Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial.

Importance: The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. Objective: To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. Design, Setting, and Participants: This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Interventions: Participants were allocated to immediate IBBR with or without ADM. Main Outcomes and Measures: The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. Results: From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Conclusions and Relevance: Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT02061527.

Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER).

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry.

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. OBJECTIVE: To report on breast device surgery characteristics across Australia. METHODS: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. RESULTS: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. CONCLUSION: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.

The Impact of the COVID-19 Pandemic on Breast Reconstruction Practices in the United States.

BACKGROUND/AIM: We employed a survey to the American Society of Plastic Surgeons (ASPS) to investigate the management of breast reconstruction across the US during the COVID-19 pandemic. PATIENTS AND METHODS: An electronic survey on breast reconstruction practice demographics, COVID-19-related restrictions on breast reconstruction, and pertinent dates of restrictions was employed. RESULTS: A total of 228 responses were obtained. Demographics were balanced for geography with most respondents located in either urban or suburban settings (91.2%). The majority proceeded with mastectomy/reconstruction as originally planned (39.0%), followed by hormonal/chemotherapy only (22.6%). The most common reconstructive option was tissue expander/implant-based reconstruction (47.7%). Most institutions implemented restrictions between March 11-20th (59%). Almost all respondents (91.8%) reported mandatory pre-operative SARS-Cov-2 testing once cases resumed. CONCLUSION: COVID-19 has forced the breast surgical team to adapt to new conditions to the detriment of women with breast cancer requiring reconstruction. Varying restrictions have limited access to breast reconstruction, carrying consequences yet to be determined.

Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography.

This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: What the Primary Care Physician Needs to Know.

This manuscript aims to outline the pertinent epidemiology, presentation, diagnosis, and treatment of patients who present with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as it pertains to primary care, such that the primary care physician (PCP) is able to appropriately care for patients with breast implants and counsel on risks of BIA-ALCL.

Patient satisfaction in one-stage immediate breast reconstruction after mastectomy: A multi-center comparative patient evaluation of prosthesis, LDMF, and TRAM techniques.

To analyze patient satisfaction and the predictive factors characterizing three types of one-stage immediate breast reconstruction (IBR) after mastectomy, including prosthesis, latissimus dorsi myocutaneous flap (LDMF), transverse rectus abdominis myocutaneous (TRAM) flap techniques.Data were collected via face-to-face or telephone interviews from eight breast centers in China from January 2012 to December 2016. A standardized questionnaire that evaluated the general satisfaction and aesthetic satisfaction was sent to patients who had undergone IBR. Logistic regression analysis was performed to identify risk factors associated with patient satisfaction among the three types of breast reconstruction.A total of 412 questionnaires were sent out, and 309 copies were collected including 226 prosthesis, 46 LDMF, and 37 pedicle TRAM reconstruction. Logistic regression analysis showed that general satisfaction and aesthetic satisfaction were significantly correlated with radiotherapy (P < .001, P = .018), respectively. Besides, the aesthetic satisfaction was also associated with nipple-areola complex (NAC) preservation (P < .001).Our multi-center study identified factors of higher patient satisfaction, like NAC preservation and absence of radiotherapy, in order to help breast surgeons make better decisions about individualized reconstruction plan.

Meta-analysis of prepectoral implant-based breast reconstruction: guide to patient selection and current outcomes.

PURPOSE:  This meta-analysis provides a large-scale comparison of prepectoral vs. subpectoral implant-based breast reconstruction, with primary outcomes of patient safety and efficacy. METHODS: Literature review was performed via PRISMA criteria, 33 studies met inclusion criteria for prepectoral review and 13 studies met inclusion criteria for meta-analysis. Patient characteristics and per-breast complications were collected. Data were analyzed using Cochrane RevMan and IBM SPSS. RESULTS: In 4692 breasts of 3014 patients that underwent prepectoral breast reconstruction, rippling was observed as the most common complication, followed by seroma and skin flap necrosis. Meta-analysis demonstrated statistically significant decrease in odds of skin flap necrosis and capsular contracture in prepectoral groups compared to subpectoral groups. Odds of infection, seroma, and hematoma were equal between the two groups. CONCLUSIONS: Prepectoral breast reconstruction has surged in popularity in recent years. This review and large-scale analysis corroborates current literature reporting a favorable safety profile with emphasis on patient selection. Variability in skin flap thickness and vascularity mandates thoughtful selection of patients whose overall health and intra-operative skin flap assessment can tolerate a muscle-sparing reconstruction.

Skin- and Nipple-Areola-Sparing Mastectomy with Immediate Breast Reconstruction Using Transverse Rectus Abdominis Myocutaneous Flap and Silicone Implants in Breast Carcinoma Patients.

BACKGROUND: We aimed to assess patient satisfaction and aesthetic outcome in breast cancer patients undergoing nipple-sparing mastectomy (NSM) and immediate breast reconstruction. MATERIALS AND METHODS: The study population comprised 215 patients with histopathologically diagnosed breast cancer. The inclusion criteria were as follows: a diagnosis of breast cancer, a tumor of any size, any stage of nodal metastasis, and a tumor margin >2.0 cm from the margin of the nipple-areola complex. To measure the aesthetic outcome, the Lowery scale was used. After mastectomy, immediate breast reconstruction was performed using the transverse rectus abdominis myocutaneous (TRAM) flap, and by pacing the silicone implant. RESULTS: Most of the patients were aged between 40 and 51 years. Lymphadenopathy was positive in 87 out of 215 subjects; among these 87 subjects, 61 showed macrometastasis and 26 micrometastasis. A lateral incision was performed for mastectomy in all cases, and immediate breast reconstruction was performed using autologous grafts: the latissimus dorsi myocutaneous (TRAM) flap in 83% of cases, and silicone implants in 17% of cases were used for reconstruction. An excellent aesthetic outcome was seen in 70% of the cases, and 22% showed a good outcome. CONCLUSIONS: NSM is a very safe and technically feasible procedure that provides a high level of patient satisfaction and an excellent aesthetic outcome.

Factors Associated with Reconstruction in Patients Undergoing Mastectomy.

Postmastectomy reconstruction has been shown to be oncologically safe, but few studies have investigated factors influencing the type of reconstruction chosen, if at all. Records of female patients with stages 0 to 3 breast cancer undergoing mastectomy at a large academic institution between January 2010 and March 2018 were reviewed. Nine hundred sixty patients were included in this cohort; 784 patients had reconstruction. Younger age, earlier disease stage, private insurance, no history of diabetes, and bilateral mastectomy (BM) were associated with reconstruction. On multivariate analysis, younger age, BM, private insurance, and earlier disease stage predicted reconstruction. Of reconstruction patients, 453 had implants. Race, BMI, and later disease stage influenced the type of reconstruction; on multivariate analysis, higher BMI and later disease stage predicted flap reconstruction. Younger age, BM, private insurance, and earlier disease stage were associated with reconstruction, but the type of reconstruction was affected primarily by BMI and disease stage.

Postmastectomy Breast Reconstruction: Exploring Plastic Surgeon Practice Patterns and Perspectives.

BACKGROUND: Within the multidisciplinary management of breast cancer, variations exist in the reconstructive options offered and care provided. The authors evaluated plastic surgeon perspectives on important issues related to breast cancer management and reconstruction and provide some insight into factors that influence these perspectives. METHODS: Women diagnosed with early-stage breast cancer (stages 0 to II) between July of 2013 and September of 2014 were identified through the Georgia and Los Angeles Surveillance, Epidemiology, and End Results registries. These women were surveyed and identified their treating plastic surgeons. Surveys were sent to the identified plastic surgeons to collect data on specific reconstruction practices. RESULTS: Responses from 134 plastic surgeons (74.4 percent response rate) were received. Immediate reconstruction (79.7 percent) was the most common approach to timing, and expander/implant reconstruction (72.6 percent) was the most common technique reported. Nearly one-third of respondents (32.1 percent) reported that reimbursement influenced the proportion of autologous reconstructions performed. Most (82.8 percent) reported that discussions about contralateral prophylactic mastectomy were initiated by patients. Most surgeons (81.3 to 84.3 percent) felt that good symmetry is achieved with unilateral autologous reconstruction with contralateral symmetry procedures in patients with small or large breasts; a less pronounced majority (62.7 percent) favored unilateral implant reconstructions in patients with large breasts. In patients requiring postmastectomy radiation therapy, one-fourth of the surgeons (27.6 percent) reported that they seldom recommend delayed reconstruction, and 64.9 percent reported recommending immediate expander/implant reconstruction. CONCLUSIONS: Reconstructive practices in a modern cohort of plastic surgeons suggest that immediate and implant reconstructions are performed preferentially. Respondents perceived a number of factors, including surgeon training, time spent in the operating room, and insurance reimbursement, to negatively influence the performance of autologous reconstruction.

Autologous Breast Reconstruction versus Implant-Based Reconstruction: How Do Long-Term Costs and Health Care Use Compare?

BACKGROUND: The authors compared long-term health care use and cost in women undergoing immediate autologous breast reconstruction and implant-based breast reconstruction. METHODS: This study was conducted using the OptumLabs Data Warehouse, which contains deidentified retrospective administrative claims data, including medical claims and eligibility information from a large U.S. health insurance plan. Women who underwent autologous or implant-based breast reconstruction between January of 2004 and December of 2014 were included. The authors compared 2-year use rates and predicted costs of care. Comparisons were tested using the t test. RESULTS: Overall, 12,296 women with immediate breast reconstruction were identified; 4257 with autologous (35 percent) and 8039 with implant-based (65 percent) breast reconstruction. The proportion of autologous breast reconstruction decreased from 47.2 percent in 2004 to 32.7 percent in 2014. The mean predicted reconstruction cost of autologous reconstruction was higher than that of implant-based reconstruction in both unilateral and bilateral surgery. Similar results for mean predicted 2-year cost of care were seen in bilateral procedures. However, in unilateral procedures, the 2-year total costs were higher for implant-based than for autologous reconstruction. Two-year health care use rates were higher for implant-based reconstruction than for autologous reconstruction for both unilateral and bilateral procedures. Women undergoing unilateral implant-based reconstruction had higher rates of hospital admissions (30.3 versus 23.1 per 100; p < 0.01) and office visits (2445.1 versus 2283.6 per 100; p < 0.01) than those who underwent autologous reconstruction. Emergency room visit rates were similar between the two methods. Bilateral procedures yielded similar results. CONCLUSION: Although implant-based breast reconstruction is a less expensive index operation than autologous breast reconstruction, it was associated with higher health care use, resulting in similar total cost of care over 2 years.

Impact of Physician Payments on Microvascular Breast Reconstruction: An All-Payer Claim Database Analysis.

BACKGROUND: Rates of autologous breast reconstruction are stagnant compared with prosthetic techniques. Insufficient physician payment for microsurgical autologous breast reconstruction is one possible explanation. The payment difference between governmental and commercial payers creates a natural experiment to evaluate its impact on method of reconstruction. This study assessed the influence of physician payment differences for microsurgical autologous breast reconstruction and implants by insurance type on the likelihood of undergoing microsurgical reconstruction. METHODS: The Massachusetts All-Payer Claims Database was queried for women undergoing immediate autologous or implant breast reconstruction from 2010 to 2014. Univariate analyses compared demographic and clinical characteristics between different reconstructive approaches. Logistic regression explored the relative impact of insurance type and physician payments on breast reconstruction modality. RESULTS: Of the women in this study, 82.7 percent had commercial and 17.3 percent had governmental insurance. Implants were performed in 80 percent of women, whereas 20 percent underwent microsurgical autologous reconstruction. Women with Medicaid versus commercial insurance were less likely to undergo microsurgical reconstruction (16.4 percent versus 20.3 percent; p = 0.063). Commercial insurance, older age, and obesity independently increased the odds of microsurgical reconstruction (p < 0.01). When comparing median physician payments, governmental payers reimbursed 78 percent and 63 percent less than commercial payers for microsurgical reconstruction ($1831 versus $8435) and implants ($1249 versus $3359, respectively). Stratified analysis demonstrated that as physician payment increased, the likelihood of undergoing microsurgical reconstruction increased, independent of insurance type (p < 0.001). CONCLUSIONS: Women with governmental insurance had lower odds of undergoing microsurgical autologous breast reconstruction compared with commercial payers. Regardless of payer, greater reimbursement for microsurgical reconstruction increased the likelihood of microsurgical reconstruction. Current microsurgical autologous breast reconstruction reimbursements may not be commensurate with physician effort when compared to prosthetic techniques. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Breast Implant Prevalence in the Dutch Female Population Assessed by Chest Radiographs.

BACKGROUND: Breast implant-related health problems are a subject of fierce debate. Reliable population-based estimates of implant prevalence rates are not available, however, due to a lack of historical registries and incomplete sales data, precluding absolute risk assessments. OBJECTIVES: This study aimed to describe the methodology of a novel procedure to determine Dutch breast implant prevalence based on the evaluation of routine chest radiographs. METHODS: The validity of the new method was first examined in a separate study. Eight reviewers examined a series of 180 chest radiographs with (n = 60) or without (n = 120) a breast implant confirmed by a computed tomography or magnetic resonance imaging scan. After a consensus meeting with best-performing expert reviewers, we reviewed 3000 chest radiographs of women aged 20 to 70 years in 2 large regional hospitals in the Netherlands in 2015. To calculate the national breast implant prevalence, regional prevalence variations were corrected utilizing the National Breast Cancer Screening Program. RESULTS: Eight reviewers scored with a median sensitivity of 71.7% (range, 41.7%-85.0%) and a median specificity of 94.6% (range, 73.4%-97.5%). After a consensus meeting and a reevaluation by best-performing expert reviewers, sensitivity was 79.9% and specificity was 99.2%. The estimated national prevalence of breast implants among women between 20 and 70 years was 3.0%, ranging from 1.7% at 21 to 30 years to 3.9% between 51 and 60 years. CONCLUSIONS: The novel method in this study was validated with a high sensitivity and specificity, resulting in accurate prevalence estimates and providing the opportunity to conduct absolute risk assessment studies on the health consequences of breast implants.