Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 55
Filtrar
1.
Female Pelvic Med Reconstr Surg ; 28(6): e154-e156, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35234182

RESUMO

IMPORTANCE: A sequelae of the removal of pelvic organ prolapse (POP) transvaginal mesh products from the U.S. market is that current and future women's health providers may be unfamiliar with mesh products historically used to treat pelvic floor disorders. OBJECTIVES: Our goal was to create an easily accessible resource to address this knowledge gap. STUDY DESIGN: An online database of mesh products used to treat POP and urinary incontinence was created with information, photographs, and videos collated from internet searches; manufacturer materials; and other primary sources. The database was then linked to a free smartphone application. RESULTS: This smartphone application includes, to the best of our knowledge, all mesh products used in the United States for the treatment of POP and stress urinary incontinence through December 2020. Included in the application are product descriptions of mesh color, size, design, and attachment points. Photographs and videos, when available, are included. The application is organized by mesh product name, but it is also searchable by other categories, such as manufacturer name and color.To download the application to a smart phone, go to vaginalmeshcatalogue.glideapp.io/ on a web browser or access via the QR code. Once the website is loaded, you can interact with the mesh catalog as a website or save it to the phone's home screen as an application. CONCLUSIONS: Health care providers of all experience levels can use this free application for educational and clinical purposes to better understand patients' histories, improve preoperative planning, and enhance patient counseling.


Assuntos
Prolapso de Órgão Pélvico , Slings Suburetrais , Telas Cirúrgicas , Incontinência Urinária por Estresse , Bases de Dados Factuais , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Slings Suburetrais/classificação , Telas Cirúrgicas/classificação , Estados Unidos , Incontinência Urinária por Estresse/cirurgia
2.
Int Urogynecol J ; 33(7): 1989-1997, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-34586438

RESUMO

INTRODUCTION AND HYPOTHESIS: To study the mid-term safety and functional outcomes of transvaginal anterior vaginal wall prolapse repair using polyvinylidene fluoride (PVDF) mesh (DynaMesh®-PR4) by the double trans-obturator technique (TOT). METHODS: Between 2015 and 2020, we prospectively included women with symptomatic high-stage anterior vaginal wall prolapse with or without uterine prolapse or stress urinary incontinence (SUI) in the study. The patients underwent transvaginal repair of the prolapse using PVDF mesh in two medical centers. We followed all patients for at least 12 months. We recorded the characteristics of vaginal and sexual symptoms, urinary incontinence, and prolapse stage pre- and postoperatively using International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF), and Pelvic Organ Prolapse Quantification (POP-Q) system, respectively. RESULTS: One hundred eight women were included in the final analysis with a mean follow-up time of 34.5 ± 18.6 months. The anatomical success was achieved in 103 (95.4%) patients. There was a significant improvement in patients' vaginal symptoms, urinary incontinence, and quality of life scores postoperatively (p < 0.0001). Only six patients (5.5%) had mesh extrusion, five of whom were managed successfully. The total rates of complications and de novo urinary symptoms were 21.3% and 7.4%, respectively. Significant pain was reported in 17 cases (15.7%). CONCLUSION: Our findings show that using PVDF mesh in the double TOT technique for anterior vaginal wall prolapse repair is a safe procedure with high anatomic and functional success rates and acceptable complication rates in mid-term follow-up.


Assuntos
Polímeros de Fluorcarboneto/normas , Polivinil/normas , Telas Cirúrgicas , Incontinência Urinária/cirurgia , Prolapso Uterino/cirurgia , Feminino , Polímeros de Fluorcarboneto/química , Seguimentos , Humanos , Prolapso de Órgão Pélvico/complicações , Prolapso de Órgão Pélvico/cirurgia , Polivinil/química , Qualidade de Vida , Telas Cirúrgicas/efeitos adversos , Telas Cirúrgicas/classificação , Resultado do Tratamento
3.
Br J Hosp Med (Lond) ; 81(3): 1-10, 2020 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-32240006

RESUMO

Navigating the rapidly evolving field of materials for soft tissue reinforcement is challenging given the volume of clinically available options. Additionally, the current generally accepted classifications of these mesh materials confound the understanding of their utility by grouping disparate materials that have attributes overlapping category boundaries and that do not fully consider their clinically functionality. This review article highlights, from a materials science perspective, the most important attributes of these materials to improve the clinical decision-making process in the selection of the most appropriate features and design for the patient, surgery and clinical need. These characteristics include the physical attributes that directly impact the surgical procedure and immediate postoperative mechanical requirements as well as the post-implantation properties such as an adequate reinforcement time, strength of the resulting tissue and infection risk profile.


Assuntos
Produtos Biológicos/química , Procedimentos de Cirurgia Plástica/métodos , Polímeros/química , Telas Cirúrgicas/classificação , Implantes Absorvíveis , Tomada de Decisões , Humanos , Infecções Relacionadas à Prótese/fisiopatologia
4.
Female Pelvic Med Reconstr Surg ; 26(9): 536-540, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-30681427

RESUMO

OBJECTIVE: The objective of this study was to compare time to anatomic failure after robotic sacrocolpopexy with use of ultralightweight versus heavier weight mesh types. METHODS: We performed a retrospective cohort study of women who underwent robotic sacrocolpopexy, from January 2012 to September 2016. We compared (1) sacrocolpopexy with ultralightweight mesh (≤20 g/m) versus (2) sacrocolpopexy with heavier weight mesh (≤35 g/m). Our primary outcome was time to anatomic failure, defined as recurrent prolapse beyond the hymen, or retreatment for prolapse with surgery or pessary. Secondary outcomes were compartment of failure and mesh exposure. Cox proportional hazards modeling was used to estimate the hazard of failure based on mesh type. RESULTS: Of 461 patients, 248 (53.8%) underwent sacrocolpopexy with ultralightweight mesh and 213 (46.2%) with heavier weight mesh. Failures occurred in 37 women, with 21 in the ultralightweight mesh group and 16 in the heavier weight mesh group. Time to failure was statistically significant between groups (P = 0.03). Ultralightweight mesh had twice the hazard of failure within 3 years compared with heavier weight mesh (hazard ratio, 2.15; 95% confidence interval, 1.10-4.21; P = 0.03). Among failures, use of ultralightweight mesh was associated with almost 5 times the hazard of anterior compartment failure (hazard ratio, 4.46; 95% confidence interval, 1.39-14.27; P = 0.01). There was no difference in time to posterior failure. Of 17 mesh exposures, there were fewer in the ultralightweight mesh group, although this group was followed for less time (1.6% ultralightweight vs 6.0% heavier weight, P = 0.01). CONCLUSIONS: Women receiving ultralightweight mesh are more likely to experience earlier anatomic failure in the anterior compartment.


Assuntos
Falha de Equipamento/estatística & dados numéricos , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/classificação , Idoso , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos , Telas Cirúrgicas/efeitos adversos , Fatores de Tempo
5.
Br J Surg ; 107(3): 209-217, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31875954

RESUMO

BACKGROUND: Nomenclature for mesh insertion during ventral hernia repair is inconsistent and confusing. Several terms, including 'inlay', 'sublay' and 'underlay', can refer to the same anatomical planes in the indexed literature. This frustrates comparisons of surgical practice and may invalidate meta-analyses comparing surgical outcomes. The aim of this study was to establish an international classification of abdominal wall planes. METHODS: A Delphi study was conducted involving 20 internationally recognized abdominal wall surgeons. Different terms describing anterior abdominal wall planes were identified via literature review and expert consensus. The initial list comprised 59 possible terms. Panellists completed a questionnaire that suggested a list of options for individual abdominal wall planes. Consensus on a term was predefined as occurring if selected by at least 80 per cent of panellists. Terms scoring less than 20 per cent were removed. RESULTS: Voting started August 2018 and was completed by January 2019. In round 1, 43 terms (73 per cent) were selected by less than 20 per cent of panellists and 37 new terms were suggested, leaving 53 terms for round 2. Four planes reached consensus in round 2, with the terms 'onlay', 'inlay', 'preperitoneal' and 'intraperitoneal'. Thirty-five terms (66 per cent) were selected by less than 20 per cent of panellists and were removed. After round 3, consensus was achieved for 'anterectus', 'interoblique', 'retro-oblique' and 'retromuscular'. Default consensus was achieved for the 'retrorectus' and 'transversalis fascial' planes. CONCLUSION: Consensus concerning abdominal wall planes was agreed by 20 internationally recognized surgeons. Adoption should improve communication and comparison among surgeons and research studies.


ANTECEDENTES: La nomenclatura de la inserción de una malla para la reparación de una hernia incisional ventral (ventral hernia, VH) es inconsistente y confusa. En la literatura indexada se usan varios términos, tales como 'inlay', 'sublay', y 'underlay' que pueden referirse a los mismos planos anatómicos. Este hecho frustra las comparaciones de técnicas quirúrgicas e invalida los metaanálisis que comparan resultados quirúrgicos en función del plano de inserción de la malla. En consecuencia, el objetivo de este estudio fue establecer una clasificación internacional de los planos de la pared abdominal (International Classification of Abdominal Wall Planes, ICAP). MÉTODOS: Se realizó un estudio Delphi, en el que participaron 20 cirujanos de pared abdominal reconocidos internacionalmente. Se identificaron diferentes términos que describían los planos de la pared abdominal anterior mediante la revisión de la literatura y el consenso de expertos. La lista inicial incluía 59 términos posibles. Los panelistas completaron un cuestionario que sugería una lista de opciones para los planos individuales de la pared abdominal. El consenso sobre un término fue predefinido cuando dicho término había sido seleccionado por ≥ 80% de panelistas. Se eliminaron los términos con una puntuación < 20%. RESULTADOS: La votación comenzó en agosto de 2018 y se completó en enero de 2019. Durante la Ronda 1, 43 (73%) términos fueron seleccionados por < 20% de los panelistas y se sugirieron 37 términos nuevos, dejando 53 términos para la Ronda 2. Cuatro planos alcanzaron un consenso en la Ronda 2 con los términos 'onlay', 'inlay', 'pre-peritoneal' e 'intra-peritoneal'. Treinta y cinco (66%) términos fueron seleccionados por < 20% de los panelistas y fueron eliminados. Después de la Ronda 3, se logró un consenso para 'anterectus' (ante-recto), 'interoblique' (inter-oblicuo), 'retrooblique' (retro-oblicuo) y 'retromuscular'. Se alcanzó un consenso por defecto para los planos 'retrorectus' (retro-recto) y 'transversalis fascial' (fascial transverso). CONCLUSIÓN: La ICAP ha sido desarrollada por el consenso de 20 cirujanos reconocidos internacionalmente. Su implementación debería mejorar la comunicación y la comparación entre cirujanos y estudios de investigación.


Assuntos
Parede Abdominal/cirurgia , Consenso , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Próteses e Implantes/classificação , Telas Cirúrgicas/classificação , Humanos , Recidiva , Estudos Retrospectivos
6.
Hernia ; 23(5): 873-883, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31602587

RESUMO

BACKGROUND: Considering recently published high-level evidence on the management of primary midline ventral hernias, we set out to review current practices and reevaluate the literature surrounding this topic. METHODS: The Americas Hernia Society Quality Collaborative (AHSQC) was used to abstract all uncomplicated primary midline ventral hernias. The primary outcomes of interest were surgical approaches, including the use of mesh, the type and position of mesh, and the use of minimally invasive surgery (MIS). RESULTS: A total of 7030 met inclusion criteria; mean age of 52 ± 14, 71% male, with a median hernia width of 2 [1, 2]. A total 69% underwent mesh repair, while 31% underwent suture repair. The most commonly used mesh was permanent synthetic (98%), placed in either the intraperitoneal (46%) or preperitoneal (42%) spaces. The majority of repairs were performed through an open approach (72%). When mesh was used through an open approach (58%), the majority were patches (70%) placed in the preperitoneal space (50%). Through an MIS approach (95%), the majority were flat meshes (53%) placed in the intraperitoneal space (58%). CONCLUSION: Recent high-level literature recommends the use of mesh repair (flat mesh) in all patients with hernia width ≥ 1 cm. This evidence is limited to the use of flat mesh through an open approach. While AHSQC surgeons do offer mesh repair in the majority of cases, this is most commonly using a mesh patch, and is selective towards larger hernias and obese patients. Further research is required to evaluate the safety of mesh patches, and a mesh repair should be offered to a young non-obese healthy patient, as they benefit similarly from the use of mesh.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia , Complicações Pós-Operatórias , Telas Cirúrgicas , Técnicas de Sutura/normas , Feminino , Hérnia Ventral/epidemiologia , Herniorrafia/efeitos adversos , Herniorrafia/instrumentação , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/cirurgia , Melhoria de Qualidade/organização & administração , Reoperação , Telas Cirúrgicas/classificação , Telas Cirúrgicas/normas , Estados Unidos
7.
Hernia ; 23(5): 957-967, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30968286

RESUMO

PURPOSE: The aim of this study was to compare perioperative results of robotic IPOM (r-IPOM) and robotic TAPP (r-TAPP) in ventral hernia repair, and to identify risk factors associated with postoperative complications. METHODS: After obtaining balanced groups with propensity score matching, the comparative analysis was performed in terms of perioperative and early outcomes. All variables were also examined in a subset analysis in patients with and without complications. Multivariable regression analysis was used to identify independent risk factors associated with the development of complications. RESULTS: Of 305 r-IPOM and r-TAPP procedures, 104 patients were assigned to each group after propensity score matching. There was no difference in operative times between two groups. Although postoperative complications were largely minor (Clavien-Dindo grade-I and II), the rate of complications was higher in the r-IPOM group within the first 3-weeks (33.3% in r-IPOM vs. 20% in r-TAPP, p = 0.039). At the 3-month visit, outcomes between groups were not different (p = 0.413). Emergency department re-visits within 30-days and surgical site events were also higher in the IPOM group (p = 0.028, p = 0.042, respectively). In regression analysis, the development of complications was associated with incisional hernias (p = 0.040), intraperitoneal mesh position (p = 0.046) and longer procedure duration (p = 0.049). CONCLUSION: Our data suggest r-IPOM may be associated with increased complication rates in the immediate postoperative period when compared to r-TAPP. However, at 3 months, outcomes are comparable. More investigation is needed in this area, specifically with regards to long-term follow-up and multicenter data, to determine the true value of extra-peritoneal mesh placement.


Assuntos
Herniorrafia , Hérnia Incisional/cirurgia , Complicações Pós-Operatórias , Telas Cirúrgicas/classificação , Adulto , Pesquisa Comparativa da Efetividade , Feminino , Herniorrafia/efeitos adversos , Herniorrafia/instrumentação , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Peritônio/cirurgia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Procedimentos Cirúrgicos Robóticos/métodos , Fatores de Tempo , Estados Unidos
9.
Prog. obstet. ginecol. (Ed. impr.) ; 62(1): 9-14, ene.-feb. 2019. ilus
Artigo em Inglês | IBECS | ID: ibc-184886

RESUMO

Tension-free vaginal tape (TFVT) surgery is the approach of choice in women with moderate-severe stress urinary incontinence (SUI). Up to 15% of women are thought to experience complications after TFVT surgery. The sling fails in 5%, with persistence of SUI.Pelvic floor ultrasound could prove useful in the presurgical evaluation of women with SUI. Similarly, it enables us to study the location and function of the TFVT after surgery and is especially indicated in patients with symptoms suggestive of TFVT-associated complications. In fact, there is a correlation between some ultrasound parameters and the symptoms reported by the patient, such as position, distance to the urethral complex, symmetry, and Valsalva maneuver with respect to the urethra. Pelvic floor ultrasound enables us to make more detailed diag-noses and tailor decisions on therapy


La cirugía mediante banda suburetral libre de tensión es la técnica de elección en las mujeres con incontinencia urinaria de esfuerzo moderada-severa. Se estima que hasta un 15% de mujeres tendrán una complicación tras una cirugía mediante BSLT, y en un 5%, la banda fallará persistiendo la IUE. La ecografía de suelo pélvico (ESP) puede ser de utilidad para la evaluación prequirúrgica de las mujeres con IUE; a su vez, permite estudiar la localización y funcionalidad de las BSLT en el posoperatorio, especialmente indicada ante la presencia de sintomatología sugestiva de complicaciones asociadas a las BSLT. De hecho, existe una correlación entre algunos parámetros ecográficos y la clínica referida por la paciente, tales como la posición, distancia al complejo uretral, simetría, forma y movimiento en Valsalva respecto a la uretra. La ESP nos permite realizar diagnósticos más detallados y tomar decisiones terapéuticas cada vez más personalizadas


Assuntos
Humanos , Feminino , Incontinência Urinária por Estresse/cirurgia , Telas Cirúrgicas/classificação , Distúrbios do Assoalho Pélvico/diagnóstico por imagem , Diafragma da Pelve/diagnóstico por imagem , Resultado do Tratamento , Incontinência Urinária por Estresse/diagnóstico por imagem
10.
Br J Hosp Med (Lond) ; 79(8): 454-459, 2018 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-30070945

RESUMO

Breast cancer is the most common cancer diagnosed in the UK ( Cancer Research UK, 2018 ). Breast reconstruction following mastectomy can be performed with prosthetic devices or autologous tissue. In the UK implant-based breast reconstruction following mastectomy is the most common type of breast reconstruction, estimated to account for 70% of the reconstructive caseload in the UK. Since 2001 there has been a considerable increase in the number of prosthetic reconstructions performed with the use of mesh or matrix to augment the reconstructive pocket. This article introduces the main types of mesh and matrix used in implant-based breast reconstruction, reconstructive techniques and reviews the benefits and complications associated with their use.


Assuntos
Derme Acelular , Materiais Biocompatíveis/farmacologia , Implante Mamário , Neoplasias da Mama/cirurgia , Mamoplastia , Mastectomia/métodos , Telas Cirúrgicas , Implante Mamário/instrumentação , Implante Mamário/métodos , Implantes de Mama , Humanos , Mamoplastia/instrumentação , Mamoplastia/métodos , Teste de Materiais , Telas Cirúrgicas/efeitos adversos , Telas Cirúrgicas/classificação , Telas Cirúrgicas/normas
11.
Cir. Esp. (Ed. impr.) ; 94(10): 595-602, dic. 2016. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-158528

RESUMO

INTRODUCCIÓN: El objetivo de este estudio fue analizar los datos recopilados en el Registro Nacional de Hernia Incisional (EVEREG) para conocer la situación actual del tratamiento de esta dolencia en España. MÉTODOS: EVEREG es una base de datos prospectiva online en la que, desde julio de 2012, se registraron de forma anónima los datos de las hernias incisionales intervenidas en España. RESULTADOS: Hasta marzo de 2015, se han registrado 4.501 hernias en 95 de los 113 hospitales inscritos. La edad media de los casos fue de 62,7 años, un 56,5% mujeres, con un IMC medio de 30,2 kg/m2 y un 29,8% de ellos con riesgo quirúrgico elevado (ASA III-V). Un 93,7% de las intervenciones fueron electivas, el 88,3% por cirugía abierta y el 22,2% fueron hernias recurrentes. El 66,9% correspondían a una hernia tras laparotomía media, en el 81,4% el diámetro transversal fue menor de 10 cm. Se empleó una prótesis en el 96,2% de los casos. La estancia postoperatoria fue de 5,3 días, con complicaciones en el 29,1% y con una mortalidad del 0,8%. Tras una mediana de seguimiento de 7,7 meses se ha detectado un elevado índice de recurrencias (20,7% al año), sobre todo en hernias intervenidas tras una reparación previa (18,1% primarias vs. 30,6% recidivadas; p = 0,004). CONCLUSIÓN: El registro EVEREG es una herramienta útil para conocer la situación actual del tratamiento de la hernia incisional. El análisis de los datos señala como principales elementos susceptibles de mejora el bajo índice de seguimiento y la elevada tasa de recurrencias


INTRODUCTION: The aim of this study was to the data from the National Registry of Incisional Hernia (EVEREG) to determine the reality of the treatment of this condition in Spain. METHODS: EVEREG is an online prospective database which has been functioning since July 2012; operations for incisional hernia are anonymously recorded. RESULTS: Up to March 2015, 4501 hernias from 95 of the 113 participating hospitals were registered. The mean age of the patients was 62.7, and 56.5% were women, with a mean BMI of 30.2 kg/m2; 29.8% presented a high surgical risk (ASA III-V). A total of 93.7% were scheduled surgeries, 88.3% open surgery and 22.2% were recurrent incisional hernias. There were 66.9% hernias after a midline laparotomy, and 81.4% of a transverse diameter of less than 10 cm. A mesh was used in 96.2% of cases. Postoperative stay was 5.3 days and 29.1% presented a complication, with a mortality of 0.8%. After a median follow-up of 7.7 months a high rate of recurrence was detected (20.7% per year), especially in hernias that were operated on after a previous repair (18.1% primary vs. 30.6% recurrent; P=.004). CONCLUSION: the EVEREG registry is a useful tool to know the current situation of incisional hernia treatment. Analysis of the data shows several points that could be improved: a low rate of follow-up and high recurrence rate


Assuntos
Humanos , Masculino , Feminino , Hérnia/patologia , Bases de Dados como Assunto/normas , Espanha , Parede Abdominal/fisiologia , Laparotomia/métodos , Dor Crônica/diagnóstico , 28599 , Demografia/métodos , Telas Cirúrgicas/classificação , Hospitais Públicos/métodos , Hérnia/diagnóstico , Bases de Dados como Assunto/instrumentação , Parede Abdominal/patologia , Laparotomia , Dor Crônica/complicações , Demografia , Telas Cirúrgicas , Hospitais Públicos/classificação
12.
Fed Regist ; 81(2): 353-61, 2016 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-26742182

RESUMO

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury. The Agency is reclassifying surgical mesh for transvaginal POP repair on its own initiative based on new information.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/classificação , Segurança de Equipamentos/classificação , Feminino , Humanos , Estados Unidos , United States Food and Drug Administration
13.
Fed Regist ; 81(2): 363-70, 2016 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-26742183

RESUMO

The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/classificação , Segurança de Equipamentos/classificação , Feminino , Humanos , Estados Unidos , United States Food and Drug Administration
15.
Hernia ; 18(6): 781-9, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25249250

RESUMO

BACKGROUND: The current literature is void of evidence-based guidelines regarding optimal choice of mesh. We aim to perform a comparative outcome analysis of synthetic mesh and acellular dermal matrix (ADM) in Ventral Hernia Working Grade (VHWG) grade II hernias with primary fascial closure. METHODS: A retrospective review of patients undergoing ventral hernia repair (VHR) by the senior author (S.J.K.) from 2007 to 2012 was performed. Patients undergoing VHR with primary fascial closure were risk stratified using the VHWG defined grading system. RESULTS: Seventy-two patients met the abovementioned inclusion criteria with 45 receiving synthetic mesh and 27 receiving ADM. The mean length of follow-up was 12.1 ± 9.1 months. Patients were, on average, 53.2 ± 11.6 years of age with a BMI of 33.9 ± 10.6 kg/m(2). The overall incidence of surgical site occurrence (SSO) in the cohort was 41.7 % and the incidence of hernia recurrence was 5.6 %. 30-day mortality was 1.2 %. Bivariate analysis demonstrated that obesity (P = 0.038) and number of comorbidities (P = 0.043) were associated with SSO. Bivariate analysis demonstrated that prior failed hernia, use of ADM, and operative time were associated with higher rates of hernia recurrence; however, adjusted multivariate regression found only prior failed hernia (OR = 4.1, P = 0.03) and biologic mesh (OR = 3.4, P = 0.046) to be independently associated with recurrent hernia. Comparison of mesh types revealed few differences in preoperative or operative characteristics between synthetic mesh and acellular dermal matrices (ADM). The rate of hernia recurrence was significantly higher with ADM (14.8 % vs. 0.0 %, P = 0.017). Patients receiving ADM repairs incurred significantly greater cost ($56,142.1 ± 54,775.5 vs. $30,599.8 ± 39,000.8, P < 0.001). CONCLUSIONS: These data suggest synthetic mesh is indicated in higher risk VHWG grade II repairs. In comparison to ADM, synthetic mesh was associated with significantly fewer hernia recurrences and lower cost utilization at 1-year. LEVEL OF EVIDENCE: Prognostic/risk category, level III.


Assuntos
Derme Acelular , Materiais Biocompatíveis , Hérnia Ventral/cirurgia , Herniorrafia , Complicações Pós-Operatórias , Telas Cirúrgicas , Técnicas de Fechamento de Ferimentos Abdominais/efeitos adversos , Técnicas de Fechamento de Ferimentos Abdominais/economia , Técnicas de Fechamento de Ferimentos Abdominais/instrumentação , Derme Acelular/efeitos adversos , Derme Acelular/economia , Adulto , Materiais Biocompatíveis/efeitos adversos , Materiais Biocompatíveis/economia , Custos e Análise de Custo , Feminino , Hérnia Ventral/economia , Hérnia Ventral/fisiopatologia , Herniorrafia/efeitos adversos , Herniorrafia/instrumentação , Herniorrafia/métodos , Humanos , Masculino , Teste de Materiais , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Prognóstico , Próteses e Implantes/efeitos adversos , Próteses e Implantes/economia , Recidiva , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Telas Cirúrgicas/classificação , Telas Cirúrgicas/economia
16.
Pol Merkur Lekarski ; 36(211): 11-5, 2014 Jan.
Artigo em Polonês | MEDLINE | ID: mdl-24645571

RESUMO

UNLABELLED: Large incisional hernias repair is often challenging for surgeons. Despite the many available methods and technological progress, we still miss the gold standard in the treatment of incisional hernias and the results are disappointing. The aim of study was to evaluate the results of surgical treatment of large incisional hernias with the use of non-adherent mesh. MATERIAL AND METHODS: This paper presents results from the surgical treatment of large incisional hernias in 34 patients. All procedures were performed with application of non-adherent mesh. Information about patients health was obtained from medical records, interviews and physical examination, and analysis from the follow-up. RESULTS: The most frequent postoperative complication was hematoma (17.6%), wound infection (8.8%) and respiratory failure (8.8%). Seven of the implanted grafts were removed due to complications in postoperative period. In four patients with removed mesh, hernia recurrence was not observed. In all patients with recurrence, wound infection, abscess or respiratory failure during postoperative period obesity was present. CONCLUSIONS: Using non-adherent mesh in large incisional hernia repair is an effective method, and often the only possible solution for surgical treatment. During the preoperative period, individual indications and good preparation for the surgery should be included.


Assuntos
Hérnia Abdominal/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Telas Cirúrgicas/classificação , Remoção de Dispositivo , Feminino , Seguimentos , Hematoma/etiologia , Hematoma/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/prevenção & controle , Prevenção Secundária , Telas Cirúrgicas/efeitos adversos , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Resultado do Tratamento
17.
Appl Health Econ Health Policy ; 12(2): 151-63, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24526592

RESUMO

BACKGROUND: Hernioplasty is one of the most frequent surgeries in the UK. Light-weight mesh (LWM) has the potential to reduce chronic groin pain but its cost-effectiveness compared with heavy-weight mesh (HWM) is unknown. OBJECTIVE: Our objective was to conduct a cost-utility analysis between laparoscopic hernioplasty with HWM and LWM for unilateral inguinal hernias. METHODS: A Markov model simulated costs and health outcomes over a period of 1 year (2012) from the societal and National Health Service (NHS) perspective (England). The main outcome was cost per quality-adjusted life-year (QALY) gained. Surgery results were gleaned from the randomized control trial by Bittner et al. Other input parameters were drawn from the literature and public sources of the NHS. RESULTS: From the societal perspective, LWM induces lower incremental costs (-£88.85) than HWM but yields a slightly smaller incremental effect (-0.00094 QALYs). The deterministic incremental cost-effectiveness ratio (ICER) for HWM compared with LWM amounts to £94,899 per QALY, while the probabilistic ICER is £118,750 (95 % confidence interval [CI] £57,603-180,920). Owing to the withdrawal of productivity losses from the NHS perspective, LWM causes higher incremental costs (£13.09) and an inferior incremental effect (-0.00093), resulting in a dominance of HWM over LWM (ICER 95 % CI -£12,382 to -£21,590). CONCLUSIONS: There is no support for the adoption of LWM as standard treatment from an NHS perspective. However, given the small differences between HWM and LWM, LWM has at least the potential of improving patient outcomes and reducing expenditure from the societal perspective.


Assuntos
Hérnia Inguinal/economia , Hérnia Inguinal/cirurgia , Herniorrafia/economia , Herniorrafia/instrumentação , Medicina Estatal/economia , Telas Cirúrgicas/classificação , Telas Cirúrgicas/economia , Fatores Etários , Análise Custo-Benefício , Inglaterra , Feminino , Humanos , Laparoscopia/economia , Masculino , Anos de Vida Ajustados por Qualidade de Vida , Fatores Sexuais
18.
AJR Am J Roentgenol ; 201(6): 1180-3, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24261353

RESUMO

OBJECTIVE: This article analyzes radiopaque properties of meshes currently used in hernia surgery. A search was conducted using PubMed and a combination of the terms "hernia repair," "mesh," "laparoscopy," "CT," "MRI," "radiopaque," and "high-resolution techniques." CONCLUSION: The visibility of meshes varies from not visible at all (e.g., Ultrapro), to hardly discernible (Prolene), to readily seen (Composix), and finally to the always visible (Dualmesh). Radiopaque properties of meshes have been insufficiently recognized by both the manufacturers and clinicians.


Assuntos
Herniorrafia/instrumentação , Imageamento por Ressonância Magnética , Telas Cirúrgicas/classificação , Tomografia Computadorizada por Raios X , Humanos , Laparoscopia
19.
Int Urogynecol J ; 24(10): 1723-31, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23636217

RESUMO

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare failure and complication rates in patients who underwent a trocar-guided vaginal mesh repair with either a non-absorbable or a partially absorbable mesh. METHODS: Retrospective analysis of prospectively collected data from consecutive women undergoing either non-absorbable or partially absorbable mesh for symptomatic stage 2 prolapse or higher were evaluated at 12 months. Outcome measures included objective and subjective failure rates, patient's satisfaction, complications and perioperative outcomes. RESULTS: Five hundred and sixty-nine women (347 with non-absorbable mesh, 222 with partially absorbable mesh) were included. Failure rates were similar in the two groups; the re-operation rate in the untreated compartments was higher in the non-absorbable mesh group compared with the partially absorbable mesh group (5% vs 1%). Mesh exposure rate in the non-absorbable mesh group was 12% and in the partially absorbable mesh group it was 5%. Other complication and patient satisfaction rates were similar. CONCLUSIONS: Non-absorbable and partially absorbable mesh demonstrated similar outcome rates at 12 months. The risk of reoperation was lower for partially absorbable mesh. The mesh exposure rate was significantly lower for the partially absorbable mesh group compared with the non-absorbable mesh group.


Assuntos
Procedimentos Cirúrgicos em Ginecologia/instrumentação , Procedimentos Cirúrgicos em Ginecologia/métodos , Prolapso de Órgão Pélvico/cirurgia , Instrumentos Cirúrgicos , Telas Cirúrgicas/classificação , Idoso , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Satisfação do Paciente , Estudos Prospectivos , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Falha de Tratamento , Resultado do Tratamento
20.
Histol Histopathol ; 28(5): 611-21, 2013 05.
Artigo em Inglês | MEDLINE | ID: mdl-23386547

RESUMO

BACKGROUND: While lightweight (LW) polypropylene (PP) meshes are been used for hernia repair, new prosthetic meshes also of low-density and with large pores have recently been introduced composed of other polymer materials. This study compares the behavior in the short-term of two macroporous LW prosthetic materials, PP and non-expanded PTFE. METHODS: Partial defects were created in the lateral wall of the abdomen in New Zealand White rabbits and then repaired using a LW PP mesh or a new monofile, LW PTFE mesh. At 14 days postimplant, shrinkage and tissue incorporation, gene and protein expression of neo-collagens (qRT-PCR/immunofluorescence), macrophage response (immunohistochemistry) and biomechanical strength were determined. RESULTS: Both meshes induced good host tissue ingrowth, yet the macrophage response was significantly greater for the PTFE implants (p⟨0.05). Collagen 1/3 mRNA expression was greater for the PP mesh but differences lacked significance. Similar patterns of collagen I and III protein expression were observed in the neoformed tissue infiltrating the two meshes. After 14 days of implant, tensile strengths were also similar, while elastic modulus values were higher for the PTFE mesh (p⟨0.05). CONCLUSIONS: In the short term, host collagen deposition and biomechanical performance seemed unaffected by the polymer structure of the implanted mesh. In contrast, the inflammatory response to mesh implant produced at this early time point was more intense for the PTFE.


Assuntos
Parede Abdominal/cirurgia , Herniorrafia/instrumentação , Herniorrafia/métodos , Polipropilenos , Politetrafluoretileno , Telas Cirúrgicas/classificação , Parede Abdominal/patologia , Animais , Fenômenos Biomecânicos , Colágeno Tipo I/metabolismo , Colágeno Tipo III/metabolismo , Incidência , Inflamação/etiologia , Inflamação/patologia , Masculino , Teste de Materiais , Modelos Animais , Coelhos , Telas Cirúrgicas/efeitos adversos , Resultado do Tratamento
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...