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Transvaginal sling

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https://www.readbyqxmd.com/read/29212782/trials-of-transvaginal-mesh-devices-for-pelvic-organ-prolapse-a-systematic-database-review-of-the-us-fda-approval-process
#1
Carl J Heneghan, Ben Goldacre, Igho Onakpoya, Jeffrey K Aronson, Tom Jefferson, Annette Pluddemann, Kamal R Mahtani
INTRODUCTION: Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms. METHODS: We used FDA databases to determine the evidence for approval of transvaginal mesh...
December 6, 2017: BMJ Open
https://www.readbyqxmd.com/read/29119201/-implants-for-genital-prolapse-contra-mesh-surgery
#2
REVIEW
C Hampel
Alloplastic transvaginal meshes have become very popular in the surgery of pelvic organ prolapse (POP) as did alloplastic suburethral slings in female stress incontinence surgery, but without adequate supporting data. The simplicity of the mesh procedure facilitates its propagation with acceptance of higher revision and complication rates. Since attending physicians do more and more prolapse surgeries without practicing or teaching alternative techniques, expertise in these alternatives, which might be very useful in cases of recurrence, persistence or complications, is permanently lost...
November 8, 2017: Der Urologe. Ausg. A
https://www.readbyqxmd.com/read/29077924/perioperative-behavioral-therapy-and-pelvic-muscle-strengthening-do-not-enhance-quality-of-life-after-pelvic-surgery-secondary-report-of-a-randomized-controlled-trial
#3
RANDOMIZED CONTROLLED TRIAL
Alison C Weidner, Matthew D Barber, Alayne Markland, David D Rahn, Yvonne Hsu, Elizabeth R Mueller, Sharon Jakus-Waldman, Keisha Y Dyer, Lauren Klein Warren, Marie G Gantz, Susie Meikle
Background: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. Objective: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI)...
November 1, 2017: Physical Therapy
https://www.readbyqxmd.com/read/28954448/-evaluation-of-transperineal-sonography-for-lower-urinary-tract-symptoms-after-pelvic-floor-reconstruction
#4
X L Zhong, J Song, Y L Xu, X L Lyu, X H Zhong, A P Wang, Y F Song
Objective: To evaluate transperineal sonography for lower urinary tract symptoms after pelvic floor reconstruction. Methods: Eighty-three patients with severe pelvic organ prolapse received surgeries in Fuzhou General Hospital from September 2014 to September 2015, dividing into two groups: 27 patients were selected to receive transvaginal mesh (TVM) pelvic floor reconstruction surgery with tension-free vaginal tape-Abbrevo (TVT-Abbrevo) incontinence surgery, named TVM+TVT-Abbrevo group; 56 patients were selected to receive TVM pelvic floor reconstruction surgery only, named TVM group...
September 25, 2017: Zhonghua Fu Chan Ke za Zhi
https://www.readbyqxmd.com/read/28926726/fertility-and-pregnancy-outcomes-after-transvaginal-cervico-isthmic-cerclage
#5
Marie-Emmanuelle Neveu, Hervé Fernandez, Xavier Deffieux, Marie-Victoire Senat, Marie Houllier, Perrine Capmas
INTRODUCTION: Prematurity is the leading cause of neonatal morbidity and mortality. Cervical insufficiency seems to be the main risk factor. Treatment is cervical cerclage. In case of failure, a cervico-isthmic cerclage by Fernandez' technique, with the placement of a polypropylene sling by vaginal approach during the first trimester of pregnancy, has proven its effectiveness. The aim of our study is to report effectiveness of Fernandez' cervico-isthmic cerclage in subsequent pregnancies...
November 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28856017/repeatability-and-reproducibility-of-measurements-of-the-suburethral-tape-location-obtained-in-pelvic-floor-ultrasound-performed-with-a-transvaginal-probe
#6
Maria Magdalena Dresler, Jacek Kociszewski, Edyta Wlaźlak, Piotr Pędraszewski, Agnieszka Trzeciak, Grzegorz Surkont
INTRODUCTION: Implants used to treat patients with urogynecological conditions are well visible in US examination. The position of the suburethral tape (sling) is determined in relation to the urethra or the pubic symphysis. AIM OF THE STUDY: The study was aimed at assessing the accuracy of measurements determining suburethral tape location obtained in pelvic US examination performed with a transvaginal probe. MATERIAL AND METHODS: The analysis covered the results of sonographic measurements obtained according to a standardized technique in women referred for urogynecological diagnostics...
June 2017: Journal of Ultrasonography
https://www.readbyqxmd.com/read/28852790/informed-consent-checklists-for-midurethral-slings-a-common-sense-approach
#7
G Alessandro Digesu, Steven Swift, Victoria Handley
INTRODUCTION AND HYPOTHESIS: Following the US Food and Drug Administration's (FDA's) warning about the use of transvaginal mesh to treat pelvic organ prolapse (POP) and the use of single-incision slings to treat incontinence, the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina has increased tremendously. METHODS: This same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies...
November 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/28791224/midurethral-slings-in-the-mesh-litigation-era
#8
REVIEW
John Chang, Dominic Lee
Stress urinary incontinence (SUI) has always been a major health issue for women. With the progression of technology and surgical techniques, mid urethral slings (MUS) used in both transvaginal and transobturator routes have become the gold standard in the treatment of SUI. There is ample short to mid-term data confirming the efficacy and safety in using MUS in treating SUI in women. However, long-term data supporting the use of MUS in women to treat SUI is scarce. There has been much controversy surrounding the US Food and Drug Administrations' (FDA) public notification of potential complications surrounding the use of transvaginal mesh, which has been magnified and generalised by the media; but despite this there has still been substantial growth and uptake of MUS for treating SUI...
July 2017: Translational Andrology and Urology
https://www.readbyqxmd.com/read/28727128/transvaginal-six-arm-mesh-opur-in-women-with-apical-pelvic-organ-prolapse-analysis-of-short-term-results-pelvic-floor-ultrasound-evaluation
#9
Tomasz Kluz, Edyta Wlaźlak, Grzegorz Surkont
OBJECTIVES: Analysis of feasibility, efficacy and short-term results after six-arm transvaginal mesh OPUR implantation in women with apical prolapse. MATERIAL AND METHODS: The same surgeon operated all of 39 women using mesh OPUR. Preoperatively patients had a standardized interview and clinical examination. Intraoperative and postoperative complications were analyzed. Postoperative evaluation included standardized interview, clinical examination and standardized pelvic floor ultrasound performed with 2D transvaginal probe and 4D abdominal probe...
2017: Ginekologia Polska
https://www.readbyqxmd.com/read/28723719/clinical-application-of-a-transurethral-holmium-laser-excision-of-exposed-polypropylene-mesh-at-lower-urinary-tract-single-surgeon-experience-with-long-term-follow-up
#10
Chan Ho Lee, Ja Yoon Ku, Kyoung Lee, Jeong Zoo Lee, Dong Gil Shin
PURPOSE: The aim of this study was to evaluate the clinical application of a transurethral holmium laser excision of exposed polypropylene mesh as an effective minimally invasive surgical approach in patients with lower urinary tract mesh erosion following the transvaginal placement of polypropylene mesh. METHODS: A retrospective analysis was conducted on the data of 22 patients with exposed polypropylene mesh in the lower urinary tract that was managed using the transurethral holmium laser technique...
July 19, 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28660723/outcomes-of-treatment-of-stress-urinary-incontinence-associated-with-female-urethral-diverticula-a-selective-approach
#11
Alyssa Greiman, Lauren Rittenberg, Drew Freilich, Ross Rames, Ahmed El-Zawahry, Michelle Koski, Eric Rovner
AIMS: To assess surgical outcomes of concomitant treatment of SUI at time of transvaginal urethral diverticulectomy (TVUD) based on a selective approach. METHODS: Following Institutional Review Board (IRB) approval, we identified patients with a UD and SUI who underwent TVUD between July 2004 and January 2016. SUI was documented before and after surgery using subjective and objective parameters. Autologous pubovaginal slings (APVS) were used selectively based on surgeon and patient preference...
June 29, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28657993/outcomes-and-characteristics-of-patients-undergoing-surgical-management-for-mesh-related-complications
#12
Donna Mazloomdoost, Rachel N Pauls, Steven D Kleeman, Catrina C Crisp
OBJECTIVE: The aims of this study were to describe the characteristics of women presenting with mesh-related complications and evaluate postoperative quality of life, sexual functioning, and patient-perceived outcomes. METHODS: This institutional review board-approved study included a retrospective chart review and a cross-sectional follow-up with validated questionnaires. Demographics and medical histories were collected from charts of women treated for mesh-related complaints between 2010 and 2014...
June 27, 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28657986/the-truth-behind-transvaginal-mesh-litigation-devices-timelines-and-provider-characteristics
#13
Colby P Souders, Karyn S Eilber, Lynn McClelland, Lauren N Wood, Alexander R Souders, Vicki Steiner, Jennifer Tash Anger
OBJECTIVES: Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making. METHODS: We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents...
June 27, 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28657139/complications-following-the-insertion-of-two-synthetic-mid-urethral-slings-and-subsequent-removal
#14
Dominic Lee, Chasta Bacsu, Benjamin Dillon, Philippe E Zimmern
OBJECTIVE: To determine outcomes after removal of two synthetic mid-urethral slings (MUS) at a tertiary care center. METHODS: Following IRB approval, a retrospective chart review of non-neurogenic, symptomatic women requiring re-operation after ≥2 MUS was performed. Data reviewed by a third party included: demographics, prior anti-incontinence surgery, complications, pelvic/urinary symptoms, subsequent investigations, surgical repair and outcomes (including UDI-6/IIQ-7 questionnaires) at a minimum 6 months follow-up...
June 28, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28616112/choosing-the-right-sling-for-your-patient
#15
REVIEW
Stephen S Steele, Gregory G Bailly
Recent data has demonstrated a one in five lifetime risk of a woman requiring stress urinary incontinence (SUI) surgery. Currently, most women opt for a synthetic midurethral sling (MUS), with over 3.6 million placed worldwide. This article attempts to identify whether a gold standard exists with regards to surgical correction of female SUI. When considering which sling type to use for which incontinent woman, the published data demonstrates excellent results for both synthetic mesh (retropubic or transobturator routes) and fascial pubovaginal slings for most patients...
June 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
https://www.readbyqxmd.com/read/28616104/medicolegal-basics-and-update-on-transvaginal-mesh-in-canada
#16
REVIEW
Brock Hengel, Blayne Welk, Richard J Baverstock
In recent years, midurethral slings (MUS) and transvaginal mesh procedures have experienced blazing growth and popularity. However, the US Food and Drug Administration (FDA) and Health Canada regulatory advisories threw water on that fire and created a confusing environment surrounding their continued usage. MUS usage has continued in Canada and transvaginal mesh kits for pelvic organ prolapse have become a rarity. Several large organizations (the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction [SUFU], the American Urogynecologic Society [AUGS], and the Canadian Urological Association [CUA]) have developed "mesh statements" to clarify the issues surrounding mesh for patients and medical professionals; however, often the legal system sees things differently in either individual cases or class action lawsuits...
June 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
https://www.readbyqxmd.com/read/28616103/canadian-urological-association-position-statement-on-the-use-of-transvaginal-mesh
#17
REVIEW
Blayne Welk, Kevin V Carlson, Richard J Baverstock, Stephen S Steele, Gregory G Bailly, Duane R Hickling
Stress incontinence (SUI) and pelvic organ prolapse (POP) are common conditions. There is high-level evidence that midurethral mesh slings for stress incontinence are effective and safe; however, the rare but serious potential risks of this surgery must be discussed with the patient. The use of transvaginal mesh for prolapse repair does not appear to be supported by the current evidence, and its use should be restricted to specialized pelvic floor surgeons and specific clinical situations.
June 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
https://www.readbyqxmd.com/read/28506944/effect-of-sacrocolpopexy-and-retropubic-sling-on-overactive-bladder-symptoms
#18
Muhammad Faisal Aslam, William T Gregory, Blake Osmundsen
OBJECTIVE: In this study, we aimed to evaluate the effect of sacrocolpopexy and retropubic midurethral sling, or transvaginal tape (TVT) procedure, on overactive bladder (OAB) symptoms. Our null hypothesis was that concomitant sacrocolpopexy and TVT exacerbate OAB symptoms. MATERIAL AND METHODS: This is a prospective cohort study. All subjects had apical/anterior prolapse and underwent robotic-assisted sacrocolpopexy and TVT, with or without concomitant hysterectomy...
March 15, 2017: Journal of the Turkish German Gynecological Association
https://www.readbyqxmd.com/read/28479238/challenging-the-myth-transvaginal-mesh-is-not-associated-with-carcinogenesis
#19
Bilal Chughtai, Art Sedrakyan, Jialin Mao, Dominique Thomas, Karyn S Eilber, J Quentin Clemens, Jennifer T Anger
PURPOSE: We sought to determine if there was a potential link between synthetic polypropylene mesh implantation for transvaginal pelvic organ prolapse and stress urinary incontinence, and carcinogenesis using statewide administrative data. MATERIALS AND METHODS: Women who underwent transvaginal surgery for pelvic organ prolapse or stress urinary incontinence with mesh between January 2008 and December 2009 in New York State were identified using ICD-9-CM procedure codes and CPT-4 codes...
May 4, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28394497/prediction-of-mid-urethral-sling-failure-with-clinical-findings-and-urodynamics
#20
Serdar Aydin, Çağrı Arioğlu Aydin, Fırat Ersan
OBJECTIVE: Mid-urethral slings (MUS) become a standard, minimally invasive surgery to treat urinary stress incontinence. Our aim is to investigate the contribution of preoperative urodynamics to mid-urethral slings success and determine predictors for choosing mid-urethral sling route. METHODS: Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution...
May 2017: Lower Urinary Tract Symptoms
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