant displacement, rupture and a lifetime of implant exchanges., Objectives: We aim to describe our findings and technique for reducing progression to the second stage of a two-stage augmentation mastopexy with the appropriate use of moderate to high volume of fat grafting at the primary operation., Methods: This is a retrospective review of all patients who presented to the senior author (KT) requesting breast implants and requiring mastopexy, from January 2018 to December 2022., Results: Over the five-year period, 137 patients were identified. Seventy-one (51.8%) underwent single-stage augmentation mastopexy, 55 (40.1%) underwent mastopexy with fat grafting and 11 (8.0%) underwent mastopexy with no fat grafting. Our key finding in this study is that 52 of 66 (78.8%) of planned staged patients, who underwent mastopexy with or without fat grafting, were happy with the volume attained and no longer wished to undergo further implant augmentation., Conclusion: In selected patients, appropriate volume and position of fat grafting at the time of primary mastopexy can significantly obviate the need for a second stage implant (alloplastic) augmentation., 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 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Summary: In transumbilical breast augmentation (TUBA) with prefilled silicone implants, technical challenges remain to accommodate more implant options and dissection planes. The authors aimed to demonstrate the feasibility of TUBA using various types of prefilled silicone implants (TUSBA) and its applicability for subglandular, subfascial, dual-plane implantation. In the early stage, TUSBA was primarily performed using endoscope-assisted blunt dissection, and later converted to full endoscopy dissection to achieve better results. An endoscope was used to confirm the pocket and check bleeding for both groups. For the endoscope-assisted group, surgical techniques were modified from conventional TUBA. In full endoscopy TUSBA, the entire dissection process was performed under endoscopic monitoring. Preliminary data of patients undergoing TUSBA from June of 2016 to April of 2021 were retrospectively reviewed. Breast implants with smooth, textured, or nanotextured surface properties and round or anatomic shapes were used, with sizes up to 500 mL. Seventy-four patients with a mean age of 36.4 years (range, 21 to 55 years) were enrolled in this study. Follow-up ranged from 1 month to 4.5 years (mean, 15.6 months). No excessive postoperative pain in breast or abdomen was reported. Surgery outcomes were aesthetically pleasing in both groups. In the endoscope-assisted group, 3 patients (4.6%) required major revisional procedures. No revision was required in the full-endoscopy group. TUSBA with various types of silicone implants is feasible and accommodable to all dissection planes. The full-endoscopy technique is helpful in reducing the higher complication rate., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Textured implants were developed with the goal of reducing rates of capsular contracture and preventing implant malposition (eg, malrotation). Recent evidence has questioned whether textured implants are as resistant to malrotation as previously reported., Methods: Women presenting to a single health care system for removal of textured implants were prospectively enrolled in the study from September of 2019 to July of 2022. Patients who underwent removal of an anatomical, textured implant in the operating room were included in the study; whereas those who did not undergo implant removal, or were found to have a smooth implant, or a round, textured implant, were excluded. The degree of implant rotation on removal of the implant was measured intraoperatively. Information regarding implant-specific factors, patient demographics, clinical factors, and operative characteristics, was collected., Results: A total of 51 patients (80 implants) were included in the study; 45% of implants were malrotated (rotated >30 degrees), and the median degree of rotation was 30 degrees. Having more than one previous revision of the breast pocket was predictive of implant rotation (42 degrees) on multivariate linear regression analysis. Patients who presented with a complaint of "aesthetic dissatisfaction" had 2.89 increased odds of having an implant rotated greater than 30 degrees., Conclusion: The authors' study found a high rate of malrotation of textured shaped implants on explantation., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared with the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial vs subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on MEDLINE, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies that assessed the use of the subfascial plane for breast augmentation were included. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and 7 comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared with subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had a high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases the risk of capsular contracture, hematoma, and rippling compared with the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Breast implant illness (BII) has become a contentious subject in recent years. Although some studies have reported associations between breast implants and autoimmune diseases, others have failed to establish a definitive link., Objectives: The objective of this study was to provide a comprehensive, up-to-date evaluation of the literature surrounding BII, with an emphasis on identifying patient-related factors that may be associated with BII., Methods: A systematic review was performed following PRISMA guidelines by searching the PubMed (MEDLINE), Embase, and Cochrane databases for relevant studies published in the last 20 years., Results: Thirty-one studies were included, which covered 39,505 implant patients with a mean [standard deviation] age of 44.2 [9.30] years. Fifteen studies reported implant explantation status, with 72.4% patients choosing to remove their implants. Among these, 9 studies reported symptom improvement in 83.5% patients. Fifty-three percent of patients undergoing explantation had total capsulectomy. Twenty-eight studies documented total numbers of patients experiencing symptoms related to BII, with 31.3% patients reporting such symptoms. Among these, 16 studies of 4109 BII patients distinguished whether the reason for implantation was cosmetic augmentation or reconstruction. When specified, more patients experiencing BII-related symptoms received implants for "cosmetic" vs "reconstructive" reasons (cosmetic, 3864/4109 [94.0%] vs reconstruction, 245/4109 [5.96%]; P < .001)., Conclusions: This review provides an overview of the current state of knowledge regarding BII. The study highlights a potential relationship between BII and indication for implants (cosmetic vs reconstructive) among other variables, offering valuable insight on factors associated with BII and directions for future research., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Nanotextured breast implants (classified as smooth implants by the latest ISO 14607:2018) have been described as possibly reducing major textured implant-related complications such as capsular contracture and breast implant-associated anaplastic large cell lymphoma. On the other hand, microtextured breast implants benefit from an optimal safety profile based on a much larger body of literature., Objectives: The aim of this study was to directly compare the incidence of complications between Motiva Ergonomix (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) and POLYTECH MESMO (POLYTECH Health & Aesthetics GmbH, Dieburg, Germany) breast implants, especially regarding the displacement issues that might arise after breast augmentation., Methods: Consecutive patients who previously underwent surgery by the same physician for placement of Motiva Ergonomix and POLYTECH MESMO implants were included in this study. They were divided into 2 groups according to the type of implant. The onset of complications was assessed through survival analysis., Results: Data were collected from 329 patients, 185 (56.2%) with POLYTECH MESMO and 144 (43.8%) with Motiva Ergonomix implants. The median follow-up was 8 months for both groups. Of the 42 women (12.8%) who experienced at least one complication, 26 belonged to the Motiva Ergonomix subgroup (P = .013). The most represented complications during this period resulted from displacement issues, with a clear prevalence of bottoming out in the Motiva Ergonomix cohort: 15 cases vs 0 cases in the POLYTECH MESMO cohort (P < .001). For 7 patients, a reoperation was required, more frequently for patients with Motiva Ergonomix implants (4.2% vs 0.5%; P = .046)., Conclusions: POLYTECH MESMO devices provided a more favorable outcome. Motiva Ergonomix devices revealed a concerning incidence of displacement issues during the first postsurgery years, with no advantage over other major complications., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Polyurethane (PU)-coated breast implants are known for their strong integration into breast tissue and the formation of capsules around them. However, capsular contracture can pose both aesthetic and clinical challenges., Objectives: The objectives of this study were to analyze the biological and morphological characteristics of the capsular tissue surrounding PU-coated implants, irrespective of their contracture status, and to assess their potential suitability as a flap in revisional breast surgery for capsular contracture., Methods: A total of 23 tissue samples were harvested from the capsules surrounding PU-coated breast implants in 12 female patients during replacement or revisional surgery. We evaluated collagen abundance, cellular and vascular density, inflammation, collagen band types and alignment, synovial metaplasia, capsule thickness, and the expression of inflammatory biomarkers and myofibroblasts with immunohistochemical techniques. Scanning electron microscopy was employed to assess implant surface characteristics over time., Results: We found a significant association of capsule contraction with longer implantation durations and greater implant surface roughness (P = .018 and P = .033, respectively). Synovial metaplasia was significantly more frequent in noncontracted capsules (P = .0049). Both capsule types consisted of paucicellular, type I collagen-rich compact fibrous tissue with low vascularization. There was a marked reduction in inflammatory cells within the foreign body granuloma. The expression of inflammatory biomarkers in the capsular tissue was negligible., Conclusions: Given the reduced levels of inflammatory and vascular components within the dense, fibrous capsular tissue, we consider them to be viable alternatives for capsular flaps in revisional surgery. This strategy has the potential to mimic the reconstruction achieved with acellular dermal matrix., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Despite increasing demand for breast capsular surgery to treat various benign and malignant implant-related pathologies, high-quality evidence elucidating complication profiles of capsulectomy and capsulotomy is lacking., Objectives: The aim of this study was to provide the largest-scale analysis of associated outcomes and complications using the Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database, and to investigate clinical scenarios that may subject patients to increased risks for complications, most notably extent of capsular surgery (complete vs partial) and index indication of implantation (aesthetic vs reconstructive)., Methods: An analysis of the TOPS database from 2008 to 2019 was performed. CPT codes were used to identify complete capsulectomy and partial capsulectomy/capsulotomy cases. Breast implant exchange procedures constituted procedural controls., Results: In total, 7486 patients (10,703 breasts) undergoing capsulectomy or capsulotomy were assessed. Relative to controls, capsulectomy (4.40% vs 5.79%), but not capsulotomy (4.40% vs 4.50%), demonstrated higher overall complication rates. Both capsulectomies (0.83% vs 0.23%) and capsulotomies (0.56% vs 0.23%) also had greater rates of seroma relative to controls. Subgroup analyses demonstrated that reconstructive patients, relative to aesthetic patients, experienced greater overall complications (6.76% vs 4.34%), and increased risks for seroma (1.06% vs 0.47%), dehiscence (0.46% vs 0.14%), surgical site infections (1.03% vs 0.23%), and implant loss (0.52% vs 0.23%). A detailed synthesis of 30-day outcomes, including all patient- and breast-specific complications, for both capsulectomy and capsulotomy, stratified according to all potential confounders, is presented herein., Conclusions: Surgeries on the breast capsule are safe overall, although complete capsulectomies and reconstructive patients are associated with significantly increased operative risks. The present findings will enhance patient selection, counseling, and informed consent., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Nanotextured implants, an innovation in implant technology, are designed to enhance tissue interaction, reduce inflammation, and mitigate complications of traditional implants., Objectives: The aim of the study was to evaluate the aesthetic potential and safety profile of nanotextured breast implants in breast augmentation from a single-surgeon experience., Methods: This prospective cohort study included 1000 patients who underwent breast augmentation with nanotextured implants. Aesthetic outcomes were assessed with direct measurements and BCCT.core software, focusing on breast projection, symmetry, and upper pole fullness. Patient satisfaction was measured with BREAST-Q and overall satisfaction surveys. Safety profiles were evaluated based on the incidence of complications such as infection, hematoma, capsular contracture, and implant rupture. Statistical analyses were conducted to assess the outcomes., Results: The study found significant improvements in aesthetic outcomes, with 92.8% of cases achieving substantial aesthetic enhancements. Patient satisfaction was high, with 96.4% of patients reporting enhanced self-esteem and contentment. The safety profile was favorable, with a low incidence of complications (0.7% requiring revisional surgery) and no major complications reported. Long-term follow-up data indicated sustained aesthetic outcomes and a stable safety profile., Conclusions: The synergistic quality of nanotextured implants in relation to the natural breast gland tissue is defined by a significantly wider range of aesthetic options. The findings of this study underscore the positive impact of nanotextured breast implants on enhancing the aesthetic potential of breast augmentation and their contribution to a low incidence of complications., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: In immediate breast reconstruction (IBR), it is unclear whether there is any difference in the complication rates between prepectoral versus subpectoral implant placement without acellular dermal matrix (ADM)., Aim: To compare the rates of early post-operative complications and time to initiation of adjuvant treatment in patients undergoing IBR between prepectoral and subpectoral implant placement without ADM for the two surgical procedure., Methods: We retrospectively retrieved data of patients who underwent IBR with prepectoral versus subpectoral implant placement between January 1, 2020 and December 31, 2022 in a large cancer center in France., Results: We included 192 patients: 119 in the prepectoral and 73 in the subpectoral group. Their clinical characteristics were similar. Thirty patients (15.6%) received adjuvant chemotherapy, among them 27 (14.1%) received it within 12 weeks, and there was no difference between the groups (p = 0.12). In the prepectoral group, 39 patients (32.8%) received adjuvant radiotherapy versus 5 (6.8%) in the subpectoral group (p < 0.001), but there was no significant difference in time to treatment commencement. Overall, 35 patients (29.4%) in the prepectoral group and 17 (23.3%) in the subpectoral group experienced post-operative complications (p = 0.44). Using multivariable analysis, the only factor associated with post-operative complications was determined to be mastectomy weight (odds ratio 1.98 (1.10-3.59) for weight ≥500 g; p = 0.02)., Conclusion: Prepectoral implant placement without ADM can be proposed to patients undergoing IBR with an indication for adjuvant treatment. However, in our study, the reoperation rate with this technique was slightly higher (p = 0.008). This is partly due to the learning curve for surgeons using this new technique., (Copyright © 2024. Published by Elsevier Ltd.)

Background: The number of patients undergoing exchange of textured implants for smooth devices has greatly increased because of concern over breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The authors examined long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications., Methods: Patients who underwent reconstruction with shaped, textured implants replaced with round, smooth implants between 1994 and 2022 and who had a minimum follow-up of 1 year were included. Patient-reported outcomes were collected using the BREAST-Q Reconstruction module and a survey evaluating aesthetics and comfort. Surgeon-reported outcomes included evaluation of aesthetics and capsular contracture., Results: A total of 530 patients were reviewed, and 307 patients were included. Pairwise comparison of BREAST-Q data demonstrated that psychosocial well-being (72.68 to 76.45; P = 0.0075) and physical well-being (78.79 to 81.88; P = 0.0078) increased significantly. Overall breast satisfaction (61.94 to 67.27; P = 0.0082) and sexual well-being (53.89 to 57.98; P = 0.0002) were also significantly higher in parallel with a clinically meaningful increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they appeared better (56.4%) or similar (27.3%) and were more comfortable (54.4%) or similar (39.4%) after the exchange procedure. The senior surgeon (P.G.C.) rated 40.1% of patients as having a better aesthetic grade after replacement and 50.3% as the same; 36.8% of patients were rated as having a decrease in Baker capsular contracture grade; 2.9% of patients experienced a perioperative complication; and there were no reconstructive failures., Conclusion: Exchange of textured to smooth implants is safe, does not sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with minimal complications., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Hybrid breast reconstruction combines free tissue transfer with implant placement. Various mesh products have been successfully used to secure the implant position in these reconstructions. In this study, the authors investigate the impact of mesh type on long-term outcomes following hybrid breast reconstruction., Methods: A retrospective analysis of all patients with at least 24 months of follow-up after immediate bilateral prepectoral hybrid breast reconstruction was performed. Univariate and multivariable regression analyses were used to evaluate long-term outcomes and compare breasts reconstructed with polyglactin mesh versus acellular dermal matrix (ADM)., Results: Thirty-nine patients (78 breasts) who underwent hybrid breast reconstruction with an average follow-up period of 50.4 months (range, 27 to 73 months) were included in the study. Postoperative complications included hematoma ( n = 2 [2.6%]), mastectomy skin necrosis ( n = 12 [15.4%]), and fat necrosis ( n = 6 [7.7%]). There were no instances of implant infection, implant exposure, or flap failure. Polyglactin mesh and ADM were used in 24 breasts and 54 breasts, respectively. Implant malposition and capsular contracture occurred more frequently in the polyglactin cohort leading to 10 (41.7%) instances of reoperation for implant replacement compared with only 1 (1.9%) in the ADM cohort ( P < 0.001). On multivariable regression analysis, polyglactin mesh was associated with a 36-fold greater probability of requiring implant replacement compared with ADM ( P = 0.006)., Conclusion: ADM (versus polyglactin mesh) is associated with lower rates of capsular contracture and implant malposition in the context of hybrid breast reconstruction., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Direct-to-implant (DTI) reconstruction has multiple advantages over a staged tissue expander (TE) approach. However, its use may be limited by concerns of increased complications. This study is the largest series to date comparing postoperative outcomes for DTI versus TE reconstruction in the prepectoral plane., Methods: The authors retrospectively reviewed 348 patients who underwent 536 total immediate, prepectoral implant-based breast reconstructions between January of 2018 and December of 2021. The authors compared the presence of risk factors and the rate of six separate complications between patients who underwent DTI versus TE reconstruction up to 1 year after surgery., Results: Of 348 patients, 147 (42%) and 201 (58%) underwent TE and DTI reconstruction ( P = 0.1813), respectively. The overall infection rate was 16.4% ( n = 57). DTI patients had a significantly greater incidence of wounds ( P < 0.0001), including minor ( P < 0.0011) and major wounds ( P < 0.0053). Significantly greater mastectomy resection weights were found for DTI patients who experienced any complication ( P < 0.0076), postoperative wounds ( P < 0.0001), and major wounds specifically ( P < 0.0035). Compared with medium-thickness acellular dermal matrix (ADM), extra thick ADM was associated with significantly increased rates of infection ( P < 0.0408) and wounds ( P < 0.0001)., Conclusions: Prepectoral DTI reconstruction in patients with adequate flap perfusion may have complication rates comparable to staged TE reconstruction, apart from a higher incidence of postoperative wounds. Greater mastectomy resection weights and thickness of ADM may specifically contribute to infection and wound-healing complications. Prepectoral DTI reconstruction is encouraged in the patients with adequate flap perfusion and moderate to low mastectomy resection weights who desire comparable or smaller implant volumes., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Postoperative infection of breast implants can lead to implant removal and other complications. This study aimed to investigate the presence of costal cartilage infection following breast implant surgery and the diagnostic role of PET/CT in identifying this rare complication., Patients and Methods: A retrospective study included 16 patients with persistent infections after breast implant removal surgery. Patients underwent PET/CT scans before surgery, and surgical plans were made based on PET/CT findings. Surgical procedures were guided by PET/CT, and specimens were collected for pathological examination and microbiological culture. Follow-up assessments were performed at 1, 3, and 12 months postoperatively., Results: Among the 16 patients, 11 were diagnosed with costal cartilage infection, whereas 5 had subcutaneous soft tissue infections. PET/CT accurately identified costal cartilage infection in all cases and localized the infected costal cartilage in the majority of cases. Microbiological culture results showed various pathogens. All patients were cured with one or staged surgery., Conclusion: Costal cartilage infection following breast implant surgery is a significant concern. PET/CT plays a crucial role in the accurate diagnosis and localization of infected costal cartilage, aiding in appropriate surgical management. Patients should be closely monitored for the possibility of costal cartilage infection when experiencing persistent symptoms after breast implant surgery., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Considerable research has been carried out on the postoperative benefits of extended antibiotic prophylaxis (EAP) in different surgical contexts, generating various results regarding its effectiveness. Some studies indicate positive outcomes, whereas others indicate no significant advantages. Our approach involves conducting a comprehensive systematic review and meta-analysis to provide a more nuanced understanding of the role of extended antibiotic use because of the lack of a consistent consensus., Methods: A thorough search of the Cochrane Library, Embase, and MEDLINE electronic databases was conducted to identify relevant studies. The metafor package in R software was used for meta-analysis. We collected risk ratios (RRs) for surgical site infection (SSI) in the EAP versus non-EAP groups from the included studies to assess the effects of EAP on reducing the risk of SSI. The meta-analysis used a random-effects model, and effect sizes were presented with their corresponding 95% confidence intervals (CIs)., Results: Fourteen studies, involving 12,572 patients who underwent implant-based reconstruction postmastectomy, were included. Pooling the results of the studies that used EAP until drain removal revealed no protective effect of EAP against SSI risk (RR = 0.84; 95% CI: 0.60-1.18). Similarly, our analysis revealed no significant benefit of EAP in studies where EAP was not contingent on drain removal (RR = 0.70; 95% CI: 0.46-1.07)., Conclusions: EAP administration did not decrease the incidence of SSI in individuals undergoing implant-based breast reconstruction surgery postmastectomy., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Systemic symptoms associated with breast implants (SSBI) is a term used to describe a group of patients who attribute a variety of symptoms to their implants. Previous studies have shown symptom improvement after implant removal in these patients irrespective of whether part or all the implant capsule has been removed., Objectives: The aim of this study was to evaluate implant removal with no capsule removed in symptomatic and control subjects., Methods: Eligible study subjects were sequentially enrolled at 5 investigator sites. The SSBI Cohort included patients with systemic symptoms they attributed to their implants who requested explantation. The Non-SSBI Cohort included subjects without systemic symptoms attributed to their implants who requested explantation with or without replacement. All subjects agreed to undergo explantation without removal of any capsule., Results: Systemic symptom improvement was noted in SSBI subjects without removal of the implant capsule, comparable to the results of our previously published study. SSBI patients showed a 74% reduction in self-reported symptoms at 6 months with no capsulectomy which was not statistically different from partial or total capsulectomies (P = .23)., Conclusions: Explantation with or without capsulectomy provides symptom improvement in patients with systemic symptoms they associate with their implants., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Direct-to-implant (DTI) breast reconstruction after mastectomy has gained increasing popularity. While concerns over ischemic complications related to tension on the mastectomy flap persist, newer techniques and technologies have enhanced safety of this technique., Objectives: To compare clinical and patient-reported outcomes of DTI and 2-stage tissue expander (TE) reconstruction., Methods: A prospective cohort design was utilized to compare the incidence of reconstructive failure among patients undergoing DTI and TE reconstruction by unadjusted bivariate and adjusted multivariable logistic regression analyses. Secondary clinical outcomes of interest included specific complications requiring intervention (infection, seroma, hematoma, mastectomy flap necrosis, incisional dehiscence, device exposure) and time to final drain removal. Patient-reported outcomes on BREAST-Q were also compared., Results: A total of 134 patients (257 breasts) underwent DTI reconstruction and 222 patients (405 breasts) received TEs. DTI patients were significantly younger with lower BMIs; less diabetes, hypertension, and smoking; and smaller breast sizes; they also underwent more nipple-sparing mastectomies with prepectoral reconstructions. Rates of any complication (18% DTI vs 24% TE, P = .047), reconstructive failure (5.1% vs 12%, P = .004), and seroma (3.9% vs 11%, P < .001) were significantly lower in the DTI cohort on unadjusted analyses; however, there were no significant differences on adjusted regressions. Patient-reported satisfaction with breasts, psychosocial well-being, and sexual well-being were more substantively improved with DTI reconstruction., Conclusions: Prepectoral DTI reconstruction is a viable option for postmastectomy reconstruction in carefully selected patients, with no significant increase in reconstructive failure or other complications., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Broad evidence supports the use of antiseptic pocket rinse in breast implant surgery to minimize the risk of capsular contracture or other complications. However, there is limited consensus or standardization of antiseptic rinse in practice., Objectives: In this preliminary study, we sought to determine contemporary trends in antiseptic rinse use in primary breast implant surgery based on Australian Breast Device Registry (ABDR) data, and whether these trends align with the suggestions of the 14-point plan. This further served as a feasibility study for subsequent comparison of antiseptic rinse effects on clinical outcomes., Methods: Institutional ethics approval was obtained and national ABDR data for primary breast implant surgery from 2015 to 2020 were analyzed for the use and type of antiseptic rinse. The surgeon-reported data were homogenized with regard to terminology and categorized by major trends, and the literature was reviewed., Results: We analyzed data for 37,143 patients, totaling 73,935 primary implants. Antiseptic rinse included povidone-iodine (PVP-I) in 35,859 (48.5%), no antiseptic use in 24,216 (32.8%), other concentrations of PVP-I in 4200 (5.7%), and Betadine triple antibiotic in 1831 implants (2.5%). Multiple other antiseptic permutations were noted in 7004 implants (9.5%)., Conclusions: The majority (56.7%) of Australian practitioners utilize previously described antiseptic pocket irrigation solutions that align with the 14-point plan. A third (32.8%), however, do not record any antiseptic pocket irrigation. These findings will permit a subsequent (ongoing) study of outcomes comparing PVP-I pocket rinse to no antiseptic pocket rinse, which will likely constitute the largest study of its kind., (© 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.)