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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: An increasing number of women are undergoing breast implantation for cosmetic purposes or for reconstructive purposes after breast excision. The surface morphology of the breast implant is a key factor associated with the induction of capsule contraction. The effect of surface morphology on the inflammatory response after implant insertion remains unclear, however. The authors conducted comparative analyses to determine the effect of the textured and smooth surface morphology of silicone sheets., Methods: Each type of silicone sheet was inserted into the subcutaneous pocket below the panniculus carnosus in C57BL/6 mice and mice with genetic disruption of CARD9 , Dectin-1 , Dectin-2 , or Mincle . The authors analyzed collagen fiber capsule thickness, histologic findings, and macrophage inflammatory response, including transforming growth factor (TGF)-β synthesis., Results: The authors found that textured surface morphology contributed to the formation of collagen fiber capsules and the accumulation of fibroblasts and myofibroblasts, and was accompanied by the accumulation of TGF-β-expressing macrophages and foreign-body giant cells. CARD9 deficiency attenuated collagen fiber capsule formation, macrophage responses, and TGF-β synthesis, although the responsible C-type lectin receptors remain to be clarified., Conclusion: These results suggest that CARD9 may have a strong impact on silicone sheet morphology through the regulation of macrophage responses., Clinical Relevance Statement: Silicone breast implants have been widely used for postmastectomy and cosmetic augmentation mammaplasty breast reconstruction. The authors sought to elucidate the surface morphology of the breast implant as one of the key factors associated with the formation of collagen fiber capsules., Clinical Question/level of Evidence: Therapeutic, V., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Acellular dermal matrix (ADM) has become popular in various reconstructive procedures of different anatomic regions. There are different needs depending on the clinical application, including breast, abdominal wall, and any other soft-tissue reconstruction. Removal of the basement membrane, which consists of collagen fibers, may help achieve natural and soft breast reconstruction, which requires highly elastic ADMs. Given the lack of knowledge of the effectiveness of ADM without the basement membrane, the authors compared the clinical outcomes of ADMs with and without basement membrane in breast reconstruction., Methods: The authors conducted a single-blind randomized controlled trial to evaluate differences in clinical outcomes. The patients were randomized into 2 groups: ADM with or without basement membrane. Both groups underwent immediate prepectoral direct-to-implant breast reconstruction. Demographic characteristics, surgical outcomes, and breast shape change using nipple position were compared between the 2 groups., Results: A total of 56 patients were divided into 2 groups: ADM with basement membrane (n = 30 [53.6%]) or ADM without basement membrane (n = 26 [46.4%]). Clinical and surgical characteristics were similar between the 2 groups. The authors detected no statistically significant differences in the overall rate of complications or breast shape change between the 2 groups. However, the rate of seromas was higher in the ADM with basement membrane group than in the ADM without basement membrane group (10% versus 0%; P = 0.09)., Conclusions: The 2 groups showed similar surgical outcomes. ADM without basement membrane in implant-based breast reconstruction was safe, and had mechanical properties of lower tensile strength and higher elasticity., Clinical Question/level of Evidence: Therapeutic, II., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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.)

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.)

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: In the absence of high-quality evidence, there is a need for guidelines and multidisciplinary consensus recommendations on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis and management of BIA-ALCL caused by textured implants. This article aims to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL., Methods: A comprehensive search was conducted in the MEDLINE, Cochrane Library, and Embase databases, and supplemented by manual searches of relevant English-language articles and "related articles" sections. Studies focusing on breast surgery and lymphoma associated with breast implants were included for analysis. Meta-analyses were performed and reviewed by experts selected by the American Association of Plastic Surgeons using a Delphi consensus method., Results: A total of 840 articles published between January of 2011 and January of 2023 were initially identified and screened. The full text of 188 articles was assessed. An additional 43 articles were excluded for focus, and 145 articles were included in the synthesis of results, with 105 of them being case reports or case series. The analysis encompassed a comprehensive examination of the selected articles to determine the incidence, risk factors, clinical presentation, diagnostic approaches, and treatment modalities related to BIA-ALCL., Conclusions: Plastic surgeons should be aware of the elevated risks by implant surface type, implement appropriate patient surveillance, and follow the recommendations outlined in this statement to ensure patient safety and optimize outcomes. Ongoing research on the pathogenesis, genetic drivers, and preventative and prophylactic measures for BIA-ALCL is crucial for improving patient care., Clinical Question/level of Evidence: Risk, V., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of 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.)

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.)

Summary: Skin-reducing mastectomy for single-stage reconstruction is an oncologically safe procedure used in women with large and ptotic breasts. This study describes a new technique, the J-pattern skin-reducing breast reconstruction with prepectoral implant and acellular dermal matrix (Braxon fast), which is indicated for patients with large and ptotic breasts who would benefit from a breast reduction and need a mastectomy for curative or prophylactic purposes. The authors present a case series of 35 breasts of 19 women who underwent this procedure from January of 2021 through December of 2022 at the Plastic and Reconstructive Surgery Department of the University Hospital Santa Maria della Misericordia, in Udine, Italy, with a median follow-up of 15 months. The advantages of the J scar consist of a reduced risk of skin necrosis, a reduced bottoming-out rate, simplification of the surgical design, and lower impact of scars not involving the medial quadrants of the breast. Patients were administered the BREAST-Q 2.0 postoperative questionnaire at 3 months postoperatively, which showed a high average level of satisfaction with the reconstruction. This surgical technique is a valid option for patients who have voluminous breasts and adequate pinch test results who wish to undergo immediate heterologous reconstruction along with curative or prophylactic mastectomy., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Necrosis of a cutaneous flap including the nipple-areola complex is a common complication in immediate implant-based breast reconstruction following nipple-sparing mastectomy (NSM)/skin-sparing mastectomy (SSM). This study aimed to evaluate the efficacy of prostaglandin E1 (PGE1) in reducing such complications., Methods: A retrospective analysis of prospectively collected data was conducted at two centers, and the cohort consisted of patients undergoing NSM/SSM followed by immediate reconstruction with a prosthesis. Patients who were randomly allocated to the treatment group were administered daily intravenous PGE1 (10 μg/2 mL) beginning intraoperatively through postoperative day 6. Skin flap complications including nipple/skin necrosis, delayed wound healing, and postoperative wound revision were recorded. Complication rates were compared between the PGE1 and control groups., Results: A total of 276 breasts in 259 patients were included for analysis (139 breasts in the treatment group and 137 breasts in the control group). There was no difference in patient demographics between the control and treatment groups. Reconstructed breasts receiving PGE1 had significantly lower rates of overall skin complications (21.6% versus 34.3%; P = 0.022) and wound revision (2.9% versus 9.5%; P = 0.025). Among NSM cases, the PGE1 group showed a significantly lower rate of nipple necrosis (15.5% versus 29.4%; P = 0.027). In the multivariate analysis, the use of PGE1 significantly reduced the risk of overall skin flap complications (OR, 0.491; P = 0.018) and wound revision (OR, 0.213; P = 0.018) in NSM/SSM cases, and nipple necrosis (OR, 0.357; P = 0.008) in NSM cases., Conclusion: PGE1 can be effective in reducing risk of mastectomy flap complications in immediate implant-based breast reconstructions., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Textured implants have been linked to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). Patients who undergo explantation have options for reconstruction, but data on safety and patient-reported outcomes (PROs) are limited. The purpose of this study was to classify complications and PROs in patients opting for surgical management of textured implants., Methods: Complication rates and BREAST-Q scores were compared between (1) asymptomatic patients who underwent conversion from textured to smooth implants ( n = 224), (2) symptomatic patients who underwent conversion from textured to smooth implants ( n = 83), (3) patients who underwent explantation without replacement ( n = 44), and (4) patients who underwent replacement with autologous reconstruction ( n = 33). Linear regression examined PROs controlling for clinical and surgical variables., Results: Overall complication rates in 384 patients (637 implants) differed across groups ( P = 0.034), with the highest rate (25%) in patients who underwent explantation without replacement. These patients were specifically more impacted by minor complications, notably seroma. Capsulectomy extent did not significantly impact complications. Asymptomatic and symptomatic smooth implant patients had improvements in Satisfaction with Breasts ( P < 0.05). Autologous reconstruction patients had significant improvements in Satisfaction with Breasts sustained after 3 months postoperatively ( P < 0.01) and Sexual Well-being sustained after 6-months postoperatively ( P < 0.05). Patients who underwent removal without replacement had lower Physical Well-being of the Chest scores at 1 year or more than the other groups., Conclusions: Replacement of textured implants with smooth implants or flaps is safe and is associated with improved satisfaction with breasts and quality of life. The degree of capsulectomy does not appear to impact the incidence of perioperative complications., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Antibiotic implant irrigation is increasingly used to prevent deep infection after implant-based breast reconstruction. However, there is limited evidence of the clinical effect. In this study, the authors compare the risk of a deep infection in a Danish population of women who received antibiotic implant irrigation with either gentamicin or vancomycin, or no irrigation., Methods: The authors retrospectively reviewed consecutive patients undergoing all types of breast reconstruction with implants at Rigshospitalet and Herlev Hospital, Denmark, from 2010 to 2019. Logistic regression was used to compare the risk of deep infection between no irrigation and irrigation with gentamicin or vancomycin, and to account for the difference in risk between patient subgroups and risk factors., Results: The authors included 1508 patients who received antibiotic irrigation with gentamicin (500 patients), vancomycin (304 patients), or no irrigation (704 patients). The univariable risk analysis showed a significant decreased risk of deep infection using gentamicin irrigation compared with no irrigation (OR, 0.58; P < 0.05). However, when adjusting for risk factors for infection, there was no significant decrease in the risk of infection when using gentamicin (OR, 0.90; P = 0.71) or vancomycin (OR, 1.0; P = 0.99) compared with the control group., Conclusions: The authors found no significant effect of using antibiotic implant irrigation after isolating it from risk factors for deep infection. However, because of the limitations of the study, the authors cannot conclude that there is no effect of antibiotic implant irrigation. There is a need for a randomized, placebo-controlled trial to investigate the effect, and potential side-effects, of antibiotic implant irrigation., Clinical Question/level of Evidence: Risk, II., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation., Methods: Patient- and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Covariate-adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses., Results: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4% of all registered TEs ( n = 3190). Independent factors associated with unplanned reoperation were body mass index (BMI) greater than or equal to 25 kg/m 2 (adjusted OR [aOR], 1.63, 99% CI, 1.20 to 2.57 for BMI of 25 to 29.9 kg/m 2 ; aOR, 2.57, 99% CI, 1.74 to 3.78 for BMI ≥30 kg/m 2 ), low institutional volume (aOR, 1.51; 99% CI, 1.06 to 2.18), no drains (aOR, 2.06; 99% CI, 1.15 to 3.60), subcutaneous TE placement (aOR, 5.71; 99% CI, 3.59 to 9.10), and partial pectoralis major muscle coverage (aOR, 1.35; 99% CI, 1.02 to 1.79). Age younger than 40 years (aOR, 0.49; 99% CI, 0.32 to 0.74) and delayed PMBR (aOR, 0.35; 99% CI, 0.19 to 0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4%)., Conclusion: This study identified several risk factors for unplanned reoperation that may be used to reduce complications in expander-based PMBR., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: The central pedicle technique (CPT) is rarely used to perform mastopexy or mastopexy with implant augmentation despite having robust perfusion and allowing for great exposure, resulting in reproducible results. This study was conducted to review one surgeon's experience using the CPT for both mastopexy and mastopexy with implant augmentation., Method: A retrospective review of consecutive patients who had a mastopexy or mastopexy with augmentation using a standardized CPT from 2017 through 2021 was performed., Results: A total of 201 patients were identified for inclusion: 120 had a bilateral central pedicle mastopexy, 75 had bilateral central pedicle mastopexy and implants, and 6 had unilateral central pedicle mastopexy with implants because of asymmetry. Mean follow-up was 11.2 months. The average age was 45.4 years, body mass index 25.1 kg/m², and implant size 275 cc. The overall complication rate was 9.5%: 9.2% for CPT mastopexy and 9.9% for CPT mastopexy with implants. No revisional surgery was requested. None of the patients experienced nipple or skin necrosis., Conclusions: This study demonstrates that CPT mastopexy with or without an implant can be performed safely with a low complication rate. Additional benefits include standardized markings before surgery, visualization of the entire breast mound, and reliable perfusion. The technique excels in correcting asymmetry. CPT mastopexy with or without an implant is a safe and effective option for the treatment of breast ptosis., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. postapproval study. The authors present results from the first 6 years of this study., Methods: An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients undergoing breast augmentation, reconstruction, and revision in the postmarket environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015 (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022)., Results: Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1% (3.9% with submuscular placement and 6.75%with subglandular placement), the risk of reoperation was 11.6%, and the risk of implant removal was 7.8% (5.9% with implant replacement and 2.0% without replacement). The primary reason (>50%) for reoperation was aesthetic (eg, style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8%. Overall, 82.6% of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported., Conclusion: Six-year results of the postapproval study were consistent with the 10-year core study and provide additional evidence in a large data set supporting the comprehensive safety and effectiveness profile of the Sientra implants., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Background: Absorbable mesh has been used to mitigate the potential drawbacks of acellular dermal matrix (ADM)-based breast reconstruction. Poly-4-hydroxybutyrate (P4HB) has been demonstrated to be a lower-cost, safe, and effective alternative to ADM in subpectoral breast reconstruction. In this study, the authors used P4HB for pocket control and implant support in immediate two-stage prepectoral breast reconstruction, examining nonintegration, capsular contracture, implant malposition, patient comorbidities, and risk factors., Methods: A retrospective review of a single surgeon's (K.M.) experience was performed over a 4-year span for patients who had undergone immediate two-stage prepectoral implant-based breast reconstruction with P4HB mesh. Complications (implant loss, rippling, capsular contracture, and malposition) and patient satisfaction were examined., Results: From 2018 to 2022, 105 patients underwent breast reconstruction using P4HB mesh on a total of 194 breasts. P4HB mesh integration was 97%. Sixteen breasts (8.2%) experienced minor complications, and 10.3% of devices required explantation, which was significantly higher in the irradiated group at 28.6% ( P < 0.01). Patients who were older, had a higher body mass index, were active smokers, or had an increased mastectomy specimen size were more likely to undergo explantation. The capsular contracture rate and overall lateral malposition rate were 1.0%. Visible rippling was present in 15.6% of breasts. There was no significant difference between smile mastopexy and inferolateral incision with regard to capsular contracture, lateral malposition, and rippling. Overall, patients demonstrated a high level of satisfaction. There were no significant predictors of capsular contracture, lateral malposition, or visible rippling., Conclusions: The authors show the safety and efficacy of P4HB in two-stage prepectoral breast reconstruction. There appears to be equal, if not reduced, capsular contracture rates when compared with the published data on ADM. This represents a large cost reduction to both the patient and the health care system., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Prepectoral breast reconstruction has become popularized with the concurrent use of acellular dermal matrix (ADM). The authors sought to compare 3-month postoperative complication rates and explantation rates for first-stage, tissue-expander-based, prepectoral breast reconstruction with and without the use of ADM., Methods: A single-institution retrospective chart review was performed to identify consecutive patients undergoing prepectoral tissue-expander-based breast reconstruction from August of 2020 to January of 2022. Chi-square tests were used to compare demographic categorical variables, and multiple variable regression models were used to identify variables associated with 3-month postoperative outcomes., Results: The authors enrolled 124 consecutive patients. Fifty-five patients (98 breasts) were included in the no-ADM cohort and 69 patients (98 breasts) were included in the ADM cohort. There were no statistically significant differences between the ADM and no-ADM cohorts with regard to 90-day postoperative outcomes. On multivariable analysis, there were no independent associations between seroma, hematoma, wound dehiscence, mastectomy skin flap necrosis, infection, unplanned return to the operating room, or explantation in the ADM and no-ADM groups after controlling for age, body mass index, history of diabetes, tobacco use, neoadjuvant chemotherapy, and postoperative radiotherapy., Conclusions: The authors' results reveal no significant differences in odds of postoperative complications, unplanned return to the operating room, or explantation between the ADM and no-ADM cohorts. More studies are needed to evaluate the safety of prepectoral, tissue expander placement without ADM., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Breast augmentation is the most commonly performed procedure for gender affirmation in transfeminine individuals. Although adverse events among breast augmentation in cisgender women are well described, their relative incidence in transfeminine patients is less elucidated. This study aims to compare complication rates after breast augmentation between cisgender women and transfeminine patients and to evaluate the safety and efficacy of breast augmentation in transfeminine individuals., Methods: PubMed, the Cochrane Library, and other resources were queried for studies published up to January of 2022. A total of 1864 transfeminine patients from 14 studies were included in this project. Primary outcomes including complications (capsular contracture, hematoma or seroma, infection, implant asymmetry/malposition, hemorrhage, skin or systemic complications), patient satisfaction, and reoperation rates were pooled. A direct comparison of these rates was performed against historical rates in cisgender women., Results: Within the transfeminine group, the pooled rate of capsular contracture was 3.62% (95% CI, 0.0038 to 0.0908); the hematoma/seroma rate was 0.63% (95% CI, 0.0014 to 0.0134); the infection incidence was 0.08% (95% CI, 0.0000 to 0.0054); and implant asymmetry rate was 3.89% (95% CI, 0.0149 to 0.0714). There was no statistical difference between rates of capsular contracture ( P = 0.41) and infection ( P = 0.71) between the transfeminine versus cisgender groups, whereas there were higher rates of hematoma/seroma ( P = 0.0095) and implant asymmetry/malposition ( P < 0.00001) in the transfeminine group., Conclusion: Breast augmentation is an important procedure for gender affirmation and, in transfeminine individuals, carries relatively higher rates of postoperative hematoma and implant malposition relative to cisgender women., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: With ongoing investigations of the impact of device texturing on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), studies have begun comparing complication profiles of tissue expanders. However, there is a paucity of timing and severity data of complications. The aim of this study was to provide a comparative survival analysis of postoperative complications between smooth (STEs) and textured tissue expanders (TTEs) in breast reconstruction., Methods: A single-institution experience with tissue expander breast reconstruction was reviewed for complications up to 1 year after second-stage reconstruction from 2014 to 2020. Demographics, comorbidities, operation-related variables, and complications were evaluated. Kaplan-Meier curves, Cox proportional hazard models, and a consensus-based ordinal logistic regression model were used to compare complication profiles., Results: Of 919 total patients, 600 (65.3%) received TTEs and 319 (34.7%) received STEs. There was increased risk of infection ( P < 0.0001), seroma ( P = 0.046), expander malposition ( P < 0.0001), and wound dehiscence ( P = 0.019) in STEs compared with TTEs. However, there was also a decreased risk of capsular contracture ( P = 0.005) in STEs compared with TTEs. Failure of breast reconstruction ( P < 0.001) and wound dehiscence ( P = 0.018) occurred significantly earlier in STEs compared with TTEs. Predictors for significantly higher severity complications included the following: smooth tissue expander use ( P = 0.007), shorter time to complication ( P < 0.0001), higher body mass index ( P = 0.005), smoking history ( P = 0.025), and nipple-sparing mastectomy ( P = 0.012)., Conclusions: Differences in the timing and severity of complications contribute to the safety profiles of tissue expanders. STEs are associated with increased odds of higher severity and earlier complications. Therefore, tissue expander selection may depend on underlying risk factors and severity predictors., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Intensity-modulated radiation therapy and other modifiable radiation factors have been associated with decreased radiation toxicity. These factors could allow for improved reconstructive outcomes in patients requiring postmastectomy radiation therapy (PMRT). However, they have not yet been well studied in implant-based breast reconstruction., Methods: The authors performed a retrospective chart review of patients who underwent mastectomy with immediate tissue expander placement followed by PMRT. Radiation characteristics were collected, including radiation technique, bolus regimen, x-ray energy, fractionation, maximum radiation hot spot, and tissue volume receiving more than 105% or more than 107% of the prescription dose. Reconstructive complications occurring after initiation of PMRT were analyzed with respect to these radiation characteristics., Results: Sixty-eight patients (70 breasts) were included in this study. The overall complication rate was 28.6%, with infection being the most common complication (24.3%), requiring removal of the tissue expander or implant in greater than half of infections (15.7%). Maximum radiation hot spot was greater in patients who required explantation after PMRT, and this approached statistical significance (114.5% ± 7.2% versus 111.4% ± 4.4%; P = 0.059). Tissue volume receiving more than 105% and 107% were also greater in patients who required explantation after PMRT (42.1% ± 17.1% versus 33.0% ± 20.9% and 16.4% ± 14.5% versus 11.3% ± 14.6%, respectively); however, this was not statistically significant ( P = 0.176 and P = 0.313, respectively). There were no significant differences in complication rates between patients with respect to radiation technique or other radiation characteristics studied., Conclusion: Minimizing the radiation hot spots and volumes of tissue receiving greater than the prescription dose of radiation may improve reconstructive outcomes in patients undergoing implant-based breast reconstruction followed by PMRT., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Capsular contracture is the most common complication following breast implant placement. Cathelicidin LL-37 is a cationic peptide involved in innate immunity. Initially investigated for its antimicrobial role, it was found to have pleiotropic activities, such as immunomodulation, angiogenesis stimulation, and tissue healing. The aim of the study was to investigate the expression and localization of LL-37 in human breast implant capsules and its relationship with capsular formation, remodeling, and clinical outcomes., Methods: The study enrolled 28 women (29 implants) who underwent expander substitution with definitive implant. Contracture severity was evaluated. Specimens were stained with hematoxylin and eosin, Masson trichrome, immunohistochemistry, and immunofluorescence for LL-37, CD68, α-smooth muscle actin, collagen type I and type III, CD31, and Toll-like receptor-4., Results: LL-37 was expressed in macrophages and myofibroblasts of capsular tissue in 10 (34%) and nine (31%) of the specimens, respectively. In eight cases (27.5%), it was expressed by both macrophages and myofibroblasts of the same specimen. In infected capsules, expression by both cell types was found in all (100%) specimens. LL-37 expression by myofibroblasts positively correlated with its expression by macrophages ( P < 0.001). Moreover, LL-37 expression by macrophages of periexpander capsules negatively correlated with the severity of capsular contracture on definitive implants ( P = 0.04)., Conclusions: This study demonstrates the expression of LL-37 in macrophages and myofibroblasts of capsular tissue and its negative correlation with the severity of capsular contracture following permanent implant placement. Expression or up-regulation of LL-37 may be involved in myofibroblast and macrophage modulation, thus playing a role in the pathogenic fibrotic process underlying capsular contracture., Clinical Relevance Statement: This is the first study to demonstrate LL37 expression in capsular tissue and to hypothesize its role in contracture and as a prognostic marker for contracture severity. If confirmed, medical strategies or implant coating could be implemented to reduce the risk of contracture for high-risk patients., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Symmastia, first defined by Spence et al. in 1984, is a medical condition characterized by the convergence of breast tissues in the midline, resulting in the absence of adhesion between the skin and subcutaneous tissue over the presternal area. It can be either congenital or acquired. Currently, there is no universally accepted treatment for symmastia. This study presents a surgical approach and preoperative and postoperative care for the correction of symmastia., Methods: Between January of 2014 and December of 2020, a surgical technique was performed on 100 patients, including 59 with congenital symmastia and 41 with acquired symmastia. The technique involved creating a thin skin flap and attaching it to the sternum to reconstruct the intermammary V-shaped region., Results: All patients in both groups underwent subglandular implant placement, with textured/polyurethane prostheses used in 97% of cases. Three cases did not use any implants. In the corrective surgery, patients received smaller, round implants, following the steps of the surgical approach devised by the author. The median satisfaction scores were high in both groups., Conclusions: The surgical approach described in this study is a safe, one-time procedure with a low risk of complications and high patient satisfaction. The technique is reproducible and provides consistent outcomes., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Prepectoral tissue expander (TE) placement for two-stage postmastectomy reconstruction is usually performed in conjunction with insertion of acellular dermal matrix (ADM). However, the effects of ADM use on TE loss or other early complications remain unknown. Therefore, the aim of this study was to compare early postoperative complications in patients who underwent prepectoral breast implant reconstruction with or without ADM use., Methods: The authors performed a retrospective cohort study of all patients at their institution who underwent prepectoral breast reconstruction from January of 2018 to June of 2021. The primary outcome was TE loss within 90 days of surgery; secondary outcomes included other complications such as infection, TE exposure, mastectomy skin flap necrosis requiring revision, and seroma., Results: Data on 714 patients with 1225 TEs (1060 with ADM and 165 without) were analyzed. Baseline demographics did not differ by ADM use, although mastectomy breast tissue weight was higher in patients without ADM (750.3 g versus 540.8 g; P < 0.001). Rates of TE loss were similar in reconstructions with (3.8%) ADM and without (6.7%; P = 0.09). We also did not find differences in the rates of secondary outcomes between cohorts., Conclusions: ADM use had no statistically significant effect on early complication rates among patients undergoing breast reconstruction with prepectoral TEs. Still, this study was underpowered, and data trended toward statistical significance; thus, larger studies are required in the future. Additional research and randomized studies should focus on larger cohorts and examine long-term complications such as capsular contracture and implant malposition., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Limited comparability between study groups can generate significant selection and observer bias when evaluating the efficacy of the SPY system and fluorescence imaging for implant-based breast reconstruction. In this study, the authors compared the surgical outcomes and complications during the first stage of reconstruction between reconstructions evaluated intraoperatively with fluorescence imaging using the SPY system and clinical assessment using a matched analysis., Methods: The authors conducted a retrospective review of patients undergoing total mastectomy and immediate two-stage implant-based breast reconstruction with TEs from January of 2011 to December of 2020. The rate of complication, time for TE-to-implant exchange, and time to start radiotherapy were compared between groups (intraoperative fluorescence imaging versus clinical assessment) using a propensity score-matched analysis., Results: After propensity score matching, 198 reconstructions were evaluated. There were 99 reconstructions in each group. The median time for TE-to-implant exchange (140 days versus 185 days; P = 0.476) and time to initiate adjuvant radiotherapy (144 days versus 98 days; P = 0.199) were comparable between groups. The 30-day rate of wound-related complications (21% versus 9%; P = 0.017) and 30-day rate of wound-related unplanned interventions were significantly higher in reconstructions evaluated with clinical assessment when compared with the SPY system (16% versus 5%; P = 0.011). A higher 30-day rate of seroma (19% versus 14%; P = 0.041) and hematoma (8% versus 0%; P = 0.004) were found in reconstructions assessed intraoperatively with the SPY system., Conclusions: After matching, reconstructions evaluated with fluorescence imaging exhibited a lower incidence of early wound-related complications when compared with clinical evaluation alone. Nonetheless, the Wise pattern for mastectomy was found to be the only independent predictor associated with early wound-related complications., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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: 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: Implant-based reconstruction is the most common method of immediate breast reconstruction in the United States, with acellular dermal matrices (ADMs) playing a significant role in implant support and coverage. This study evaluated recent national trends in ADM use in immediate breast reconstruction and assessed patient characteristics and 30-day complication rates., Methods: The authors queried the American College of Surgeons National Surgical Quality Improvement Program database for all patients undergoing immediate breast reconstruction from 2015 to 2020. Primary outcomes were major surgical and medical complications, as well as ADM use per year. Subset analysis was performed to compare patients undergoing immediate breast reconstruction with ADM in 2015 versus 2020., Results: In 39,800 immediate breast reconstructions, ADMs were used in 55.5% of cases ( n = 22,087). ADM usage increased annually from 2015 through 2020. Direct-to-implant reconstruction was significantly associated with ADM use ( P < 0.001). Compared with the no-ADM cohort, there was a significantly increased rate of return to the operating room for any reason ( P < 0.001). When comparing the 2015 and 2020 ADM cohorts, the 2020 ADM cohort had a significantly higher rate of superficial infections. Obesity, smoking history, and insulin-dependent diabetes were independent risk factors for superficial wounds in patients receiving ADM., Conclusions: ADM use in immediate breast reconstruction increased significantly from 2015 to 2020, likely reflecting national trends in increasing direct-to-implant and prepectoral breast reconstruction. Obesity, smoking history, and insulin-dependent diabetes were independent risk factors for superficial wound infections in the ADM cohort. Patients with ADM had a slight increased incidence of return to the operating room., Clinical Question/level of Evidence: Risk, II., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Breast implant-related complications can be reduced by strict antiseptic precautions during insertion, but bacteria can often be found on implant surfaces on the occasion of revision surgery. The authors prospectively analyzed the association of bacteria found on breast implant surfaces with implant-related complications in breast implant revision cases., Methods: The authors analyzed a total of 100 breast implant revisions in 66 patients between August of 2018 and January of 2021. Capsular swabs and capsular samples were taken intraoperatively. Analyses on the occurrence of bacteria and the occurrence of implant-related complications were performed. In addition, correlations between bacteria-contaminated breast implant surfaces and implant-related complications were performed., Results: Implant-related complications (perforation, rupture, capsular contraction) were observed in 42 implant sites: eight unilateral and 34 bilateral cases. In total, 16 swabs showed positive bacterial growth, 10 of which were associated with a breast implant-related complication (χ 2 = x, y, and z; P = 0.006). The most common implant-based complication at contaminated prosthetics was implant rupture. The association of contaminated breast implants and implant rupture was statistically significant., Conclusions: The authors identified a correlation between implant complications and Gram-positive bacteria found on breast implant surfaces. The most common implant-based complication seen at simultaneously positive samples was implant rupture in 50% of the authors' cases. No capsular contraction or other complications were seen., 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.)

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: Postmastectomy radiotherapy (PMRT) is associated with altered cosmetic outcomes and higher complication rates in implant-based breast reconstruction (IBR). Conventional wisdom suggests that muscle coverage is somewhat protective against PMRT-related complications. In this study, the authors compared surgical outcomes in patients who underwent two-stage prepectoral versus subpectoral IBR in the setting of PMRT., Methods: The authors performed a retrospective cohort study of patients who underwent mastectomy and PMRT with two-stage IBR from 2016 to 2019. The primary outcome was breast-related complications, including device infection; the secondary outcome was device explantation., Results: The authors identified 179 reconstructions (101 prepectoral and 78 subpectoral) in 172 patients with a mean follow-up time of 39.7 ± 14.4 months. There were no differences between the prepectoral and subpectoral reconstructions in rates of breast-related complications (26.7% and 21.8%, respectively; P = 0.274), device infection (18.8% and 15.4%, respectively; P = 0.307), skin flap necrosis (5.0% and 1.3%, respectively; P = 0.232), or device explantation (20.8% and 14.1%, respectively; P = 0.117). In adjusted models, compared with prepectoral device placement, subpectoral device placement was not associated with a lower risk of breast-related complications [hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.41 to 1.36], device infection (HR, 0.73; 95% CI, 0.35 to 1.49), or device explantation (HR, 0.58; 95% CI, 0.28 to 1.19)., Conclusions: Device placement plane was not predictive of complication rates in IBR in the setting of PMRT. Two-stage prepectoral IBR provides safe long-term outcomes with acceptable postoperative complication rates comparable to those with subpectoral IBR, even in the setting of PMRT., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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.)

Summary: The purpose of this article is to review the pivotal events in the history of breast implants in the United States, including the events leading to the U.S. Food and Drug Administration moratorium on the use of silicone gel implants and subsequent approval; the emergence of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL); and persistent concerns about an association between breast implants, autoimmune disease, and systemic symptoms. This article reviews the medical literature to outline our current knowledge on BIA-ALCL; offers recommendations for diagnosis and management of symptomatic and asymptomatic patients with textured implants; and reviews the science of potential associations of implants with autoimmune and systemic symptoms. The authors hope to help patients separate myths from reality and make educated decisions on having breast implants placed or removed., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry., Method: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication., Results: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification)., Conclusions: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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.)