Mesh-related complications in single-incision transvaginal mesh (TVM) and laparoscopic abdominal sacrocolpopexy (LASC)

ObjectiveFew studies have investigated the long-term impact of synthetic mesh reconstructive surgery for pelvic organ prolapse (POP) on patient outcomes. This study aimed to examine the incidence and risk factors of mesh exposure and the subsequent requirement for surgical interventions due to mesh-related complications.Materials and methodsThis retrospective study was conducted from November 2010 to April 2018. We recruited women with Pelvic Organ Prolapse Quantification (POP-Q) stage 3 or 4 who underwent mesh reconstructive surgery for POP, and enrolled 487 women who received transvaginal mesh (TVM) and 110 women who received laparoscopic abdominal sacrocolpopexy (LASC). Assessments included mesh exposure rate and mesh-related complications requiring surgical interventions in both groups.ResultsIn the LASC group, the overall mesh-related complication rate was 8.18% over a mean follow-up period of 18 months. Concomitant laparoscopic-assisted vaginal hysterectomy was associated with mesh exposure (OR = 9.240; 95% CI = 1.752–48.728). No patients in the concurrent supracervical hysterectomy group were exposed to mesh. In the single-incision TVM group, the overall rate of mesh-related complications was 3.29% over a mean follow-up period of 19 months. Concomitant total vaginal hysterectomy was also a risk factor for mesh exposure (OR = 4.799; 95% CI = 1.313–17.359).ConclusionPreserving the cervix or uterus decreased the rate of mesh exposure in those undergoing TVM and LASC surgery. The overall rate of mesh-related complications was low after up to 8 years of follow-up.     

Continuing Medical Education: Urogenital Complaints and Female Sexual Dysfunction (Part 2) (CME)

IntroductionFemale sexual dysfunction (FSD) is common in women with urogenital disorders that occur as a result of pelvic floor muscle and fascial laxity.AimProvide a comprehensive review of FSD as it relates to common urogenital disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and to discuss the impact of the surgical repair of these disorders on sexual function.MethodsSystematic search of the medical literature using a number of related terms including FSD, POP, SUI, surgical repair, graft augmentation, complications, and dyspareunia.Main Outcome MeasuresReview of the medical literature to identify the relation between FSD and common urogenital disorders in women and to describe appropriate treatment strategies to improve quality of life (QOL) and sexual function.ResultsFSD is common in women with POP and SUI. Treatment options for POP and SUI include behavioral, pharmacological, and surgical methods which can also affect sexual function.ConclusionsSexual dysfunction is a common, underestimated complaint in women with POP and SUI. Treatment should be tailored toward improving sexual function and QOL. Surgical correction is generally beneficial but occasionally can result in negative alterations in sexual function. Patient selection and methods used for surgical repair are important factors in determining anatomical and functional success. Wehbe SA, Kellogg S, and Whitmore K. Urogenital complaints and female sexual dysfunction (part 2).     

Management of complications of mesh surgery

Polypropylene mesh (PPM) has been used in abdominal sacrocoplopexies since the 1990's however following a patient led campaign controversy surrounds its use incontinence procedures, midurethral slings (MUS) and vaginal mesh prolapse repairs. The complication rates following mesh surgery may be as high as 10%. NHS England paused the vaginal insertion of polypropylene mesh in July 2018 pending a review by Baroness Cumberledge. This review will outline the assessment and basic management of complications of polypropylene mesh. This is a relatively new area of urogynaecological practice which non-specialist obstetric and gynaecology clinicians and GPs need to be aware of. Symptoms which could be due to mesh complications are vaginal discharge or bleeding, recurrent urinary tract infection, haematuria, dyspareunia and pelvic pain. Women presenting with any of the above symptoms should be asked if they have had previous surgery for stress incontinence or prolapse. The women may not recall having mesh inserted and may use different terms “sling” “net” or “tape”. They should be examined to both look and feel for PPM. Mesh complications should be managed by the designated mesh centres which are listed on the BAUS and BSUG websites. All mesh complications should be reported to the Medicines & Healthcare products Regulatory Agency (MHRA) by the yellow card system. All mesh complications requiring further surgical intervention should be recorded on the British Society of Urogynaecology (BSUG) national database.     

The efficacy and complications of using transvaginal mesh to treat pelvic organ prolapse in Taiwan: A 10-year review

Transvaginal mesh (TVM) insertion for the treatment of pelvic organ prolapse (POP) is significantly associated with lower failure rates, although its use remains controversial due to the potential risk of mesh-related complications. In this review, we collected the published literature regarding the use of TVM to treat POP in an attempt to assess both the efficacy and complications related to TVM usage in Taiwan.We searched 25 English language articles using PubMed related to TVM in Taiwan from 2010 to 2019. The present article focuses on the efficacy and complications of TVM and analyzes the data.There were 25 studies on TVM selected for this review. Regarding their success rate, 21 out of the 22 studies (95.5%) had more than a 90% objective success rate. Twenty studies (90.9%) had less than 10% major complications of TVM. Twenty out of the 25 studies (80.0%) had 5% or less mesh exposure. For self-cut TVM and the later single-incision TVM, both the complication rates and exposure rates decreased. The rate of de novo dyspareunia ranged from 2.6% to 14.3%, and the incidence decreased yearly from 2011 to 2019.This review showed both the high treatment efficacy and low complication rate of TVM usage for the short-term treatment of POP in Taiwan. However, a longer-term study is needed to draw a conclusion regarding the safety of this treatment.     

经阴道网片置入手术的利与弊

随着社会老龄化的日益加重,盆腔器官脱垂（POP）成为中老年妇女的常见疾病。经阴道网片置入（TVM）手术作为一种微创的自然通道手术用于治疗POP,具有解剖复位、功能恢复及疗效持久的优势,近20年来被广泛应用。然而,因网片相关并发症问题其被美国食品药品监督管理局（FDA）警告2次。国际泌尿妇科协会/国际尿控学会（IUGA/ICS）对网片相关并发症的分类包括网片暴露与侵蚀、出血血肿、膀胱尿道肠管损伤、感染、慢性盆腔痛以及原发性性交困难等,其中网片暴露与侵蚀为最常见的并发症。我国经阴道网片的去留成为一个值得深思的问题。     

Mesh-related infections after pelvic organ prolapse repair surgery

The use of vaginal meshes has been an advance in the surgical management of women with pelvic organ prolapse. We reviewed the literature to synthesize the evidence regarding the infectious complications related to this new type of foreign body. We searched PubMed, current contents, and references of initially identified relevant articles and extracted data regarding the incidence, clinical manifestation, and management of vaginal mesh-related infections. The incidence of mesh-related infections and erosion ranged from 0 to 8%, and 0 to 33%, respectively, in the published studies. Various factors influence the development of vaginal mesh-related infectious complications such as the kind of biomedical material (e.g. filament structure, pore size) of the mesh, the type of procedure, the preventive measures taken, and the age and underlying comorbidity of the treated women. Non-specific pelvic pain, persistent vaginal discharge or bleeding, dyspareunia, and urinary or faecal incontinence are the most common manifestation of vaginal mesh-related infection. Clinical examination may reveal induration of the vaginal incision, vaginal granulation tissue, draining sinus tracts, and prosthesis erosion or rejection. Various pathogens have been implicated, including Gram-positive and Gram-negative aerobic and anaerobic bacteria. The management of mesh-related infections in women who underwent pelvic organ reconstruction is combined surgical and medical treatment. Although the use of vaginal meshes has become a new effective method of pelvic organ prolapse surgery clinicians should be aware of the various post-operative complications, including mesh-related infections.     

Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery—A systemic review

Pelvic organ prolapse (POP) is a common condition in women. Women with POP often experience pelvic discomfort, urinary and fecal problems, sexual dysfunction, and an overall decrease in their quality of life. Surgical treatment is a feasible option if conservative management fails. Various surgical techniques have been proposed to correct POP with or without the use of graft material. Owing to recent U.S. Food and Drug Administration warnings about mesh-related complications, sacrospinous ligament fixation (SSF), as a traditional vaginal procedure, may play an important role again. To answer this question and evaluate quantitatively the efficacy of SSF in POP, we conducted a systemic review of the available data about SSF and POP. Interventions had to include SSF as a point of attachment. To eliminate confounding bias and effect modification, at least one arm must include SSF without mesh or graft. All follow-up periods were allowed. Information on the following parameters was extracted and entered into a database: study design, type of intervention, number of patients, follow-up in months, cure rate, recurrence rate, intra/postoperative complications, and/or uni/bilateral, preventive/therapeutic, or concomitant procedures. Published papers from the years 1995 to 2011 were selected for analysis.     

Autologous Fascial Slings for Surgical Management of Stress Urinary Incontinence: A Come Back

Stress urinary incontinence (SUI) is a common type of urinary incontinence adversely affecting the quality of life of women. For mild SUI, life style changes, pelvic floor exercises and medical treatment with duloxetine may help. Most patients of moderate to severe SUI usually require surgical treatment. Various surgical treatment options include Kelly’s plication, Burch colposuspension, bulking agents and sling surgeries. Although, suburethral fascial slings including the autologous rectus fascia slings were in vogue before 1990, they were overtaken by minimally invasive, faster and easier artificial midurethral slings (tension free vaginal tape and transobturator tape). However, observation of serious long-term and life changing complications of synthetic midurethral slings like mesh erosion, chronic pelvic pain and dyspareunia led to their adverse publicity and medico legal implications for the operating surgeons. This led US FDA (Food and Drug Administration) to issue a warning against their use. Currently, their use has significantly decreased in many countries, and they are no longer available in some countries. This has led to renaissance of use of natural autologous fascial sling, especially rectus fascia for surgical management of SUI. Although performing rectus fascia sling surgery is technically more challenging, takes longer, has more short-term morbidity like voiding dysfunction, their long-term success is high with very little risk of serious complications like mesh erosion, chronic pelvic pain and dyspareunia. However, multicentric trials and longer follow ups are needed before it’s routine recommendation This review discusses the role of autologous fascial sling (especially rectus fascia) for the surgical management of SUI in the current time and the need of ongoing training of this procedure to gynecology residents and urogynecology fellows.     

Concomitant trocar-guided transvaginal mesh surgery with a midurethral sling in treating advanced pelvic organ prolapse associated with stress or occult stress urinary incontinence

ObjectiveThe purpose of this study was to evaluate the efficacy and feasibility of concomitant trocar-guided transvaginal mesh (TVM) surgery with a midurethral sling (MUS) for treating women with advanced pelvic organ prolapse (POP) and stress urinary incontinence (SUI) or occult SUI (OSUI).Materials and methodsEighty-nine women with advanced POP and SUI or OSUI were retrospectively enrolled. The Total Prolift and Tension-free Vaginal Tape-Obturator Systems were used for trocar-guided TVM surgery and MUS. Patients received regular follow-up at 1 week, and 1 month, 3 months, 6 months, and 12 months postoperatively, and then annually thereafter. The endpoints were the success rate for POP, and perioperative and postoperative complications. Functional outcomes were the presence of voiding difficulty, persistent or de novo overactive bladder symptoms, postoperative SUI, and paresthesia.ResultsThe median follow-up period was 35 months (range, 12–50 months). Within the follow-up period, 84 patients (94.4%) were objectively cured, five patients (5.6%) had vaginal apical mesh exposure, 29 individuals (32.6%) had persistent or de novo overactive bladder symptoms, six individuals (22.5%) had de novo SUI (two were found by urodynamics), and nine individuals (10.1%) had voiding difficulties (two were found by urodynamics). In addition, the vaginal hysterectomy group had greater blood loss, longer operation times, and a higher mesh erosion rate compared to the uterine suspension group.ConclusionConcomitant trocar-guided TVM surgery and MUS with the use of total Prolift and Tension-free Vaginal Tape-Obturator offer good efficacy in treating women with advanced POP and SUI or OSUI. The vaginal hysterectomy group had more perioperative complications.     

经阴道植入网片手术并发症的理解与认识

经阴道植入网片（transvaginal mesh,TVM）手术是广泛应用于盆腔器官脱垂（pelvic organ prolapse,POP）治疗的手术术式。理解与认识TVM手术并发症,从而有效预防并发症的发生是提高手术安全性、减少不良预后的关键。降低TVM手术并发症的发生率,既要求术者要对盆底疾病有正确的理解与认识及准确的诊断,做好术前准确的评估,又要求术者具有完善的手术操作技能,以及丰富的盆底手术分离、穿刺等技术的临床经验。同时围手术期的护理和术后维护,也是预防术后并发症的发生应当注意的问题。     

经阴道植入网片手术并发症的理解与认识

经阴道植入网片（transvaginal mesh,TVM）手术是广泛应用于盆腔器官脱垂（pelvic organ prolapse,POP）治疗的手术术式。理解与认识TVM手术并发症,从而有效预防并发症的发生是提高手术安全性、减少不良预后的关键。降低TVM手术并发症的发生率,既要求术者要对盆底疾病有正确的理解与认识及准确的诊断,做好术前准确的评估,又要求术者具有完善的手术操作技能,以及丰富的盆底手术分离、穿刺等技术的临床经验。同时围手术期的护理和术后维护,也是预防术后并发症的发生应当注意的问题。     

Prolift网片联合尿道中段悬吊治疗POP或合并SUI患者的近期疗效

目的:探讨全阴道修复网片(total vaginal mesh,TVM)即Gynecare Prolift网片修复系统及联合经闭孔无张力阴道吊带(tensiongfree vaginal tape-obtutor,TVT-O)尿道中段悬吊手术治疗盆腔器官脱垂(pelvic organ prolapse,POP)或合并压力性尿失禁(stress urinary incontinence,SUI)的近期疗效。方法:选择Ⅱ度以上子宫和(或)阴道壁脱垂患者24例,其中本次手术前已切除子宫5例,术中同时切除子宫12例,保留子宫7例。16例用全盆底修复网片(total Prolift),8例用前盆修复网片(anterior Prolift);10例因合并压力性尿失禁同时行TVT-O尿道中段悬吊术。结果:24例患者术中均无严重并发症发生,3例(12.5%)出血量超过500ml;术后随访12～20个月,1例至术后10个月时发现阴道壁网片侵蚀(4.2%,1/24),经门诊4次修剪好转;24例患者均无复发。结论:用Prolift盆底修复网片系统进行盆底重建术,手术安全、易行、微创,近期疗效肯定;合并SUI者同时使用TVT-O不增加手术难度和并发症的发生率。     

The management of mesh complications

Polypropylene mesh has been widely used in Urogynaecology for the management of prolapse and stress urinary incontinence. Growing recognition of long-term complications has led to the pause on all vaginally inserted mesh within the UK and other countries. These complications include vaginal mesh exposure, visceral perforation and chronic pain. It is important for all gynaecologists to be aware of these complications, signs, assessment and possible management options. Ultimately, a regional mesh centre should be involved in the care of these women as management if often complex. This article discusses different types of mesh, possible clinical presentations and the investigations which may be offered. Management options are outlined, however, involvement of the multidisciplinary team to provide adequate management options is essential.     

Place of mesh in vaginal surgery, including its removal and revision

In this review, I aim to establish the place of vaginal pelvic organ prolapse surgery with mesh, drawing on personal experience. Physiopathologic justifications for the use of synthetic implants are described, and reasonable indications are highlighted. Major recommendations for the insertion are made. Possible complications, such as erosion, retraction, pain, failure and dysfunction are explained, and treatments, including secondary surgery are reviewed. The need for specific training is emphasised, including indications, standard techniques of insertion, follow up, and mesh-related symptoms of complications, their management, including indications, and techniques of revision or excision. Mesh surgery in pelvic organ prolapse aims to replace defective ligaments and fascias by a synthetic implant that provokes a foreign body reaction and fibrosis around it, recreating new connective support. Women indicated for this type of surgery include those at high risk of recurrence after autologous surgery resulting from defective connective tissue. Insertion techniques and the management of complications need specific training before using mesh in pelvic organ prolapse surgery. Revision and removal should be carried out in referral centres.     

Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse? Results of a Pragmatic Approach

ObjectivePelvic organ prolapse (POP) surgery may unmask occult stress urinary incontinence (OSUI) in otherwise asymptomatic patients. Preoperative urodynamic studies (UDSs) with prolapse reduction may, by potentially unmasking OSUI, assist surgical decision making. This study investigated the long-term objective postoperative rate of SUI, according to the presence of OSUI.MethodsThis retrospective cohort study was conducted with a cross-sectional survey of women with no SUI or rare SUI presenting at Kingston General Hospital in Kingston, Ontario from 2003-2013 for POP. Patients were compared on the basis of preoperative UDS results and whether an anti-incontinence procedure was performed in addition to POP surgery. The study included a chart review of 1-year follow-up subjective results and a survey of long-term objective results (symptoms and quality of life) ascertained by validated questionnaires.ResultsThe study enrolled 113 women, 51 of whom had undergone anti-incontinence surgery (42 for identified OSUI, 9 prophylactically). In women whose UDS results indicated OSUI, 1-year subjective and long-term objective postoperative SUI results were, respectively, 8.8% and 12.5% among women undergoing POP and anti-incontinence surgery and 18.2% and 42.9% among those undergoing POP surgery alone. In women with negative UDS results, those rates were 0.0% and 50.0% and 12.8% and 27.6%, respectively. There was no significant difference in any outcomes, according to procedure choice in the OSUI-positive group. There were no predictors for postoperative SUI.ConclusionAlthough a trend was seen for less long-term validated subjective SUI in women having a concomitant SUI procedure along with POP corrective surgery, no significant difference in outcomes was found, on the basis of procedure of choice, and no reliable predictors for postoperative SUI could be identified. UDS testing may be useful to rule in OSUI, but its clinical value in surgical decision making is uncertain.     

A comparison of the use of mesh to native tissue in the management of vaginal vault prolapse

Vaginal vault prolapse afflicts millions of women and evokes significant psychosocial and pelvic floor dysfunction. The risk factors and modalities of conservative management are discussed in this study. There remains controversy in the optimal surgical management. This review serves to study the clinical conundrum of the decision-making process to utilize the mesh and the approach. In-depth evaluation of mesh-related postsurgical complications as compared to those associated with the native tissue is explored.     

Management of selected complications following urogynecological surgeries with the use of synthetic prostheses--own observations

The article presents the results of treatment and management of certain selected complications following urogynecological operations with the use of synthetic materials. The study group consisted of 76 women with vaginal wound healing problem after surgical treatment of POP with the use of polypropylene monofilament mesh: vaginal erosion (44), protrusion of the mesh (18), vaginal granulation (14) - after surgical treatment of Pelvic Organ Prolapse (POP) with the use of polypropylene monofilament mesh. The article describes the applied methods of treatment of the above mentioned complications, as well as their effectiveness. The conservative way of treatment was found to be the best way of treating vaginal granulation, partial removal of the synthetic material proved to be the best method of treating vaginal erosion, whereas in case of mesh protrusion - total polypropylene prosthesis removal was necessary.     

经阴道植入网片手术与疼痛

经阴道植入网片（tranvaginal mesh,TVM）手术已广泛用于盆腔器官脱垂（pelvic organ prolapse,POP）的修复治疗,复发率较自体组织修复术有所降低,但由于网片相关的独特并发症,美国食品药品监督管理局（FDA）曾多次通告并于2019年4月宣布禁止TVM在美国销售。疼痛作为TVM术后的主要并发症之一,严重影响患者生活质量。文章重点论述TVM术后相关疼痛的类型、原因、可能的机制及处理原则,并展望TVM的未来发展应用。     

经阴道植入网片手术与疼痛

经阴道植入网片（tranvaginal mesh，TVM）手术已广泛用于盆腔器官脱垂（pelvic organ prolapse，POP）的修复治疗，复发率较自体组织修复术有所降低，但由于网片相关的独特并发症，美国食品药品监督管理局（FDA）曾多次通告并于2019年4月宣布禁止TVM在美国销售。疼痛作为TVM术后的主要并发症之一，严重影响患者生活质量。文章重点论述TVM术后相关疼痛的类型、原因、可能的机制及处理原则，并展望TVM的未来发展应用。     

The controversy of polypropylene mesh

Synthetic mid-urethral tapes have become the commonest operation for stress urinary incontinence (SUI) since introduction to the UK in 1998. Transvaginal mesh for vaginal prolapse repair became available in 2002. Tapes were implanted in over 90% of SUI procedures in UK at their peak of adoption, compared to less than 10% mesh utilisation in prolapse operations. However, increasing concern about adverse events associated with prolapse devices has led to worldwide scrutiny of all mesh devices, and some manufacturers have withdrawn from the market. Systematic reviews into safety and efficacy have been undertaken in the UK with publications by MHRA (2014), Scottish Independent Enquiry (2017) and NHS England Review (2018). NICE is currently reviewing clinical guidance on incontinence and prolapse; in the interim they continue to recommend tapes be included amongst the treatment options for SUI, but suggest mesh for prolapse only be used in a research setting.