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1.
Cureus ; 16(3): e55610, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38586802

RESUMO

In the treatment of pelvic organ prolapse, the insertion of polypropylene mesh is often necessary but can lead to subsequent complications, such as a high incidence of pain and infections, necessitating mesh removal. However, the removal of polypropylene mesh can be challenging due to the risks of postoperative complications and technical difficulties. The key to effective healing often lies in the complete removal of the mesh, but this process is associated with complications, including severe pain and potential foreign body reactions. These challenges underscore the need for less invasive and more precise removal techniques. In our clinical practice, traditional approaches, such as vaginal and open abdominal surgeries, have often been hindered by limited visibility and accessibility at the mesh fixation sites. To address these issues, our team has pioneered the development of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for mesh removal. This innovative and minimally invasive technique, performed through the vaginal route, holds particular promise for repairs within the pelvic cavity. vNOTES not only enhances surgical visibility but also reduces the invasiveness of the procedure. In this case report, we present an 85-year-old female patient, who underwent transvaginal mesh (TVM) insertion at the age of 68 years. The patient developed pain in the left buttock, left lower back, and vulvar region, necessitating the removal of TVM. The vNOTES approach significantly reduced postoperative pain and complications, enabling efficient and safe removal of the polypropylene mesh. Moreover, the pathological examination of the polypropylene mesh, which was causing hip and buttock pain, revealed the presence of poor granulation tissue, indicative of a specific pathological tissue pattern. To the best of our knowledge, this is the first detailed account of the successful application of vNOTES in mesh removal.

2.
BMC Health Serv Res ; 24(1): 436, 2024 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-38600470

RESUMO

BACKGROUND: Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. METHOD: We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. RESULTS: Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. CONCLUSION: We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.


Assuntos
Prolapso de Órgão Pélvico , Telas Cirúrgicas , Humanos , Feminino , Segurança do Paciente , Austrália , Prolapso de Órgão Pélvico/cirurgia , Pacientes
3.
Cureus ; 16(3): e57106, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38681380

RESUMO

INTRODUCTION: Transvaginal mesh surgery (TVM) is an effective treatment measure for pelvic organ prolapse (POP). However, the ORIHIME mesh (Kono Seisakusho, Japan, Tokyo), which has the disadvantage of poor adherence to tissues, is currently the only product available for this procedure. Our research team has previously developed a modified ORIHIME mesh with wider arms with the aim of minimizing the risk of POP recurrence. Additionally, the length of the mesh behind the anterior vaginal wall has been adjusted to prevent urinary incontinence. The current study aims to examine the efficacy of this modified mesh in minimizing postoperative complications in patients undergoing uphold-type TVM. METHODS: The data of 84 patients who underwent TVM using ORIHIME at our hospital since July 2019 were retrospectively analyzed. The patients were divided into three groups as follows: (a) normal arms (NA; arm width < 6 cm; n = 29 cases); (b) wide arms without length adjustment (WA and LA (-); arm width > 6 cm; n = 27 cases); and (c) wide arms with length adjustment (WA and LA (+); n = 28 cases). Data were collected using various questionnaires, and the residual urine volume was measured before and after surgery. Additionally, the 60-minute pad test was performed where possible, and the recurrence and complication rates were recorded. RESULTS: The incidence of mesh exposure and urinary incontinence in daily life tended to be lower in the WA and LA (+) groups, although this difference was not statistically significant. The one-year postoperative POP recurrence rate, residual urine volume, International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score were significantly lower in the WA and LA (+) groups compared to the other groups. CONCLUSION: Uphold-type TVM using the modified ORIHIME mesh with wider arms and adjusted length was associated with better postoperative treatment outcomes compared to TVM using the traditional ORIHIME mesh.

4.
Cureus ; 16(2): e53388, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38435168

RESUMO

Introduction Transvaginal mesh surgery (TVM) is an effective treatment option for pelvic organ prolapse (POP). Although ORIHIME®, the only available mesh product, is thin, soft, and easy to handle, it has the disadvantages of sliding off or mildly adhering to the surrounding tissues. The current study compared the efficacy of using wide-arm ORIHIME (Kono Seisakusho, Japan, Tokyo), non-wide arm ORIHIME, Gynemesh PS (Johnson and Johnson, Japan, Tokyo), and Polyform (Boston Scientific Japan, Japan, Tokyo) meshes for TVM. Methods The study included 116 patients who underwent TVM (Prolift with Gynemesh PS (n = 14); Elevate with Polyform (n = 43); Uphold with non-wide-arm ORIHIME (n = 24); Uphold with wide-arm ORIHIME (n = 35)) at our hospital. Pre- and post-surgical changes in symptoms were measured using questionnaires and 60-minute pad weight testing and compared by mesh type and surgical methods used. Results The residual urine volume, 60-minute pad weight testing, international prostate symptom score (IPSS), overactive bladder symptom score (OABSS), and international consultation on incontinence questionnaire-short form score (ICIQ-SF) significantly improved one year postoperatively in the TVM with the wide-arm ORIHIME group. Comparison of pre and one-year postoperative findings by mesh type and surgical methods used showed no significant differences in the 60-minute pad test, IPSS, Quality of Life (QOL), OABSS, and urinary incontinence in daily life scores, and improvement in residual urine volume, ICIQ-SF, and mesh exposure and POP recurrence rates in the TVM with the wide-arm ORIHIME group. Conclusion TVM with wide-arm ORIHIME had better postoperative outcomes compared to TVM with other mesh products.

5.
Int Urogynecol J ; 35(5): 1011-1019, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38466345

RESUMO

INTRODUCTION AND HYPOTHESIS: Calistar-S is a single-incision synthetic mesh kit that addresses apical and anterior compartment prolapse. The aims of this study were to evaluate the short-term objective and subjective outcomes at the 1-year follow-up. The secondary objectives were to evaluate quality of life and lower urinary tract symptoms (LUTS) outcomes, as well as surgical complications. METHODS: Records of 108 patients with symptomatic advanced pelvic organ prolapse (stages III and IV) who underwent prolapse surgery using the Calistar-S system from June 2018 to August 2022 were reviewed. The primary outcome was the objective cure of anterior and apical prolapse < stage 1, and the subjective cure was the negative response to questions 2 and 3 of the Pelvic Organ Prolapse Distress Inventory-6. Secondary outcomes measured quality of life, the presence of lower urinary tract symptoms, and complications. RESULTS: A total of 101 patients were evaluated. The overall objective cure rate is 97% and the subjective cure rate is 92.1%. Good outcomes were seen in all three compartments. Secondary outcomes show significant improvement in all validated questionnaires. Persistence and de novo urinary incontinence were 15.2% and 18.2% post-operatively. There is one case of bladder injury and one case of vaginal mesh exposure. CONCLUSIONS: The Calistar-S System is a safe and efficient method for treating advanced-stage POP. We observed good anatomical results and subjective relief with a minimal complication rate. LUTS have also been positively affected, showing a high success rate. Additional studies are needed to establish the long-term efficacy of this system.


Assuntos
Prolapso de Órgão Pélvico , Qualidade de Vida , Telas Cirúrgicas , Humanos , Feminino , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/efeitos adversos , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Vagina/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Idoso de 80 Anos ou mais , Seguimentos
6.
J Clin Med ; 13(4)2024 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-38398300

RESUMO

BACKGROUND: Pelvic organ prolapse constitutes a prevalent condition associated with a considerable impact on the quality of life. The utilization of transvaginal mesh surgery for managing POP has been a subject of extensive debate. Globally, trends in TVM surgery experienced significant shifts subsequent to warnings issued by the FDA. METHODS: This study aims to explore temporal patterns in transvaginal mesh surgery in the German healthcare system. A comprehensive analysis was conducted on in-patient data from the German Federal Statistical Office spanning 2006 to 2021. A total of 1,150,811 operations, each associated with specific codes, were incorporated into the study. Linear regression analysis was employed to delineate discernible trends. RESULTS: The trends in transvaginal mesh surgery within the anterior compartment exhibited relative stability (p = 0.147); however, a significant decline was noted in all other compartments (posterior: p < 0.001, enterocele surgery: p < 0.001). A subtle increasing trend was observed for uterine-preserving transvaginal mesh surgery (p = 0.045). CONCLUSION: Surgical trends over the specified timeframe demonstrate how POP management has evolved globally. Notably, despite observed fluctuations, transvaginal mesh surgery remains a viable option, particularly for specific cases with a high risk of relapse and contraindications to alternative surgical approaches.

7.
Cureus ; 16(2): e55128, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38420295

RESUMO

Background Vaginal erosion caused by the polypropylene mesh is a serious side effect, and the development of effective treatment methods is required. This study explored the potential of non-ablative vaginal erbium yttrium aluminum garnet (YAG) laser treatment (VEL) as a novel treatment approach. Methods In this study, VEL was performed on nine women who experienced vaginal erosion after undergoing treatment for pelvic organ prolapse (POP) with polypropylene mesh. These patients visited our hospital between April and December 2020. Using the Renovalase (SP Dynamis Fotona d.o.o., Ljubljana, Slovenia), the laser was applied to the entire vagina, with intensive irradiation focused on the erosion areas. Detailed analyses of symptoms before and after treatment, as well as histopathological changes, were conducted one year post-treatment. Results Nine women were referred to our hospital due to vaginal erosion caused by polypropylene mesh. The participants' average age was 73.2 years (range: 69-81 years), with four patients having undergone transvaginal mesh (TVM) surgery and five undergoing laparoscopic sacrocolpopexy (LSC). The average time from mesh insertion to treatment initiation was 7.2 years (range: 3-15 years), with eight patients having previously attempted mesh removal. Post-treatment, significant improvements were observed in managing vaginal erosion and related bleeding, corroborated by histopathological analysis confirming cell regeneration and tissue repair. These improvements also resulted in significant improvements in bleeding management and quality of life (QoL). Conclusion VEL suggests the possibility of being an effective treatment method for vaginal erosion caused by a polypropylene mesh. However, further research is needed because of the small sample size and the limitations inherent in the retrospective case series design.

8.
Sci China Life Sci ; 67(5): 1061-1068, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38418758

RESUMO

Although transvaginal mesh (TVM) repair is no longer used in some countries, long-term outcomes after TVM surgery are of great importance globally. However, reports with follow-up >10 years are limited. Thus, this study aimed to report outcomes in a prospective cohort with at least 10 years of follow-up. Women with stage III-IV symptomatic prolapse were approached consecutively from 2008 to 2013 at one tertiary hospital. The main outcome measure was symptomatic failure. Secondary outcomes included anatomic failure, recurrence, patient satisfaction, complications, and reoperation. The Kaplan-Meier curve was used to estimate the cumulative failure rate. Of the 121 patients enrolled in the study, 103 (85.1%) completed a median follow-up of 11 years. The estimated probability rates of symptomatic and anatomic failure were 17.6% and 8.8% in 11 years, respectively. The estimated incidence of symptomatic failure increased by 8.2% between 5 and 11 years; however, the corresponding rate for anatomic failure was 3.7%. The most common complication was vaginal mesh exposure, and its estimated probability increased from 19.3% to 28.4% from 5 to 11 years, respectively. Office trimming resolved 80.0% of vaginal exposures. These patients did not report decreased overall satisfaction. Patients with vaginal mesh exposure requiring>3 office procedures or mesh removal in the operating room (5.8% by 11 years) had lower satisfaction rates (P<0.01) and were defined as having severe mesh exposure. The rates of postoperative pain, reoperation, and Patient Global Impression of Improvement ⩾2 were 2.5%, 3.3%, and 94.2%, respectively. The results of this study implied that TVM treatment gradually increased the symptomatic failure rate but provided durable anatomical support of the vaginal wall. Vaginal mesh exposure was common in women who were largely not sexually active; however, 80% of the cases could be managed in the outpatient clinic, which did not affect patient satisfaction.


Assuntos
Prolapso de Órgão Pélvico , Reoperação , Telas Cirúrgicas , Humanos , Feminino , Telas Cirúrgicas/efeitos adversos , Seguimentos , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Prolapso de Órgão Pélvico/cirurgia , Reoperação/estatística & dados numéricos , Estudos Prospectivos , Satisfação do Paciente , Vagina/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estimativa de Kaplan-Meier , Recidiva , Estudos de Coortes
9.
J Formos Med Assoc ; 123(3): 331-339, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37996329

RESUMO

BACKGROUND AND PURPOSE: We present this current study to complement with mesh inlays plausible benefits (UPHOLD-LITE System) on available long-term study amidst FDA's concern on mesh complications. This study aims to assess the medium-term outcomes of UPHOLD-LITE system for treatment of advanced pelvic organ prolapse (POP) and its complications, and lower urinary tract symptoms. METHODS: This is a retrospective case series of 53 months follow-up of 123 consecutive patients who underwent UPHOLD-LITE system. Objective outcome measures the anatomical correction of prolapse with POP-Q ≤ Stage 1. Subjective outcome was patient's feedback to questions 2 and 3 of POPDI-6. Secondary outcome measures the quality of life, presence of lower urinary tract symptoms and complications. Quality of life is assessed by validated questionnaires on Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ-12) at 1 and 3 years post-operatively. RESULTS: Objective outcome at 1 and 3 years was at 96.7 % and 95.4 % respectively. The subjective cure was 95.1 % and 91.6 %. Five-year cumulative cure rate maintained at 87.2 %. Secondary outcomes observed improvement on UDI-6, IIQ-7, POPDI-6 and PISQ-12 postoperatively. Bladder outlet obstruction improved while de novo urodynamic stress incontinence (USI) increased slightly post surgically. Mesh erosion rate was 0.8 %. CONCLUSION: The UPHOLD-LITE system demonstrated good medium term anatomical correction of apical and anterior prolapse, with good subjective cure and improved quality of life. Whilst complication rate was low, slight increase in de novo USI was observed.


Assuntos
Prolapso de Órgão Pélvico , Incontinência Urinária por Estresse , Incontinência Urinária , Humanos , Feminino , Seguimentos , Resultado do Tratamento , Polipropilenos , Estudos Retrospectivos , Qualidade de Vida , Telas Cirúrgicas , Prolapso de Órgão Pélvico/cirurgia , Incontinência Urinária/cirurgia , Inquéritos e Questionários
10.
Eur J Obstet Gynecol Reprod Biol ; 291: 162-167, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37898047

RESUMO

OBJECTIVE: The aim of the present study was to compare efficacy and safety of the vaginal patch plastron (VPP) associated to the anterior sacrospinous fixation (SSLF-A) with a TVM procedure (Uphold™ LITE support-system) for the treatment of the advanced anterior vaginal wall prolapse. STUDY DESIGN: Single-center retrospective study. Women with symptomatic anterior prolapse ≥ III stage according to the POP-quantification (POP-Q) system and submitted to the VPP associated with the SSLF-A or to the Uphold™ procedure were included. Primary outcome was to compare objective and subjective cystocele relapse and reoperation rate at 6- and 12-month follow-up. Secondary outcome was to describe peri- and postoperative complications. Pearson chi-square test and exact Fisher test were adopted for categorical variables, while intergroup Mann-Whitney U test and intragroup Wilcoxon Rank Sum Test for continuous variables; the statistical analysis was conducted at 95 % confidence level. RESULTS: Fifty-five women in VPP-group and 118 women in Uphold-group were included. At 6-month follow-up, objective anterior relapse in VPP-group (3/55, 5.4 %) was like Uphold-group (5/118, 4.2 %; p = 0.71), as well as objective apical relapse (0/55, 0 % vs 3/118, 2.5 %; p = 0.55); no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 5/118, 4.2 %; p = 0.67). At 12-month follow-up women were telephonically investigated; no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 6/118, 5.1 %; p = 0.43). Reoperation rate for the composite outcome POP relapse, stress urinary incontinence (SUI) and remotion of the TVM resulted lower in the VPP group (1/55, 1.8 % vs 13/118, 11 %; p = 0.03). Post-operative buttock pain (32/55, 58.2 % vs 24/118, 20.3 %; p < 0.0001) and post-operative urinary retention (16/55, 29.1 % vs 6/118, 5.1 %; p < 0.0001) were higher in VPP-group, with a complete resolution between 2 and 3 weeks after treatment. CONCLUSION: VPP associated with SSLF-A was as effective as Uphold™ LITE support-system for both anterior and central compartment prolapse treatment at 6- and 12-month follow-up. VPP-group presented a lower reoperation rate for the composite outcome prolapse relapse repair, SUI, and removal of the mesh.


Assuntos
Cistocele , Prolapso de Órgão Pélvico , Incontinência Urinária por Estresse , Prolapso Uterino , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Estudos Retrospectivos , Prolapso Uterino/cirurgia , Prolapso Uterino/complicações , Cistocele/cirurgia , Incontinência Urinária por Estresse/etiologia , Complicações Pós-Operatórias/etiologia , Recidiva , Resultado do Tratamento , Telas Cirúrgicas/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos
11.
J Biomed Mater Res B Appl Biomater ; 111(12): 2064-2076, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37596906

RESUMO

Polypropylene (PP) surgical mesh had reasonable success in repair of hernia and treatment of stress urinary incontinence (SUI); however, their use for the repair of pelvic organ prolapse (POP) resulted in highly variable results with lifelong complications in some patients. One of several factors that could be associated with mesh-related POP complications is changes in the properties of the implanted surgical mesh due to oxidative degradation of PP in vivo. Currently, there are no standardized in vitro bench testing methods available for assessing the susceptibility to oxidative degradation and estimating long-term in vivo stability of surgical mesh. In this work, we adapted a previously reported automated reactive accelerated aging (aRAA) system, which uses elevated temperatures and high concentrations of hydrogen peroxide (H2 O2 ), for accelerated bench-top oxidative degradation testing of PP surgical mesh. Since H2 O2 is highly unstable at elevated temperatures and for prolonged periods, the aRAA system involves a feedback loop based on electrochemical detection methods to maintain consistent H2 O2 concentration in test solutions. Four PP mesh samples with varying mesh knit designs, filament diameter, weight, and % porosity, were selected for testing using aRAA up to 4 weeks and characterized using thermal analysis, Fourier-transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR) and scanning electron microscopy (SEM). Additionally, the oxidation index (OI) values were calculated based on the FTIR-ATR spectra to estimate the oxidative degradation and oxidation reaction kinetics of PP surgical mesh. The OI values and surface damage in the form of surface flaking, peeling, and formation of transverse cracks increased with aRAA aging time. The aRAA test method introduced here could be used to standardize the assessment of long-term stability of surgical mesh and may also be adopted for accelerated oxidative degradation testing of other polymer-based medical devices.

12.
Urologiia ; (1): 34-40, 2023 Mar.
Artigo em Russo | MEDLINE | ID: mdl-37401681

RESUMO

INTRODUCTION: The use of large vaginal meshes for the treatment of pelvic organ prolapse (POP) combined with insufficient surgeon experience are the important risk factors for serious postoperative complications. AIM: To find the most safe and effective method of surgical treatment of POP. MATERIALS AND METHODS: To evaluate the efficiency of surgical techniques, a retrospective study of 5031 medical records from an electronic database was carried out. As the primary endpoint, we assessed the duration of the procedure, the volume of blood loss and the length of stay. As a secondary endpoint, the number of intra- and postoperative complications was assessed. In addition to objective data, we assessed subjective measures using the validated PFDI20 and PISQ12 questionnaires. RESULTS: The best results in terms of blood loss were shown by unilateral hybrid pelvic floor reconstruction and three-level hybrid reconstruction (33+/-15 ml and 36+/-17 ml, respectively). Patients who underwent the three-level hybrid pelvic floor reconstruction technique had the highest result: 33+/-15 points of the PISQ12 questionnaire, 50+/-28 points of the PFDI20 questionnaire, which was significant in comparison with other techniques (p<0.001). The number of postoperative complications was also significantly lower for this procedure. CONCLUSION: Three-level hybrid pelvic floor reconstruction is a safe and effective technique for the treatment of pelvic organ prolapse. In addition, this procedure can be done in a specialized hospital with the appropriate skills of surgeons.


Assuntos
Prolapso de Órgão Pélvico , Telas Cirúrgicas , Feminino , Humanos , Resultado do Tratamento , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias/etiologia
13.
Expert Rev Med Devices ; 20(5): 393-400, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37014111

RESUMO

INTRODUCTION: In recent decades, concerns about safety of synthetic non-absorbable materials transvaginally implanted emerged. We aim to define the actual role of synthetic non-absorbable transvaginal mesh (TVM) for pelvic organ prolapse (POP) and mid-urethral sling (MUS) for stress urinary incontinence (SUI), in relation with the worldwide legislative evolution. AREAS COVERED: While in the United Kingdom MUS is not considered the first-line surgical option, other countries adopt MUS as the main procedure. United States, United Kingdom, Australia, New Zealand, France banned or paused TVM use for POP repair. At the same time, Germany, Asian, and South American countries adopt TVM after adequate counseling for selected populations such as women affected by or at high risk of POP relapse and contraindication for other surgical routes. EXPERT OPINION: The worldwide evolution of recommendations determined deep modification of clinical practice, with native tissue repair returning to forefront when the vaginal route is indicated. A more careful evaluation of the safety and efficacy profile of meshes' materials and the assessment of the minimal surgeon's expertise in performing TVM procedures became crucial. A multidisciplinary approach and a high specialization of the hospitals both in performing mesh procedures and in managing complications are mandatory.


Assuntos
Prolapso de Órgão Pélvico , Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Telas Cirúrgicas/efeitos adversos , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/complicações , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária por Estresse/complicações , Slings Suburetrais/efeitos adversos , Contraindicações
14.
Health Expect ; 26(3): 1189-1201, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36811617

RESUMO

INTRODUCTION: Transvaginal mesh (mesh) surgeries have been used to treat stress urinary incontinence (incontinence) and/or pelvic organ prolapse (prolapse). In Australia, as in many other countries, the harms caused by mesh eventually prompted individual and collective attempts to achieve redress. The rise of mesh surgery as a procedure, the experience of mesh-affected women and the formal inquiries and legal actions that followed all occurred in social, cultural and discursive contexts. One strategy to understand these contexts is to track how the mesh and key actors in the mesh stories have been portrayed in mass media sources. We conducted a media analysis of the most highly read Australian newspapers and online news media platforms, focusing on how mesh and the interaction of stakeholders in mesh stories were presented to the Australian public. METHOD: We searched systematically in the top 10 most-read print and online media outlets in Australia. We included all articles that mentioned mesh, from the date of first use of mesh in Australia to the date of our final search (1996-2021). RESULT: After early scant media reporting focusing on the benefits of mesh procedures, major Australian medicolegal processes created a hook to shift reporting about mesh. The news media then played a significant role in redressing women's experienced epistemic injustice, including by amplifying previously ignored evidence of harm. This created an opportunity for previously unreported suffering to be revealed to powerful actors, in settings beyond the immediate control and epistemic authority of healthcare stakeholders, validating women's testimony and creating new hermeneutic resources for understanding mesh. Over time, media reports show healthcare stakeholders responding sympathetically to these new understandings in public discourse, contrasting with their statements in earlier media coverage. CONCLUSION: We argue that mass media reporting, in synergy with medicolegal actions and the Australian Senate Inquiry, appears to have provided women with greater epistemic justice, giving their testimony privileged epistemic status such that it was considered by powerful actors. Although medical reporting is not recognised in the hierarchy of evidence embedded in the medical knowledge system, in this case, media reporting appears to have contributed to shaping medical knowledge in significant ways. PATIENT OR PUBLIC CONTRIBUTION: We used publicly available data, print and online media outlets, for our analysis. Therefore, this manuscript does not contain the direct contribution of patients, service users, caregivers, people with lived experience or members of the public.


Assuntos
Prolapso de Órgão Pélvico , Incontinência Urinária por Estresse , Humanos , Feminino , Telas Cirúrgicas , Austrália , Meios de Comunicação de Massa , Prolapso de Órgão Pélvico/cirurgia
15.
Arch Gynecol Obstet ; 307(5): 1513-1520, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36773045

RESUMO

OBJECTIVE: To explore clinical outcomes and complications of modified Transvaginal mesh (M-TVM) for advanced anterior vaginal wall prolapse in 1 year follow-up. METHODS: 574 patients underwent TVM surgeries from 2019 to 2020 were collected and divided into TVM group and M-TVM group, all preoperative and postoperative data was obtained and compared between the two groups. RESULTS: 285 women were involved eventually, including 181 in TVM group and 104 in M-TVM group. No significant difference of general conditions was found between these two groups. After long-term follow-up, patients in TVM group were more likely to suffer from pelvic pain than M-TVM group (P = 0.046). Meshes seemed much wider in M-TVM group (4.5 ± 0.69 cm) than in TVM group (3.0 ± 0.91 cm). No matter TVM or M-TVM, surgeries can significantly change point Aa and Ba when compared to preoperative data. Compared to TVM group, point C and D were significant changed in patients in M-TVM group after surgery (P < 0.001) CONCLUSION: M-TVM is a commendable procedure that can significant correct anterior prolapse with mesh extended wider, and also supply stable apical support at the same time.


Assuntos
Prolapso de Órgão Pélvico , Humanos , Feminino , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/complicações , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Vagina/cirurgia , Próteses e Implantes , Resultado do Tratamento
16.
J Obstet Gynaecol Res ; 49(5): 1429-1434, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36787726

RESUMO

PURPOSE: This study established the prognostic significance of the uroflowmetry flow curve shape in the presence of voiding dysfunction following transvaginal mesh surgery. METHODS: This is a retrospective study of 439 symptomatic cystocele patients who underwent anterior wall repair with transvaginal mesh surgery. Uroflowmetry and postvoid residual were used to evaluate voiding function both preoperatively and 12 months postoperatively. The patients were divided into two groups: those with and without postoperative voiding dysfunction, and the predictors of postoperative voiding dysfunction were analyzed. The shape of the urine flow curve was analyzed for its influence on the presence of postoperative voiding dysfunction. RESULTS: Thirty-five participants were in the voiding dysfunction group, while 404 were in the nonvoiding dysfunction group. Multivariate analysis was conducted by adding an interrupted-shaped curve to age, Qmax, and postvoid residual, which showed significant differences in univariate analysis, found that age 68 years or older (odds ratio [OR]: 7.68, 95%CI 1.02-58, p = 0.048), postvoid residual ≥110 mL (OR: 2.8, 95%CI 1.25-6.29, p = 0.013) and interrupted-shaped curve (OR: 2.47, 95%CI 1.07-5.69, p = 0.034) were discovered to be independent risk factors for the presence of voiding dysfunction after transvaginal mesh surgery. CONCLUSIONS: Following transvaginal mesh surgery for cystocele, three variables were found to be predictive of voiding dysfunction: the old age, excessive postvoid residual, and an interrupted-shaped flow curve. The uroflowmetry flow curve shape has the potential to be a new predictor of postoperative voiding dysfunction.


Assuntos
Cistocele , Prolapso de Órgão Pélvico , Transtornos Urinários , Feminino , Humanos , Idoso , Prolapso de Órgão Pélvico/cirurgia , Cistocele/complicações , Cistocele/cirurgia , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Transtornos Urinários/etiologia
17.
J Obstet Gynaecol Res ; 49(3): 1036-1042, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36597262

RESUMO

AIM: To present the techniques of transvaginal mesh surgery for pelvic organ prolapse without the blind maneuver and elucidate its safety and efficacy. METHODS: This retrospective study included 45 women with a mean age of 77.9 years old. We investigated surgical outcomes including complications, anatomical recurrence rates, and changes in both subjective symptoms and quality of life. RESULTS: The surgery required 111 ± 18 min and blood loss was 40 ± 24 g. Minor injuries of the bladder and rectum occurred in two and one patient, respectively. The urethral catheter was removed on postoperative day 1.1 and patients were discharged on postoperative day 4.4. No one experienced voiding dysfunction requiring catheterization. Wound infections occurred in two patients but they subsided with only antibiotics administered. Five patients had anatomical recurrence during a median follow-up of 17 months. Of these, two underwent reoperation and the remaining three were solely followed-up because there were no or few associated problems. Chronic pain, mesh erosion, and exposure were absent in all cases. Subjective symptoms and quality of life significantly improved after surgery at 12 months postoperatively. CONCLUSION: It is considered that transvaginal mesh surgery without the blind maneuver is a safe and effective way to treat women with pelvic organ prolapse.


Assuntos
Prolapso de Órgão Pélvico , Slings Suburetrais , Humanos , Feminino , Idoso , Estudos Retrospectivos , Telas Cirúrgicas , Qualidade de Vida , Prolapso de Órgão Pélvico/cirurgia , Resultado do Tratamento
18.
ANZ J Surg ; 93(3): 469-475, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36629143

RESUMO

BACKGROUND: To assess the contemporary trends in the types and incidence of pelvic organ prolapse (POP) surgery in Australia after the removal of transvaginal mesh from the Australian market. METHODS: This was a retrospective Australian cohort study utilizing three large Governmental databases covering all private and public POP procedures in Australia. All females ≥25 years old undergoing POP procedures between 2005 and 2021 were included. RESULTS: From 2005-2006 to 2020-2021 there have been a total of 408 881 POP procedures in Australia. The total number of procedures peaked in 2005-2006 at 537.8 procedures per 100 000 age-standardized female population, decreasing by an average of 3.5% per year to 329.0 procedures per 100 000 in 2018-2019, an overall 38.8% decrease (P < 0.001). A sudden growth in private operative procedures was noted between 2019-2020 and 2020-2021, from 218.2 to 268.6 procedures per 100 000 population, a 23.1% increase (P < 0.001). Laparoscopic and abdominal POP repair has seen a 115.8% increase from 13.7 procedures to 29.6 per 100 000 between 2005-2006 and 2020-2021. Over the last 15 years, the most common age group to undergo a procedure has changed from the 55 to 64 years demographic to a later decade of 65 to 74 years. CONCLUSION: Over the last 15 years, the total number of POP procedures performed has significantly decreased. There has however been a recent rise in interventions seen in the private sector and the utilization of laparoscopic or abdominal POP repair has increased, which has implications for procedural credentialing to ensure patient safety.


Assuntos
Procedimentos Cirúrgicos em Ginecologia , Prolapso de Órgão Pélvico , Feminino , Humanos , Pessoa de Meia-Idade , Adulto , Estudos de Coortes , Estudos Retrospectivos , Procedimentos Cirúrgicos em Ginecologia/métodos , Austrália/epidemiologia , Prolapso de Órgão Pélvico/epidemiologia , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas , Resultado do Tratamento
19.
J Biomed Mater Res B Appl Biomater ; 111(5): 1142-1152, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36610021

RESUMO

Titanium-coated polypropylene (Ti-PP) mesh was introduced in 2002 as a surgical mesh for the treatment of hernias and shortly after for pelvic floor surgery, with the aim of improving biocompatibility when compared to non-titanised/regular PP mesh implants. The application of a titanium coating could also be beneficial to address concerns regarding the exposure of PP in an in vivo environment. Many studies have shown that PP, although it is widely accepted as a stable polymer, is subject to oxidation and degradation, such degradation affects the mechanical behavior, that is, the stiffness and tensile strength of PP mesh. Despite the wide clinical use of Ti-PP surgical meshes, no study has yet investigated the residual material properties post clinical deployment and subsequent explantation. In this study, two explanted Ti-PP mesh samples each having different incorporation durations from two patients were examined. Material analysis conducted within this study includes the following techniques: attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR), Raman spectroscopy, low voltage - scanning electron microscopy (LV-SEM), backscattered electron (BSE) imaging, energy dispersive X-ray spectroscopy (EDS) and secondary election hyperspectral imaging (SEHI). The hypothesis of this study is that the Ti coating successfully shields the PP mesh from oxidative stress in vivo and thus protects it from degradation. The results of this analysis show for the first time evidence of bulk oxidation, surface degradation, and environmental stress cracking on explanted Ti-PP meshes.


Assuntos
Materiais Biocompatíveis , Telas Cirúrgicas , Humanos , Materiais Biocompatíveis/química , Teste de Materiais , Polipropilenos/química , Titânio
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