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BACKGROUND: Explantation is the proposed treatment for breast implant illness (BII). Little is known about which medical specialists are visited and what diagnoses are made before explantation is provided as the treatment. OBJECTIVES: This study investigated medical specialist care utilization in women with cosmetic breast implants who underwent explantation compared to women who chose breast implant replacement surgery and to women without breast implants. METHODS: Retrospective cohort study using data linkage with the Dutch Breast Implant Registry and the Dutch health insurance claims database. Visits to medical specialists were examined over the 3 years before explantation. A total of 832 explantation patients were matched and compared to 1463 breast implant replacement patients and 1664 women without breast implants. RESULTS: Explantation patients were more likely to have visited > 5 different medical specialties compared to both replacement patients (12.3% vs. 5.7%; p < 0.001) and women without breast implants (12.3% vs. 3.7%; p < 0.001). Among explantation patients, women who underwent explantation because of BII were more likely to have visited > 5 different medical specialties compared to women who underwent explantation because of other reasons (25.0% vs. 11.0%; p < 0.001). CONCLUSIONS: Women who underwent explantation of breast implants had higher utilization of medical specialist care in the years before explantation compared to women who underwent breast implant replacement surgery and women without breast implants. Medical specialist care use was especially high among women for whom BII was the registered reason for explantation. These findings suggest further research is needed into the link between BII and the use of medical specialist care. 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 www.springer.com/00266 .
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INTRODUCTION: The goal of lower-extremity reconstructions is primarily to salvage the leg; however, esthetic outcomes are also important. This study aimed to assess the impact of a lower extremity free tissue transfer regarding social functioning, patient-reported esthetic outcomes, and possible differences between fasciocutaneous vs. muscle flaps. MATERIAL AND METHODS: For this cross-sectional multicenter study, patients operated between 2003 and 2021, with a minimum follow-up of 12 months, were identified. Outcomes were obtained from 89 patients. Patient-reported outcomes were assessed using a questionnaire containing 5-point Likert scale questions grouped in three groups: aspect of the reconstructed leg, the aspect of the donor site, and the negative impact on social functioning. Physical functioning and mental health were assessed with the Short-Form-36. RESULTS: The overall score for negative impact on social functioning was 22.2. This was 46.7 for the esthetic satisfaction of the reconstructed leg and 57.1 for the donor site. No significant differences were seen between patients who underwent a reconstruction with a fasciocutaneous flap compared to a muscle flap. Secondary surgical procedures for improving the esthetic aspect were performed in 12% of the patients in the fasciocutaneous group and 0% in the muscle group. CONCLUSION: Our results show that the most optimal esthetic outcome is not defined by the type of flap. We found a strong correlation between physical functioning and the negative impact on social functioning that a reconstructed lower extremity may have. The result of this study can be taken into consideration during the shared decision-making process of choosing the most optimal reconstruction.
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Estética , Retalhos de Tecido Biológico , Medidas de Resultados Relatados pelo Paciente , Procedimentos de Cirurgia Plástica , Humanos , Estudos Transversais , Masculino , Feminino , Pessoa de Meia-Idade , Procedimentos de Cirurgia Plástica/métodos , Adulto , Extremidade Inferior/cirurgia , Idoso , Satisfação do PacienteRESUMO
SUMMARY: The impact of clinical prediction models within Artificial Intelligence (AI) and machine learning (ML) is significant. With its ability to analyze vast amounts of data and identify complex patterns, machine learning has the potential to improve and implement evidence-based plastic, reconstructive, and hand surgery. Among others, it is capable of predicting the diagnosis, prognosis, and outcomes of individual patients. This modeling aids daily clinical decision making, most commonly at the moment, as decision-support.Therefore, the purpose of this paper is to provide a practice guideline to plastic surgeons implementing AI in clinical decision-making or setting up AI research to develop clinical prediction models using the 7-step approach and the ABCD validation steps of Steyerberg et al. Secondly, we describe two important protocols which are in the development stage for AI research: 1) the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) checklist, and 2) The PROBAST checklist to access potential biases.
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BACKGROUND: Hyaluronic acid (HA) dermal fillers are widely used in aesthetic medicine. While generally safe, potential complications can arise. OBJECTIVE: This systematic review aims to identify and classify potential complications linked to the use of HA dermal fillers, as informed by high-quality, low-risk-of-bias studies. METHODS: This review follows the Cochrane review standards for clinical systematic reviews. This systematic review analyzed 48 high level of evidence studies on the use of hyaluronic acid (HA) dermal fillers in non-surgical facial aesthetics and the adverse events that occurred.The inclusion criteria were randomized control studies on HA dermal fillers and their complications. Excluded were case reports, case series, observational studies, and other non-randomized research due to their inability to provide generalized conclusions and their inherent publication bias. RESULTS: Adverse events were classified into three categories: expected reactions, product or technique-related adverse events, and severe adverse events. Most adverse events were short-lived injection site reactions, which resolved spontaneously. Specific HA fillers and injection techniques influenced the occurrence of adverse events, which generally resolved within weeks without treatment. Severe adverse events were rare, persisting for months and requiring active medical intervention. DISCUSSION: This classification system can enhance understanding, prevention, and treatment of HA filler complications, and support patient education. The common complications were injection site reactions, with persistent symptoms treated with topical steroids, NSAIDs, or hyaluronidase. Severe complications included severe edema, angioedema and others, often necessitating specific treatments. CONCLUSION: HA dermal fillers are generally safe and effective, with most adverse events being transient and mild to moderate in severity. Severe adverse events, although rare, do occur and are generally non-treatment related. Informed consent, patient education, and professional training are crucial for safe and successful outcomes. Level of Evidence II 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 .
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Técnicas Cosméticas , Preenchedores Dérmicos , Humanos , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico/efeitos adversos , Resultado do Tratamento , Reação no Local da Injeção/etiologia , Injeções Subcutâneas , Estética , Técnicas Cosméticas/efeitos adversosRESUMO
BACKGROUND: COVID-19 has impacted breast implant surgery for oncological and non-oncological patients worldwide. This population-based study aimed to evaluate the impact of the COVID-19 pandemic on access to reconstructive and cosmetic breast implant surgery in the Netherlands using real-world data to describe trends, and to identify lessons to prevent future capacity problems within (inter)national healthcare. METHODS: This longitudinal study included patients undergoing breast implant surgery from the mandatory nationwide Dutch Breast Implant Registry. For 2020, the first COVID-19 wave, intermediate period, and second wave were defined. We compared data from during the pandemic to a pre-pandemic (2019) reference year, assessing differences in the number of registered breast implants, and patient and surgery-related characteristics. RESULTS: A total of 34133 breast implants (17459 patients) were included. Compared to 2019, fewer implants were registered for post-cancer (n=484; -14.7%), cosmetic (n=480; -3.6%), and gender-affirming indications (n=104; -38.0%) during 2020. Fewer implants were registered in academic (n=196; -22.0%) and regional hospitals (n=1591; -16.5%), but more in private clinics (n=725; +10.1%). After the first wave, up to twice as many implants were registered in private clinics compared to 2019. No differences were found in characteristics of patients undergoing surgery in 2020 versus 2019. CONCLUSION: Hospital-based reconstructive and gender-affirming surgery were heavily impacted during the pandemic, while private-clinic-based cosmetic surgery quickly recovered. These outcomes are useful to fuel discussions about how healthcare could be reorganized in times of capacity problems. We suggest exploring options to deploy private clinics for ambulatory surgery aiming to keep hospital capacity available for acutely ill patients.
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Implante Mamário , Implantes de Mama , Neoplasias da Mama , COVID-19 , Mamoplastia , Humanos , Feminino , Estudos Longitudinais , Pandemias , COVID-19/epidemiologia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/epidemiologia , Sistema de RegistrosRESUMO
BACKGROUND: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation. METHODS: Patient and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Co-variate adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses. RESULTS: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4 percent). CONCLUSION: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.
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BACKGROUND: Recurrent scandals involving breast implants have revealed that scientific evidence on the performance of these devices is lacking, and passive monitoring systems are not capable of detecting problems at an early stage. The German health authorities therefore decided to implement a prospective, mandatory registry. OBJECTIVES: The aim of this article was to provide information about the advantages of implementing a mandatory registry, the potential hurdles involved, and to establish structural requirements that future registries can use. METHODS: Since 2018, the authors have assisted the German Ministry of Health in refining the Implant Law and its implementation. They adapted an internationally consented dataset, promoted international data amplification and conducted monthly trial inputs for over 2 years. By identifying several key issues they were able to assist in developing solutions. RESULTS: The cooperation with the authorities was characterized by appreciation of the authors' expertise and previous international work. Challenges included data privacy issues, federal competence, longitudinal follow-up, and contact data; as well as associated costs and technical solutions for data inclusion and the use of information technology to communicate with stakeholders. Addressing these challenges required considerable interference with personal rights and complementary measures for all stakeholders. Extensive structural precautions were taken to safeguard personal data privacy as far as possible. CONCLUSIONS: The authors' experience and lessons learned can guide registries seeking to engage in high levels of evidence data. The authors describe their approach, the obstacles they encountered, and the strategies employed to overcome the setbacks of other registries.
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OBJECTIVES: Patients with head and neck cancer (HNC) are often highly affected by disease and treatment, resulting in impaired physical functioning and quality of life. Therefore, evaluation of patients' psychosocial and functional outcomes can be facilitated by patient-reported outcome measures (PROMs). By providing the patients' own perspectives, PROMs are crucial to improving patient-centered care. This study aimed to improve understanding of the perceived value of PROMs in HNC care and how to optimize their clinical value based on patients' and multidisciplinary healthcare professionals' (HCPs) perspectives. METHODS: Population-based surveys among patients with HNC through their patient association and among HCPs nationwide through the Dutch Head and Neck Audit. RESULTS: A total of 54 patients and 40 multidisciplinary HCPs from all 14 nationwide HNC centers (100%) responded. For patients, the most important element of patient-reported outcome collection systems was including a call to action for those with worse-than-average scores (28%), whereas clinicians found discussing scores during clinical visits the most important (39%). Although 16% of clinicians found short completion time the most important element, none of the patients selected completion time as most important. Additionally, 17% of patients stated completion time was not an issue, provided clinicians would use the outcomes for clinical purposes. CONCLUSIONS: Although patients and clinicians acknowledged the value of patient-reported outcomes, patients would like to be more involved in the clinical implications of their outcomes. Enhancing patients' involvement by a call to action and providing feedback on their scores during outpatient clinic visits may improve the clinical value of PROMs.
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Neoplasias de Cabeça e Pescoço , Qualidade de Vida , Humanos , Neoplasias de Cabeça e Pescoço/terapia , Pessoal de Saúde , Medidas de Resultados Relatados pelo Paciente , Atenção à SaúdeRESUMO
Noma is an infectious disease affecting mostly children aged 0-10. Although it has almost completely disappeared from the Western world, it is still prevalent in many developing regions, mainly Africa's Sahel region. The infection behaves like a necrotizing fasciitis of the face, originating from the gums and progressively expanding into the cheek, nose, or eye regions. In an estimated 90% of cases, the disease is lethal as a result of systemic sepsis. For survivors, typical results are extensive defects of the cheek, nose, and periorbital and perioral regions. Due to the defects, extensive scarring is common, which leads to secondary problems such as growth alterations in an infant's skeleton due to inhibition and restraint of growth resulting typically in cicatricial skeletal hypoplasia. Other sequelae include trismus, partially caused by scarring or complete fusion between maxilla/zygomatic arch and mandible. The resulting overall disfiguring facial appearance results in patients being disabled and socially isolated. Methods: Facing Africa is a UK-based non-governmental organization that treats the secondary problems of Ethiopian noma survivors. Operations are performed in Addis Ababa by a visiting expert team. Postoperatively, patients are seen annually for years after the surgery. Results: This article discusses basic principles, goals, and a practical surgical algorithm for operating on lip, cheek, and oral defects, based on 210 noma patients who were operated on in Ethiopia over a period of 11 years. Conclusions: The suggested algorithm has proven to work for the Facing Africa team members and is considered shareware for all surgeons to use and benefit from.
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BACKGROUND: Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. METHODS: Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. RESULTS: A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. CONCLUSIONS: For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.
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Implante Mamário , Implantes de Mama , Mamoplastia , Humanos , Adulto , Pessoa de Meia-Idade , Implantes de Mama/efeitos adversos , Austrália/epidemiologia , Implante Mamário/efeitos adversos , Mamoplastia/efeitos adversos , Sistema de RegistrosRESUMO
BACKGROUND: In immediate implant-based breast reconstruction (IBBR), large variation is observed in current practices between a direct-to-implant and a two-stage approach (insertion of a breast implant after a tissue expander). This population-based study aimed to compare unplanned short- and long-term revision incidence between direct-to-implant and two-stage IBBR in The Netherlands. METHODS: All patients who underwent immediate IBBR following a mastectomy between 2015 and 2019 were selected from the nationwide Dutch Breast Implant Registry. Short- and long-term unplanned revision incidences were studied per immediate IBBR, including revision indications and the total number of additional operations. Confounding by indication was limited using propensity score matching. RESULTS: A total of 4512 breast implants (3948 women) were included, of which 2100 (47%) were for direct-to-implant IBBR and 2412 (53%) were for two-stage IBBR. Median (IQR) follow-up was 29 months (range, 16 to 45 months) and 33 months (range, 21 to 47 months), respectively. Short-term revision incidence was 4.0% and 11.7%, respectively (conditional OR, 0.31; 95% CI, 0.23 to 0.42%). Long-term revision incidence was 10.6% (95% CI, 9.2 to 12.1%) and 16.4% (95% CI, 14.8 to 17.9%), respectively. In the propensity score-matched cohort, similar results were found. In the direct-to-implant group, more breasts were reconstructed within the planned number of operations than in the two-stage group. CONCLUSIONS: Unplanned revision surgery occurred less often after direct-to-implant IBBR, and more breasts were reconstructed within the planned number of operations compared to two-stage IBBR. These results, based on real-world data, are important for improving patient counseling and shared decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.
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Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Feminino , Humanos , Incidência , Mastectomia/efeitos adversos , Mastectomia/métodos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Resultado do Tratamento , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Implantes de Mama/efeitos adversos , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgiaRESUMO
Background: The use and effect of most infection control measures (ICMs) in breast implant surgery are still debated, likely resulting in undesired variation in current practices. Objectives: This study investigated the relationship between the number and combinations of ICMs used and the infection-related revision incidence after breast implant surgery. Additionally, national variation between Dutch healthcare institutions in ICM use was evaluated. Methods: For this multicentre, population-based study, all patients who received a primary breast implant or tissue expander for breast augmentation or reconstruction between 2015 and 2019 were identified from the Dutch Breast Implant Registry. Seven prospectively collected ICMs were investigated: preoperative antibiotics, implant and/or pocket irrigation, glove change, nipple guards, insertion sleeve, postoperative drains, and postoperative antibiotics. Results: This study included 52,415 implants (85% augmentation, 15% reconstruction).The median (IQR) number of ICMs used was 3 (3-4) for augmentation and 4 (4-5) for reconstruction. Median follow-up was 30 months for augmentation and 34 months for reconstruction. Infection-related revision incidence was 0.1% for augmentation and 2.1% for reconstruction. Most infection-related revisions occurred within 2 months for augmentation and 2.5 months for reconstruction. The impact of ICM use on infection-related revision incidence remained unclear, given its low incidence. A significant variation was observed between institutions in the use of postoperative antibiotics and drains. Conclusions: Although the use of different ICMs varied considerably between institutions, the infection-related revision incidence after breast implant surgery was generally low. Most surgeons used four ICMs for breast reconstruction and three ICMs for breast augmentation. Further studies on the causes and effects of the observed variation are needed.
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Importance: It is unknown how often breast implant illness (BII) is the indication for revision in women with silicone breast implants. Objective: To examine how often women with silicone breast implants have their implants explanted or replaced because of BII compared with local postoperative complications. Design, Setting, and Participants: A legacy cohort study on breast implant revision surgery was conducted between April 1, 2015, and December 31, 2020, and a prospective cohort study on breast implantation and revision surgery was conducted between April 1, 2015, and December 31, 2019 (with follow-up until December 31, 2020). Data were obtained from the Dutch Breast Implant Registry. Data analysis was performed from September 2021 to August 2022. Exposures: Silicone breast implant. Main Outcomes and Measures: Breast implant revision with the indication BII or local postoperative complications. Results: All 12â¯882 cosmetic breast implants (6667 women; mean [SD] age, 50.6 [12.7] years) and 2945 reconstructive breast implants (2139 women, mean [SD] age, 57.9 [11.3] years) in the legacy cohort and all 47â¯564 cosmetic breast implants (24â¯120 women, mean [SD] age, 32.3 [9.7] years) and 5928 reconstructive breast implants (4688 women, mean [SD] age, 50.9 [11.5] years) in the prospective cohort were included for analysis. In the prospective cohort, 739 cosmetic breast implants (1.6%) were revised after a median (IQR) time to reoperation of 1.8 (0.9-3.1) years, and 697 reconstructive breast implants (11.8%) were revised after a median (IQR) time to reoperation of 1.1 (0.5-1.9) years. BII was registered as the reason for revision in 35 cosmetic revisions (4.7%) and 5 reconstructive revisions (0.7%) in the prospective cohort, corresponding to 0.1% of the inserted implants. In the legacy cohort, 536 cosmetic revisions (4.2%) and 80 reconstructive breast implant revisions (2.7%) were performed because of BII. Conclusions and Relevance: In this cohort study of women with silicone breast implants, BII was an uncommon indication for revision compared with local complications, both in the short and long term. In contrast to the increasing public interest in BII, these results showed that local complications are a far more common reason for breast implant revision.
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Implante Mamário , Implantes de Mama , Adulto , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Implantes de Mama/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Prevalência , Estudos Prospectivos , Géis de SiliconeRESUMO
BACKGROUND: Oncological safety of different types and timings of PMBR after breast cancer remains controversial. Lack of stratified risk assessment in literature makes current clinical and shared decision-making complex. This is the first systematic review and meta-analysis to evaluate differences in oncological outcomes after immediate versus delayed postmastectomy breast reconstruction (PMBR) for autologous and implant-based PMBR separately. METHODS: A systematic literature search was performed in MEDLINE, Cochrane Library, and Embase. The Cochrane Collaboration Handbook and Meta-analysis Of Observational Studies in Epidemiology checklist were followed for data abstraction. Variability in point estimates attributable to heterogeneity was assessed using I2 -statistic. (Loco)regional breast cancer recurrence rates, distant metastasis rates, and overall breast cancer recurrence rates were pooled in generalized linear mixed models using random effects. RESULTS: Fifty-five studies, evaluating 14,217 patients, were included. When comparing immediate versus delayed autologous PMBR, weighted average proportions were: 0.03 (95% confidence interval [CI], 0.02-0.03) versus 0.02 (95% CI, 0.01-0.04), respectively, for local recurrences, 0.02 (95% CI, 0.01-0.03) versus 0.02 (95% CI, 0.01-0.03) for regional recurrences, and 0.04 (95% CI, 0.03-0.06) versus 0.01 (95% CI, 0.00-0.03) for locoregional recurrences. No statistically significant differences in weighted average proportions for local, regional and locoregional recurrence rates were observed between immediate and delayed autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrences after autologous PMBR, and of all outcome measures after implant-based PMBR. CONCLUSIONS: Delayed autologous PMBR leads to similar (loco)regional breast cancer recurrence rates compared to immediate autologous PMBR. This study highlights the paucity of strong evidence on breast cancer recurrence after specific types and timings of PMBR. LAY SUMMERY: Oncologic safety of different types and timings of postmastectomy breast reconstruction (PMBR) remains controversial. Lack of stratified risk assessment in literature makes clinical and shared decision-making complex. This meta-analysis showed that delayed autologous PMBR leads to similar (loco)regional recurrence rates as immediate autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrence after autologous PMBR, and of all outcome measures after implant-based PMBR. Based on current evidence, oncological concerns do not seem a valid reason to withhold patients from certain reconstructive timings or techniques, and patients should equally be offered all reconstructive options they technically qualify for.
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Neoplasias da Mama , Mamoplastia , Neoplasias da Mama/patologia , Feminino , Humanos , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Mastectomia , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/cirurgia , Transplante AutólogoRESUMO
BACKGROUND: Conventional breast-conserving surgery (C-BCS) has equal oncological outcomes and superior cosmetic and patient-reported outcomes compared to mastectomy with immediate two-stage implant-based breast reconstruction (M-IBR). Oncoplastic breast-conserving surgery (OP-BCS) is increasingly being used, as it often has better cosmetic results and it enables larger tumour resection. However, OP-BCS and M-IBR compared to C-BCS lengthens operative time and might lead to more complications and consequently to additional costs. Therefore, this study aimed to compare costs and complication rates of C-BCS, OP-BCS and M-IBR. METHODS: This single-centre, retrospective cohort study, calculated costs for all patients who had undergone breast cancer surgery between January 2014 and December 2016. Patient-, tumour- and surgery-related data of C-BCS, OP-BCS and M-IBR patients were retrieved by medical record review. Treatment costs were calculated using hospital financial data. Differences in costs and complications were analysed. RESULTS: A total of 220 patients were included: 74 patients in the C-BCS, 78 in the OP-BCS and 68 in the M-IBR group. From most expensive to least expensive, differences in total costs were found between C-BCS vs. OP-BCS and C-BCS vs. M-IBR (p=<0.01 and p=0.04, respectively). Costs of OP-BCS and M-IBR were comparable. Complication rates were 5.5% for C-BCS, followed by 17% for OP-BCS, and 34% for M-IBR (p<0.01). CONCLUSION: Considering total treatment costs, OP-BCS was financially non-inferior to M-IBR, whereas complication rates were higher following M-IBR. Therefore, when considering other benefits of OP-BCS, such as higher patient-reported outcomes and similar oncological outcomes, a shift from M-IBR to BCS using oncoplastic techniques seems justified.
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Neoplasias da Mama , Mamoplastia , Neoplasias da Mama/patologia , Feminino , Humanos , Mamoplastia/métodos , Mastectomia/métodos , Mastectomia Segmentar/efeitos adversos , Mastectomia Segmentar/métodos , Estudos RetrospectivosRESUMO
BACKGROUND: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS: Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. RESULTS: A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (Pâ <â 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). CONCLUSIONS: Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.
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Implante Mamário , Implantes de Mama , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Implantes de Mama/efeitos adversos , Confiabilidade dos Dados , Humanos , Sistema de RegistrosRESUMO
The purpose was to describe the operation technique of an anterior lateral intercostal artery perforator (LICAP) flap and analyse outcomes and complications. An anterior LICAP flap is a good and safe alternative for direct oncoplastic breast reconstruction. It is a reliable flap that provides sufficient volume and good esthetic outcomes.
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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.