Capsular Contracture Rate Research Articles

Pre-pectoral Breast Reconstruction: Surgical and Patient-Reported Outcomes of Two-Stages vs Single-Stage Implant-Based Breast Reconstruction

BackgroundTwo-stages pre-pectoral breast reconstruction may confer advantages over direct to implant (DTI) and subpectoral reconstruction in selected patients who have no indication for autologous reconstruction. The primary endpoint of the study was to evaluate and compare the incidence of capsular contracture in the pre-pectoral two-stages technique versus the direct to implant technique. Complications related to the two surgical techniques and patient satisfaction were also evaluated.MethodsA retrospective review of 45 two stages and 45 Direct-to-implant, DTI patients was completed. Acellular dermal matrix was used in all patients. An evaluation of anthropometric and clinical parameters, surgical procedures and complications was conducted. Minimum follow-up was 12 months after placement of the definitive implant.ResultsThere was no statistically significant difference in the rate of capsular contracture in the two groups. Rippling occurred more in DTI reconstruction. In the two-stages reconstruction, lipofilling was applied more often and there was a higher incidence of seroma. Patient satisfaction extrapolated from the Breast Q questionnaire was better for patients submitted to two-stage implant-based breast reconstruction.ConclusionDual-stage pre-pectoral reconstruction with acellular dermal matrix appears to be a good reconstructive solution in patients with relative contraindications for one-stage heterologous reconstruction with definitive prosthesis and no desire for autologous reconstruction.

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.

Long-Term Outcomes following Hybrid Breast Reconstruction.

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. 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). 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). ADM (versus polyglactin mesh) is associated with lower rates of capsular contracture and implant malposition in the context of hybrid breast reconstruction. Therapeutic, III.

Topical Tranexamic Acid in Primary Breast Augmentation Surgery: Short- and Long-term Outcomes.

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

Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review.

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. 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. 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. 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. Therapeutic, IV.

Use of Antimicrobial Irrigation and Incidence of Capsular Contracture in Breast Augmentation and Immediate Implant-Based Breast Reconstruction.

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

ADM-Assisted Direct-to-Implant Prepectoral Breast Reconstruction in Postmastectomy Radiation Therapy Setting: Long-Term Results

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

The Keller Funnel, Capsular Contracture, and Conflict of Interest: A Review.

The Keller funnel (Allergan; AbbVie Inc, North Chicago, IL) is commonly used to insert breast implants as part of a "no touch" protocol. Many plastic surgeons believe that this device reduces the risk of capsular contracture. This review was undertaken to evaluate the evidence regarding any reduction in capsular contracture rate, other possible benefits, safety and to investigate financial conflict of interest. A PubMed electronic literature search was conducted to identify studies comparing capsular contracture rates with and without the Keller funnel. The Open Payments database was accessed for information regarding corporate payments to plastic surgeons. Two retrospective historical case-control studies, published in 2016 and 2018, were identified. Both studies had important confounders, including implant type and placement, which are known to affect capsular contracture rates. Major financial conflicts of interest were present. Most authors did not disclose these conflicts, which totaled more than $1 million and were usually categorized as gifts from Allergan, which purchased the Keller funnel in 2017. Financial conflict of interest, along with publication bias, creates a bias toward publication of positive findings. No reliable evidence supports a "no touch" technique, which is a misnomer because manual handling of implants is unavoidable, even when using a funnel. Recent microbiological studies do not support a specific bacterial etiology for capsular contracture. No evidence supports contamination by the surgeon touching the implant. Among other proposed benefits, such as reduced operating time, less contamination, a shorter incision, and less implant trauma, only a slightly shorter incision (1 cm) is supported by the evidence. The cost is $150 per funnel. No reliable evidence supports the use of a Keller funnel to reduce the risk of capsular contracture. Both supportive studies contain confounding variables, limited follow-up time, and no plausible scientific basis for efficacy. Institutional review board approval of studies on human subjects is not optional. Financial conflicts of interest are extraordinary in their magnitude and potential for creating undue influence. Greater transparency and honest disclosures are needed.

Capsular Contracture Rate in Augmentation Mammoplasty With Motiva Breast Implant Insertion: A Single-Center Experience in Korea.

Capsular contracture is the most common complication following breast implant surgery, and the implant shell characteristics are important in preventing this complication. The aim of this study was to evaluate the capsular contracture rate for SmoothSilk Motiva implants (Establishment Labs Holdings Inc., New York, NY) in females who underwent primary and revisional breast augmentation over a 3-year period. A total of 1324 cases that took place from 2017 to 2020 were retrospectively analyzed, with 1027 being primary surgeries and 297 being revisional surgeries. In the 1324 cases of augmentation mammoplasty with SmoothSilk Motiva implants, the overall capsular contracture rate was 1.8% (n = 24). The capsular contracture rate in the 1027 primary surgery cases was 1.07% (n = 11), and the capsular contracture rate in the 297 revisional surgery cases was significantly different at 4.39% (n = 13, P = .0001). More specifically, the capsular contracture rate in 182 revisional surgery for cases without capsular contracture was 1.12% (n = 2), and it showed no statistically significant difference from the rate in primary surgery cases (P = .965). However, the rate in 115 revisional surgery for cases with capsular contracture was 9.57% (n = 11), and it showed a statistically significant difference from the rate in primary surgery cases (P = .000) and the rate in revisional surgery for cases without capsular contracture (P = .001). Augmentation mammoplasty with SmoothSilk Motiva implants demonstrated a lower rate of capsular contracture than traditional smooth or textured implants. Revisional surgery for cases without capsular contracture showed a similar rate of capsular contracture to primary surgery cases, but the rates were higher in revisional surgery for cases with capsular contracture.

SP37. Fortification or Fibrosis? An Evaluation of Immune System Disorders and the Development of Capsular Contracture

PURPOSE: Two-stage implant-based procedures remain the most common approach for women pursuing post-mastectomy reconstruction. Up to 20% of patients develop capsular contracture after surgery, which can lead to poor functional and aesthetic outcomes, cause significant discomfort, and require additional corrective procedures. While the etiology of capsular contracture has not been fully elucidated, most literature attribute the process to a pro-inflammatory response involving the innate immune system. Additionally, some have postulated that peri-operative bacterial colonization of the implant site may lead to fibrosis and contracture formation. Autoimmune disorders, which are linked to abnormal systemic inflammatory responses, and immunosuppression, which can increase susceptibility to a range of infections, are not uncommon in patients diagnosed with breast cancer. Thus, an understanding of the intersectionality between these conditions and post-operative complications could prove useful for surgical planning. The aim of this study is to evaluate the effects of autoimmune disorders and immunodeficiency on rates of capsular contracture among two-stage breast reconstruction patients. METHODS: A dataset consisting of 296 patients (520 samples) who had undergone two-stage breast reconstruction between 2009 - 2021 at a tertiary-care facility was used in the study. An array of patient data, such as demographics, past medical history, and social history were collected. The primary endpoint was contracture development, which was ascertained by reviewing the electronic health record. The secondary outcome of interest was time to contracture formation. The date of contracture development (t_c) is defined as the first mention of capsular contracture based on clinical assessment. The time to event is defined as t_c - t_implant if the subject developed contracture, t_c - t_present if the subject was contracture-free. Univariate logistic regression was used for statistical analysis. RESULTS: Among the cohort, 5% (26/520) and 10.6% (55/520) had concurrent immunosuppression and autoimmune disorders, respectively. The autoimmune disorders examined were rheumatologic and endocrine in origin. The immunosuppressed states included both viral (HIV, Hepatitis A/B/C) and oncological (multiple myeloma, monoclonal gammopathy of undetermined significance, chronic myelogenous leukemia) conditions. On univariate analysis, compared to patients without either conditions, autoimmune disorders (OR 1.15, p-value 0.64) and immunosuppression (OR 1.06, p-value 0.88) were not linked to significantly higher odds or earlier development of capsular contracture (p-value > 0.05). Further stratified analysis examining only patients with immune-based conditions did not reveal statistically significant differences in the timeline (OR 0.14, p-value 0.43) or odds (OR 1.07, p-value 0.878) of contracture formation between the subgroup with immune-overactivation and the subgroup with immunosuppression. CONCLUSION: Comorbid autoimmune disorders and immunosuppression do not appear to significantly affect the odds or timeline of capsular contracture development. When counseling post-mastectomy patients with similar past medical history, surgeons may safely offer the choice of implant-based procedures when presenting the various reconstruction modalities.

Complications following Breast Augmentation in Transfeminine Individuals: A Systematic Review and Meta-Analysis.

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. 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. 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. 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.

D82. Acellular Dermal Matrix-assisted, Implant-based Breast Reconstruction: A Comparison of SurgiMend, AlloDERM, and DermACELL

PURPOSE: Acellular dermal matrices (ADMs) are frequently employed during implant-based breast reconstruction (IBBR) to provide structural support and optimize outcomes. ADMs differ in derivative (fetal bovine, porcine, human), cost and processing; yet few studies directly compare their outcomes. We sought to compare outcomes across three ADMs: SurgiMend (bovine-derived), AlloDerm (human-derived), and DermACELL (human-derived). METHODS: A multicenter retrospective review of patients receiving IBBR with SurgiMend, AlloDerm, or DermACELL between January 2014 and July 2022 was performed. Primary outcomes included explantation or total reconstructive failure. Secondary outcomes included 90-day postoperative complications and rates of capsular contracture within a two-year follow-up. RESULTS: A total of 439 patients receiving IBBR using ADM were identified. Of those, 215 patients (367 breasts) had full chart reviews. Mastectomy type preceding ADM use differed significantly (p=0.034), though nipple-sparing mastectomy was the most common for all cohorts. While most patients received direct-to-implant reconstruction, significant differences existed between ADM (p<0.0001). Short-term complications, total reconstruction failure, and reoperation within 90-days were comparable. No differences were found for rates of capsular contracture (p=0.385) and explantation (p=0.694). CONCLUSION: This preliminary data demonstrates equivalence in short- and long-term complications between SurgiMend, AlloDerm, and DermACELL. Our findings support further evidence-based use of ADMs.

PC61. Comparative Postoperative Complications of Acellular Dermal Matrix and Mesh in Prepectoral and Subpectoral One Stage Direct to Implant Reconstruction: A Retrospective Cohort Study

PURPOSE: One-stage direct to implant (DTI) breast reconstruction has become increasingly popular with the use of prepectoral reconstruction. This technique leads to an increased demand for acellular dermal matrix (ADM). It is incumbent on the surgical community to determine if differences in outcomes exist among available products. METHODS: We performed a retrospective cohort study of consecutive patients in our quaternary-care breast cancer center undergoing DTI reconstruction utilizing different matrices. Patient demographics and outcomes extracted through chart review. Outcomes included cellulitis, capsular contracture, hematoma or seroma requiring drainage, skin necrosis, readmission, revisions, and explantation for infection/exposure/capsular contracture. Univariate and multivariate analysis determined differences in outcomes and account for confounding variables. RESULTS:240 consecutive patients (399 breasts) underwent DTI reconstruction. 192 breasts were reconstructed with FlexHD Pliable, 120 AlloDerm, 23 autologous dermal flaps, 21 DermACELL, 21 Galaflex, and 22 Meso BioMatrix. There were no differences in demographics, implant type or size, mastectomy type, or chemoradiation exposure. Univariate analysis demonstrated increased cellulitis (p=0.037), capsular contracture (p=0.008), explantation for capsular contracture (p=0.004), and seroma requiring drainage (p=0.008) with AlloDerm versus the other materials. There were no differences in readmission, explantation for infection/exposure, revisions, skin necrosis, or hematoma incidence. Multivariate regression analysis found no difference in the incidence of cellulitis or seroma of AlloDerm versus other products; however, FlexHD demonstrated a decreased rate of capsular contracture (OR:0.17, p=0.023) and explantation for capsular contracture (OR:0.15, p=0.030) versus AlloDerm. CONCLUSION: While there were no differences in autologus and ADM DTI reconstruction outcomes, certain products have differing safety profiles requiring careful consideration.

Prevention of Postoperative Complications by Prepectoral versus Subpectoral Breast Reconstruction: A Systematic Review and Meta-Analysis.

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. 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. 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). 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.

ADMs and synthetic meshes improve implant-based breast reconstruction aesthetics, but at what cost?

Acellular dermal matrices (ADMs) have shown promise for use in reconstructive breast surgery as they improve aesthetic outcomes and decrease capsular contracture rates. However, concerns about their use remain because of the higher cost and complication profile. We report a single institution's implant-based-reconstruction (IBR) experience between 2007 and 2021, including cases performed by 51 plastic surgeons. For each stage of IBR, data on age, comorbidities, type of mesh used, and acute complications were collected. Of 1379 patients who underwent subpectoral IBR, 937 received an ADM or synthetic mesh as part of their reconstruction. 256 patients out of 264 treated with prepectoral IBR received an ADM or mesh. Infection and wound dehiscence rates were highest for patients who underwent prepectoral IBR with ADM. Both subpectoral and prepectoral IBR with ADM were associated with higher rates of infection and wound complications compared to without ADM or mesh, but only the difference among the subpectoral cohort reached statistical significance. Prepectoral IBR with ADM or mesh had the lowest rates of capsular contracture and aesthetic reoperations. Although the use of Vicryl® mesh in subpectoral IBR was associated with a higher risk of capsular contracture and skin flap necrosis compared to reconstruction with ADMs (10.53% versus 3.29%; p<0.05), Vicryl® was associated with fewer aesthetic revisions. Our study demonstrated that prepectoral IBR with ADM or mesh resulted in the fewest aesthetic reoperations and the lowest rates of capsular contracture. Infection and wound dehiscence rates were notably higher for patients who had reconstruction with ADM.

Effect of The Keller Funnel Method “No Touch” on Breast Augmentation and Reconstruction: A Systematic Review

Introduction: Breast augmentation is one of the most common aesthetic surgeries. Implant contamination remains a critical problem with these surgeries resulting in acute infection as well as capsular contracture. To reduce the risk of implant contamination, the “no-touch technique” utilizing the Keller funnel© has been adopted by many surgeons. This systematic review aims to investigate the advantages of the Keller Funnel method for breast augmentation-reconstruction. Materials and Methods: A systematic review of PubMed, EMBASE, the Cochrane database, and Google Scholar was performed between years 2005 to 2021. All clinical-based, retrospective and prospective studies utilizing the Keller Funnel method for breast implant insertion were selected. Results: Six studies were identified for evaluation: 5 were retrospective cohorts and 1 was prospective trial. No randomized controlled trials were found. Outcomes reported included less rates of capsular contracture (RR:0.42; P=0.0006, %95 CI=0.25-0.69), decreased levels of contamination and implant shell trauma, shorter incision lengths (35.5+/-2.1mm), less insertion time (mean=6 s), decreased complications, and ultimately greater patient satisfaction with outcomes. Conclusion: This review suggests that the Keller Funnel is a useful method “no-touch” breast augmentation and reconstruction surgery. The Keller funnel reduces bacterial contamination and subsequent capsular contracture rate, surgical time, and incision length as well as allows for easier insertion. All of these mitigate the variables that lead to reoperation. However, our findings support recommendation of a prospective randomized controlled clinical trial with larger population size and follow-up intervals.

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.

Abstract P2-15-05: Prepectoral versus subpectoral implant-based breast reconstruction: A systemic review and meta-analysis

Abstract Prepectoral versus subpectoral implant-based breast reconstruction: A systemic review and meta-analysis. Edvin Ostapenko, MD1,2, Larissa Nixdorf, MD1, Yelena Devyatko, MD1, Ruth Exner, MD1, Kerstin Wimmer, MD1, Florian Fitzal, MD1 1Department of General Surgery and Breast Health Center, Medical University of Vienna, Vienna, Austria. 2Faculty of Medicine, Vilnius University, Vilnius, Lithuania Abstract Background Implant-based breast reconstruction (IBBR) is still standard and most popular option for women undergoing breast reconstruction after mastectomy worldwide. Recently, prepectoral IBBR has resurged in popularity, despite limited data comparing prepectoral with subpectoral IBBR. Methods A systematic search of PubMed and Cochrane Library from January 1, 2011, to December 31, 2021, was performed following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting guideline, data were extracted by independent reviewers. Random and fixed-effect models were applied to obtain pooled proportions and 95% CIs. The Risk of Bias in Nonrandomized Studies- of Interventions (ROBINS-I) tool was used for critical appraisal of cohorts and funnels plots, and the Egger bias test were used for evaluating the publication bias. Studies that compared prepectoral IBBR with subpectoral IBBR for breast cancer were included. Results Overall, 15 studies with 3101 patients were included in this meta-analysis. Our results showed that patients receiving prepectoral IBBR experienced fewer capsular contracture (odds ratio [OR], 0.54; 95% CI, 0.32-0.92; P=.02), animation deformity (OR, 0.02; 95% CI, 0.00-0.25; P=.002), and prosthesis failure (OR, 0.58; 95% CI, 0.42-0.80; P=.001). There was no significant difference between prepectoral and subpectoral IBBR in overall complications (OR, 0.83; 95% CI, 0.64-1.09; P=.19), seroma (OR, 1.21; 95% CI, 0.59-2.51; P=.60), hematoma (OR, 0.76 95% CI, 0.49-1.18; P=.22), infection (OR, 0.87; 95% CI, 0.63-1.20; P=.39), skin flap necrosis (OR, 0.70 95% CI, 0.45-1.08; P=.11), and recurrence (OR, 1.31; 95% CI, 0.52-3.39; P=.55). Similarly, no significant difference was found in Breast-Q scores between prepectoral and subpectoral IBBR groups. Conclusion The results of our systematic review and meta-analysis demonstrated that prepectoral implant-based breast reconstruction is a safe modality and have similar outcomes with significantly lower rates of capsular contracture, prosthesis failure and animation deformity compared to subpectoral implant-based breast reconstruction. Future research should include randomized clinical trials or well-designed prospective matched studies with adequate follow-up to assess long-term as well as oncologic outcomes between comparative groups. Key Words: immediate implant-based breast reconstruction, breast cancer, outcomes, prepectoral, subpectoral; Citation Format: Edvin Ostapenko, Larissa Nixdorf, Yelena Devyatko, Kerstin Wimmer, Ruth Exner, Florian Fitzal. Prepectoral versus subpectoral implant-based breast reconstruction: A systemic review and meta-analysis. [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 P2-15-05.

Abstract P6-05-44: REASONS FOR CHOOSING DELAYED RATHER THAN IMMEDIATE CONTRALATERAL PROPHYLACTIC MASTECTOMY IN PATIENTS WITH UNILATERAL BREAST CANCER

Abstract Background: Rates of contralateral prophylactic mastectomy (CPM) have more than doubled in the past decade amongst breast cancer patients irrespective of inherited genetic predisposition related to high penetrance genes. Increasing numbers of women with unilateral breast cancer are opting for removal of both the affected ipsilateral and unaffected contralateral ‘normal’ breast even when suitable for breast conserving surgery. Reasons for requesting CPM include prevention of recurrence, peace of mind and moving on after breast cancer. Some women seek CPM as a delayed procedure but factors influencing this are poorly understood. Methods: A retrospective analysis examined patients undergoing CPM as either an immediate or delayed procedure with or without breast reconstruction (BR) at a single tertiary referral centre between January 2009 and December 2019. A cross-sectional survey was undertaken that was compiled and based on validated questionnaires and responses to defined statements generated using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) with calculation of mean scores and standard deviation (SD). This questionnaire explored patient’s decision-making process in terms of timing of CPM and any BR and was supported by subjective free-text boxes to gauge qualitative and quantitative aspects of the patient-related decision-making process. Those patients who consented to participate were provided with access to an online questionnaire. Results: Amongst this cohort of 39 delayed CPM patients, there were 6 decliners and therefore questionnaires were issued to the remaining 33 patients. The response rate was 67% (22/33) and the most common reason for seeking delayed CPM was to allow completion of adjuvant treatment recommendations (including radiotherapy/chemotherapy) before surgery on the unaffected breast [mean score 2.91; SD 1.0]. This avoided risk of delay in commencement of adjuvant treatment consequent to potential complications of contralateral surgery (especially with BR). The second most important reason for choosing delayed CPM was unavailability of genetic test results at the time of therapeutic mastectomy [mean score 2.64; SD 1.4]. The third most common reason was a subsequent change in family history cancer history after their personal breast cancer diagnosis that often prompted genetic testing [mean score 2.55; SD 2.7]. Several patients cited a shorter recovery time as a strong reason for requesting delayed CPM. Conclusion: Factors determining delayed CPM are patient-driven and this accords with documented reasons for women seeking CPM in general. Patients tend to make decisions about CPM based on two main themes relating to either ‘fear’ of cancer or a desire to ‘take control’. Temporal factors are important in the context of a delayed procedure and relate to subsequent availability of genetic test results and changes in family history in relatives who were otherwise unaffected at the time of initial diagnosis. Completion of all cancer treatments prior to delayed CPM (with BR) can be advantageous when implant-based BR is planned at the time of an immediate CPM. Radiotherapy can increase capsular contracture rates and surgical complications can delay start of chemotherapy. CPM should be offered as a potentially delayed option with informed discussion of risks and benefits. Citation Format: Chien Lin Soh, Samantha Muktar, Charles M Malata, John R Benson. REASONS FOR CHOOSING DELAYED RATHER THAN IMMEDIATE CONTRALATERAL PROPHYLACTIC MASTECTOMY IN PATIENTS WITH UNILATERAL BREAST CANCER. [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 P6-05-44.

Ideal Implant Structured Breast Implants: Core Study Results through 10 Years.

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