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Çetin Arslan H, Arslan K. Risk factors and outcomes of vaginal mesh erosions after pelvic reconstructive surgery: A retrospective cohort study. Medicine (Baltimore) 2025; 104:e42442. [PMID: 40355194 PMCID: PMC12073847 DOI: 10.1097/md.0000000000042442] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2025] [Accepted: 04/25/2025] [Indexed: 05/14/2025] Open
Abstract
Mesh erosions can occur in pelvic reconstructive surgeries for pelvic organ prolapse and stress urinary incontinence. The purpose of this study was to investigate the risk factors and outcomes of mesh erosion after surgical procedures using synthetic mesh. Pelvic reconstructive surgeries performed at a tertiary center during the 5 years between January 2019 and January 2024 were retrospectively analyzed. Patients were classified into the mesh erosion group and the non-erosion group. Clinical features and outcomes were compared. The study included 510 patients, 49 in the mesh erosion group and 461 in the non-erosion group. The incidence of mesh erosion was 9.6%. There was no significant difference between the groups in terms of age, parity, menopausal status, pelvic organ prolapse stage, and concomitant hysterectomy (P = .243, P = .066, P = .349, P = .374, and P = .119, respectively). In the mesh erosion group, body mass index (27.1 ± 3.3 vs 25.9 ± 3.6, P = .016), smoking (28.6% vs 14.3%), sexual activity (77.6% vs 61.8%), vaginal incision size (3.5 ± 1.7 vs 2.3 ± 0.8, P = .001) and hypertension (22.4% vs 13%, P = .070) were significantly higher. Vaginal incision size (>2.5 cm) and sexual activity were found to be independent risk factors for mesh erosion. In patients with mesh erosion, 18.3% (n = 9) received conservative treatment, and 81.7% (n = 40) received surgical treatment. In patients who underwent surgical treatment, mesh erosion size (>0.5 cm) and body mass index were significantly higher (P = .015 and P < .001, respectively). Erosion recurrence was detected in 16.3% (n = 8) of patients in the mesh erosion group. Although mesh erosions do not occur frequently in pelvic reconstructive surgeries, they are complications that can disrupt patient comfort. Vaginal incision size and sexual activity were determined as independent risk factors for mesh erosions. When mesh erosion is detected, conservative treatment may benefit small erosions. The surgical approach should be performed in patients with severe symptoms and extensive erosions.
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Affiliation(s)
- Hale Çetin Arslan
- Department of Gynecology and Obstetrics, University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey
| | - Kadir Arslan
- Department of Anesthesiology and Reanimation, University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey
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Chen YP, Lo TS, Chien YH, Kuo YH, Liu SJ. In Vitro and In Vivo Drug Release from a Nano-Hydroxyapatite Reinforced Resorbable Nanofibrous Scaffold for Treating Female Pelvic Organ Prolapse. Polymers (Basel) 2024; 16:1667. [PMID: 38932015 PMCID: PMC11207985 DOI: 10.3390/polym16121667] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 06/05/2024] [Accepted: 06/08/2024] [Indexed: 06/28/2024] Open
Abstract
Pelvic prolapse stands as a substantial medical concern, notably impacting a significant segment of the population, predominantly women. This condition, characterized by the descent of pelvic organs, such as the uterus, bladder, or rectum, from their normal positions, can lead to a range of distressing symptoms, including pelvic pressure, urinary incontinence, and discomfort during intercourse. Clinical challenges abound in the treatment landscape of pelvic prolapse, stemming from its multifactorial etiology and the diverse array of symptoms experienced by affected individuals. Current treatment options, while offering relief to some extent, often fall short in addressing the full spectrum of symptoms and may pose risks of complications or recurrence. Consequently, there exists a palpable need for innovative solutions that can provide more effective, durable, and patient-tailored interventions for pelvic prolapse. We manufactured an integrated polycaprolactone (PCL) mesh, reinforced with nano-hydroxyapatite (nHA), along with drug-eluting poly(lactic-co-glycolic acid) (PLGA) nanofibers for a prolapse scaffold. This aims to offer a promising avenue for enhanced treatment outcomes and improved quality of life for individuals grappling with pelvic prolapse. Solution extrusion additive manufacturing and electrospinning methods were utilized to prepare the nHA filled PCL mesh and drug-incorporated PLGA nanofibers, respectively. The pharmaceuticals employed included metronidazole, ketorolac, bleomycin, and estrone. Properties of fabricated resorbable scaffolds were assessed. The in vitro release characteristics of various pharmaceuticals from the meshes/nanofibers were evaluated. Furthermore, the in vivo drug elution pattern was also estimated on a rat model. The empirical data show that nHA reinforced PCL mesh exhibited superior mechanical strength to virgin PCL mesh. Electrospun resorbable nanofibers possessed diameters ranging from 85 to 540 nm, and released effective metronidazole, ketorolac, bleomycin, and estradiol, respectively, for 9, 30, 3, and over 30 days in vitro. Further, the mesh/nanofiber scaffolds also liberated high drug levels at the target site for more than 28 days in vivo, while the drug concentrations in blood remained low. This discovery suggests that resorbable scaffold can serve as a viable option for treating female pelvic organ prolapse.
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Affiliation(s)
- Yi-Pin Chen
- Department of Obstetrics and Gynecology, Keelung Chang Gung Memorial Hospital, Keelung 20401, Taiwan;
- School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan
| | - Tsia-Shu Lo
- Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan 33305, Taiwan;
| | - Yu-Han Chien
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-H.C.); (Y.-H.K.)
| | - Yi-Hua Kuo
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-H.C.); (Y.-H.K.)
| | - Shih-Jung Liu
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-H.C.); (Y.-H.K.)
- Department of Orthopedic Surgery, Bone and Joint Research Center, Chang Gung Memorial Hospital-Linkou, Taoyuan 33305, Taiwan
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Lin CJ, Liu CK, Hsieh HY, Chen MJ, Tsai CP. Modified Vaginal Mesh Procedure with DynaMesh ®-PR4 for the Treatment of Anterior/Apical Vaginal Prolapse. Diagnostics (Basel) 2023; 13:2991. [PMID: 37761358 PMCID: PMC10528822 DOI: 10.3390/diagnostics13182991] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2023] [Revised: 09/14/2023] [Accepted: 09/15/2023] [Indexed: 09/29/2023] Open
Abstract
(1) Background: Treating female pelvic organ prolapse (POP) is challenging. Surgical meshes have been used in transvaginal surgeries since the 1990s, but complications such as mesh exposure and infection have been reported. Polyvinylidene fluoride (PVDF) mesh, known for its stability and non-reactive properties, has shown promise in urogynecological surgeries. (2) Methods: A retrospective analysis was conducted on 27 patients who underwent a modified PVDF vaginal mesh repair procedure using DynaMesh®-PR4 and combined trans-obturator and sacrospinous fixation techniques. Additional surgeries were performed as needed. (3) Results: The mean operation time was 56.7 min, and the mean blood loss was 66.7 mL. The average hospitalization period was 4.2 days with Foley catheter removal after 2 days. Patients experienced lower pain scores from the day of the operation to the following day. Postoperative follow-up revealed that 85.2% of patients achieved anatomic success, with 14.8% experiencing recurrent stage II cystocele. No recurrence of apical prolapse was observed. Complications were rare, with one case (3.7%) of asymptomatic mesh protrusion. (4) Conclusions: The modified vaginal mesh procedure using DynaMesh®-PR4 showed favorable outcomes with a short operation time, low recurrence rate, rare complications, and improved functional outcomes. This surgical option could be considered for anterior and apical pelvic organ prolapse in women.
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Affiliation(s)
- Chia-Ju Lin
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Chih-Ku Liu
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Hsiao-Yun Hsieh
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Ming-Jer Chen
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Ching-Pei Tsai
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
- Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung 40204, Taiwan
- Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung 40204, Taiwan
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Zhang YA, Wang W, Li XL, Xian-hui-Zhang, Pan J, Li ZA. The effect evaluation of traditional vaginal surgery and transvaginal mesh surgery for severe pelvic organ prolapse: 5 years follow-up. Open Med (Wars) 2022; 17:801-807. [PMID: 35529471 PMCID: PMC9034344 DOI: 10.1515/med-2022-0467] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2021] [Revised: 02/27/2022] [Accepted: 03/10/2022] [Indexed: 11/15/2022] Open
Abstract
Abstract
The objective of this study was to compare the clinical effectiveness of traditional vaginal surgery and transvaginal mesh (TVM) surgery on severe pelvic organ prolapse (POP). We performed a retrospective chart review study of 258 severe POP patients who underwent surgery between November 2010 and September 2016. One hundred forty patients underwent traditional vaginal surgery and 118 TVM surgery. The Pelvic Organ Prolapse Quantitation (POP-Q) staging was used for objective evaluation. The Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Floor Disease Life Impact Questionnaire Simplified Version-7 (PFIQ-7), and Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire (PISQ-12) were used for subjective evaluation. Their complications were also recorded. All the data were collected in the outpatient department through the follow-up at 3 months, 1, 3, and 5 years after the operation. Forty patients in the traditional vaginal surgery group and 25 in the TVM group were lost to follow-up. There was no difference in the POP-Q score between the groups (P = 0.346). The recurrence rate increased with follow-up time, reaching nearly 20% in the two groups by 5 years. The TVM group has higher PFDI-20 and PFIQ-7 scores and lower PISQ-12 scores than the traditional vaginal surgery group at six months, 1, 3, and 5 years, respectively (P < 0.001). Mesh exposure has occurred in the TVM group. Both surgeries showed similar objective satisfaction and recurrence rate. However, traditional vaginal surgery has higher subjective satisfaction than TVM in our study and does not risk exposure to prosthetic material.
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Affiliation(s)
- Ying-an Zhang
- Department of Gynecology and Obstetrics, Children’s Hospital of Shanxi and Women Health Center of Shanxi , Taiyuan , China
| | - Wei Wang
- Department of Laboratory Medicine, Shanxi Provincial People’s Hospital , Taiyuan , China
| | - Xiao-li Li
- Department of Gynecology and Obstetrics, Children’s Hospital of Shanxi and Women Health Center of Shanxi , Taiyuan , China
| | - Xian-hui-Zhang
- Department of Gynecology and Obstetrics, Children’s Hospital of Shanxi and Women Health Center of Shanxi , Taiyuan , China
| | - Jie Pan
- Department of Pathology, Stanford University School of Medicine , Stanford , CA 94305 , United States of America
| | - Zhao-ai Li
- Department of Gynecology and Obstetrics, Children’s Hospital of Shanxi and Women Health Center of Shanxi , Taiyuan , China
- Department of Gynecology and Obstetrics, Coal Hospital of Shanxi , Taiyuan , China
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Eslami MJ, Zargham M, Gholipour F, Hajian M, Bakhtiari K, Hajebrahimi S, Eghbal M, Farajzadegan Z. Transvaginal repair of anterior vaginal wall prolapse with polyvinylidene fluoride (PVDF) mesh: an alternative for previously restricted materials? Int Urogynecol J 2021; 33:1989-1997. [PMID: 34586438 DOI: 10.1007/s00192-021-04977-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2021] [Accepted: 08/08/2021] [Indexed: 10/20/2022]
Abstract
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.
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Affiliation(s)
| | - Mahtab Zargham
- Department of Urology, Isfahan University of Medical Sciences, Isfahan, Iran.
| | - Farshad Gholipour
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Mohammadreza Hajian
- Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Katayoun Bakhtiari
- Department of Obstetrics & Gynecology, Michigan Medicine, University of Michigan, Ann Arbor, USA
| | - Sakineh Hajebrahimi
- Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
| | - Melina Eghbal
- Department of Urology, Urmia University of Medical Sciences, Isfahan, Iran
| | - Ziba Farajzadegan
- Department of Community Medicine, Faculty of Medicine, Child Growth and Development Center, Isfahan University of Medical Sciences, Isfahan, Iran
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Chen YP, Lo TS, Lin YT, Chien YH, Lu CJ, Liu SJ. Fabrication of Drug-Eluting Polycaprolactone/poly(lactic- co-glycolic Acid) Prolapse Mats Using Solution-Extrusion 3D Printing and Coaxial Electrospinning Techniques. Polymers (Basel) 2021; 13:polym13142295. [PMID: 34301052 PMCID: PMC8309226 DOI: 10.3390/polym13142295] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2021] [Revised: 07/05/2021] [Accepted: 07/12/2021] [Indexed: 12/21/2022] Open
Abstract
We developed biodegradable drug-eluting prolapse mats using solution-extrusion 3D printing and coaxial electrospinning techniques. The mats were composed of polycaprolactone (PCL) mesh and lidocaine-, estradiol-, metronidazole-, and connective tissue growth factor (CTGF)-incorporated poly(lactic-co-glycolic acid) (PLGA) nanofibers that mimic the structure of the natural extracellular matrix of most connective tissues. The mechanical properties of degradable prolapse membrane were assessed and compared to commercial non-degradable polypropylene knitted meshes clinically used for pelvic organ prolapse (POP) repair. The release behaviors of the drug-loaded hybrid degradable membranes were also characterized. The experimental results suggest that 3D-printed PCL meshes exhibited comparable strengths to commercial POP meshes and survived through 10,000 cycles of fatigue test without breakage. Hybrid PCL meshes/PLGA nanofibrous membranes provided a sustainable release of metronidazole, lidocaine, and estradiol for 4, 25, and 30 days, respectively, in vitro. The membranes further liberated high levels of CTGF for more than 30 days. The animal tests show that the mechanical property of PCL mesh decreased with time, mainly due to degradation of the polymers post-implantation. No adverse effect of the mesh/nanofibers was noted in the histological images. By adopting solution-extrusion 3D printing and coaxial electrospinning, degradable drug-eluting membranes can be fabricated for POP applications.
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Affiliation(s)
- Yi-Pin Chen
- Department of Obstetrics and Gynecology, Keelung Chang Gung Memorial Hospital, Keelung 20401, Taiwan;
| | - Tsia-Shu Lo
- Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital-Linkou, School of Medicine, Chang Gung University, Taoyuan 33305, Taiwan;
| | - Yu-Ting Lin
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-T.L.); (Y.-H.C.); (C.-J.L.)
| | - Yu-Han Chien
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-T.L.); (Y.-H.C.); (C.-J.L.)
| | - Chia-Jung Lu
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-T.L.); (Y.-H.C.); (C.-J.L.)
| | - Shih-Jung Liu
- Department of Mechanical Engineering, Chang Gung University, Taoyuan 33302, Taiwan; (Y.-T.L.); (Y.-H.C.); (C.-J.L.)
- Bone and Joint Research Center, Department of Orthopedic Surgery, Chang Gung Memorial Hospital-Linkou, Taoyuan 33305, Taiwan
- Correspondence: ; Tel.: +886-3-211-8166; Fax: +886-3-211-8558
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7
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Aghaei-Ghareh-Bolagh B, Mukherjee S, Lockley KM, Mithieux SM, Wang Z, Emmerson S, Darzi S, Gargett CE, Weiss AS. A novel tropoelastin-based resorbable surgical mesh for pelvic organ prolapse repair. Mater Today Bio 2020; 8:100081. [PMID: 33210083 PMCID: PMC7658716 DOI: 10.1016/j.mtbio.2020.100081] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2020] [Revised: 09/30/2020] [Accepted: 10/05/2020] [Indexed: 11/03/2022] Open
Abstract
Pelvic organ prolapse is a common condition that affects 1 in 4 women across all age groups. It is mainly caused by vaginal birth injury and can be exacerbated by obesity and increased age. Until recently, treatment strategies often used non-degradable synthetic meshes for reconstructive surgery. However, owing to their frequent, unacceptable rate of adverse events such as mesh erosion, transvaginal meshes have been banned in many countries. Recent reports have highlighted the urgent need for biocompatible design of meshes for a safe and effective treatment in the long term. This study reports the design and evaluation of a novel, elastin based degradable mesh using an ovine model of POP as a potential surgical treatment. Elastin is a protein component of the ECM and provides elasticity to tissues throughout the body. Tropoelastin, the monomer subunit of elastin, has been used with success in electrospun constructs as it is a naturally cell interactive polymer. Biomaterials that incorporate tropoelastin support cell attachment and proliferation, and have been proven to encourage elastogenesis and angiogenesis in vitro and in vivo. The biological properties of tropoelastin were combined with the physical properties of PCL, a degradable synthetic polymer, with the aim of producing, characterizing and assessing the performance of continuous tropoelastin:PCL electrospun yarns. Using a modified spinneret electrospinning system and adjusting settings based on relative humidity, four blends of tropoelastin:PCL yarns were fabricated with concentration ratios of 75:25, 50:50, 25:75 and 0:100. Yarns were assessed for ease of manufacture, fibrous architecture, protein/polymer content, yarn stability - including initial tropoelastin release, mechanical strength, and ability to support cell growth. Based on overall favorable properties, a mesh woven from the 50:50 tropoelastin:PCL yarn was implanted into the vagina of a parous ewe with vaginal wall weakness as a model of pelvic organ prolapse. This mesh showed excellent integration with new collagen deposition by SEM and a predominant M2 macrophage response with few pro-inflammatory M1 macrophages after 30 days. The woven tropoelastin:PCL electrospun mesh shows potential as an alternative to non-degradable, synthetic pelvic organ prolapse mesh products.
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Affiliation(s)
- B Aghaei-Ghareh-Bolagh
- Charles Perkins Centre, University of Sydney, NSW, 2006, Australia.,School of Life and Environmental Sciences, University of Sydney, NSW, 2006, Australia
| | - S Mukherjee
- The Ritchie Centre, Hudson Institute of Medical Research, Victoria, 3168, Australia.,Department of Obstetrics and Gynaecology, Monash University, Victoria, 3168, Australia
| | - K M Lockley
- Charles Perkins Centre, University of Sydney, NSW, 2006, Australia.,School of Life and Environmental Sciences, University of Sydney, NSW, 2006, Australia
| | - S M Mithieux
- Charles Perkins Centre, University of Sydney, NSW, 2006, Australia.,School of Life and Environmental Sciences, University of Sydney, NSW, 2006, Australia
| | - Z Wang
- Charles Perkins Centre, University of Sydney, NSW, 2006, Australia.,School of Life and Environmental Sciences, University of Sydney, NSW, 2006, Australia
| | - S Emmerson
- The Ritchie Centre, Hudson Institute of Medical Research, Victoria, 3168, Australia.,Department of Obstetrics and Gynaecology, Monash University, Victoria, 3168, Australia
| | - S Darzi
- The Ritchie Centre, Hudson Institute of Medical Research, Victoria, 3168, Australia
| | - C E Gargett
- The Ritchie Centre, Hudson Institute of Medical Research, Victoria, 3168, Australia.,Department of Obstetrics and Gynaecology, Monash University, Victoria, 3168, Australia
| | - A S Weiss
- Charles Perkins Centre, University of Sydney, NSW, 2006, Australia.,School of Life and Environmental Sciences, University of Sydney, NSW, 2006, Australia.,The University of Sydney Nano Institute, University of Sydney, NSW, 2006, Australia
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Abhyankar P, Wilkinson J, Berry K, Wane S, Uny I, Aitchison P, Duncan E, Calveley E, Mason H, Guerrero K, Tincello D, McClurg D, Elders A, Hagen S, Maxwell M. Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models. BMC Health Serv Res 2020; 20:910. [PMID: 32998714 PMCID: PMC7528592 DOI: 10.1186/s12913-020-05748-8] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2020] [Accepted: 09/18/2020] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.
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Affiliation(s)
- Purva Abhyankar
- Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.
| | - Joyce Wilkinson
- Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK
| | - Karen Berry
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
| | - Sarah Wane
- Department of Sport, Exercise and Rehabilitation, University of Northumbria, Sutherland Building, Newcastle-upon-Tyne, NE1 8ST, UK
| | - Isabelle Uny
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
| | - Patricia Aitchison
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
| | - Edward Duncan
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
| | - Eileen Calveley
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
| | - Helen Mason
- Yunus Centre for Social Business and Health, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK
| | - Karen Guerrero
- Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK
| | - Douglas Tincello
- Department of Health Sciences, University of Leicester, Centre for Medicine, University Road, Leicester, LE1 RRH, UK
| | - Doreen McClurg
- Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Govan Mbeki Building, Cowcaddens Road, Glasgow, G4 0BA, UK
| | - Andrew Elders
- Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Govan Mbeki Building, Cowcaddens Road, Glasgow, G4 0BA, UK
| | - Suzanne Hagen
- Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Govan Mbeki Building, Cowcaddens Road, Glasgow, G4 0BA, UK
| | - Margaret Maxwell
- Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling Innovation Park, Stirling, FK9 4NF, UK
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9
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Schiano di Visconte M, Azzena A. A 10-year retrospective cohort study to assess objective and subjective outcomes of combined stapled transanal rectal resection and urogynecological surgery for pelvic floor dysfunction. Arch Gynecol Obstet 2020; 302:393-404. [PMID: 32458133 DOI: 10.1007/s00404-020-05605-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2019] [Accepted: 05/15/2020] [Indexed: 10/24/2022]
Abstract
PURPOSE To assess the subjective and objective outcomes of combined stapled transanal rectal resection (STARR) and urogynecological surgery to treat pelvic organ prolapse, with a 10-year follow-up. METHODS This was a retrospective cohort study analyzing prospectively collected data from 53 consecutive patients who underwent combined stapled transanal rectal resection and urogynecological surgery, from 1 January 2005 to 31 December 2007 at a tertiary referral Pelvic Floor Unit of an Italian hospital. RESULTS Fifty-three patients with a median age of 60 years (interquartile range (IQR) 67-52t), underwent STARR and concomitant urogynecological surgery. No serious postoperative complications were recorded, and 37/53 women (70%) were evaluated at the 10-year follow-up visit. The cure rate was optimal in 34 women (64.1%). Regarding persistent and/or recurrent symptoms, five sexually-active patients (9%) reported dyspareunia only; obstructed defecation symptoms recurred in ten women (19%); urinary incontinence occurred in eight patients (15%); four patients (11%) reported persistent perineal pain; and two patients (5%) experienced both the urge to defecate and voiding dysfunction. At the 10-year follow-up, 14/27 patients (52%) stated that they would undergo the same operation again, if necessary. Furthermore, the survey found that patients would recommend the combined surgery. CONCLUSION The 10-year results of this study proved that combined rectal and urogynecological surgery is well tolerated, associated with low morbidity, and more effectively treats a distressing and debilitating condition vs separate surgeries for rectal and pelvic organ prolapse. We recommend complementing the relatively small scale of this study with randomized trials involving a sufficient number of patients, to provide more conclusive evidence on the cumulative long-term effects of combined surgery vs 2- or 3-stage surgery.
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Affiliation(s)
- Michele Schiano di Visconte
- Department of General Surgery, Colorectal and Pelvic Floor Diseases Center, Santa Maria Dei Battuti Hospital, Via Brigata Bisagno 4, Conegliano, 31015, Treviso, Italy.
| | - Antonio Azzena
- Department of Obstetrics, Gynecology and Urogynecology, Santa Maria Dei Battuti Hospital, Conegliano, Treviso, Italy
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Zangarelli A, Curinier S, Campagne-Loiseau S, Guy L, Mansoor A. [Cystocele repair by a light tension-free vaginal mesh: results after 6 years of follow-up]. Prog Urol 2020; 30:367-373. [PMID: 32234421 DOI: 10.1016/j.purol.2020.02.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2018] [Revised: 02/07/2020] [Accepted: 02/11/2020] [Indexed: 10/24/2022]
Abstract
INTRODUCTION The objective of this study was to evaluate the long-term anatomical and functional efficacy, but also the safety of tension-free vaginal mesh in cystocele repair. METHODS This retrospective and monocentric study included 90 women who underwent a prolapse repair between June 2006 and November 2008. A light-weight polypropylene vaginal mesh (22g/m2, Novasilk COLOPLAST®) was used without any fixation. Females were followed at 1 month, 1 year, 3 years and 6 years. Only long-term results are presented in this study. The anatomical result was assessed by the POP-Q classification and the functional results by standardized symptoms (PFDI-20), sexuality (PISQ-12) and quality of life (PFIQ-7) questionnaires. RESULTS 6 years after surgery, the follow-up rate was 74%. Anatomically, the prolapse recurrence rate (Ba≥0) was 17% (n=8). Functionally, the overall patient satisfaction rate was 89%. Quality of life and symptoms scores (4,11±8.45 vs. 17.5±14.4 and 35.8±15.9 vs 94±23.4 respectively) were significantly improved (p<0.001). Concerning the prevalence of the complication, the retraction and exposition rate was 1.7% (n=1) and a re-intervention rate was 6.7% (n=4). The rate of de novo dyspareunia was 1.7% (n=1). CONCLUSION In this short retrospective series of vaginal mesh interposition for cystocele repair, the prevalence of medium-term patient satisfaction was high.
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Affiliation(s)
- A Zangarelli
- Service d'Urologie, CH de Vichy, boulevard Denière, 03200 Vichy, France.
| | - S Curinier
- Service de Gynécologie, CHU Estaing, 1, rue Lucie Aubrac, 63100 Clermont-Ferrand, France
| | - S Campagne-Loiseau
- Service de Gynécologie, CHU Estaing, 1, rue Lucie Aubrac, 63100 Clermont-Ferrand, France
| | - L Guy
- Service d'Urologie, CHU Clermont-Ferrand, 58, rue Montalembert 63000 Clermont-Ferrand, France
| | - A Mansoor
- Service de Gynécologie, CH d'Issoire, 13, rue du Dr Sauvat, 63500 Issoire, France
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Bergersen A, Hinkel C, Funk J, Twiss CO. Management of vaginal mesh exposure: A systematic review. Arab J Urol 2019; 17:40-48. [PMID: 31258942 PMCID: PMC6583711 DOI: 10.1080/2090598x.2019.1589787] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/29/2018] [Indexed: 11/25/2022] Open
Abstract
Objectives: To identify various predisposing factors, the clinical presentation, and the management of vaginal mesh-related complications, with special emphasis on mesh exposure and the indications for and results of vaginal mesh removal. Methods: A systematic literature review was performed using a search strategy based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. PubMed was queried for studies regarding aetiology, risk factors, and management of vaginal mesh exposure from 1 January 2008 to June 2018. Full-text articles were obtained for eligible abstracts. Relevant articles were included, and the cited references were used to identify relevant articles not previously included. Results: A total of 102 abstracts were identified from the PubMed search criteria. An additional 45 studies were identified based on review of the cited references. After applying eligibility criteria and excluding impertinent articles, 58 studies were included in the final analysis. Conclusion: Numerous studies have found at least some degree of symptomatic improvement regardless of the amount of mesh removed. Focal areas of exposure or pain can be successfully managed with partial mesh removal with low rates of complications. With partial mesh removal, many patients will ultimately require subsequent mesh removal procedures. For this reason, complete mesh excision is an alternative for patients with diffuse vaginal pain, large mesh exposure, and extrusion of mesh into adjacent viscera. However, when considering complete mesh removal, it is important to counsel patients regarding possible complications of removal and the increased risk of recurrent stress urinary incontinence and pelvic organ prolapse postoperatively. Abbreviations: MUS: midurethral sling; OR: odds ratio; POP: pelvic organ prolapse; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-analyses; SUI: stress urinary incontinence; TOT: transobturator; TVT: tension-free vaginal tape
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Affiliation(s)
- Andrew Bergersen
- Department of Surgery, Division of Urology, University of Arizona College of Medicine, Tucson, AZ, USA
| | - Cameron Hinkel
- Department of Surgery, Division of Urology, University of Arizona College of Medicine, Tucson, AZ, USA
| | - Joel Funk
- Department of Surgery, Division of Urology, University of Arizona College of Medicine, Tucson, AZ, USA
| | - Christian O Twiss
- Department of Surgery, Division of Urology, University of Arizona College of Medicine, Tucson, AZ, USA
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Fabricated tropoelastin-silk yarns and woven textiles for diverse tissue engineering applications. Acta Biomater 2019; 91:112-122. [PMID: 31004842 DOI: 10.1016/j.actbio.2019.04.029] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/09/2019] [Revised: 03/23/2019] [Accepted: 04/11/2019] [Indexed: 12/13/2022]
Abstract
Electrospun yarns offer substantial opportunities for the fabrication of elastic scaffolds for flexible tissue engineering applications. Currently available yarns are predominantly made of synthetic elastic materials. Thus scaffolds made from these yarns typically lack cell signaling cues. This can result in poor integration or even rejection on implantation, which drive demands for a new generation of yarns made from natural biologically compatible materials. Here, we present a new type of cell-attractive, highly twisted protein-based yarns made from blended tropoelastin and silk fibroin. These yarns combine physical and biological benefits by being rendered elastic and bioactive through the incorporation of tropoelastin and strengthened through the presence of silk fibroin. Remarkably, the process delivered multi-meter long yarns of tropoelastin-silk mixture that were conducive to fabrication of meshes on hand-made frames. The resulting hydrated meshes are elastic and cell interactive. Furthermore, subcutaneous implantation of the meshes in mice demonstrates their tolerance and persistence over 8 weeks. This combination of mechanical properties, biocompatibility and processability into diverse shapes and patterns underscores the value of these materials and platform technology for tissue engineering applications. STATEMENT OF SIGNIFICANCE: Synthetic yarns are used to fabricate textile materials for various applications such as surgical meshes for hernia repair and pelvic organ prolapse. However, synthetic materials lack the attractive biological and physical cues characteristic of extracellular matrix and there is a demand for materials that can minimize postoperative complications. To address this need, we made yarns from a combination of recombinant human tropoelastin and silk fibroin using a modified electrospinning approach that blended these proteins into functional yarns. Prior to this study, no protein-based yarns using tropoelastin were available for the fabrication of functional textile materials. Multimeter-long, uniform and highly twisted yarns based on these proteins were elastic and cell interactive and demonstrated processing to yield textile fabrics. By using these yarns to weave fabrics, we demonstrate that an elastic human matrix protein blend can deliver a versatile platform technology to make textiles that can be explored for efficacy in tissue repair.
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Perioperative hemorrhagic complications in pelvic floor reconstructive surgery. Int Urogynecol J 2018; 30:1141-1146. [PMID: 29785542 DOI: 10.1007/s00192-018-3667-6] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2018] [Accepted: 04/25/2018] [Indexed: 12/26/2022]
Abstract
INTRODUCTION AND HYPOTHESIS We sought to assess the incidence, symptoms, and risk factors of perioperative hemorrhagic complications in patients undergoing pelvic floor reconstructive surgery. METHODS This is a retrospective study on 694 consecutive patients who underwent pelvic floor reconstructive surgery with or without using mesh in our hospital over a 3-year period. RESULTS We identified 694 pelvic floor reconstructive procedures from 2014 to 2016, including complete/incomplete colpocleisis (176, 25.4%), sacral colpopexy/hysteropexy with mesh (140, 20.1%), colporrhaphy (77, 11.1%) or vaginal mesh repair (99, 43.1%). Two patients who received only sacrospinous ligament suspension were excluded. There were 68 (9.8%) and 3 (0.1%) patients whose blood loss reached 200 and 500 ml respectively. Procedures involving mesh and vaginal hysterectomy (VH) caused more intraoperative blood loss. Postoperative hemoglobin drop was least in colpocleisis (p < 0.05). All 6 of the patients (0.9%) who developed postoperative pelvic hematoma underwent concomitant VH, and 5 of them received mesh. CONCLUSIONS Hemorrhagic complications during or after pelvic floor reconstructive surgery are rare. Mesh use and concomitant VH are two major surgical risk factors for hemorrhagic complications in pelvic floor reconstructive surgery.
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Larouche M, Geoffrion R, Walter JE. No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2018; 39:1085-1097. [PMID: 29080723 DOI: 10.1016/j.jogc.2017.05.006] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
OBJECTIVE This guideline reviews the evidence related to the risks and benefits of using transvaginal mesh in pelvic organ prolapse repairs in order to update recommendations initially made in 2011. INTENDED USERS Gynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse. TARGET POPULATION Adult women with symptomatic pelvic organ prolapse considering surgery and those who have previously undergone transvaginal mesh procedures for the treatment of pelvic organ prolapse. OPTIONS The discussion relates to transvaginal mesh procedures compared with other surgical options for pelvic organ prolapse (mainly about vaginal native tissue repairs and minimally about other alternatives such as biological and absorbable vaginal mesh and abdominally placed surgical mesh). OUTCOMES The outcomes of interest are objective and subjective success rates and intraoperative and postoperative complications, such as adjacent organ injury (urinary, gastrointestinal), infection, hematoma/bleeding, vaginal mesh exposure, persistent pain, dyspareunia, de novo stress urinary incontinence, and reoperation. EVIDENCE PubMed, Medline, the Cochrane Database, and EMBASE were searched using the key words pelvic organ prolapse/surgery*, prolapse/surgery*, surgical mesh, surgical mesh*/adverse effects, transvaginal mesh, and pelvic organ prolapse. RESULTS were restricted to English or French language and human research. Articles obtained through this search strategy were included until the end of June 2016. Pertinent new studies were added up to September 2016. Grey literature was not searched. Clinical practice guidelines and guidelines of specialty societies were reviewed. Systematic reviews were included when available. Randomized controlled trials and observational studies were included when evidence for the outcome of interest or in the target population was not available from systematic reviews. New studies not yet included in systematic reviews were also included. Only publications with study groups larger than 20 individuals were selected because this criterion was used in the largest meta-analysis referenced in this guideline. A total of 1470 studies were obtained; after selecting only applicable studies and excluding duplicates, 68 manuscripts were reviewed and included. VALUES The content and recommendations were drafted and agreed upon by the principal authors and members of the Urogynaecology Committee. The Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation methodology framework. The Summary of Findings is available upon request. BENEFITS, HARMS, AND/OR COSTS It is expected that this guideline will benefit women with pelvic organ prolapse by ensuring that health care providers are aware of outcomes related to transvaginal mesh procedures and steps in the management of related complications. This should guide patient-informed consent before such procedures are undertaken. The benefits clearly outweigh the potential harms or costs of implementation of this guideline, although no direct harms or costs are identified. GUIDELINE UPDATE Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations. SUMMARY STATEMENTS RECOMMENDATIONS.
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Balsamo R, Illiano E, Zucchi A, Natale F, Carbone A, Sio MD, Costantini E. Sacrocolpopexy with polyvinylidene fluoride mesh for pelvic organ prolapse: Mid term comparative outcomes with polypropylene mesh. Eur J Obstet Gynecol Reprod Biol 2018; 220:74-78. [DOI: 10.1016/j.ejogrb.2017.11.018] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2017] [Revised: 11/12/2017] [Accepted: 11/20/2017] [Indexed: 10/18/2022]
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Larouche M, Geoffrion R, Walter JE. N o 351-Interventions de treillis transvaginales visant le prolapsus des organes pelviens. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2017; 39:1098-1112. [DOI: 10.1016/j.jogc.2017.08.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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17
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El-saman AM, Abbas AM, Amin AF, Fetih AN, Bahloul M, Salem MN, Salem HT. Laparoscopic cervicopexy: a novel minimally invasive fertility conservative procedure for stages III and IV uterine prolapse – case series. JOURNAL OF CLINICAL UROLOGY 2017. [DOI: 10.1177/2051415816686791] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Objective: To evaluate the safety and efficacy of laparoscopic anterior abdominal wall cervicopexy (LAWC), a novel minimally invasive procedure for management of stages III and IV uterine prolapse. Subjects and methods: The procedure was performed on 39 cases with symptomatic uterine prolapse during the period from June 2012 to January 2015. The procedure was started with obliteration of the pouch of Douglas through the approximation of the uterosacral ligaments with non-absorbable suture. Then, the procedure completed through anchoring the supravaginal cervix to the anterior abdominal wall by two non-absorbable sutures taken in good bites in the dense stroma of the supravaginal cervix. Results: Uterine prolapse was diagnosed as stage III in 36 (92.3%) women and stage IV in three cases. The procedure was conducted safely without any intraoperative complications. At 3 month follow-up, there was a statistically significant reduction in the extent of prolapse at all pelvic organ prolapse quantification (POP-Q) points as compared with preoperative assessment ( p = 0.000). Only five cases (12.8%) were found to have stage I uterine prolapse on evaluation by the POP-Q system after one year. Conclusion: LAWC is a minimally invasive, simple, and highly effective procedure to treat marked uterine prolapse and seems not to compromise fertility.
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Affiliation(s)
- Ali M El-saman
- Department of Obstetrics and Gynecology, Assiut University, Egypt
| | - Ahmed M Abbas
- Department of Obstetrics and Gynecology, Assiut University, Egypt
| | - Ahmed F Amin
- Department of Obstetrics and Gynecology, Assiut University, Egypt
| | - Ahmed N Fetih
- Department of Obstetrics and Gynecology, Assiut University, Egypt
| | - Mustafa Bahloul
- Department of Obstetrics and Gynecology, Assiut University, Egypt
| | - Mohammed N Salem
- Department of Obstetrics and Gynecology, Sohag University, Egypt
| | - Hossam T Salem
- Department of Obstetrics and Gynecology, Assiut University, Egypt
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Caveney M, Haddad D, Matthews C, Badlani G, Mirzazadeh M. Short-term complications associated with the use of transvaginal mesh in pelvic floor reconstructive surgery: Results from a multi-institutional prospectively maintained dataset. Neurourol Urodyn 2017; 36:2044-2048. [DOI: 10.1002/nau.23231] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2016] [Revised: 12/24/2016] [Accepted: 01/20/2017] [Indexed: 11/12/2022]
Affiliation(s)
- Maxx Caveney
- Wake Forest School of Medicine; Winston-Salem North Carolina
| | - Devin Haddad
- Wake Forest School of Medicine; Winston-Salem North Carolina
| | - Catherine Matthews
- Wake Forest School of Medicine; Winston-Salem North Carolina
- Department of Urology; Wake Forest School of Medicine; Winston-Salem North Carolina
| | - Gopal Badlani
- Wake Forest School of Medicine; Winston-Salem North Carolina
- Department of Urology; Wake Forest School of Medicine; Winston-Salem North Carolina
| | - Majid Mirzazadeh
- Wake Forest School of Medicine; Winston-Salem North Carolina
- Department of Urology; Wake Forest School of Medicine; Winston-Salem North Carolina
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Niu K, Lu YX, Shen WJ, Zhang YH, Wang WY. Risk Factors for Mesh Exposure after Transvaginal Mesh Surgery. Chin Med J (Engl) 2017; 129:1795-9. [PMID: 27453227 PMCID: PMC4976566 DOI: 10.4103/0366-6999.186631] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
Background: Mesh exposure after surgery continues to be a clinical challenge for urogynecological surgeons. The purpose of this study was to explore the risk factors for polypropylene (PP) mesh exposure after transvaginal mesh (TVM) surgery. Methods: This study included 195 patients with advanced pelvic organ prolapse (POP), who underwent TVM from January 2004 to December 2012 at the First Affiliated Hospital of Chinese PLA General Hospital. Clinical data were evaluated including patient's demography, TVM type, concomitant procedures, operation time, blood loss, postoperative morbidity, and mesh exposure. Mesh exposure was identified through postoperative vaginal examination. Statistical analysis was performed to identify risk factors for mesh exposure. Results: Two-hundred and nine transvaginal PP meshes were placed, including 194 in the anterior wall and 15 in the posterior wall. Concomitant tension-free vaginal tape was performed in 61 cases. The mean follow-up time was 35.1 ± 23.6 months. PP mesh exposure was identified in 32 cases (16.4%), with 31 in the anterior wall and 1 in the posterior wall. Significant difference was found in operating time and concomitant procedures between exposed and nonexposed groups (F = 7.443, P = 0.007; F = 4.307, P = 0.039, respectively). Binary logistic regression revealed that the number of concomitant procedures and operation time were risk factors for mesh exposure (P = 0.001, P = 0.043). Conclusion: Concomitant procedures and increased operating time increase the risk for postoperative mesh exposure in patients undergoing TVM surgery for POP.
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Affiliation(s)
- Ke Niu
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Yong-Xian Lu
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Wen-Jie Shen
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Ying-Hui Zhang
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Wen-Ying Wang
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
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It is a Bigger Question Than What to Do With the Uterus. Female Pelvic Med Reconstr Surg 2016; 22:397-398. [PMID: 27636209 DOI: 10.1097/spv.0000000000000293] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
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Zambon JP, Badlani GH. Vaginal Mesh Exposure Presentation, Evaluation, and Management. Curr Urol Rep 2016; 17:65. [DOI: 10.1007/s11934-016-0617-z] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
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Une interposition prothétique synthétique inter-vésico-vaginale implantée par voie vaginale diminue-t-elle le risque de récidive de cystocèle ? Recommandations pour la pratique clinique. Prog Urol 2016; 26 Suppl 1:S38-46. [DOI: 10.1016/s1166-7087(16)30427-4] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
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Hamuro A, Tachibana D, Wang H, Hayashi M, Yanai S, Kurihara Y, Misugi T, Katayama H, Nakano A, Koyama M. Combined reconstructive surgery involving uterosacral colpopexy and anterior vaginal mesh implantation for pelvic organ prolapse. J Obstet Gynaecol Res 2016; 42:707-15. [DOI: 10.1111/jog.12952] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2015] [Revised: 11/14/2015] [Accepted: 12/22/2015] [Indexed: 12/21/2022]
Affiliation(s)
- A. Hamuro
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - D. Tachibana
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - H. Wang
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - M. Hayashi
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - S. Yanai
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - Y. Kurihara
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - T. Misugi
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - H. Katayama
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - A. Nakano
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
| | - M. Koyama
- Division of Women's Life Care Medicine, Department of Obstetrics and Gynecology; Osaka City University Graduate School of Medicine; Osaka Japan
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Singh W, Wadhwa H, Halgrimson W, Kocjancic E. Role of ultrasound imaging in advancing treatment of female patients with pelvic floor mesh complications. World J Obstet Gynecol 2016; 5:73-77. [DOI: 10.5317/wjog.v5.i1.73] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/03/2015] [Revised: 10/14/2015] [Accepted: 12/11/2015] [Indexed: 02/05/2023] Open
Abstract
Application of vaginal mesh for stress urinary incontinence has seen widespread use due to its relatively short operative time in combination with its efficacy in treatment. However, vaginal mesh is not without its drawbacks and can lead to mesh erosion or extrusion, infection, dyspareunia, and recurrence of incontinence. Vaginal mesh complications can lead to feelings of hopelessness, isolation, shame, and emotional distress. Furthermore, failure to identify and address these complications in a timely manner can be permanently damaging to patient health. It is vital to be able to identify mesh complications early. Various imaging methodologies exist to visualize vaginal mesh placement and complications, including ultrasound, magnetic resonance imaging (MRI), and computed tomography (CT). This invited review paper focuses on the role of ultrasound in mesh visualization, mesh complication identification, and operative planning in the event of subsequent surgical mesh revision. Polypropylene mesh is echogenic on ultrasound, making it a useful tool for visualizing post-operative mesh placement. Transperineal, translabial and endovaginal ultrasound technique use has been described in the pre- and peri-operative setting to identify mesh in complex cases. Efficacy and practicality of CT and MRI use in identifying mesh in these cases is limited.
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Arora S, Kapoor R, Yadav P, Mittal V, Sureka SK, Kapoor D. Trans-vaginal anterior vaginal wall prolapse repair using a customized tension-free bell-shaped prolene mesh: A single-center experience with long-term functional analysis. Indian J Urol 2015; 31:339-343. [PMID: 26604446 PMCID: PMC4626919 DOI: 10.4103/0970-1591.166470] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
INTRODUCTION The existing literature shows that mesh reinforcement improves the anatomical success rate of cystocele repair. We report the long-term results of a custom bell-shaped mesh with simultaneous urethral support for the repair of cystocele. MATERIALS AND METHODS The present study was a single-center, single-surgeon case series of 36 patients. Only patients with Pelvic Organ Prolapse Quantification system (POP-Q) stage 2 and above were included in the study. Patients having rectocele or uterine/vault prolapse were excluded. Body of the mesh was used for reinforcement of the cystocele repair and two limbs were left tension free in the retropubic space. Patients were followed 3 monthly for the first year and yearly thereafter. Recurrence was defined as cystocele ≥stage 2 (Aa or Ba 0) any time after the first follow-up. RESULTS Mean patient age was 58.5 ± 6.2 years. The mean parity was 3.2 ± 1.6. Of 36 patients, 11 (30.5%) of the patients were POPQ stage 2, 15 (41.7%) were stage 3 and 10 (27.7%) were stage 4 cystocele. The mean follow-up period was 53.4 months, with 32 patients reporting for follow-up till date (88.9%). There was no bladder injury, no mesh erosion or infection. No patient required CIC (clean intermittent catheterization) or had stress urinary incontinence post-operatively at 5 years of follow-up. CONCLUSION The bell-shaped mesh is a simple, effective and safe procedure in the surgical management of cystocele with excellent long-term outcome.
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Affiliation(s)
- Sohrab Arora
- Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Rakesh Kapoor
- Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Priyank Yadav
- Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Varun Mittal
- Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Sanjoy Kumar Sureka
- Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Deepa Kapoor
- Department of Obstetrics and Gynaecology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
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Al-Kharabsheh AM, Lo TS, Cortes EFM, Wu PY. Conventional surgery for recurrent pelvic organ prolapse with mesh erosion after failed transvaginal mesh operation. Gynecol Minim Invasive Ther 2015. [DOI: 10.1016/j.gmit.2015.04.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
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Vaginally Placed Meshes: A Review of Their Complications, Risk Factors, and Management. CURRENT OBSTETRICS AND GYNECOLOGY REPORTS 2015. [DOI: 10.1007/s13669-015-0118-y] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
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Elsaman AM, Salem HT, Amin M, Fetih AN, Othman EER, Zahran KM. Modified cervicopexy: a novel, less-invasive technique for Stages III and IV uterine prolapse. Eur J Obstet Gynecol Reprod Biol 2014; 183:159-63. [PMID: 25461371 DOI: 10.1016/j.ejogrb.2014.10.014] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2014] [Accepted: 10/10/2014] [Indexed: 01/07/2023]
Abstract
OBJECTIVE To evaluate modified anterior abdominal wall cervicopexy (AWC) as a less invasive (via 3-cm minilaparotomy) and more augmented (via securing posterior vaginal wall to uterosacral ligaments) technique. METHODS Case series of 30 women with Stages III and IV apical uterine prolapse assessed by the pelvic organ prolapse quantification system. RESULTS The modified AWC procedure was performed successfully for 17 cases with Stage III uterovaginal prolapse and 13 cases with Stage IV uterovaginal prolapse. The procedure was conducted safely with no operative or postoperative complications, apart from two cases with postoperative urinary retention. Operative time ranged from 45 to 70min. Follow-up was available for 1-3 years. Overall, 27 cases were satisfied with the procedure, and three cases developed recurrence after caesarean section due to cutting the supporting sutures. CONCLUSIONS The modified AWC procedure is less invasive, simple and effective for Stages III and IV uterine prolapse.
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Affiliation(s)
- Ali M Elsaman
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut Woman's Health Hospital, Assiut University, Assiut, Egypt
| | - Hosam T Salem
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut Woman's Health Hospital, Assiut University, Assiut, Egypt
| | | | - Ahmed N Fetih
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut Woman's Health Hospital, Assiut University, Assiut, Egypt.
| | - Essam-Edin R Othman
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut Woman's Health Hospital, Assiut University, Assiut, Egypt
| | - Kamal M Zahran
- Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut Woman's Health Hospital, Assiut University, Assiut, Egypt
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Risk factors for vaginal mesh exposure after mesh-augmented anterior repair: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2014; 20:305-9. [PMID: 25185633 DOI: 10.1097/spv.0000000000000095] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
OBJECTIVES The aim of this study is to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse. METHODS We performed a retrospective cohort study of all patients who had mesh-augmented anterior repair by 1 surgeon between January 2007 and February 2012. Data were extracted from medical records. The primary outcome was the rate of anterior or apical vaginal mesh exposure. Both univariate and multivariate analyses were performed. RESULTS A total of 201 subjects were included. The mean (SD) follow-up was 14.3 (12.4) months. All cases were done using a type 1 macroporous monofilament polypropylene mesh. The overall mesh exposure rate was 8.5% (17/201). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower body mass index (BMI) (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with distal transverse incision) (P = 0.026), concurrent total hysterectomy (P < 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (P = 0.007). After multivariate analysis using logistic regression, only BMI (P < 0.001) and concomitant total hysterectomy (odds ratio, 48; P < 0.001) remained relevant. The exposure rate was 23.5% (16/68) when concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m, 9.5% (8/84) for BMI of 25 to 29.9 kg/m, 3.1% (1/32) for BMI of 30 to 34.9 kg/m, and 0% (0/23) for BMI greater than or equal to 35 kg/m. CONCLUSIONS Concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates.
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de Tayrac R, Sentilhes L. Complications of pelvic organ prolapse surgery and methods of prevention. Int Urogynecol J 2014; 24:1859-72. [PMID: 24142061 DOI: 10.1007/s00192-013-2177-9] [Citation(s) in RCA: 49] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The aim was to review complications associated with pelvic organ prolapse surgery. METHODS Every 4 years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 (case reports). The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. Grade A recommendation usually depends on consistent level 1 evidence. Grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs. Grade C recommendation usually depends on level 4 studies or "majority evidence from level 2/3 studies or Delphi processed expert opinion. Grade D "no recommendation possible" would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi. RESULTS AND CONCLUSIONS Transvaginal mesh has a higher re-operation rate than native tissue vaginal repairs (grade A). If a synthetic mesh is placed via the vaginal route, it is recommended that a macroporous polypropylene monofilament mesh should be used. At sacral colpopexy mesh should not be introduced or sutured via the vaginal route and silicone-coated polyester, porcine dermis, fascia lata and polytetrafluoroethylene meshes are not recommended as grafts. Hysterectomy should also be avoided (grade B). There is no evidence to recommend routine local or systemic oestrogen therapy before or after prolapse surgery using mesh. The first cases should be undertaken with the guidance of an experienced surgeon in the relevant technique (grade C). Expert opinion suggests that by whatever the surgical route pre-operative urinary tract infections are treated, smoking is ceased and antibiotic prophylaxis is undertaken. It is recommended that a non-absorbable synthetic mesh should not be inserted into the rectovaginal septum when a rectal injury occurs. The placement of a non-absorbable synthetic mesh into the vesicovaginal septum may be considered after a bladder injury has been repaired, if the repair is considered to be satisfactory. It is possible to perform a hysterectomy in association with the introduction of a non-absorbable synthetic mesh inserted vaginally, but this is not recommended routinely.
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Affiliation(s)
- Renaud de Tayrac
- Department of Obstetrics and Gynecology, Caremeau University Hospital, Place du Prof Robert Debré, 30900, Nîmes, France,
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Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2014; 177:146-50. [DOI: 10.1016/j.ejogrb.2014.03.039] [Citation(s) in RCA: 47] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2013] [Revised: 01/21/2014] [Accepted: 03/31/2014] [Indexed: 01/07/2023]
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Tamayol A, Akbari M, Annabi N, Paul A, Khademhosseini A, Juncker D. Fiber-based tissue engineering: Progress, challenges, and opportunities. Biotechnol Adv 2013; 31:669-87. [PMID: 23195284 PMCID: PMC3631569 DOI: 10.1016/j.biotechadv.2012.11.007] [Citation(s) in RCA: 271] [Impact Index Per Article: 22.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2012] [Revised: 11/16/2012] [Accepted: 11/19/2012] [Indexed: 12/28/2022]
Abstract
Tissue engineering aims to improve the function of diseased or damaged organs by creating biological substitutes. To fabricate a functional tissue, the engineered construct should mimic the physiological environment including its structural, topographical, and mechanical properties. Moreover, the construct should facilitate nutrients and oxygen diffusion as well as removal of metabolic waste during tissue regeneration. In the last decade, fiber-based techniques such as weaving, knitting, braiding, as well as electrospinning, and direct writing have emerged as promising platforms for making 3D tissue constructs that can address the abovementioned challenges. Here, we critically review the techniques used to form cell-free and cell-laden fibers and to assemble them into scaffolds. We compare their mechanical properties, morphological features and biological activity. We discuss current challenges and future opportunities of fiber-based tissue engineering (FBTE) for use in research and clinical practice.
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Affiliation(s)
- Ali Tamayol
- Biomedical Engineering Department, McGill University, Montreal, H3A 0G1, Canada
| | - Mohsen Akbari
- Biomedical Engineering Department, McGill University, Montreal, H3A 0G1, Canada
| | - Nasim Annabi
- Center for Biomedical Engineering, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Cambridge, MA 02139, USA
- Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute ofTechnology, Cambridge, MA 02139, USA
- Wyss Institute for Biologically Inspired Engineering, Harvard University, Cambridge, Massachusetts 02139, USA
| | - Arghya Paul
- Center for Biomedical Engineering, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Cambridge, MA 02139, USA
- Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute ofTechnology, Cambridge, MA 02139, USA
- Wyss Institute for Biologically Inspired Engineering, Harvard University, Cambridge, Massachusetts 02139, USA
| | - Ali Khademhosseini
- Center for Biomedical Engineering, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Cambridge, MA 02139, USA
- Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute ofTechnology, Cambridge, MA 02139, USA
- Wyss Institute for Biologically Inspired Engineering, Harvard University, Cambridge, Massachusetts 02139, USA
| | - David Juncker
- Biomedical Engineering Department, McGill University, Montreal, H3A 0G1, Canada
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Risk factors for mesh extrusion after prolapse surgery: a case-control study. Female Pelvic Med Reconstr Surg 2013; 18:357-61. [PMID: 23143431 DOI: 10.1097/spv.0b013e318274ff7d] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVES To identify risk factors for mesh extrusion in women undergoing pelvic organ prolapse repair by abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP). METHODS A multicenter case-control study of patients who underwent ASC or VMP from 2006 to 2009 identified using diagnosis and procedure coding. Cases were defined as women who underwent eligible index procedure with synthetic mesh and had mesh visible through the vaginal epithelium at postoperative evaluation; controls were matched in an approximate 1:3 ratio by date and type of procedure. Two conditional logistic regression models were constructed to assess variables associated with mesh extrusion among women who underwent ASC and among women who underwent VMP. RESULTS Eighty-four cases were identified (43 cases after ASC and 41 cases after VMP), and 252 patients were matched as controls (147 patients who underwent ASC and 105 patients who underwent VMP). Concomitant hysterectomy was positively associated with mesh extrusion) among women who underwent ASC (adjusted odds ratio, 3.18; 95% confidence interval, 1.27-7.93; P = 0.01) and VMP (adjusted odds ratio, 3.72, 95% confidence interval, 1.20-11.54; P = 0.02). Age, race, type of vaginal incision, menopausal status, medical comorbidities, and smoking were not significantly associated with extrusion in either group. CONCLUSIONS Concomitant hysterectomy is a risk factor for mesh extrusion after ASC and VMPs. This information may be helpful during informed preoperative counseling and planning.
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Deffieux X, Letouzey V, Savary D, Sentilhes L, Agostini A, Mares P, Pierre F. Prevention of complications related to the use of prosthetic meshes in prolapse surgery: guidelines for clinical practice. Eur J Obstet Gynecol Reprod Biol 2012; 165:170-80. [PMID: 22999444 DOI: 10.1016/j.ejogrb.2012.09.001] [Citation(s) in RCA: 55] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2012] [Revised: 08/01/2012] [Accepted: 09/03/2012] [Indexed: 11/19/2022]
Abstract
The objective of the study was to provide guidelines for clinical practice from the French College of Obstetrics and Gynecology (CNGOF), based on the best evidence available, concerning adverse events related to surgical procedures involving the use of prosthetic meshes. French and English-language articles from Medline, PubMed, and the Cochrane Database were searched, using key words (mesh; pelvic organ prolapse; cystocele; rectocele; uterine prolapse; complications; adverse event; sacral colpopexy; extrusion; infection). As with any surgery, recommendations include perioperative smoking cessation (Expert opinion) and compliance with the prevention of nosocomial infections (regulatory recommendation). There is no evidence to recommend routine local or systemic estrogen therapy before or after prolapse surgery using mesh, regardless of the surgical approach (Grade C). Antibiotic prophylaxis is recommended, regardless of the approach (Expert opinion). It is recommended to check for pre-operative urinary tract infection and treat it (Expert opinion). The first procedure should be undertaken under the guidance of a surgeon experienced in the relevant technique (Grade C). It is recommended not to place a non-absorbable synthetic mesh into the rectovaginal septum when a rectal injury occurs (Expert opinion). Placement of a non-absorbable synthetic mesh into the vesicovaginal septum may be considered after suturing of a bladder injury if the suture is considered to be satisfactory (Expert opinion). If a synthetic mesh is placed by vaginal route, it is recommended to use a macroporous polypropylene monofilament mesh (Grade B). It is recommended not to use polyester mesh for vaginal surgery (Grade B). It is permissible to perform hysterectomy associated with the placement of a non-absorbable synthetic mesh placed by the vaginal route but this is not routinely recommended (Expert opinion). It is recommended to minimize the extent of the colpectomy (Expert opinion). The laparoscopic approach is recommended for sacral colpopexy (Expert opinion). It is recommended not to place and suture meshes by the vaginal route when a sacral colpopexy is performed (Grade B). It is recommended not to use silicone-coated polyester, porcine dermis, fascia lata, and polytetrafluoroethylene meshes (Grade B). It is recommended to use polyester (without silicone coating) or polypropylene meshes (Grade C). Suture of the meshes to the promontory can be performed using thread/needle or tacks (Grade C). Peritonization is recommended to cover the meshes (Grade C). If hysterectomy is required, it is recommended to perform a subtotal hysterectomy (Expert opinion). Implementation of this guideline should decrease the prevalence of complications related to surgical procedures involving the use of prosthetic meshes.
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Affiliation(s)
- Xavier Deffieux
- AP-HP, Hôpital Antoine Béclère, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, Clamart, F-92141, France.
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Managing mesh exposure following vaginal prolapse repair: a decision analysis comparing conservative versus surgical treatment. Int Urogynecol J 2012; 24:119-25. [DOI: 10.1007/s00192-012-1847-3] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2012] [Accepted: 05/26/2012] [Indexed: 12/26/2022]
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Shah HN, Badlani GH. Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review. Indian J Urol 2012; 28:129-53. [PMID: 22919127 PMCID: PMC3424888 DOI: 10.4103/0970-1591.98453] [Citation(s) in RCA: 98] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
We reviewed the incidence, predisposing factors, presentation and management of complications related to the use of synthetic mesh in the management of stress urinary incontinence and pelvic organ prolapse repair. Immediate complications, such as bleeding, hematoma, injury to adjacent organs during placement of mesh and complication of voiding dysfunction are not discussed in this review, since they are primarily related to technique. A PubMed search of related articles published in English was done from April 2008 to March 2011. Key words used were urinary incontinence, mesh, complications, midurethral sling, anterior prolapse, anterior vaginal repair, pelvic organ prolapse, transvaginal mesh, vault prolapse, midurethral slings, female stress urinary incontinence, mesh erosion, vaginal mesh complications, and posterior vaginal wall prolapse. Since there were very few articles dealing with the management of mesh-related complications in the period covered in the search we extended the search from January 2005 onwards. Articles were selected to fit the scope of the topic. In addition, landmark publications and Manufacturer and User Facility Device Experience (MAUDE) data (FDA website) were included on the present topic. A total of 170 articles were identified. The use of synthetic mesh in sub-urethral sling procedures is now considered the standard for the surgical management of stress urinary incontinence. Synthetic mesh is being increasingly used in the management of pelvic organ prolapse. While the incidence of extrusion and erosion with mid-urethral sling is low, the extrusion rate in prolapse repair is somewhat higher and the use in posterior compartment remains controversial. When used through the abdominal approach the extrusion and erosion rates are lower. The management of mesh complication is an individualized approach. The choice of the technique should be based on the type of mesh complication, location of the extrusion and/or erosion, its magnitude, severity and potential recurrence of pelvic floor defect.
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Affiliation(s)
- Hemendra N. Shah
- Wake Forest University School of Medicine, Department of Urology, Medical Center Boulevard, Winston-Salem, NC, country USA
| | - Gopal H. Badlani
- Wake Forest University School of Medicine, Department of Urology, Medical Center Boulevard, Winston-Salem, NC, country USA
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Factors associated with exposure of transvaginally placed polypropylene mesh for pelvic organ prolapse. Int Urogynecol J 2012; 23:1461-6. [DOI: 10.1007/s00192-012-1706-2] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2011] [Accepted: 02/09/2012] [Indexed: 12/26/2022]
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Davila GW, Baessler K, Cosson M, Cardozo L. Selection of patients in whom vaginal graft use may be appropriate. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 2012; 23 Suppl 1:S7-14. [PMID: 22395288 DOI: 10.1007/s00192-012-1677-3] [Citation(s) in RCA: 43] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2011] [Accepted: 01/16/2012] [Indexed: 01/08/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The recent rapid and widespread adoption of the use of mesh, and mesh-based surgical kits for pelvic organ prolapse (POP) repair surgery has occurred largely unchecked, and is now being subjected to critical analysis and re-evaluation. METHODS There have been multiple driving forces for this phenomenon, including aggressive marketing by surgical device manufacturing companies, contagious hype among pelvic surgeons and regulatory processes which facilitated relatively rapid marketing of new devices. RESULTS Patient-related factors such as indications for mesh use, expected risks and benefits relative to mesh implantation, and appropriately selected outcome measures have been slow to be defined. CONCLUSIONS This manuscript reviews the currently available literature in the use of grafts and mesh in POP surgery with a focus on identifying situations where graft use may be appropriate for an individual patient. It also identifies specific clinical situations where mesh use may not be recommended.
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Davila GW. Optimizing safety and appropriateness of graft use in pelvic reconstructive surgery: introduction to the 2nd IUGA Grafts Roundtable. Int Urogynecol J 2012; 23 Suppl 1:S3-6. [PMID: 22395287 DOI: 10.1007/s00192-012-1676-4] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2011] [Accepted: 01/16/2012] [Indexed: 12/26/2022]
Affiliation(s)
- G Willy Davila
- Department of Gynecology, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL 33331, USA.
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Deffieux X, Savary D, Letouzey V, Sentilhes L, Agostini A, Mares P, Pierre F. Prévenir les complications de la chirurgie prothétique du prolapsus : recommandations pour la pratique clinique – Revue de la littérature. ACTA ACUST UNITED AC 2011; 40:827-50. [PMID: 22056180 DOI: 10.1016/j.jgyn.2011.09.011] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/15/2022]
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Do we need meshes in pelvic floor reconstruction? World J Urol 2011; 30:479-86. [DOI: 10.1007/s00345-011-0794-9] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2011] [Accepted: 10/29/2011] [Indexed: 12/26/2022] Open
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Huang KH, Chuang FC, Fu HC, Kung FT. Polypropylene mesh as an alternative option for uterine preservation in pelvic reconstruction in patients with uterine prolapse. J Obstet Gynaecol Res 2011; 38:97-101. [PMID: 21955133 DOI: 10.1111/j.1447-0756.2011.01647.x] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
AIM The aim of this study was to evaluate the efficacy and safety of polypropylene mesh for uterine preservation during pelvic reconstruction in patients with severe uterine prolapse. MATERIALS AND METHODS The study included 67 women with severe uterine prolapse (pelvic organ prolapse quantification stage III/IV) who received transvaginal mesh reconstruction with uterine preservation. Surgery combined with a transobturator membrane sling procedure (tension-free vaginal tape-transobturator route) was performed in 54 patients. Among them, 18 had urodynamic stress incontinence, 30 had occult stress urinary incontinence, and six had mixed urinary incontinence. Objective assessments were carried out with the pelvic organ prolapse quantification staging system, urodynamic examination, and 1-h pad test. Evaluation of urinary and prolapse symptoms comprised the subjective assessment. RESULTS The mean follow-up interval was 19.6 months (12-40 months). The objective cure rate for the treatment of uterine prolapse was 89.5%, and the objective cure rate for the treatment of urinary incontinence was more than 90%. CONCLUSIONS Uterine preservation in pelvic reconstruction is technically feasible and the subjective and objective assessments imply that uterine preservation in pelvic reconstruction is an alternative option for indicated patients.
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Affiliation(s)
- Kuan-Hui Huang
- Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
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Chen CH, Hsiao SM, Chang TC, Wu WY, Lin HH. Transvaginal cystocele repair using pursestring technique reinforced with custom-tailored two-armed mesh. Urology 2011; 78:1275-80. [PMID: 21908027 DOI: 10.1016/j.urology.2011.07.1380] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2011] [Revised: 06/24/2011] [Accepted: 07/09/2011] [Indexed: 11/16/2022]
Abstract
OBJECTIVE To evaluate the efficacy and safety of vaginal cystocele repair using a pursestring suture technique reinforced with custom-tailored 2-armed mesh. METHODS The records of patients who underwent isolated cystocele repair by a single surgeon were retrospectively reviewed. All women were assessed by clinical examination and lower urinary tract symptoms preoperatively and at 3 and 6 months and every year postoperatively. The principal outcome measure was anatomic cure (stage 1 or lower) assessed by the Pelvic Organ Prolapse Quantification system. RESULTS From May 2005 to June 2009, 50 consecutive patients with minimum stage 2 (Aa or Ba 0) cystocele were treated using the procedure. The mean follow-up was 24 months (range 12-54), and the success rate was 96% (48 of 50). No intraoperative complications occurred. Two developed vaginal erosion (4%) and underwent excision of the extruded mesh smoothly. The final 21 consecutive patients underwent urodynamic assessment pre- and postoperatively. Compared with the baseline urodynamic findings, surgery resulted in decreased maximal urethral pressure and maximal urethral closure pressures. However, neither increased de novo incontinence nor reduced cystometric bladder capacity developed. CONCLUSION The use of the pursestring suture technique reinforced with custom-tailored 2-armed mesh for vaginal cystocele repair is safe, effective, and economic.
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Affiliation(s)
- Chi-Hau Chen
- Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan
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Applications of knitted mesh fabrication techniques to scaffolds for tissue engineering and regenerative medicine. J Mech Behav Biomed Mater 2011; 4:922-32. [PMID: 21783102 DOI: 10.1016/j.jmbbm.2011.04.009] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2011] [Revised: 04/07/2011] [Accepted: 04/11/2011] [Indexed: 02/05/2023]
Abstract
Knitting is an ancient and yet, a fresh technique. It has a history of no less than 1,000 years. The development of tissue engineering and regenerative medicine provides a new role for knitting. Several meshes knitted from synthetic or biological materials have been designed and applied, either alone, to strengthen materials for the patching of soft tissues, or in combination with other kinds of biomaterials, such as collagen and fibroin, to repair or replace damaged tissues/organs. In the latter case, studies have demonstrated that knitted mesh scaffolds (KMSs) possess excellent mechanical properties and can promote more effective tissue repair, ligament/tendon/cartilage regeneration, pipe-like-organ reconstruction, etc. In the process of tissue regeneration induced by scaffolds, an important synergic relationship emerges between the three-dimensional microstructure and the mechanical properties of scaffolds. This paper presents a comprehensive overview of the status and future prospects of knitted meshes and its KMSs for tissue engineering and regenerative medicine.
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Lucot JP, Bot-Robin V, Giraudet G, Rubod C, Boulanger L, Dedet B, Vinatier D, Collinet P, Cosson M. Place du matériel prothétique dans le traitement du prolapsus par voie vaginale. ACTA ACUST UNITED AC 2011; 39:232-44. [DOI: 10.1016/j.gyobfe.2011.02.012] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2011] [Accepted: 02/11/2011] [Indexed: 11/30/2022]
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Stanford EJ, Mattox TF, Pugh CJ. Outcomes and complications of transvaginal and abdominal custom-shaped light-weight polypropylene mesh used in repair of pelvic organ prolapse. J Minim Invasive Gynecol 2010; 18:64-7. [PMID: 20965793 DOI: 10.1016/j.jmig.2010.09.004] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/14/2010] [Revised: 09/14/2010] [Accepted: 09/16/2010] [Indexed: 10/18/2022]
Abstract
STUDY OBJECTIVE To assess the outcomes and complications of transvaginally placed custom-shaped light-weight polypropylene mesh for repair of pelvic organ prolapse. DESIGN Retrospective review of medical records (Canadian Task Force classification II-2). SETTING Two urogynecologic centers. PATIENTS Between March 2006 and September 2007, 154 women with anterior, posterior, or apical prolapse underwent vaginal reconstructive surgery using custom-shaped transvaginal or abdominal mesh. Surgical procedures were chosen after informed consent. The primary outcome for the study was recurrence of prolapse, defined as POP-Q (Pelvic Organ Prolapse Quantitative) stage II or greater. Secondary end points included perioperative and postoperative complications. INTERVENTIONS Anterior compartment repair was performed in 94 patients (61%), and posterior compartment repair in 60 (39%). Combined anterior and posterior repairs were performed in 25 patients. Hysterectomy was performed in 27 patients (18%) (abdominal in 1, vaginal in 19, and laparoscopy-assisted in 7). Apical support techniques included sacrospinous fixation in 69 patients (45%), abdominal sacral colpopexy in 30 (19%), and vaginal culdoplasty in 7 (5%). Transobturator sling procedures were performed in 65 patients (42%). MEASUREMENTS AND MAIN RESULTS Postoperative follow-up exceeded 24 months in all patients. The overall success of these procedures was 97.4%. There were 4 failures (2.6%), defined as stage II prolapse or greater. Comparison of POP-Q points Aa, Ba, C, Ap, and Bp preoperatively and postoperatively revealed statistically significant improvement at each point (p <.001). Complications were observed in 17 patients (11%), with mesh extrusion in 1 (0.7%). CONCLUSIONS Long-term follow-up demonstrated that use of custom-shaped light-weight polypropylene mesh is safe and effective, with a low rate of complications.
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Affiliation(s)
- E J Stanford
- Gynecologic Specialties and Urogynecology, Germantown, Tennessee, USA.
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Finamore PS, Hunter K, Goldstein HB, Vakili B, Holzberg AS. Does local injection with lidocaine plus epinephrine prior to vaginal reconstructive surgery with synthetic mesh affect exposure rates? A retrospective comparison. Arch Gynecol Obstet 2010; 284:659-62. [DOI: 10.1007/s00404-010-1715-7] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2010] [Accepted: 09/28/2010] [Indexed: 12/26/2022]
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Current World Literature. Curr Opin Obstet Gynecol 2010; 22:430-5. [DOI: 10.1097/gco.0b013e32833f1219] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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