The Cumberlege Report and the development of the UK mesh centre network

Very few clinical debates have been as emotionally charged as the transvaginal mesh debate. The public furore over its use led to an independent enquiry, the IMMDS Review (Independent Medicines and Medical Devices Safety Review) better known as the Cumberlege Review after Baroness Cumberlege who led it. The report of the two year long enquiry was published in July 2020 and recommendations to avoid similar situations arising in future were made. One of the recommendations was the establishment of Mesh Centres which could provide standardised care to women with mesh complications irres-pective of where they presented in the UK. Lessons need to be learned from the mesh saga, and though innovation cannot be stifled, safeguards to protect patients must be put in place when any new procedure or intervention is introduced into clinical practice.     

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.     

如何理解经阴道植入网片手术的专家共识

近年来,经阴道植入网片（transvaginal mesh,TVM）手术的临床应用价值引起国际学术界的广泛争论。2019年底中华医学会妇产科学分会妇科盆底学组专家对原盆腔器官脱垂（pelvic organ prolapse,POP）诊治草案进行了讨论、更新和完善,形成了新的诊疗指南。全面理解制定本指南的背景及内涵,特别是提高对网片问题由来、TVM手术临床存在的问题及其应用的前景与挑战等关键问题的认知,有助于临床医生在POP防治中做出合理的临床决策。     

如何理解经阴道植入网片手术的专家共识

近年来,经阴道植入网片（transvaginal mesh,TVM）手术的临床应用价值引起国际学术界的广泛争论。2019年底中华医学会妇产科学分会妇科盆底学组专家对原盆腔器官脱垂（pelvic organ prolapse,POP）诊治草案进行了讨论、更新和完善,形成了新的诊疗指南。全面理解制定本指南的背景及内涵,特别是提高对网片问题由来、TVM手术临床存在的问题及其应用的前景与挑战等关键问题的认知,有助于临床医生在POP防治中做出合理的临床决策。     

Complications of polypropylene mesh in prolapse surgery: an update

Over the last five years, there has been a considerable increase in the use of synthetic mesh to correct uterovaginal prolapse. More recently there has been an increased reporting of complications resulting in a health warning notification by the Food and Drug Administration Agency, for clinicians and the public. Evidence from recent systematic reviews supports the use of synthetic mesh for central and recurrent anterior compartment prolapse. Trials show a higher incidence of mesh related complications that can present with debilitating pain requiring reoperations and significant impact on quality of life. The lack of strict premarketing approval and post marketing surveillance along with the acceptance of the mesh without robust evidence remains an issue. It is the joint responsibility of manufacturers, clinicians and organizations to ensure that synthetic mesh is used appropriately using evidence-based data for mesh selection, usage along with post treatment surveillance.     

Laparoscopic Excision of Sacrocolpopexy Mesh

Study ObjectiveTo demonstrate surgical maneuvers to facilitate laparoscopic excision of sacrocolpopexy mesh and prevent potential complications.DesignStep-by-step illustration of various surgical techniques using a video compiled from 3 laparoscopic sacrocolpopexy mesh excision procedures performed at Magee–Womens Hospital for various indications (Canadian Task Force classification xx-xx).SettingMesh complications such as infection and erosion are frequently managed conservatively but often necessitate mesh excision for symptom relief. Laparoscopic excision of sacrocolpopexy mesh procedures is typically challenging, even in the hands of experienced surgeons. Synthetic mesh, being a foreign body, activates an inflammatory process that leads to surrounding tissue fibrosis and scar tissue formation that can distort the pelvic anatomy, thereby putting vital organs at risk of injury. Such organs include the bladder, rectum, and vagina caudally; the left common iliac vein and middle sacral vessels cephalad; and the ureters at the level of the vaginal cuff angles.InterventionLaparoscopic excision of sacrocolpopexy mesh.ConclusionWhen planning laparoscopic sacrocolpopexy mesh excision, complications can be prevented with use of proper surgical technique. It is important to identify vital structures because they may be displaced due to tissue fibrosis. When developing various surgical planes, surgeons should first operate in areas that are free of adhesions. This will enhance exposure when dissecting the mesh in proximity of scarred tissue and vital organs. Use of vaginal and rectal probes helps to delineate the vesicovaginal and rectovaginal spaces to prevent bladder and bowel injury.     

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。     

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.     

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.     

Does pelvic mesh treated with phosphorylcholine improve outcomes? An early experience

Objectives

Implantable devices treated with phosphorylcholine (PC) have been successfully used in cardiac, ophthalmic, and other applications. This surface modification has resulted in a reduction in the host inflammatory responses. This pilot study tested the safety and efficacy of PC treated polypropylene mesh grafts implanted for the treatment of pelvic organ prolapse.

Study design

Surgeons from five U.S. sites collected data on subjects implanted with Perigee IntePro Lite + PC. Pre-procedure data collected included demographics and prolapse severity. At follow-up, subjects were assessed for anatomical outcomes (success ≤ stage I POPQ or Baden Walker), symptomatic improvement, and complications, particularly mesh exposure.

Results

A total of 40 subjects were enrolled with 80% (32/40) of them completing at least 5–7 months of follow-up. Mean patient age was 60 years (range 36–78 years) and the mean BMI was 28 (range 20–40). There were no cases of mesh exposure/extrusion or granuloma formation. The anatomical success rate was 100% at 5–7 months (32/32).

Conclusions

This is the first publication on pelvic mesh treated with PC. There were no adverse events attributed to this surface modification. However, as the numbers are small, the results are not statistically significant. PC surface modification of pelvic mesh shows promise in its application for the reduction of mesh related complications.     

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。     

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.