Baker Grade Research Articles

Treatment of Capsular Contracture in Previously Irradiated Breasts Implants and Expanders with the Use of Porcine Acellular Dermal Matrices: Outcomes and Complications.

Background: Radiation therapy is a crucial component of breast cancer treatment. However, it is well known to increase the risk of unsatisfactory cosmetic outcomes and higher complication rates. The aim of this study is to provide further insight into the use of acellular dermal matrices (ADMs) for the prevention of capsular contracture. Materials and Methods: This single-center, retrospective study analyzed irradiated patients who underwent post-mastectomy, ADM-assisted implant reconstructions. Of the 60 patients included, 26 underwent expander-to-implant substitution after radiotherapy (Group A), while 34 required implant replacement due to capsular contracture following radiotherapy (Group B). The primary objective was to evaluate the effectiveness of ADMs in reducing reconstructive failures, complications, and capsular contracture after breast irradiation. Results: We recorded a total of 15 complications and four implant losses. Reconstructive failures were attributed to implant exposure in two cases, full-thickness skin necrosis in one case, and severe Baker grade IV contracture in one case. Both Group A and Group B showed a significant decrease in postoperative Baker grades. US follow-up was used to demonstrate ADM integration with host tissues over time. Conclusions: Based on our findings, the use of ADM in selected cases appears to be a viable option for treating and preventing capsular contracture in irradiated breasts. This approach is associated with relatively low complication rates, a low rate of reconstructive failure, and satisfactory cosmetic outcomes and can be applied both in breast reconstructed with implants and with expanders.

Evaluation of safety, efficacy, and risk factors of different breast reconstruction strategies following polyacrylamide hydrogel removal: A 20-year retrospective cohort study of 436 cases

BackgroundGlobally implemented for breast augmentation, polyacrylamide hydrogel (PAAG) always leads to breast deformity upon its removal. Despite a pressing need for breast reconstruction following PAAG removal to address aesthetic issues, the optimal timing remains controversial. MethodsA retrospective cohort study analyzed patients who underwent PAAG removal between 2003 and 2023. They were categorized into three cohorts: immediate (IBR), delayed (DBR), or no breast reconstruction (NBR) post-PAAG removal. Complication rates, re-operation frequencies, risk factors, and BREAST-Q scores were assessed. ResultsA total of 436 breasts were identified and divided into IBR (n = 126), DBR (n = 48), and NBR (n = 262). Complication rates were 50.0 % (IBR), 31.3 % (DBR), and 26.7 % (NBR) (P < 0.001); reoperation rates were 26.2 % (IBR), 18.8 % (DBR), and 13.0 % (NBR) (P = 0.006). IBR showed significantly shorter complication-free survival than NBR (113.38 ± 8.34 vs. 178.21 ± 6.82 months; log-rank P < 0.001). Cox regression identified injection period, aspiration history, Baker grade II/III/IV, glandular infiltration, and IBR as independent predictors of higher postoperative complications. As for the Breast-Q scores, physical well-being was similar across groups. However, NBR scored significantly lower for postoperative sexual well-being (P < 0.001), psychosocial well-being (P < 0.001), and satisfaction with breasts (P = 0.001) compared to both IBR and DBR. ConclusionsDBR is a safe and effective solution for secondary breast deformities after PAAG removal. Notably, patients with prolonged injection histories, previous aspiration history, Baker Grade II/III/IV, and MRI evidence of gel infiltration into glandular tissues are at a higher risk for postoperative complications. These findings may be beneficial for optimizing strategies to manage patients with PAAG injections in clinical practice.

A Comparison of Capsular Contracture Rates after Immediate Implant-based Breast Reconstruction Using Biologic versus Synthetic Mesh.

Capsular contracture is one of the most common reasons for reoperation after implant-based breast reconstruction. Prior investigations have suggested that biologic mesh may mitigate capsular contracture development. This study sought to compare capsular contracture rates between patients undergoing immediate implant-based breast reconstruction with biologic versus synthetic mesh. A retrospective review was conducted of the senior author's primary implant-based breast reconstructions between 2008 and 2023. Demographics and the incidence of clinically significant Baker grade III or IV capsular contractures were compared between biologic and synthetic mesh cohorts. Univariate and multivariate logistic regressions were then performed to assess potential risk factors for the development of capsular contracture. A total of 772 breasts underwent immediate reconstruction, of which 689 (89.2%) used biologic and 83 (10.8%) used synthetic mesh. Capsular contracture occurred in 15 (2.2%) biologic mesh breasts and three (3.6%) synthetic mesh breasts with no significant difference between the two groups (P = 0.430). Logistic regression showed that radiation was a borderline significant risk factor for developing capsular contracture, but the use of either biologic or synthetic mesh was not significant (P = 0.351). Biologic and synthetic meshes function as effective tools in prosthetic breast reconstruction. Our long-term data suggest that the risk of capsular contracture with these devices is low, and there does not seem to be a difference between the two materials. However, there does need to be a shift in how capsular contracture is assessed and discussed in the reconstruction population.

The impact of adjuvant radiotherapy for cosmetic results after immediate breast reconstruction based on the tissue expander and permanent implant

Background. One of the causes of complications in breast cancer patients after immediate breast reconstruction (IBR) is postmastectomy radiation therapy (PMRT).Aim. Retrospective analysis of the results of IBR, and evaluating the effect of PMRT on the frequency and type of complications.Materials and methods. Between 2015 and 2021, 798 patients underwent IBR with tissue expander or implant in N.N. Petrov National Medical Research Center of Oncology, Ministry of Health of Russia. PMRT was performed in 375 patients (group 1). The remaining 423 patients did not receive PMRT (group 2). Complications, including reconstructive failure (RF), Baker grade III/IV capsular contracture (CC), were recorded and analyzed.Results. Finally, cosmetic result analyzed in 521 patients. In 281 patients of PMRT group (group 1) IBR with expander or implant were performed in 144 and 137 cases, respectively. In the 240 patients without PMRT (group 2), IBR with expander was performed in 81 patients, with implant – in 159 cases. Pooled analysis revealed that overall rate of complications in the PMRT group was 33.8 % (in 95 of 281 patients), in non-irradiation patients – 22.9 % (in 55 of 240 patients), p &lt;0.01. In group 1, RF were recorded in 67 (23.8 %) patients, in group 2 – in 44 (18.3 %) patients, p &gt;0.05. CC in group 1 were detected in 28 (10 %) patients, in group 2 in 11 (4.6 %) patients, p &lt;0.05. In patients with permanent implants RF were detected in 21 (14.6 %) of irradiation patients and in 22 (13.8 %) non-irradiation patients (p &gt;0.2). On the contrary, CC were mentioned in 22 (16.1 %) of irradiated patient and in 8 (5 %) patients that didn’t receive PMRT, p &lt;0.005. After reconstruction with expander RF were diagnosed in 46 (31.9 %) patients after PMRT and in 22 (27.2 %) non-irradiation patients, p &gt;0.2. CC were observed in 6 (4.2 %) patients from PMRT group and in 3 (3.7 %) patients treated without PMRT, p &gt;0.2.Conclusion. PMRT in patients after IBR with simultaneous installation of a permanent implant is characterized by a decrease in the incidence of RF, but an increase in the incidence of CC.

Patient-Reported Outcomes and Complication Profiles of Implant-Based Breast Reconstruction in Patients With Postmastectomy Radiation Therapy.

This study aims to investigate the patient-reported outcomes (PROs) and complications of distinct implant-based breast reconstruction modality for patients with postmastectomy radiation therapy (PMRT). A retrospective review was conducted on breast cancer patients with stage II-III disease who performed implant-based breast reconstruction following with PMRT between September 2016 and April 2022. The patients were categorized into two matched groups: (1) patients receiving prepectoral breast reconstruction (PBR) or (2) subpectoral breast reconstruction (SBR) followed by PMRT. Following reconstruction, the patients were further compared for PMRT with the tissue expander (PMRT-TE) versus PMRT with permanent implant (PMRT-PI). PROs were measured with BREAST-Q questionnaire. Early and late complications were recorded and analyzed. A total of 55 eligible patients were recruited. Patients who underwent PBR reported significantly higher satisfaction with breasts scores (P = 0.003) compared with the SBR group. The PMRT-TE group had higher satisfaction with breasts (P = 0.001) but lower physical well-being (P = 0.029) scores compared with PMRT-PI group. Moreover, patients in SBR cohort had a higher risk of capsular contracture (Baker grade III or IV) (20.5% vs 6.3%) and implant dislocation (48.7% vs 12.5%) than patients in PBR cohort. Patients in PMRT-PI group had a slightly higher rate of capsular contracture (Baker grade III or IV) than PMRT-TE group (20.8% vs 12.9%). PBR was associated with lower rates of late complications, especially for implant dislocation, and higher satisfaction with breasts scores compared to SBR. In addition, compared to PMRT-TE with PMRT-PI, patients in PMRT-TE cohort reported superior PROs of satisfaction with breasts.

Revision Breast Reconstruction With Biologic or Synthetic Mesh: An Analysis of Post-Operative Capsular Contracture Rates

Abstract Background Both biologic and synthetic mesh have been found to reduce the risk for capsular contracture, yet there is limited data assessing the use of these scaffold materials in revision breast reconstruction surgery. Objectives This investigation sought to assess the ability of either biologic or synthetic mesh to prevent capsular contracture in the revision breast reconstruction population. Methods A retrospective chart review was conducted of implant-based revision reconstructions performed by the senior author between 2008 and 2023. Patient demographics and outcomes were assessed, including the incidence of Baker grade III or IV capsular contractures. Results were compared between biologic and synthetic mesh groups using univariate and multivariate analysis. Results Ninety-five breasts underwent revision reconstruction with 90 (94.7%) for correction of malposition, four (4.2%) for size change, and one (1.1%) for revision after additional oncologic breast surgery. Of these breasts, 26 (27.4%) used biologic mesh and 69 (72.6%) used synthetic mesh. Capsular contracture occurred in one (3.8%) biologic mesh breast and four (5.8%) synthetic mesh breasts. There was no significant difference in the incidence of capsular contracture between the two groups (p=1.000). None of the recorded demographics were risk factors for capsular contracture, including the use of biologic or synthetic mesh (p=0.801). Conclusions Both biologic and synthetic mesh are successful at preventing capsular contracture in patients undergoing implant-based revision reconstruction. This adds to the growing evidence that both scaffold materials can be used in complex revision breast reconstruction to aid in preventing capsular contracture.

Abstract PO3-23-05: Capsular contracture after post-mastectomy radiotherapy in the patients undergoing implant-based breast reconstruction: impact of implant positioning and two-stage surgery

Abstract Background Capsular contracture is a significant concern in patients undergoing post-mastectomy radiotherapy (PMRT) following implant-based breast reconstruction. It negatively impacts cosmetic outcomes and can have a profound effect on the individual's quality of life. Our study aimed to explore whether the degree of capsular contracture varies based on the placement of the inserted implant and the type of operation (one- or two-staged). Patients and Methods This retrospective study was conducted at a single center, Ganganm Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. Our study included patients who underwent PMRT following total mastectomy and implant-based breast reconstruction surgery between January 2017 and September 2022. To assess the degree of capsular contracture, we evaluated the presence of capsular contracture, particularly severe capsular contracture classified as Baker grade 3 or higher, as well as implant migration. The implants were placed either in the pre-or sub-pectoral position, and the surgical approach employed was either direct-to-implant (DTI) or two-staged operation. Results A total of 195 patients were included in the study, with 83 (42.6%) patients in the pre-pectoral group and 112 (57.4%) patients in the sub-pectoral group. In addition, 116 underwent a two-stage operation, while 79 underwent DTI surgery. There was a significant difference in the occurrence of capsular contracture based on the implant placement, with 16 patients (19.3%) in the pre-pectoral group and 46 patients (41.1%) in the sub-pectoral group experiencing this complication (OR 4.142 [1.973-8.698]). Furthermore, the severity of capsular contracture differed significantly between the two groups, with 5 patients (6.0%) in the pre-pectoral group and 16 patients (14.3%) in the sub-pectoral group affected (OR 3.434 [1.153-10.227]). The incidence of capsular contracture was lower in the two-stage operation group compared to the DTI group (28 [23.9%] vs 34 [38.6%]; OR 3.064 [1.528-6.141]), and the severity of capsular contracture was also reduced (9 [7.7%] vs 12 [14.5%]; OR 2.854 [1.092-7.455]). There were no significant differences in other complications such as seroma and infection. In addition, sub-pectoral placement was identified as a significant risk factor for implant upward migration (OR 2.531 [95% CI, 1.263-5.071]). Conclusions Our findings suggest that pre-pectoral reconstruction and the two-stage operation are beneficial for patients who may undergo PMRT based on their initial nodal stage. These approaches can help reduce the incidence of capsular contracture and abnormal implant migration following radiation, leading to improved aesthetic outcomes and greater patient satisfaction. Citation Format: Sohyun Moon, Kyunghyun Min, Jung Hwan Eom, Yoonwon Kook, Seung Ho Baek, Junghyun Kim, Min Ji Kim, Seung Eun Lee, In Sik Yun, Tai Suk Roh, Soong June Bae, Joon Jeong, Young Seok Kim, Sung Gwe Ahn. Capsular contracture after post-mastectomy radiotherapy in the patients undergoing implant-based breast reconstruction: impact of implant positioning and two-stage surgery [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-05.

Abstract PO3-23-04: Patient-reported outcomes and complication profiles of implant-based breast reconstruction in patients with postmastectomy radiation therapy

Abstract Objective: This study aims to investigate the patient-reported outcomes (PROs) and complications of distinct implant-based breast reconstruction (IBBR) modality for patients with postmastectomy radiation therapy (PMRT). Methods: A retrospective review was conducted on breast cancer patients with stage II-III disease who performed IBBR following with PMRT between September 2016 and April 2022. The patients were categorized into two matched groups: (1) patients receiving prepectoral breast reconstruction (PBR) or subpectoral breast reconstruction (SBR) followed by PMRT; (2) patients undergoing PMRT with the tissue expander (PMRT-TE) or permanent implant (PMRT-PI) groups. PROs were measured with BREAST-Q questionnaire. Early and late complications were recorded and analysed. Results: A total of 55 eligible patients were recruited. For PROs, patients underwent PBR reported significantly higher Satisfaction with Breasts scores (P = 0.003) compared with SBR group, and PMRT-TE group presented higher Satisfaction with Breasts (P = 0.001) but lower Physical Well-being (P = 0.029) scores compared with PMRT-PI group. Moreover, Patients in SBR cohort had a higher risk of capsular contracture (Baker grade III or IV) (20.5% vs 6.3%) and implant dislocation (48.7% vs 12.5%) than patients in PBR cohort. Patients in PMRT-PI group had a slightly higher rate of capsular contracture (Baker grade III or IV) than PMRT-TE group (20.8% vs 12.9%). Conclusions: PBR was associated with lower rates of late complications, especially for implant dislocation, and higher Satisfaction with Breasts scores compared to SBR. In addition, compared to PMRT-TE with PMRT-PI, patients in PMRT-TE cohort reported superior patient-reported outcomes of Satisfaction with Breasts. Table 1. Patient and Tumor Characteristics of 55 Patients Stratified with Prepectoral/Subpectoral and PMRT-TE/PMRT-PI Reconstructive Procedure. XX- XX Table 2. Patient-Reported BREAST-Q Scores XX- XX Table 3. Association of Reconstruction Techniques with Late Complications. XX- XX Citation Format: Jian Liu, Cong Chen, Honggang Chen, Aizhai Xiang, Ruzhen Zheng, Shufang Hu, Jufeng Guo, Li Qu, Jun Zhou, Jiong Wu. Patient-reported outcomes and complication profiles of implant-based breast reconstruction in patients with postmastectomy radiation therapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-04.

A Comparison of Capsular Contracture Rates after Implant-Based Breast Reconstruction Using ADM Versus Synthetic Mesh

Abstract Goals/Purpose Capsular contracture is a local complication in which there is tightening of the capsule around the implant. This complication has been shown to occur in 15-30% of implant-based breast reconstruction patients and often requires revision surgery for correction. Prior investigations have suggested that the use of ADM can reduce the risk for development of capsular contracture, with more recent research suggesting that synthetic mesh may provide the same benefit. Several meta-analyses have attempted to compare ADM and mesh use for the prevention of capsular contracture, but they all emphasize the continued need for clinical investigation with direct comparisons. The goal of this study is to assess our own reconstruction patient population to compare capsular contracture rates between ADM and mesh cohorts, as well as to assess for other potential risks that may increase the rate of capsular contracture in these patients. Methods/Technique A 15-year retrospective review of all implant-based breast reconstructions performed by the senior author was performed. All operations occurred between 2008 and 2023 in a hospital setting. Patient demographics were assessed including age, BMI, implant size, radiation history, location of malposition, and use of either ADM or mesh. Post-operative complications including incidence of capsular contracture were recorded. Patients who had documented capsular contracture prior to scaffold insertion were excluded from the study. Wilcoxon signed rank test, 2-sided t-test, and Fischer’s Exact test were used to compare baseline demographics and capsular contracture rates between the two groups, along with a multivariate logistic regression analysis to control for potential confounders. Results/Complications Fifty-two breasts underwent capsulorraphy, of which 25 (48.1%) used ADM and 27 (51.9%) used mesh. Average age was 50.6 years, average BMI was 27.7, average implant size was 541.8 cc, and eight breasts (15.4%) had been irradiated. Average follow-up time was seven years (mean = 85.4 months, range 22 – 149 months, SD = 35.9). Fourteen (26.9%) capsulorraphies were for inferior malposition, 13 (25.0%) for lateral malposition, and 25 (48.1%) were for inferolateral malposition. Patients in the ADM group had significantly more lateral malposition prior to insertion as compared to the mesh group which had more inferior malposition (p=0.0246). There was no significant difference between the two groups for any other recorded baseline demographic; these demographics included age, BMI, hypertension, diabetes, history of tobacco use, radiation, chemotherapy, implant volume, and implant surface texture. Capsular contracture occurred in 2 ADM breasts (8.0%) and 4 mesh breasts (14.8%) with no significant difference between the two groups (p=0.6695). Five of these capsular contractures had documented Baker grades with three grade II, one grade III, and one grade IV. None of the recorded baseline demographics significantly increased the risk for capsular contracture development. Conclusion ADM and synthetic mesh both function as effective tools for reducing the risk of developing capsular contracture after prosthetic breast reconstruction. The rate of capsular contracture with ADM was only 8.0% and the rate with mesh was only 14.8%. Both rates are lower than the 15-30% incidence that has been found in breast reconstruction patients without mesh. None of the patient demographics were significant risk factors for capsular contracture development, so these are unlikely to be confounders. There was no significant difference in rate of capsular contracture between the two groups, suggesting that ADM and mesh are similarly efficacious at preventing capsular contracture in reconstruction patients.

A Phase II Study Evaluating the Effect of Intensity Modulated Postmastectomy Radiation Therapy on Implant Failure Rates in Breast Cancer Patients With Immediate, 2-Stage Implant Reconstruction With an MRI Imaging Correlative Substudy

BackgroundPostmastectomy radiation therapy (PMRT) is a mainstay in the adjuvant treatment of node-positive breast cancer, but it poses risks for women with breast reconstruction. Multi-beam intensity-modulated radiation therapy (IMRT) improves dose conformality and homogeneity, potentially reducing complications in breast cancer patients with implant-based reconstruction. To investigate this hypothesis, we conducted a single-arm phase II clinical trial of breast cancer patients who underwent mastectomy/axillary dissection and prosthesis-based reconstruction. MethodsThe primary endpoint was the rate of implant failure within 24 months of permanent implant placement, which would be considered an improvement over historical controls if below 16%. Implant failure (IF) was defined as removal leading to a flat chest wall or replacement with another reconstruction. Patients were analyzed in two cohorts. Cohort 1 (RT-PI) received RT to the permanent implant (PI). Cohort 2 (RT-TE) received RT to the TE. Implant failure rates, adverse events, and quality of life (QOL) were analyzed. Follow-up/post-RT assessments were compared to the baseline/pre-RT assessments at 3-10 weeks after exchange surgery. A subgroup underwent serial MRIs to explore the association of MRI-detected changes with capsular contracture, a known adverse effect of RT. ResultsBetween June 2014 and March 2017, 119 women were enrolled. Cohort 1 included 45 patients, and Cohort 2 had 74 patients. Among 100 evaluable participants, 25 experienced IF during the study period. IF occured in 8/42 (19%) and 17/58 (29%) in Cohorts 1 and 2, respectively. Among the IFs, the majority were due to capsular contracture (13), infection (7), exposure (3), and other reasons (2). Morphological shape features observed in longitudinal MRI images were associated with the development of Baker grade 3-4 contracture. ConclusionsThe rate of implant failure in reconstructed breast cancer patients treated with IMRT was similar to, but not improved over, conventional, 3D-conformal methods. MRI imaging features show promise for predicting capsular contracture but require validation in larger studies.

A Comparison of Ovine-Reinforced Hybrid Mesh (OviTex PRS) With Porcine Acellular Dermal Matrix (STRATTICE) in the Treatment of Advanced Breast Implant Capsular Contracture.

Tissue reinforcement techniques with porcine acellular dermal matrices (ADMs) have been widely adopted as standard care in treating capsular contracture. However, the application of alternative xenograft or mesh materials has not been widely studied. To examine the efficacy of OviTex PRS Reinforced Tissue Matrix (Resorbable) (TELA Bio, Malvern, PA), a hybrid ovine-reinforced mesh, in comparison with STRATTICE Reconstructive Tissue Matrix (Allergan, Irvine, CA), in patients with advanced capsular contracture. A retrospective review was conducted on patients who underwent breast revision surgery for Baker Grade III or IV capsular contracture. Patient data were reviewed for outcomes, complications, cost, and postoperative incidence of recurrent capsular contracture after treatment with each specific mesh. Fifty-nine of 89 breasts (66.3%) were treated with OviTex and 30 (33.7%) were treated with STRATTICE. All patients experienced a reduction in Baker grades. In patients treated with OviTex, 96.6% (n = 57) of breasts had a postoperative Baker Grade I with the remaining 3.4% (n = 2) breasts presenting with a Baker Grade II. In comparison, 73.3% (n = 22), 23.3% (n = 7), and 3.3% (n = 1) of the STRATTICE cohort presented with Baker Grades I, II, and III, respectively. This demonstrated a statistically significant improvement in Baker grade capsular contracture in the OviTex cohort (P < .05) compared with STRATTICE. Average cost was $27.37/cm2 for STRATTICE compared with $22.28/cm2 for OviTex PRS. OviTex may be successfully utilized to treat capsular contracture. Patient outcomes may be superior to STRATTICE in recurrent capsular contracture, particularly when a previous ADM had been utilized. Cost data show improved savings with the use of OviTex compared with STRATTICE.

Discussion: Baker Grade IV Capsular Contracture Is Correlated with an Increased Amount of Silicone Material: An Intrapatient Study.

Discussion: Baker Grade IV Capsular Contracture Is Correlated with an Increased Amount of Silicone Material: An Intrapatient Study.

Complication Avoidance of Reconstruction Implant Radiation Therapy (CARIT): A Retrospective Case-Cohort Analysis.

Patients are increasingly offered implant-based reconstruction prior to radiotherapy. However, it is unclear if the radiation treatment technique itself impacts upon toxicity. We performed this study to compare outcomes following implant-based reconstruction amongst breast cancer patients treated with a standard radiotherapy technique that irradiates the entire chest wall versus a novel technique which uses a smaller clinical target volume (CTV) to spare the implant. Need for corrective surgery, capsular contracture, and cosmetic outcomes were evaluated, with the hypothesis that the novel technique would result in fewer adverse outcomes and less need for corrective surgery. A retrospective case-cohort analysis of 57 patients who had post-mastectomy, implant-based reconstruction was conducted. Patients with invasive mammary carcinoma (IMC) or ductal carcinoma in-situ (DCIS) who were treated either with the novel radiotherapy technique (n = 26) or standard PMRT (n = 31) were included. Patient demographics such as age, BMI, TNM stage, implant size, hormone receptor status, and radiation course was collected. Primary endpoint was the need for corrective surgery within two years and cosmetic outcomes, measured using the Baker Classification Scale for capsular contracture and the Modified Harvard Harris Cosmetic Scale. Secondary endpoint was radiation-induced toxicity measured using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Cosmesis and toxicity were evaluated at 3 months post-radiation, 1 year, and after 13 months. Unpaired t-tests were used to compare need for corrective surgery, cosmesis (Baker Grade 2 or higher and Harvard Harris "Good" or worse), and toxicity (NCI CTCAE Grade 2 or higher). For the primary endpoint, need for corrective surgery, there was no significant difference between the novel and standard groups (two-sided p = 0.378, CI -0.38-0.14). The other primary endpoint of cosmesis, measured with the Baker scale and Harvard Harris, was also not significantly different (two-sided p = 0.147, CI -0.06-0.45), with the Harvard Harris cosmesis differences remaining insignificant across the 3 month, 1 year, and greater than 13 month periods (two-sided p = 0.854, 0.351, 0.468, respectively). The secondary endpoint, toxicity, was not significantly different between the novel and standard PMRT groups across 3 months and 1 year time periods (two-sided p = 0.328, 0.323, respectively). We will also be reporting the analysis for predictive factors related to toxicity, need for corrective surgery and cosmesis. Compared with standard PMRT, the novel technique was not significantly different in rates of reoperation, toxicity and cosmetic outcomes. Better understanding the factors involved in PMRT outcomes for breast cancer patients with implant-based reconstructions will aid in the development of standardized approaches to treating the breast cancer patient population.

Transcriptomic and machine learning analyses identify hub genes of metabolism and host immune response that are associated with the progression of breast capsular contracture

Capsular contracture is a prevalent and severe complication that affects the postoperative outcomes of patients who receive silicone breast implants. At present, prosthesis replacement is the major treatment for capsular contracture after both breast augmentation procedures and breast reconstruction following breast cancer surgery. However, the mechanism(s) underlying breast capsular contracture remains unclear. This study aimed to identify the biological features of breast capsular contracture and reveal the potential underlying mechanism using RNA sequencing. Sample tissues from 12 female patients (15 breast capsules) were divided into low capsular contracture (LCC) and high capsular contracture (HCC) groups based on the Baker grades. Subsequently, 41 lipid metabolism-related genes were identified through enrichment analysis, and three of these genes were identified as candidate genes by SVM-RFE and LASSO algorithms. We then compared the proportions of the 22 types of immune cells between the LCC and HCC groups using a CIBERSORT analysis and explored the correlation between the candidate hub features and immune cells. Notably, PRKAR2B was positively correlated with the differentially clustered immune cells, which were M1 macrophages and follicular helper T cells (area under the ROC = 0.786). In addition, the expression of PRKAR2B at the mRNA or protein level was lower in the HCC group than in the LCC group. Potential molecular mechanisms were identified based on the expression levels in the high and low PRKAR2B groups. Our findings indicate that PRKAR2B is a novel diagnostic biomarker for breast capsular contracture and might also influence the grade and progression of capsular contracture.

Efficacy of Acellular Dermal Matrix Type in Treatment of Capsular Contracture in Breast Augmentation: A Systematic Review and Meta-Analysis.

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

Bovine Acellular Dermal Matrix-Based Breast Reconstruction in Previously Irradiated Breasts: Complications and Outcomes From a Single-Center Experience.

Radiation therapy is considered today an integral part of the management of breast cancer. However, radiotherapy significantly increases the incidence of total complications in breast reconstruction. Several procedures have been adopted to reduce complication rates in irradiated fields, including the use of acellular dermal matrices (ADMs). We conducted a retrospective analysis of our single-center experience with ADM-assisted implant-based reconstruction or revision surgeries for capsular contracture treatment in irradiated breasts. We divided our population into 4 groups based on prior surgical history: group A (previous quadrantectomy), group B (previous mastectomy and expander reconstruction), group C (previous mastectomy and implant reconstruction), and group D (prior quadrantectomy followed by mastectomy and implant reconstruction). At the European Oncology Institute in Milan, Italy, between June 2017 and April 2019, we identified 84 patients for a total of 86 irradiated breasts reconstructed with implant and ADM. We observed a total of 12 reconstructive failure, with the highest rate of failure in group B (16.6%) and in group D (15.38%). Overall, we recorded 22 total complications (24.4%): 12 major complications and 10 minor complications. The most common complication was infection, with 9 cases (10.4%), 6 of which were classified as severe and required implant removal. In group B, we observed the highest complication rate, both major and minor, with 7 of 42 patients (16.6%) experiencing each. Before reconstruction with ADM, the Baker grade ranged from 3 to 4, with a mean of 3.25. At the 2-year follow-up, the Baker grade ranged from 1 to 4, with a mean of 1.9. Surgeons were highly satisfied with the aesthetic result in 72.1% of cases, moderately in 8.1% and unsatisfied in 5.81%, and in 13.9%, the outcome was not assessable because of reconstructive failure. The worst aesthetic result was in group B. We observed significant reduction in capsular contracture in revision surgeries despite a moderately high rate of complications in previous quadrantectomy and radiotherapy. In our experience, breast reconstruction with implant and ADM is not the primary surgical indication in case of prior irradiation, but it can be considered as a valid alternative with reasonable safety profile, to be used in selected cases.

Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the U.S. Postapproval Study.

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. 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). 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. 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.

Baker Grade IV Capsular Contracture Is Correlated with an Increased Amount of Silicone Material: An Intrapatient Study.

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. 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. 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). 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. Risk, III.

Abstract P6-05-03: Post-Mastectomy Implant Complications in a Hispanic Breast Cancer Patient Population

Abstract Introduction: Breast cancer is the most common cancer diagnosed in women in the United States with primary treatment consisting of a combination of surgery, systemic therapy, and radiation. Breast reconstruction has been shown to improve quality of life in women and utilization is increasing with time. There is a large amount of evidence demonstrating the complications of radiation therapy on implant-based breast reconstruction including but not limited to, capsular contracture, infection, and reoperation. However, the majority of these studies have examined populations consisting primarily of non-Hispanic white patients with breast cancer. In general, hispanic populations are not well represented in research studies or Phase II/III clinical trials. Therefore, the goal of this study was to analyze the impact of radiation therapy on post mastectomy implant-based breast reconstruction complications in self-identified Hispanic patients. Methods: We retrospectively reviewed patients who underwent mastectomy with implant reconstruction between January 1, 2017 and December 1, 2019. The inclusion criteria included female patients 18 years or older who self-reported as Hispanic or Latino. Exclusion criterias included patients who did not undergo mastectomy, did not undergo tissue-expander or implant reconstruction, or did not self identify as Hispanic descent. Outcomes infection needing antibiotics, capsular contracture Baker grade II-IV, and implant loss. Statistical analysis was performed using Chi-squared analysis. Results: A total of 258 patients of Hispanic or Latino women were included in the study. This included 343 total number of breasts, with 228 breasts that underwent mastectomy with reconstruction due to breast cancer and 115 breasts that underwent prophylactic mastectomy with reconstruction. The median age at time of initial mastectomy was 49 years (range 19-86). 46 total breasts received adjuvant postoperative radiation and 296 breasts did not receive radiation. Median radiation dose to the chest wall was 50 Gy (range 42.56 - 60) in 2Gy (range 1.8 - 2.66) fractions. All patients who received postoperative radiation had at least 1 complication. The rate of complications and comparison between radiated breast compared to non-radiated breasts is demonstrated in table 1. Conclusion: The goal of this study was to analyze the impact of radiation therapy complications on post-mastectomy implant-based breast reconstruction surgeries in patients of Hispanic descent. We demonstrate that the rate of capsular contracture is significantly higher after radiation therapy and the rate of overall complication after radiation therapy is higher (even though non statistically significant) compared with patients who do not undergo radiation. While these results are comparable to similar studies done in non-Hispanic groups, this is the first study to our knowledge that has looked at post-mastectomy complications focusing specifically on a Hispanic population. Mastectomy and subsequent implant reconstruction, radiation, and complications can have negative psychological effects on patients and can manifest differently with varying cultural backgrounds. It is imperative to understand the complications associated with race to better allow practitioners to cater treatment and support for a diverse patient population with breast cancer. Table 1. Complications. Citation Format: Brianna Conte, Caroline Shermoen, Danielle Cerbon, Susan Kesmodel, Caroline Fiser, sophia liu, Cristiane Takita, Jessica Meshman, John Oeltjen, Lora Wang. Post-Mastectomy Implant Complications in a Hispanic Breast Cancer Patient Population [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-03.

Simultaneous Salvage Auto-augmentation: Contemporary Strategy for Management of the Breast Explantation Patient.

Sixteen cases (32 breasts) were reviewed over a 19-year period. The management of the capsule is based on intraoperative findings and not on preoperative evaluation because of the poor interobserver correlation of Baker grades. The mean age and clinical follow-up duration were 48 years (range: 41-65) and 9 months, respectively. We observed no complications, and only one patient underwent unilateral surgical revision of the periareolar scar, under local anaesthesia. This study suggests that SSAA with or without autologous fat injection is a safe option for women undergoing explantation, with potential aesthetic and cost-saving benefits. In the current climate of public anxiety regarding breast implant illness, breast implant-associated atypical large cell lymphoma, and asymptomatic textured implants, it is anticipated that the number of patients desiring explantation and SSAA will continue to increase.