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transvaginal mesh complications

Dani Zoorob, Mickey Karram, Anna Stecher, Rose Maxwell, James Whiteside
OBJECTIVES: To identify litigation predictors among women with complications of transvaginal mesh. METHODS: Chart review and patient survey were conducted among women who had undergone a complication-related explant of a transvaginal prolapse or incontinence sling mesh. Trained study personnel administered a 57-question survey addressing subjective complaints related to bowel, bladder, sexual dysfunction, and development of pain or recurrent prolapse. These data were analyzed with respect to the subject's reported pursuit of litigation related to the mesh complication...
September 16, 2016: Female Pelvic Medicine & Reconstructive Surgery
Wan Song, Tae Heon Kim, Jin Woo Chung, Won Jin Cho, Ha Na Lee, Young Suk Lee, Kyu-Sung Lee
OBJECTIVES: To evaluate anatomical and functional outcomes of the Prolift Transvaginal Mesh for treatment of pelvic organ prolapse (POP) with regard to safety and satisfaction. METHODS: We reviewed the medical records of 163 patients who underwent POP repair with Prolift Transvaginal Mesh between December 2005 and March 2012. An "optimal" anatomic outcome was defined as Pelvic Organ Prolapse Quantification System (POP-Q) stage 0, and a "satisfactory" anatomic outcome was defined as POP-Q stage 1...
September 2016: Lower Urinary Tract Symptoms
Vani Dandolu, Megumi Akiyama, Gayle Allenback, Prathamesh Pathak
OBJECTIVE: Our objective was to quantitate the extent of complications and failure rate for apical prolapse repair with transvaginal mesh (TVM) use versus sacrocolpopexy over a minimum of 2 years of follow-up. METHODS: Truven CCAE and Medicare Supplemental databases 2008-2013 were used for analysis. Patients with apical prolapse repair via transvaginal mesh (TVMR), abdominal sacrocolpopexy (ASCP), laparoscopic sacrocolpopexy (LSCP), or native tissue repair (NTR) and continuously enrolled for years were in the study cohort...
August 25, 2016: International Urogynecology Journal
Shilpa Iyer, Sylvia M Botros
INTRODUCTION: Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States...
August 22, 2016: International Urogynecology Journal
Marisa M Clifton, Howard B Goldman
INTRODUCTION AND HYPOTHESIS: Complications of synthetic midurethral sling surgery include bladder outlet obstruction, mesh extrusion, and vaginal pain. A treatment of these complications is transvaginal mesh removal. The objectives of this video are to present cases of complications after sling placement and describe techniques to help with successful sling removal. METHODS: Three patients are presented in this video. One experienced urinary hesitancy and was found to have bladder outlet obstruction on urodynamic study...
August 16, 2016: International Urogynecology Journal
Rui Liang, Katrina Knight, Steve Abramowitch, Pamela A Moalli
PURPOSE OF REVIEW: Polypropylene mesh has been widely used in the surgical repair of pelvic organ prolapse. However, low but persistent rates of complications related to mesh, most commonly mesh exposure and pain, have hampered its use. Complications are higher following transvaginal implantation prompting the Food and Drug Administration to release two public health notifications warning of complications associated with transvaginal mesh use (PHN 2008 and 2011) and to upclassify transvaginal prolapse meshes from Class II to Class III devices...
October 2016: Current Opinion in Obstetrics & Gynecology
Tanja Hüsch, René Mager, Erika Ober, Ralf Bentler, Kurt Ulm, Axel Haferkamp
BACKGROUND: Transvaginal mesh repair has been discredited due to high complications rates in the past years. Therefore, we evaluated the quality of life (QoL) and complication rates after transvaginal mesh (TVM) repair for pelvic organ prolapse (POP). METHODS: A total of 148 women who underwent TVM repair for symptomatic POP were retrospectively enrolled. Complication rates and functional outcomes were retrospectively assessed and validated, standardised questionnaires were used prospectively for evaluation of QoL...
September 2016: International Journal of Surgery
Goran Rac, Austin Younger, James Q Clemens, Kathleen Kobashi, Aqsa Khan, Victor Nitti, Ilana Jacobs, Gary E Lemack, Elizabeth T Brown, Roger Dmochowski, Lara MacLachlan, Arthur Mourtzinos, David Ginsberg, Michelle Koski, Ross Rames, Eric S Rovner
AIMS: To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. METHODS: Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013...
July 26, 2016: Neurourology and Urodynamics
Joao P Zambon, Gopal H Badlani
INTRODUCTION: According to FDA, in 2010, approximately 300,000 women underwent surgical procedures in the USA to repair pelvic organ prolapse and approximately 260,000 underwent surgical procedures to repair stress urinary incontinence. From 560,000 surgeries, synthetic mesh was used in one out of three, and three out of four were performed transvaginally. The incorporation of mesh into pelvic organ prolapse repair has improved the long-term surgical anatomical outcomes and lower recurrence rates...
September 2016: Current Urology Reports
M Denancé, E Quiboeuf, C Hocké
OBJECTIVE: To assess at 6 months the efficiency, the safety and the satisfaction of a lightweight polypropylene mesh used for the transvaginal repair of cystocele by bilateral anterior sacrospinous ligament fixation (NUVIA™ SI). MATERIEL AND METHODS: A prospective cohort study was performed from January 2014 to June 2015. Preoperative assessment included an evaluation using the Pelvic Organ Prolapse Quantification system (POP-Q) and 3 questionnaires about symptoms, quality of life and quality of sex life (PFDI-20, PFIQ7, PISQ-12)...
September 2016: Progrès en Urologie
Lin Li Ow, Yik N Lim, Peter L Dwyer, Debjyoti Karmakar, Christine Murray, Elizabeth Thomas, Anna Rosamilia
INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess outcomes in native tissue (NT) and transvaginal mesh (TVM) repair in women with recurrent prolapse. METHODS: A retrospective two-group observational study of 237 women who underwent prolapse repair after failed NT repair in two tertiary hospitals. A primary outcome of "success" was defined using a composite outcome of no vaginal bulge symptoms, no anatomical recurrence in the same compartment beyond the hymen (0 cm on POPQ) and no surgical re-treatment for prolapse in the same compartment...
September 2016: International Urogynecology Journal
Megan O Schimpf, Husam Abed, Tatiana Sanses, Amanda B White, Lior Lowenstein, Renée M Ward, Vivian W Sung, Ethan M Balk, Miles Murphy
OBJECTIVE: To update clinical practice guidelines on graft and mesh use in transvaginal pelvic organ prolapse repair based on systematic review. DATA SOURCES: Eligible studies, published through April 2015, were retrieved through, MEDLINE, and Cochrane databases and bibliography searches. METHODS OF STUDY SELECTION: We included studies of transvaginal prolapse repair that compared graft or mesh use with either native tissue repair or use of a different graft or mesh with anatomic and symptomatic outcomes with a minimum of 12 months of follow-up...
July 2016: Obstetrics and Gynecology
Erin C Kelly, Jennifer Winick-Ng, Blayne Welk
OBJECTIVE: To measure the proportion of women with transvaginal prolapse mesh complications and their association with surgeon volume. METHODS: We conducted a retrospective, population-based cohort study of all women who underwent a mesh-based prolapse procedure using administrative data (hospital procedure and physician billing records) between 2002 and 2013 in Ontario, Canada. The primary outcome was surgical revision of the mesh. Primary exposure was surgeon volume: high (greater than the 75th percentile, requiring a median of five [interquartile range 5-6] procedures per year) and very high (greater than the 90th percentile, requiring a median of 13 [interquartile range 11-14] procedures per year) volume mesh implanters were identified each year...
July 2016: Obstetrics and Gynecology
Gery Lamblin, Chloé Gouttenoire, Laure Panel, Stéphanie Moret, Gautier Chene, Christophe Courtieu
INTRODUCTION AND HYPOTHESIS: To compare apical correction in stage ≥3 cystocele between two mesh kits. METHODS: This was a retrospective, nonrandomized study that compared two groups matched on anterior/apical POP-Q stage: 84 received Elevate Ant™ single-incision mesh (Elevate Ant group) and 42 Perigee™ transvaginal mesh (Perigee group). Follow-up at 1 and 2 years comprised objective (POP-Q) and subjective (PFDI-20, PFIQ-7, PISQ-12) assessments. The primary endpoint was objective success: 2-year apical POP-Q stage ≤1...
May 24, 2016: International Urogynecology Journal
Rodolfo Milani, Matteo Frigerio, Stefano Manodoro, Alice Cola, Federico Spelzini
INTRODUCTION AND HYPOTHESIS: Uterine-sparing procedures could be attractive in patients concerned about preservation of fertility and change in corporeal image and sexuality. Transvaginal uterosacral hysteropexy can provide an alternative mesh-free technique for uterine suspension. This study aimed to evaluate the feasibility of transvaginal uterine suspension to uterosacral ligaments in terms of operative data, complications, midterm efficacy, and patient satisfaction. MATERIALS AND METHODS: This retrospective study analyzed the first 20 cases of transvaginal hysteropexy through bilateral high uterosacral ligaments (modified Shull technique) performed in our Institution...
May 19, 2016: International Urogynecology Journal
Virva Nyyssönen, Markku Santala, Seija Ala-Nissilä, Risto Bloigu, Mervi Haarala
BACKGROUND/AIMS: To report objective and subjective outcomes and adverse events after placement of Elevate® Posterior transvaginal mesh without concurrent surgery. Changes in non-affected anterior compartment were under special interest. METHODS: A prospective study of Elevate® Posterior procedure in patients with symptomatic posterior compartment prolapse. Pelvic organ prolapse (POP) quantification (POP-Q) measurements and Pelvic Floor Dysfunction Inventory-20 (PFDI-20) and POP/urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires were used...
May 13, 2016: Gynecologic and Obstetric Investigation
Zhixing Sun, Lan Zhu, Tao Xu, Xinwen Shi, Jinghe Lang
OBJECTIVE: The literature advocates preoperative vaginal estrogen (VE) therapy to reduce mesh exposure in pelvic organ prolapsed (POP); however, there are no comparative studies so far. This study aims to compare the effects of preoperative VE and non-VE therapy for the incidence of mesh exposure in postmenopausal women after transvaginal pelvic reconstructive surgery (PRS) with mesh. METHODS: A randomized noninferiority single-surgeon study of 186 women with severe POP was conducted...
July 2016: Menopause: the Journal of the North American Menopause Society
Devin N Patel, Jennifer T Anger
PURPOSE OF REVIEW: Surgical repair of pelvic organ prolapse remains one of the most commonly performed inpatient procedures. New evidence has helped establish risk factors for recurrence and helped define the outcomes of native tissue repairs. The role of transvaginal mesh and minimally invasive techniques continues to evolve. RECENT FINDINGS: Recent emphasis on mesh complications and litigation has led to new research showing native tissue vaginal repairs to have higher success rates than previously reported...
July 2016: Current Opinion in Urology
B H Li, H J Huang, Y F Song
OBJECTIVE: To evaluate the effect and safety of a modified Prolift procedure, without preceding partial trachelectomy or hysterectomy for pelvic organ prolapse (POP) with coexistent cervical elongation. METHODS: Clinical data of 72 patients that underwent a modified Prolift procedure for POP with coexistent cervical elongation, between December 2008 and June 2012 in Fuzhou General Hospital of Nanjing Military Command was retrospectively analysed. A comparison was carried out between preoperative and postoperative parameters of pelvic organ prolapse quantitation system (POP-Q), and an objective evaluation was made according to the overall cure rate and recurrence rate...
March 2016: Zhonghua Fu Chan Ke za Zhi
William R Barone, Pamela A Moalli, Steven D Abramowitch
BACKGROUND: Although synthetic mesh is associated with superior anatomic outcomes for the repair of pelvic organ prolapse, the benefits of mesh have been questioned because of the relatively high complication rates. To date, the mechanisms that result in such complications are poorly understood, yet the textile characteristics of mesh products are believed to play an important role. Interestingly, the pore diameter of synthetic mesh has been shown to impact the host response after hernia repair greatly, and such findings have served as design criteria for prolapse meshes, with larger pores viewed as more favorable...
September 2016: American Journal of Obstetrics and Gynecology
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