One-stage Implant-based Breast Reconstruction Research Articles

Abstract PO4-22-11: Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Abstract Background: The use of TiLOOP@ Bra in implant-based breast reconstruction (IBBR) becomes standard of care in mainland China. But evidence is limited about complication of one-stage and two-stage IBBR using TiLOOP@ Bra. A prospective randomized trial was conducted to compare the safety of immediate IBBR with that of immediate-delayed IBBR, both with TiLOOP@ Bra. Methods: We did an open label, randomized, controlled trial in eleven hospitals in the mainland China. Inclusion criteria: Women aged above 18 with cT0-T2N0M0 breast carcinoma which requires to undergo nipple or skin-sparing mastectomy (NSM or SSM) and immediate IBBR. Randomization was done electronically, stratified per center and in blocks of four of six to achieve approximately balanced groups of patients assigned to undergo one-stage or two-stage IBBR. Both procedures were undergone pectoralis major and TiLOOP@ Bra to build pockets. The primary endpoint of the present study was the incidence of postoperative complications (within 90 days after surgery), while the secondary endpoints were the quality of life at 18 months after surgery, satisfaction with breast appearance, aesthetic scores of reconstructed breasts, type of reoperation and TiLOOP@ Bra angiopathological assessment. This study is registered at clinicaltrials.gov, number NCT03589924. Findings: Between June 2018 and May 2022, a total of 418 eligible patients were randomly assigned to either two-stage implant reconstruction (n=194) group or immediate one-stage implant reconstruction (n=224) group. In terms of surgical procedures, NSM was more commonly (72.7%) chosen, with the two-stage implant reconstruction group having a lower proportion compared to the immediate one-stage implant reconstruction (66.3% vs. 78.3%; p=0.010). At 3 months after breast reconstruction surgery, the incidence of complications was lower in the two-stage implant reconstruction group than that in the immediate one-stage implant reconstruction group, with significant difference of 14.5% vs 23%; p=0.038. The incidence of nipple or areola necrosis was lower in the two-stage implant reconstruction group compared to the immediate one-stage implant reconstruction group, with statistically significant difference of 9.8% vs 17.1%; p=0.048. The implant loss rate was only 0.7%. It was discovered that the incidence of severe complications was lower in the two-stage implant reconstruction group than in the immediate one-stage implant reconstruction group (2.6% vs. 3.7%), and the difference was not statistically significant. Patients who experienced complications had a higher proportion of chemotherapy (69.2% vs. 38.9%; p< 0.001), endocrine therapy (74.4% vs. 53.9%; p=0.002), and targeted therapy (24.4% vs. 9.6%; p=0.001), and the differences were statistically significant. In terms of surgical procedures, 67 (85.9%) patients who experienced complications underwent NSM, while the proportion of NSM in patients who did not experience complications was lower at 69.6%, which were 231 patients, and the difference was statistically significant (p=0.011). In addition, the complication incidence of patients who received implants sizes of 300-400ml was higher than that of the group that did not (32.1% vs. 17.8%; p=0.012). Conclusion: Both one-stage and two-stage TiLOOP@-assisted IBBR demonstrated perioperative safety. The complication rate within three month of two-stage is lower than one-stage. The implant loss rate was only 0.7% perioperatively. Our results suggest that use of TiLOOP@ Bra be considered carefully for one-stage NSM with IBBR but can be considered for SSM patients. Citation Format: Benlong Yang, Jian Liu, Haibo Wang, Yiding Chen, Cuizhi Geng, Nanyan Rao, Siyuan Han, Antai Zhang, Jinping Shi, Qiang Zhang, Wenhe Zhao, Jiong Wu. Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA) [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 PO4-22-11.

Outcomes after elevation of serratus anterior fascia flap versus serratus muscle flap in direct-to-implant breast reconstruction following mastectomy: a prospective study.

The purpose of this study was to compare postoperative pain between SF flap and serratus anterior muscle (SM) in direct-to-implant breast reconstruction. This is a prospective cohort study that included 53 women diagnosed with breast cancer who underwent mastectomy and one-stage implant-based breast reconstruction from January 2020 to March 2021. Twenty-nine patients (54.7%) had SF elevation, and 24 patients (45.3%) underwent SM elevation. We evaluated patient-reported early postoperative pain on the first day after surgery. Also, it was reported that all surgical complications in the first month and patient reported outcomes (PROs) were measured with the BRECON 23 questionnaire. The serratus fascia group used implants with larger volumes, 407.6 ± 98.9 cc (p < 0.01). There was no significant difference between the fascial and muscular groups regarding the postoperative pain score reported by the patients (2 versus 3; p = 0.30). Also, there was no difference between the groups regarding early surgical complications and PROs after breast reconstruction. The use of SF seems to cause less morbidity, which makes the technique an alternative to be considered in breast reconstruction. Although there was no statistical difference in postoperative pain scores between the fascia and serratus muscle groups.

One-Stage Implant-Based Breast Reconstruction With Polyurethane-Coated Device: Standardized Assessment of Outcomes.

Nipple-sparing mastectomies (NSMs) and implant-based breast reconstructions have evolved from 2-stage reconstructions with tissue expansion and implant exchange to direct-to-implant procedures. In this study, we tested safety and efficacy of polyurethane-based implants according to standard assessment tools. This study aimed to test safety and feasibility of polyurethane-coated implants with standardized assessment employing internationally acknowledged evaluation criteria. Cases of NSMs followed by breast reconstruction in 1 stage with immediate prepectoral polyurethane-coated implant placement were retrospectively reviewed. Preoperative characteristics of the population have been collected. Adherence to quality assurance criteria of the Association of Breast Surgery-British Association of Plastic Reconstructive and Aesthetic Surgeons was verified. Complications were assessed with the Clavien Dindo classification, modified for the breast. Rippling, implant rotation, and malposition were also evaluated. Sixty-three consecutive patients underwent 74 NSMs and immediate breast reconstruction with micro polyurethane foam-coated anatomic implants. In 5 cases we had unplanned readmissions with return to the operating room under general anesthesia (6.7%) and implant loss within 3 months from breast reconstruction (5 implants, 6.7%). Postoperative complications according to Clavien Dindo were grade 1 in 6 cases (8.1%), grade 2 in 3 cases (4%), and 3b in 5 cases (6.7%). Polyurethane-coated implants may prevent rotation and malposition and capsular contracture in the short term. Unplanned readmission rates and implant loss rates in the short term may be slightly higher.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad301.

Oncologic Safety of One-Stage Implant-Based Breast Reconstruction in Breast Cancer Patients With Positive Sentinel Lymph Nodes: A Single-Center Retrospective Study Using Propensity Score Matching

ObjectiveThe purpose of this study is to evaluate the oncologic safety of one-stage implant-based breast reconstruction (OIBR) following mastectomy in breast cancer patients with positive sentinel lymph nodes (SLNs). MethodsWe collected clinical and pathological data from breast cancer patients with positive SLNs who underwent OIBR or not after mastectomy between January 2015 and December 2018. A total of 194 patients were included, with 130 patients undergoing mastectomy alone (MA) and 64 patients receiving OIBR after mastectomy. The clinical and pathological features, as well as the postoperative oncologic outcomes, of the 2 groups were retrospectively analyzed. Propensity score matching (PSM) was employed to mitigate the effects of data bias and confounding factors. ResultsThe median follow-up time was 66 months for the OIBR group and 64 months for the MA group after PSM. The majority of reconstructive surgeries use an approach of prosthetic implantation (52.0%). This is followed by prosthetic implantation combined with a latissimus dorsi (LD) flap (32.0%), and acellular dermal matrix (ADM)-assisted implant placement (16.0%). During the follow-up period, a local recurrence was observed in 1 case, regional recurrence in 3 cases, and distant metastasis leading to death in 3 cases among the OIBR group patients. No significant difference was found between the OIBR and MA groups in disease-free survival (DFS) (P = .66), distant metastasis-free survival (DMFS) (P = .91), locoregional recurrence-free survival (LRRFS) (P = .44), and overall survival (OS) (P = .57). ConclusionOIBR is a safe option for breast cancer patients with positive SLNs and does not negatively impact cancer recurrence or overall survival.

Resource utilization and patient reported outcomes using acellular dermal matrix in breast reconstructive procedures

Background: The introduction of acellular dermal matrices revolutionized implant-based breast reconstructive procedures. Literature reports both advantages and disadvantages associated to the use of acellular dermal matrix (ADM). The increasing number of breast reconstructive procedures being performed leads to an awareness of improving the psychosocial and functional result and reduce costs associated with these procedures. One-stage implant-based breast reconstruction (BR) with ADM has potential advantages for the patient, but literature shows conflicting results regarding the cost-effectiveness of this approach compared to the two-stage expander-to-implant method. The patient’s subjective assessment of the physical and psychosocial effects of BR is extremely important. To contribute to knowledge on the subject, we present a study where the aim was to compare immediate implant-based BR using the ADM assisted one-stage approach with the two-stage expander-to-implant approach regarding resource utilization and patient reported outcomes (PROs).

Clinical outcomes and patient satisfaction with the use of biological and synthetic meshes in one-stage implant-based breast reconstruction.

Biological and synthetic meshes were used to cover the damaged muscle and augment the subpectoral pocket in breast reconstruction. However, few studies have directly compared the effects of biological and synthetic meshes. This study analyzed postoperative complications and assessed the patient-reported outcomes with the use of BioDesign® Surgisis and TiLOOP Bra/TiMesh® in one-stage implant-based breast reconstruction. Patients undergoing one-stage implant-based breast reconstruction were enrolled in this study. Post-mastectomy breast reconstructions were facilitated with either Surgisis mesh or TiLOOP mesh. Complications were examined and patient-reported quality-of-life outcomes were evaluated using the BREAST-Q questionnaire (ver 2.0). The multivariate linear regression models were used for data analysis. Overall, 79 of 116 patients (68%) received breast reconstruction with Surgisis mesh and 37 (32%) with TiLOOP mesh. There was no difference in complication rates between the two groups postoperatively. But patient-reported satisfaction was higher with the use of Surgisis mesh than with TiLOOP mesh (P = 0.05). This study reported no difference between the Surgisis group and the TiLOOP group in either complication rates or most patient-reported outcomes postoperatively. Yet the assessment of patient-reported satisfaction showed preference toward Surgisis mesh, a finding with a potential implication for mesh selection.

Biological Matrix-Assisted One-Stage Implant-Based Breast Reconstruction Versus Two-Stage Implant-Based Breast Reconstruction: Patient-Reported Outcomes and Complications.

Biological matrix-assisted one-stage implant-based breast reconstruction (IBBR) could improve the inframammary fold to achieve good esthetic results. However, whether biological matrix-assisted one-stage IBBR yields better postoperative outcomes compared with two-stage IBBR remains unclear. We aimed to compare and analyze surgical complications and patient-reported outcomes (PROs) based on the BREAST-Q version 2.0 questionnaire between biological matrix-assisted one-stage IBBR and traditional two-stage IBBR. From May 2015 to June 2019, eligible patients who underwent SIS matrix-assisted one-stage IBBR or two-stage IBBR were enrolled in this retrospective cohort study. PROs were measured with BREAST-Q version 2.0, which scored the health-related quality of life, satisfaction, and experience domains. Complications were divided into major complications (patients requiring reoperation) and minor complications (patients who could be treated in the dressing room). PROs and complications were compared between the SIS matrix-assisted one-stage IBBR and two-stage IBBR groups. A multivariate linear regression analysis was used to identify the social and surgical factors that affected PROs. At our institution, 124 eligible patients were recruited. Seventy-nine patients (63.7%) underwent SIS matrix-assisted one-stage IBBR reconstruction, and 45 patients (36.3%) underwent tissue expander/implant reconstruction (two-stage IBBR). Postoperative BREAST-Q version 2.0 was completed by 68 of 79 patients (86.1%) in the SIS matrix-assisted one-stage IBBR group and by 35 of 45 patients (77.8%) in the two-stage IBBR group. In the satisfaction-related quality of life domain, satisfaction with breast was 9.27 points higher in the SIS matrix-assisted one-stage IBBR group (p = 0.012) compared with the two-stage IBBR group. The multivariate linear regression analysis showed that implant volume (p = 0.031) and postoperative radiotherapy (p = 0.036) significantly influenced the PRO of satisfaction with breast. However, patients in the SIS matrix-assisted one-stage IBBR group had a higher minor complication rate compared with patients in the two-stage IBBR group (p = 0.026). Our retrospective study showed that although patients treated with biological matrix-assisted one-stage IBBR tended to have higher postoperative complication rates, this technique correlated with better PROs compared with two-stage IBBR. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Outcomes and quality of life in immediate one-stage versus two-stage breast reconstructions without an acellular dermal matrix: 17- years of experience.

Advantages of one-stage implant-based reconstructions include expedited surgery and recovery. This study aimed to investigate clinical and patient-reported outcomes in one-stage implant-based breast reconstructions without acellular dermal matrix (ADM). A prospectively collected database from 2002 to 2018 was retrospectively reviewed. One-stage and two-stage groups were compared for demographics, implant properties, early complications (hematoma, seroma, poor wound healing, implant removal), late complications (skin necrosis, capsular contracture, implant exposure, implant rupture), revision procedures, and Breast-Q questionnaire outcomes. A total of 223 patients, 187 one-stage (84%) and 36 two-stage (16%) patients were recruited. At a mean follow-up of 124.9 and 92.5 months, respectively (p < .01), there were no differences in early (p = .85) or late (p = .23) complications or revision procedures (p = .12). Eighty patients (36%) returned the Breast-Q questionnaire (60 one-stage, 20 two-stage patients). There were no statistical differences in patient reported outcomes in breast well-being (p = .07), psychosocial well-being (p = .84), or sexual well-being (p = .78). One-stage implant-based breast reconstruction without an ADM is a viable reconstruction providing comparable outcomes to two-stage procedures, with the benefit of minimal complications, a shorter reconstructive journey, and satisfactory quality of life.

Comparisons of Therapeutic and Aesthetic Effects of One-Stage Implant-Based Breast Reconstruction with and without Biological Matrix.

BackgroundBiological matrix can provide coverage of compromised muscle and augment the subpectoral pocket in the one-stage reconstruction. However, few studies compared one stage implant-based breast reconstruction with and without biological matrix. The primary endpoint of our study was to assess the patient-reported outcomes (PROs) based on BREAST-Q version 2.0 and analyze complications between SIS matrix-assisted implant-based breast reconstruction (IBBR) and no-matrix-assisted IBBR.MethodsThis retrospective single-center study was conducted from May 2015 to April 2019, and we analyzed 155 patients who underwent one-stage IBBR with at least 1 year of follow-up. Seventy-nine patients underwent one-stage IBBR with SIS matrix group and 76 patients underwent one-stage IBBR without SIS matrix group were evaluated of PROs with BREAST-Q version 2.0 (from 3 different domains) and compared with complications. Complications occurred in patients were divided into major complications and minor complications.ResultsIn the satisfaction domain, the mean score for satisfaction with breasts was 60.27 (17.71) in the SIS matrix group and 54.49 (14.76) in the no-matrix group, p=0.045. The multivariate logistic regression for postoperative complications in the whole series pointed out a statistical significance for age>40 years old (odds ratio 3.314, 95% CI 1.012–10.854, p=0.048) and patients with endocrine therapy (odds ratio 0.260, 95% CI 0.092–0.736, p=0.011).ConclusionPatients who underwent SIS matrix-assisted one-stage IBBR yield better results in PROs of satisfaction with breasts. Other domains and complications between the two groups had no significant difference.

One-stage and two-stage breast reconstruction have no meaningful difference in patient quality of life

A clinical decision report appraising Negenborn VL, Young-Afat DA, Dikmans REG, et al. Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial. Lancet Oncology. 2018;19(9):1205-14. https://doi.org/10.1016/s1470-2045(18)30378-4.

Immediate One-Stage Implant-Based Breast Reconstruction after Conservative Mastectomy: Sub-Pectoral or Pre-Pectoral? A Proposal for a Randomized Multicentric Trial to Define Indications and Outcomes.

Background: Implant-based breast reconstruction (IBR) is the most common reconstructive procedure after mastectomy. During the last 10-15 years, the introduction of Acellular Dermal Matrices (ADMs)/synthetic meshes has driven a change in practice from complete submuscular implants to sub-pectoral implants. In the last 5-7 years pre-pectoral IBR with complete ADM/mesh cover gained popularity as an alternative to sub-pectoral IBR and is considered the procedure of choice in athletic, active women. Avoiding disturbance of muscular structures has the theoretical advantages of reduced post-operative pain and operative time and prevention of animation deformity. However, long-term outcomes are still not available and possible disadvantages of pre-pectoral IBR might be increased palpability of implant edges and upper pole wrinkling, possibly leading to more revisional surgery.

Short-term cost-effectiveness of one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage expander-implant reconstruction from a multicentre randomized clinical trial

BackgroundImplant‐based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure and its economic impact is significant. This study aimed to analyse whether a direct one‐stage IBBR with use of an acellular dermal matrix (ADM) is more cost‐effective than two‐stage (expander‐implant) breast reconstruction.MethodsThe BRIOS (Breast Reconstruction In One Stage) study was an open‐label multicentre RCT in which women scheduled for skin‐sparing mastectomy and immediate IBBR were randomized between one‐stage IBBR with ADM or two‐stage IBBR. Duration of surgery and hospital stay, and visits for the primary surgery, unplanned and cosmetic procedures were recorded. Costs were estimated at an institutional level. Health status was assessed by means of the EuroQol Five Dimensions 5L questionnaire.ResultsFifty‐nine patients (91 breasts) underwent one‐stage IBBR with ADM and 62 patients (92 breasts) two‐stage IBBR. The mean(s.d.) duration of surgery in the one‐stage group was significantly longer than that for two‐stage IBBR for unilateral (2·52(0·55) versus 2·02(0·35) h; P < 0·001) and bilateral (4·03(1·00) versus 3·25(0·58) h; P = 0·017) reconstructions. Costs were higher for one‐stage compared with two‐stage IBBR for both unilateral (€12 448 (95 per cent c.i. 10 722 to 14 387) versus €9871 (9373 to 10 445) respectively; P = 0·025) and bilateral (€16 939 (14 887 to 19 360) versus €13 383 (12 414 to 14 669); P = 0·002) reconstructions. This was partly related to the use of relatively expensive ADM. There was no difference in postoperative health status between the groups.ConclusionOne‐stage IBBR with ADM was associated with higher costs, but similar health status, compared with conventional two‐stage IBBR. Registration number: NTR5446 ( http://www.trialregister.nl).

More evidence for implant-based breast reconstruction.

More evidence for implant-based breast reconstruction.

Breast Oncoplasty Surgery in Low- and Middle-Income Countries: Lessons From India

Purpose Breast cancer is the most common cancer in India, affecting all socio-economic strata. Despite its growing global acceptance, Breast Oncoplasty Surgery (BOS) remains nascent in India, necessitating local context-specific innovative delivery models for clinicians and the general public. Here, we present experiences from Orchids Breast Health Clinic (OBHC; Pune, India) with the implementation of BOS clinical services, training, and research and community outreach. Methods OBHC, a dedicated breast unit, has established the first dedicated BOS clinic in India, conducted hands-on training workshops for trainee surgeons, developed an MCh degree program in breast oncoplasty with the University of East Anglia (Norwich, United Kingdom), undertaken BOS research in Indian patients, and created outreach programs to popularize BOS. Results A cost-effective one surgeon–dual role concept wherein the same surgeon performs onco- and plastic surgery and one-stage implant-based breast reconstruction has been adopted. Since 2013, BOS cases included BCS (n = 440), breast reconstruction (n = 210), and therapeutic mammoplasty (n = 135). The unavailability of acellular dermal matrices has prompted the innovation of a surgical technique, termed Advanced Autologous Dermal Sling, which uses vascularized local tissue as implant cover. Significant improvement in postsurgery outcomes and protection against radiation complications has been observed. BOS hospitalization costs have been reduced by 50% thereby, which has led to high rates of acceptance (80%) of BOS in patients at OBHC. Young breast surgeons from across India and South Asian Association for Regional Cooperation countries have enrolled in the MCh degree program, which involves an embedded curriculum with online didactic modules and hands-on training workshops in Pune, India. Longitudinal follow-up after 1, 3, and 5 years postsurgery in the study cohorts is undertaken for post-BOS outcomes using clinical assessment (Bakers scale) and patient-reported outcomes measures (BREAST-Q questionnaire). Multiple research projects are undergoing peer-review before publication. To increase awareness of BOS among Indian women, community awareness campaigns with the theme of Losing Is Not an Option are underway via public talks, symposia, marathon, and op-eds in electronic and print media. Conclusion The OBHC model of Affordable Excellence in BOS, developed in the Indian context, can be extrapolated to benefit patients with breast cancer from other low- and middle-income countries. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc . No COIs from the authors.

Abstract P4-13-12: Immediate one-stage implant-based breast reconstruction without an acellular dermal matrix in Japanese breast cancer patients

Abstract Background. In immediate one-stage implant-based breast reconstruction, acellular dermal matrix (ADM) has been usually used due to cover the outside part of the pectoralis major muscle in the world. Unfortunately, ADM is not approved in Japan yet. Therefore we have performed safety one-stage implant-based breast reconstruction without ADM according to several unique technics in our institution and obtain the excellent results. We report single institution experience using the retrospective medical data. Methods. We chose the surgical method of immediate breast reconstruction (autologous and prosthetic) according to patient's preference, breast volume and cancer condition in early breast cancer patients (pts). Two hundred fifty four early breast cancer pts underwent immediate artificial breast reconstruction from January 2014 to March 2017 in our institution. Thirty seven pts were excluded in this analysis because of preplanned the expander insertion. ALLERGAN Natrelle 410 series were used as the silicon breast implant (SBI). We performed three unique steps to determine the one-stage SBI cases as follow. ICG fluorescence imaging to confirm the blood flow state of the chest skin after mastectomy is used as standard method. If there is a defective contrast region, we remove these area. And then, serratus anterior muscle/fascial and external oblique fascial flap is elevated to completely cover the SBI together with the pectoralis major muscle so that the between mastectomy field and the SBI insertion section are isolated. We used sizer to confirm the skin tension and form of breast. After confirming these steps, we adopted cases whether SBI insertion can be safety done. We evaluated the total cosmetic finding based on three categories of inframammary fold position, balance of both breast size and form at half year after operation. If the difference between both inframammary fold positions was under 1cm, if compensatory pad is not necessary with underwear, if the protrusion of the lower pole is sufficient compared with the contralateral side, we gain the point one on each categories in each cases. The total cosmetic evaluation was classified as three categories. Good, fair and poor were defined as gained 3 points, 2 points and 0/1 points, respectively. Results. Among 217 planned immediate prosthetic breast reconstruction pts, 186 pts (85.7%) were succeed one-stage implant-based breast reconstruction. Among 186 pts, the median age was 47 years old (23-75), median body weight was 53kg (35-84), median body mass index was 21.08 kg/m2(16.20-29.41), removed breast volume was 240g (56-522) and implant volume was 220cc (90-425). Implant removed in one case because of complications and infection was occurred in five cases. The revision surgery was performed in one cases because of malposition. Among all pts, the good, fair and poor of total cosmetic evaluation is 84.3%, 13.5% and 2.2%, respectively. Conclusions. Immediate one-stage implant-based breast reconstruction without ADM may be useful and safe procedure according to our unique technics in early breast cancer patients who hope the immediate prosthetic breast reconstruction in Japan. Citation Format: Okumura S, Tatibana S, Narita C, Hyodo I, Sawaki M, Hattori M, Yoshimura A, Ishiguro J, Kotani H, Gondo N, Adati Y, Iwata H, Kamei Y. Immediate one-stage implant-based breast reconstruction without an acellular dermal matrix in Japanese breast cancer patients [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-13-12.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial

The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. Pink Ribbon, Nuts-Ohra, and LifeCell.

Management of Implant Exposure in One-Stage Breast Reconstruction Using Titanium-Coated Polypropylene Mesh: Sub-Mammary Intercostal Perforator Flap.

One-stage implant-based breast reconstruction using titanium-coated polypropylene mesh is a novel approach widely used in Europe. Complication rates in breast reconstruction with the use of titanium-coated meshes seem to be comparable to those in patients with implant-based breast reconstruction alone. However, the use of synthetic meshes in implant-based breast reconstructive surgery leads to new clinical scenarios with the need for the breast surgeon to face new complications. We present an innovative treatment of implant exposure in the absence of infection in patients who underwent nipple-sparing mastectomy and immediate breast reconstruction with silicone implants and titanium-coated polypropylene mesh by using a pedicled sub-mammary intercostal perforator flap. Four patients who experienced implant exposure without infection have been treated with the use of a sub-mammary intercostal perforator flap. Whole coverage of the exposed implant/mesh with a sub-mammary intercostal perforator flap was obtained in all cases. No post-operative complications have been observed, whereas a pleasant aesthetic result has been achieved. Patients' post-operative quality of life and satisfaction levels were measured by the European Organisation for Research and Treatment of Cancer breast cancer-specific quality of life QLQ-BR23 questionnaire and showed an average good satisfaction with the post-operative outcomes (mean QLQ-BR23 score 1.9). For the first time, a sub-mammary intercostal perforator flap has been used with the aim of treating implant exposures without removing the prosthesis even in the presence of synthetic meshes, when wound infection was excluded. Although tested on a small series, the sub-mammary intercostal perforator flap might represent a simple, versatile and cost-effective procedure for the management of implant exposure following nipple-sparing mastectomy and immediate reconstruction with silicone implants and synthetic meshes. It should be considered to avoid implant removal followed by delayed free flap reconstruction as "salvage surgery." This journal requires that the authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Use of Acellular Dermal Matrices in One-stage Implant-based Breast Reconstruction.

Implant-based breast reconstruction is the most common choice in breast cancer patients. Recently,the acellular dermal matrix (ADM) technique has been widely used in implant-based breast reconstruction in the western countries. This article briefly reviews the biological characteristics,history,types,surgical techniques,and postoperative complications of ADM.

Erratum to: Simplified skin excision pattern for skin-sparing/reducing mastectomy and direct-to-implant single-stage immediate (DISSI) breast reconstruction

One-stage implant-based breast reconstruction with minimal scarring is a highly appealing option to most patients. In fact, expander/implant reconstruction accounts for nearly 70 % of all breast reconstructions. We present our experience with a simplified skin-preserving/reducing excision pattern in association with immediate breast reconstruction using permanent expander or prosthesis. Thirty-two patients with 45 reconstructed breasts (unilateral or bilateral) between February 2010 and March 2014 are included in this study. All implants, except for two reconstructed breasts, were placed in a dual plane. Implants used were either a permanent expander or permanent silicone prosthesis. Two patients developed postoperative infections requiring removal of the implants. Minor wound dehiscence without implant extrusion occurred in one breast. One breast had a late deflation of the permanent expander secondary to trauma. Another patient required postoperative revision with fat grafting to improve breast contour. One-stage prosthetic-based immediate breast reconstruction is a safe option with gratifying outcomes provided adequate patients’ selection and enough surgeons’ expertise to perform it. Level of Evidence: Level IV, therapeutic study.