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.     

经阴道植入网片盆底重建手术再认识

随着美国食品药品管理局（FDA）关于经阴道植入网片的盆底重建手术的特殊通告并伴随以部分网片厂家的产品退市,引起全球业内的很大反响,临床医生在盆底重建的术式选择中面临着困惑。全面了解FDA关于经阴道植入网片的盆底重建手术通告的背景和内涵,对于正确选择适合经阴道植入的网片进行盆底重建手术有重要的作用。     

Assessment and initial management of mesh complications

Synthetic polypropylene mesh have been used in the surgical management of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) since 1990's. However, following patients'-led campaign with concerns regarding the complications associated with mesh, their use in surgical management of SUI and/or POP has been controversial. Complications associated with these mesh implants include chronic pain, vaginal mesh exposure, perforation into organs, infections and sinus tract formation. In April, 2019, the NICE guideline (NG123) provided an evidence review for management of mesh complications. Following Independent Medicine and Medical Devices Safety Review (IMMDS) publication in 2020, a network of specialized complex mesh centres across the UK have been set up. All patients with mesh-related complications should receive specialist multidisciplinary care in these centres. In this review, we outline the assessment and initial management of patients who present with mesh-related complications. Assessment and management options should be tailored per individual cases. Assessment includes clinical assessment and investigations including radiological imaging. All management options including no treatment, conservative, medical and surgical treatment, including minimally invasive treatment with the pros and cons of every option should be offered and patient should be actively involved in their decision making in a “shared-decision making” manner.     

经典的经阴道自体组织修补术在女性盆腔器官脱垂治疗中价值的再认识

盆腔器官脱垂（pelvic organ prolapse,POP）是由于盆底支撑组织薄弱导致盆腔器官解剖位置下移的一类疾病,通过经阴道手术来加强盆底的支撑力量是严重POP的重要治疗措施。近年来,经阴道网片植入术备受争议,因此经典的经阴道自体组织修补术再次受到关注。充分认识此类手术对解剖复位和功能重建的主客观效果、并发症、复发风险及相关影响因素,将有助于临床医生正确评价和选择精准的治疗POP术式。     

Complications of polypropylene mesh in prolapse surgery

Traditional surgical repair for pelvic organ prolapse may be associated with a high recurrence rate. Mesh is being used increasingly to replace damaged endo-pelvic fascia, in an attempt to reduce recurrence. Polypropylene mesh is currently preferred over biological and synthetic absorbable meshes, aiming to reduce failure. Mesh may be placed abdominally (sacro-colpopexy) or vaginally to correct prolapse. Whilst sacro-colpopexy is a well-established procedure for the correction of vault prolapse, there is a lack of strong evidence of safety and efficacy for vaginal placement of mesh. The majority of reported complications related to mesh are minor though occasionally severe complications arise. The management of complications can be difficult, particularly when experience and evidence are lacking. Guidelines suggest that vaginal mesh repairs should only be performed by surgeons with training and expertise, with special arrangements for clinical governance, consent, audit and research.     

The use of synthetic mesh in pelvic reconstructive surgery

The use of synthetic materials in pelvic reconstructive surgery is increasing. Abdominal sacral colpopexy with permanent, type I mesh is a durable and safe operation to treat apical prolapse. The incorporation of synthetic materials during surgery to correct anterior and posterior prolapse has variable anatomic results, with several studies demonstrating moderate rates of mesh-related complications. Procedural kits for vaginal placement of synthetic materials are becoming popular, though long-term outcome and safety data are lacking.     

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 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.     

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。     

Vaginal mesh colpopexy for the treatment of concomitant full thickness rectal and pelvic organ prolapse: a case series

Objective

To present our case series of concomitant rectal and pelvic organ prolapse (POP) treated with vaginal colpopexy with synthetic mesh.

Study design

Charts of patients with full thickness rectal prolapse and POP were reviewed for presenting symptoms, physical examination with POP-Q including rectal prolapse evaluation, and perioperative complications and outcomes.

Results

Four patients aged 63-78 were identified with full thickness rectal prolapse and POP. All of them had symptoms related to both conditions. Rectal prolapse protrusion ranged from 2 cm to 3 cm outside the anus. All patients had vaginal mesh colpopexy; two of them with anterior and posterior vaginal mesh and 2 with posterior mesh only. At a follow-up of 6-44 months, all patients had resolution of both POP and rectal prolapse signs and symptoms.

Conclusion

Vaginal colpopexy with mesh may be a unique treatment to address both POP and full thickness rectal prolapse in selected patients. Further research is needed to determine the safety and efficacy of this method.     

Perioperative Complications in Vaginal Mesh Procedures Using Trocar in Pelvic Organ Prolapse Repair

Introduction and Hypothesis

This study aimed to document intraoperative and early postoperative complications associated with the use of vaginal mesh with trocar in pelvic organ prolapse (POP) repair.

Methods

This is a retrospective review of 120 cases of vaginal repair of POP using vaginal mesh. Of the 120 patients, 31 underwent anterior mesh repair (Light mesh 10, Avaulta 1, Perigee 1, and Prolift 19); 35 underwent posterior mesh repair (Light mesh 2, Posterior IVS 17, and Prolift 16); and 54 underwent anterior and posterior mesh (total) repair (Light mesh 8, Prolift 32, and Prolift M 14).

Results

Three bladder injuries (2.5%) and one distal rectal injury (0.8%) occurred during dissection. Three of four organ injuries (75%) had previous prolapse repair. Overall four patients (3%) required transfusion. Urinary retention exceeding 5 days occurred in four patients. Three of them (60%) also underwent TVT-O. Groin pain occurred in two patients one of whom underwent TVT-O. Gluteal pain occurred in one patient. Early mesh exposure occurred in the vaginal cuff of a patient who underwent hysterectomy.

Conclusions

The vaginal mesh procedures may be done with relatively few perioperative complications. However, there is a need for more randomized controlled trials with long-term follow-up to clarify its postoperative long-term complications and morbidities.     

腹腔镜下阴道骶骨固定术应用现况与思考

腹腔镜阴道骶骨固定术已成为中盆腔缺陷的金标准术式,已逐渐取代开腹的阴道骶骨固定术。由于手术方式的改进,手术适应证不断地扩大,它不仅可纠正中盆腔缺陷,同时也可纠正重度膀胱膨出或直肠膨出。长期的临床疗效显示：主、客观治愈率高,阴道顶端脱垂的复发率极低,术后对患者生活质量影响少,网片相关并发症在可接受范围。虽然网片的肠道侵蚀罕见,但应强调术后患者的长期随访。腹腔镜子宫骶骨固定术的长期疗效仍待观察。     

What's wrong with the debate on mesh surgery?

There is an increasingly acrimonious debate surrounding the use of anchored mesh in prolapse surgery. It is evident that clinicians and researchers working with this technology are under pressure from the public, from lawyers, regulators and colleagues. There is a risk that rapidly changing societal standards, championed by colleagues, lawyers and bureaucrats, will interfere with professional independence to such a degree that an entire new technology is lost before there has been time for clinical research to assess risks and benefits properly, before we learn which patients stand to benefit most, and before we get a chance to optimise implant design.     

The efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall

OBJECTIVE: The study assesses the efficacy and complications of Marlex mesh in repairing severe recurrent anterior vaginal wall prolapse. STUDY DESIGN: Twenty-four patients with two or more postsurgical recurrences of severe anterior vaginal wall prolapse were divided into control and treatment groups. Transvaginal repair was similar between groups except for reinforcement of the anterior vaginal wall with synthetic mesh. Two examiners graded preoperative and postoperative support over the following 2 years (K = 0.9). Fisher's exact test, log-linear analysis, and analysis of variance were used to compare categoric and continuous variables. RESULTS: Four patients in the control group and none in the treatment group had recurrent anterior vaginal wall prolapse (p < 0.05). Three patients had mesh-related complications. CONCLUSION: Repair with a synthetic mesh decreased the expected incidence of severe recurrent anterior vaginal prolapse but was associated with common complications related to synthetic mesh. Mesh reinforcement is an effective treatment for severe recurrent prolapse of the anterior midvaginal wall. (Am J Obstet Gynecol 1996;175:1472-5.)     

全盆底重建术并发症预防及处理

盆底重建手术是治疗重度盆腔器官脱垂的重要及有效方法,随着该种术式的广泛应用,其近期及远期并发症越来越受到重视。文章对全盆底重建手术的近、远期并发症包括出血、损伤、网片暴露与侵蚀,盆腔器官脱垂复发,盆底疼痛,新发尿失禁,性交疼痛与不适的原因、治疗方法及预防措施进行介绍。     

The role of synthetic and biological prostheses in reconstructive pelvic floor surgery

PURPOSE OF REVIEW: Uterovaginal prolapse and urinary incontinence are common problems whose pathogenesis remains unclear. As life expectancy increases, significantly greater numbers of women will present with pelvic floor prolapse and incontinence requiring surgical intervention. Currently, the lifetime risk of undergoing prolapse or continence surgery in the USA is one in 11, and up to 30% of patients will require repeat prolapse and 10% repeat continence surgery. In an attempt to improve surgical outcomes and to preserve vaginal capacity and coital function, a number of synthetic and biological prostheses have been developed. This review aims to look at the controversies that exist as the 'ideal' prosthetic material is developed. RECENT FINDINGS: The recent literature has reflected the increasing interest in the use of biological prostheses (Allograft/Xenograft) and synthetic absorbable meshes. There has been a focus on the risk factors for erosion seen with the use of synthetic non-absorbable material and a review of techniques for the reduction and management of this complication. The advent of mesh placement in minimally invasive continence surgery (tension-free vaginal tape, intravaginal sling, and Supra Public ARC) is now seeing surgical success to 5 years, but the reporting of complications remains inconsistent. SUMMARY: The use of prosthetics in pelvic floor and continence surgery is an evolving field. Further randomized controlled trials are required to evaluate the role of both biological and synthetic prostheses in reconstructive surgery, to determine which type of prosthesis is most suitable for specific procedures. Prosthetic reinforcement should not be used to replace good surgical techniques.     

阴道植入网片与自体组织修补的临床效果比较

文章对近年来发表的经阴道植入网片（transvaginal mesh,TVM）与经阴道自体组织修补（vaginal native tissue repair,VNTR）治疗盆腔器官脱垂（pelvic organ prolapsed,POP）的文献结果进行了比较。结果显示：（1）两组围手术期及短期并发症以Clavien-Dindo外科并发症严重程度分级系统进行评价,提示网片短期严重并发症并不常见,TVM与VNTR一样安全。（2）两组在近中期主客观效果、复发率、网片重量及对性功能影响方面比较,除一项研究外,多数研究结果表明TVM组患者术后脱垂感知率、前壁脱垂复发率和再次手术率方面都要低于VNTR组,虽然网片独特并发症增加了再次手术率,但两组总体再次手术率无显著差异。轻质网片并发症少于重质网片。两组在性交痛发生率比较也无显著差异。（3）两组术后长期疗效比较,TVM组在阴道前壁和多腔室脱垂治疗方面主客观效果及满意度方面优于VNTR组,且减少了解剖学上的复发率。研究结果显示TVM是治疗POP的一种安全有效术式。适应证选择恰当和训练有素的医生可进一步降低TVM的并发症。     

阴道植入网片与自体组织修补的临床效果比较

文章对近年来发表的经阴道植入网片（transvaginal mesh,TVM）与经阴道自体组织修补（vaginal native tissue repair,VNTR）治疗盆腔器官脱垂（pelvic organ prolapsed,POP）的文献结果进行了比较。结果显示：（1）两组围手术期及短期并发症以Clavien-Dindo外科并发症严重程度分级系统进行评价,提示网片短期严重并发症并不常见,TVM与VNTR一样安全。（2）两组在近中期主客观效果、复发率、网片重量及对性功能影响方面比较,除一项研究外,多数研究结果表明TVM组患者术后脱垂感知率、前壁脱垂复发率和再次手术率方面都要低于VNTR组,虽然网片独特并发症增加了再次手术率,但两组总体再次手术率无显著差异。轻质网片并发症少于重质网片。两组在性交痛发生率比较也无显著差异。（3）两组术后长期疗效比较,TVM组在阴道前壁和多腔室脱垂治疗方面主客观效果及满意度方面优于VNTR组,且减少了解剖学上的复发率。研究结果显示TVM是治疗POP的一种安全有效术式。适应证选择恰当和训练有素的医生可进一步降低TVM的并发症。     

Quoi de neuf depuis le rapport de la HAS ? Bilan de deux ans d’évaluation des implants de renfort prothétique dans le traitement des prolapsus par voie vaginale

The French Health Authorities' (HAS) report of November 2006 concluded that the use of mesh at the time of transvaginal repair of pelvic organ prolapse (POP) should be limited to clinical research. This review intends to analyse and comment the recent data on this topic. A review on PubMed, on a personal database and actualisation until May 2008 has been performed choosing French or English language series concerning prolapse surgery with mesh disposed by the vaginal route. It includes six randomised controlled trials comparing transvaginal repair of POP with or without mesh: four about cystocele, one about rectocele and one about apical prolapse. Both surgical techniques and recurrence criteria are poorly standardised. The four randomised trials focusing on cystocele repair support the anatomical superiority of techniques using mesh, with similar functional results with or without mesh reinforcement. In the other indications, the results remain unclear or controversial. According to the randomised trials, the complications rate, except mesh exposure, is similar with and without mesh. However there are some specific complications when using mesh, such as mesh infection, mesh exposure or shrinkage and visceral extrusion. We recommend using vaginal reinforcement mesh with specific care in selected patients and we suggest some guidelines to be proposed for consensus at concerned French scientific societies.