Transvaginal Mesh Procedures Research Articles

Accounts of harm and conflicts of interest in transvaginal mesh: Professional evaluations during an Australian Senate Inquiry

Transvaginal mesh (TVM) surgeries were introduced as an innovative treatment for stress urine incontinency (SUI) and/or pelvic organ prolapse (POP) in 1996. Years after rapid adoption of these surgeries into practice, it emerged that TVM-associated adverse events were uncommon but potentially severe. This initiated global action, including an Australian Commonwealth Government Senate Inquiry, in 2017. This inquiry was both a causal factor in, and surrounded by, a significant epistemic shift towards recognition of women's own accounts of their experience. The Inquiry generated copious data, mostly publicly available. There has been no systematic investigation of how professional stakeholders—clinicians, health services, regulators and manufacturers—contributed to the epistemic environment of this inquiry. MethodWe analysed 42 submissions made by professional stakeholders to this inquiry, and documents from 5 public hearings. We used framework analysis methods, applying deductive and developing inductive codes from the documents, and charting patterns across the documents.Our aim was to map:1. Professionals’ contribution to the epistemic environment of this inquiry;2. How professional actors constructed TVM-associated problems and proposed potential solutions; and,3. The relevance of conflicts of interest in TVM-associated harms. ResultsWe categorised the reasoning of professionals into two groups:a. Contesting the significance of, or evidence for, TVM-associated harms; andb. Denying or minimising conflict of interest.Professionals’ advocacy regarding policy solutions emphasised incremental change, aiming to retain TVM procedures to treat SUI and, under certain conditions, POP. ConclusionContestation regarding harms led to a testimonial quietening of TVM-affected women's interests. The close and normalised relationship between treating professionals and TVM manufacturers may have created a conflicted environment for practice. It seems unlikely that self-regulation will be adequate to ensure that harms are minimised, conflicts of interests well-managed, and patients' interests are the first priority when innovative surgical treatment options become available to practice.

Transvaginal mesh implant for pelvic organ prolapse: Huaxi protocol

AbstractWith increasing age, pelvic organ prolapse (POP), due to its high incidence, has become a common disease that seriously affects patients’ quality of life and places a heavy economic burden on families and society. Transvaginal mesh (TVM) is a minimally invasive and effective treatment for POP, although its use remains controversial due to the potential risk of mesh‐related complications. The US Foods and Drugs Administration, along with authorities in England, Australia, New Zealand, and other countries, have banned the sale and distribution of commercial TVM kits designed for POP. The TVM procedure remains an option for POP treatment and still appeals to many surgeons and patients today in Asia and most European countries, which suggests that a considerable number of POP patients can benefit from its continued refinement. Here we introduce the Huaxi protocol of the TVM plant for the treatment of POP.

The (commercialised) experience of operating: Embodied preferences, ambiguous variations and explaining widespread patient harm.

This article provides a detailed account of how surgeons perceived and used a device-procedure that caused widespread patient harm: transvaginal mesh for the treatment of pelvic floor disorders in women. Drawing from interviews with 27 surgeons in Canada, the UK, the United States and France and observations of major international medical conferences in North America and Europe between 2015 and 2018, we describe the commercially driven array of operative variations in the use of transvaginal mesh and show that surgeons' understanding of their hands-on, sensory experience with these variations is central to explaining patient harm. Surgeons often developed preferences for how to manage actual and anticipated dangers of transvaginal mesh procedures through embodied operative adjustments, but collectively the meaning of these preferences was fragmented, contested and deferred. We critically reflect on surgeons' understandings of their operative experience, including the view that such experience is not evidence. The harm in this case poses a challenge to some ways of thinking about uncertainty and errors in medical sociology, and calls for attention to a specific feature of surgical work: the extent and persistence of operative practices that elude classification as right or wrong but are still most certainly better and worse.

‘I have no life and neither do the ones watching me suffer’: women’s experiences of transvaginal mesh implant surgery

Objective: Many women are affected by pelvic floor disorders, such as stress urinary incontinence and pelvic organ prolapse. In recent years, these disorders have been treated with transvaginal mesh implant surgeries involving the vaginal insertion of woven netting. We explored women’s experiences of transvaginal mesh implant surgery through a biopsychosocial lens. Design: We analysed women’s submissions to an Australian Parliament Senate Inquiry on transvaginal mesh implant surgery using thematic analysis. Main Outcome Methods: One-hundred and fifty-three publicly available submissions detailing women’s experiences of transvaginal mesh implant surgery to an Australian Parliament Senate Inquiry were analysed. Adverse and positive accounts were eligible for inclusion. Results: We generated nine themes in three categories relating to the Biopsychosocial Model: Physical Health - comprising three themes; Psychological Health - comprising two themes; and Social Wellbeing - comprising four themes. Physical, psychological and social experiences interacted, resulting in reduced quality of life for women. Conclusion: Most women who made submissions to an Australian government inquiry about transvaginal mesh implant surgery described devastating impacts on physical, psychological, and social wellbeing. We provide recommendations to guide psychologists in assisting women with adverse transvaginal mesh-related outcomes. Further research should explore women’s long-term experiences of the various transvaginal mesh procedures.

Is transvaginal mesh procedure a potential measure for pelvic organ prolapse repair when performed by expert surgeons?

The aim of this study was to verify the safety and efficacy of transvaginal mesh by analyzing the 2-year follow-up data of patients performed by a surgeon with a high volume of procedures. A total of 617 patients with pelvic organ prolapse underwent transvaginal mesh by a single surgeon. Complications and anatomical status of each patient were examined up to 24 months after surgery. Risk factors for the recurrence were also analyzed. Regarding complications, we experienced 10 patients (3.8%) of bladder injuries in anterior transvaginal mesh and eight (3.4%) in anterior and posterior transvaginal mesh. Massive blood loss was observed in four patients, but there was no case of blood transfusion. Mesh exposures were seen in seven patients (1.2%). A total of 100 patients (16.2%) had prolapse recurrence, defined as the Pelvic Organ Prolapse Quantification System stage ≥II. As to recurrences on the operated compartments, we observed five patients (2.0%) for anterior transvaginal mesh, three (6.5%) for posterior transvaginal mesh, five (7.4%) for combined transvaginal mesh, and 31 (14.2%) in anterior and posterior transvaginal mesh. Regarding Point C before operation in the anterior and posterior transvaginal mesh, the recurrence rates were more than 23% in patients with a Point C of 4 or more. Binominal regression analyses showed that higher body mass index, younger age, and higher stage of uterine prolapse were significant risk factors. The transvaginal mesh surgery is safe when conducted by experts. However, the recurrence rate may exceed 20% for high-stage uterine prolapse even when conducted by experts.

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial

BackgroundPelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman’s quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III–IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.MethodsThe trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (β = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair.DiscussionThis multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III–IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective.Trial registrationClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.

Evaluation of single-incision apical vaginal suspension for treatment of pelvic organ prolapse

ObjectiveTo present a comprehensive evaluation of anterior/apical and/or posterior prolapse repair systems with a focus on safety and surgical efficacy. MethodsTwo hundred and twenty women with pelvic organ prolapse (POP) stage II–IV were referred for single-incision transvaginal mesh procedures in a single institution. Pre- and postoperative assessments included pelvic examination, urodynamic studies, and personal interviews about patients’ quality of life and urinary symptoms. ResultsThe anatomical success rate was 92.3 % (203/220), regardless of primary or de-novo POP, at 12–38 month follow-up. The POP quantification parameters, except total vaginal length, improved significantly after surgery (p < 0.05). Complications included bladder injury (one case), mesh exposure (six cases) and urinary retention that required intermittent catheterization (five cases). There were no cases of bowel injury during surgery. The results indicated that 29 % of patients had de-novo stress urinary incontinence and 7.7 % of patients had de-novo POP after surgery. ConclusionThe apical vaginal suspension system is a safe and effective procedure, creating good anatomical restoration and significant improvement in quality of life. However, the rate of de-novo POP in the anterior compartment of the vagina (31.8 %) seems high after treatment with apical and posterior prolapse repair systems.

Laparoscopic Sacrocolpopexy vs Transvaginal Mesh Repair for Advanced Pelvic Organ Prolapse: 1 Year Results of a Multicenter Randomized Study

Backgrounds: Laparoscopic sacrocolpopexy is considered the most durable operation for the repair of advanced uterovaginal prolapse. However, there is still disagreement about whether the efficacy and safety of vaginally implanted mesh to address advanced uterovaginal prolapse is comparable to sacrocolpopexy. Our goal was to evaluate the anatomical and subjective outcomes of laparoscopic sacrocolpopexy versus transvaginal mesh in a randomized trial in China. Methods: A multicenter randomized trial was carried out at 6 tertiary hospitals in China. Patients with symptomatic advanced prolapse (stages III-IV) were enrolled. Between January 2013 and June 2014, a total of 100 women were randomized. 40 laparoscopic sacrocolpopexy procedures and 42 transvaginal mesh procedures were performed. Patients were randomized to undergo either laparoscopic sacrocolpopexy or transvaginal mesh. Results: At 1 year, the anatomic success rate was 92.5% in the laparoscopic sacrocolpopexy arm, compared with 83.3% in the transvaginal mesh group (P=0.35). Laparoscopic sacrocolpopexy was associated with better apical support. The laparoscopic sacrocolpopexy group had a longer operative time. Mesh exposures occurred in 2.5% of laparoscopic repairs vs. 2.4% of transvaginal mesh repairs. Conclusion: In a randomized trial, 1-year objective cure rates were not statistically different. However the success rate was 9.2% higher for laparoscopic sacrocolpopexy. The two procedures had comparable mesh exposure rates, and other complications were rare in both groups. Trial registration: clinicaltrials.gov (NCT01762384). The date of registration was Jan 7th, 2013. URL was https://clinicaltrials.gov/ct2/show/NCT01762384?term=NCT01762384&draw=2&rank=1.

Predictors of persistent stress urinary incontinence after transvaginal mesh repair

BackgroundWe evaluated the effect of transvaginal mesh (TVM) surgery for voiding function and continence using noninvasive examination and questionnaire. The present study aimed to ascertain which categories of patients need concomitant mid-urethral sling (MUS) after TVM surgery.MethodsWe included women who underwent TVM procedure between November 2009 and October 2013. Data from noninstrumented uroflowmetry and questionnaires about urinary symptoms were analyzed.ResultsThe present study investigated the cases of 961 women who underwent TVM surgery. The persistence of stress urinary incontinence (SUI) was 57.6%. Almost all the parameters measured using uroflowmetry and questionnaires significantly improved in all types of urinary incontinence 12 months after surgery. A history of hysterectomy, preoperative high flow (corrected maximum flow rate > 1.5), and preoperative urge urinary incontinence were independent risk factors for the persistence of SUI.ConclusionsTVM for pelvic organ prolapse improved subjective and objective voiding function. Mixed urinary incontinence (MUI) patients with high urinary flow may be suitable for concomitant MUS with TVM because of the high level of SUI persistence.

Long term Follow-up of Transvaginal Anatomical Implant of Mesh in Pelvic organ prolapse

Transvaginal mesh (TVM) is a minimally invasive but effective treatment for pelvic organ prolapse (POP). However, mesh exposure is a common and problematic complication after TVM. This study assessed the safety and long-term outcomes of TVM. A retrospective review was performed on the medical records of 175 consecutive patients who underwent TVM with the anatomical implant technique for pelvic organ prolapse at our center from April 2007 to December 2012. All operations were performed using TVM with the anatomical implant technique. Intraoperative variables, postoperative complications, and TVM outcomes were assessed. In average of 8 years (ranging from 4 to 10 years), the objective cure ratio reached 99.4%; and the subjective success rate of the TVM operation was 91.4%. Only 2 cases (1.1%) were identified as having mesh exposure. The reoperation rate was 4.0% (95% CI, 1.1–6.9%). No patients abstained from sex due to the operation or postoperative discomfort. Our anatomical implant technique for correcting POP is feasible in TVM procedures, which lead to favourable subjective and objective outcomes with the lowest rates of mesh exposure (1.1%) in published data. Therefore, performing TVM operations with the appropriate technique could consider to be permitted.

Long-term experience with a novel uterine-sparing transvaginal mesh procedure for uterovaginal prolapse

ObjectivesTo evaluate outcomes and quality of life in patients operated transvaginally with an original mesh shape for uterus-sparing prolapse surgery and to demonstrate the safety and efficacy of the technique. Study designWe prospectively evaluated 66 postmenopausal patients (POP-Q Stage III: 32, IV: 34) operated between May 2008 and December 2013. We used wide weave polypropylene monofilament mesh that functions as a hammock anchored posteriorly to sacrospinous ligaments, its anterior wings exit the pelvis through the obturatory membrane.Follow-up was scheduled at 3-, 12- months and in May 2016. Prolapse-Quality of Life Questionnaire (P-QoL) was administered preoperatively, at 12 months and in May 2016. The chi square and Wilcoxon test were used for statistical analysis. ResultsMean follow-up was 5.6 (SD: 1.6, Range: 1.1–8.1) years. The overall success rate (POP-Q ≤ 2) was 92.5% at 12 months and 84.4% at May 2016, these data remained stable over time (p > 0.05). Early complications occurred in 2 (3%) patients, late in 5 (7.8%) of which mesh extrusion in 4 (6.3%). Data from P-QoL showed significant improvement between preoperative and postoperative data (P < 0.01 for all domains) and they remained stable with time (p > 0.05). De-novo dyspareunia was 17.6% at 12 months and 10.3% at May 2016. ConclusionsThe low rate and grade of complications demonstrates the safety of the procedure, which offers stable anatomical correction with significant improvement in QoL.

Short-term outcomes of the transvaginal minimal mesh procedure for pelvic organ prolapse

PurposeThis study aimed to evaluate the clinical outcomes and complications of transvaginal minimal mesh repair without using commercially available kits for treatment of pelvic organ prolapse (POP).Materials and MethodsThis retrospective cohort study involved 91 women who underwent surgical management of POP with originally designed small mesh between July 2014 and August 2015. This mesh is 56% smaller than the mesh widely used in Japan, and it has only two arms delivered into each right and left sacrospinous ligament. The main study outcome was the anatomic cure rate defined as recurrence of POP quantification (POP-Q) stage II or more. We also assessed changes in the overactive bladder symptom score (OABSS) and prolapse quality of life questionnaire (P-QOL) and evaluated adverse events. Finally, we compared patient backgrounds between the patients with and without recurrence.ResultsProlapse recurred in 10 of 91 patients (11.0%), and all patients with recurrence were diagnosed as POP-Q stage II. As adverse events, only mesh erosion occurred in two (2.2%) and pelvic pain in one (1.1%) of the 91 patients. The OABSS and P-QOL were significantly improved by the operation. When we compared patient backgrounds between the patients with and without recurrence, body mass index was the only factor influencing affecting recurrence.ConclusionsTransvaginal minimal mesh repair resulted in successful outcomes with low mesh-related complications and anatomic recurrence at one year. Furthermore, significant improvement in QOL was offered by this procedure. Our minimal mesh technique should be considered as one treatment option for the management of POP.

No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse

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 in2011. Gynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse. 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. 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). 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. 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. 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. 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. 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. 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. RECOMMENDATIONS.

Medicolegal basics and update on transvaginal mesh in Canada.

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. In this update, some medicolegal basics are outlined and Canadian context on legal proceedings are highlighted. This summary does not constitute legal advice and physicians should contact experts in legal matters for help with consents, complaints, litigation, or questions.

Characteristics of Providers Performing Urogynecologic Procedures on Medicare Patients 2012-2014.

To analyze the characteristics of providers performing stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures in the United States. The Centers for Medicare Services public database, released for years 2012 through 2014, was queried for SUI-related and POP-related Healthcare Common Procedure Coding System. Providers were categorized as Female Pelvic Medicine and Reconstructive Surgery (FPMRS) providers and non-FPMRS providers, using a list of FPMRS board-certified providers compiled through the American Board of Medical Subspecialties website. Other physician specialties that submitted SUI and POP procedures claims were tabulated. Six hundred twenty-nine FPMRS and 833 non-FPMRS providers submitted claims for SUI and POP procedures. The SUI procedures claims had the following provider specialty distribution: obstetrics and gynecology (OB/GYN)-FPMRS, 46.7%; urology, 26.3%; OB/GYN, 12.2%; and urology-FPMRS, 13.9%, with the remaining 0.9% being performed by other specialties. The POP procedures had the following specialty distribution: OB/GYN-FPMRS, 63.4%; OB/GYN, 16.7%; urology, 8.3%; and urology-FPMRS, 7.1%, with the remaining 4.5% being performed by other specialties.Provider distribution was compared between transvaginal mesh and sling insertion procedures to transvaginal mesh and sling removal procedures. The FPMRS providers claimed 63.6% of sling and transvaginal mesh insertion procedures and performed 84.9% of mesh and sling removal procedures. Medicare reimbursement data provides a unique insight into the distribution of provider specialties performing SUI-related and POP-related procedures in the Medicare population. The OB/GYN-FPMRS providers submitted the majority of claims for SUI and POP procedures from 2012 to 2014. The FPMRS providers are also performing the majority of mesh removal procedures.

A Proximal Straining Mesh Location Is Associated With De Novo Stress Urinary Incontinence After Transobturator Mesh Procedures.

The purpose of this study was to explore the association between mesh location and de novo stress urinary incontinence (SUI) after transvaginal mesh procedures. We retrospectively analyzed a database of women who had received transvaginal mesh procedures for stage III or greater cystocele according to the Pelvic Organ Prolapse Quantification system. Only data for women who neither reported SUI preoperatively nor had received concomitant anti-incontinence surgery were included for analyses. The mesh location was investigated by sonography via the percentage of the urethra covered by mesh, defined as the number calculated by dividing the portion of the urethral length covered by mesh (the distance from the bladder neck to the point of the urethra, which was indicated by an imaginary line at the level of the lower [caudal] mesh end and perpendicular to the urethra) by the total urethral length (the distance from the bladder neck to the external urethral meatus) in the sagittal plane. The resting, straining, coughing, and squeezing mesh locations of women who did (n = 29) and did not (n = 54) report SUI at the 12-month follow-up were compared. At the 12-month follow-up, women who reported SUI had a significantly smaller straining percentage of the urethra covered by mesh (mean ± SD, 28.5% ± 9.6%) compared with continent women (35.2% ± 15.8%), indicating a more proximal straining mesh location. Sonography is useful in investigating the location of the transvaginal mesh. De novo SUI after transvaginal mesh procedures is associated with a more proximal straining mesh location.

Application of single-incision transvaginal mesh in a woman undergoing peritoneal dialysis and suffering from refractory advanced stage pelvic organ prolapse.

Objective:We would like to provide an option of minimal invasive surgical intervention for a patient with end-stage renal disease undergoing continuous ambulatory peritoneal dialysis, who was at the advanced-stage pelvic organ prolapse (POP) and who also failed to be treated conservatively.Materials and method:We present a case of uterine prolapse stage IV in a woman who underwent continuous ambulatory peritoneal dialysis due to end-stage renal disease. Her severity of POP had only limited improvement after being switched to hemodialysis and vaginal cream use. After her informed consent, we performed a uterus-sparing transvaginal mesh procedure to adjust the anterior, apical, and posterior defects of pelvis.Results:There has been no recurrence of any compartment of POP during the 16-month follow-up period, nor any mesh-related complications. The perineal swelling subsided after switching to nocturnal automated peritoneal dialysis only in the supine position.Conclusion:Patients with POP at an advanced stage during peritoneal dialysis who failed to be treated conservatively may require a surgical intervention. Uterus-sparing transvaginal mesh was a feasible minimal invasive option.

Long-term outcome after transvaginal mesh repair of pelvic organ prolapse.

The aim of this study was to report long-term subjective and objective outcomes after the transvaginal mesh (TVM) procedurein long-term. Possible late-onset complications were of particular interest. This was a retrospective analysis of TVM performed using Prolift™ transvaginal mesh measuring subjective outcome using validated questionnaires. Objective outcome was assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system using two definitions: POP-Q stage ≤ 1, and vaginal wall prolapse at or above the hymen or vaginal apex not descending below the upper third of the vagina. Complications were reported with the Prosthesis/Graft Complication Classification Code designed by the International Continence Society/International Urogynecological Association (ICS/IUGA). Of 195 patients, 161 (82.6%) participated this study after a median of 7 years. The scores in questionnaires evaluating urinary (UI) or anal incontinence and constipation or pelvic floor symptoms were low, indicating favorable surgical outcomes. Altogether, 80.1% of patients were satisfied with the procedure. Anatomical cure was 56.4% and 69.3% depending on the definition used. Reoperation due to POP in any compartment was performed in 16.2% of patients. Mesh exposure rate was 23%, most of these being asymptomatic and of late onset. Outcome of the TVM procedure was satisfactory. Anatomical cure was inferior to subjective cure. Mesh exposure rate was high; most exposures observed in the long-term were of late onset and were asymptomatic.

Predictors for de novo stress urinary incontinence following extensive pelvic reconstructive surgery.

The aim of this study was to look for possible predictors preoperatively for the development of de novo stress urinary incontinence (SUI) in urodynamically continent women who underwent pelvic reconstructive surgery (PRS). Medical records of 637 continent women who underwent PRS for severe prolapse from January 2005 to December 2013 in our institutions were included in this study. We excluded women who had urodynamic stress incontinence (UDI) either occult or overt, detrusor overactivity, neurogenic bladder-voiding dysfunction, and previous anti-incontinent surgery. Primary outcome measure was the development of de novo SUI at 6 months to 1 year post operation. Of women in this study, 11 % developed postoperative de novo SUI at 6 months to 1 year of follow-up. Women older than 66 years were 2.86 times [95 % confidence interval (CI) 1.01-2.53, p = 0.14], diabetes mellitus (DM) 2.18 times (95 % CI 1.63-4.21, p = 0.002), certain type of transvaginal mesh procedure 3.5 times (95 % CI, p < 0.001), maximum urethral closure pressure (MUCP) < 60 mmH20 4.65 times (95 % CI, 2.87-8.64, p < 0.001), and functional urethral length (FUL) < 2 cm 3.48 times (95 % CI, 2.13-5.83, p < 0.001) at greater risk of developing de novo SUI. Continent women with advanced pelvic organ prolapse (POP) > 66 years, with DM or low MUCP and FUL values during preoperative urodynamic evaluation have higher risk of developing de novo SUI; therefore, we suggest counselling such women for concomitant PRS and anti-incontinent surgery.

Mesh Sacrocolpopexy Compared With Native Tissue Vaginal Repair

Published case series, prospective cohort studies, and large reviews have suggested that transvaginal mesh procedures are safe and effective for repair of apical prolapse. Such data led to widespread use of these devices to augment native tissue repairs. In recent years, however, several published reports have raised substantial concerns that these procedures are unsafe and may be associated with a number of significant adverse events. These concerns have led to a decreased use of transvaginal mesh procedures for repair of apical prolapse, and instead surgeons often favor native tissue vaginal repair or mesh sacrocolpopexy. Few well-designed studies have compared the safety and efficacy of mesh sacrocolpopexy with native tissue vaginal repair for repair of prolapse. This study performed a systemic literature review to compare anatomic and functional outcomes after mesh sacrocolpopexy with native tissue vaginal repairs in women with apical prolapse. A systematic search was conducted using the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov (through June 4, 2012) to identify studies comparing use of native tissue vaginal apex repairs and mesh sacrocolpopexy for treatment of apical pelvic organ prolapse. Eligible studies had a follow-up of at least 6 months. The primary study outcome was anatomic “success” following surgery. Secondary outcomes evaluated were reoperation and effects on bladder, bowel, and sexual function; surgical time; hospital stay; and blood loss. Evidence quality of individual studies was assessed using the Grades for Recommendation, Assessment, Development, and Evaluation system. Meta-analyses were performed only when 3 or more studies were identified reporting the same outcome. The initial search identified 3119 citations, 34 of which met criteria for inclusion full-text review, including 13 that compared anatomic success, reoperation, and symptom outcomes. Moderate-quality evidence supported improved anatomic outcomes following mesh sacrocolpopexy; very-low-quality evidence showed no differences between the 2 groups in reoperation. There was insufficient evidence regarding which procedure resulted in better bladder or bowel symptoms. Low-quality evidence showed no differences between the procedures in postoperative sexual function. Meta-analysis was performed on adverse event data from 79 studies; findings from longer noncomparative studies were included. More adverse events were noted after mesh sacrocolpopexy compared with native tissue vaginal repairs: ileus or small bowel obstruction (4.2% vs 0.4%, P < 0.01) and thromboembolic phenomena (0.6% vs 0.1%, P = 0.03). These data suggest that mesh sacrocolpopexy may be the preferred surgical option for repair of vaginal apex prolapse when anatomic durability is a priority. There is no strong evidence supporting one method over the other when minimizing adverse events or reoperation is the priority.