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.     

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.     

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.     

盆底重建术中合成网片应用现状分析

为降低术后复发率,近10余年来曾一度热衷采用合成的网片治疗盆底障碍性疾病。但是,随着合成网片使用增加,其手术相关的并发症也逐渐引起关注。全面认识合成网片在盆底重建术中的价值,对于盆底重建手术的发展具有重要意义。     

Single incision anterior apical mesh and sacrospinous ligament fixation in pelvic prolapse surgery at 36 months follow-up

Objective

To compare the clinical efficacy, recurrence, complications and quality of life changes 3 years after Elevate-A/single incision mesh surgery anterior apical (SIM A) and sacrospinous ligament fixation (SSF) in the management of pelvic organ prolapse (POP).

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.     

Assessment of Collagen-Coated Anterior Mesh Through Morphology and Clinical Outcomes in Pelvic Reconstructive Surgery for Pelvic Organ Prolapse

Study ObjectiveTo assess the morphologic features of anterior armed transobturator collagen-coated polypropylene mesh and its clinical outcomes in pelvic reconstructive surgery to treat pelvic organ prolapse.DesignEvidence obtained from several timed series with intervention (Canadian Task Force classification II-3).SettingChang Gung Memorial Hospital, Taoyuan, Taiwan, China.PatientsBetween April 2010 and October 2012, 70 patients underwent surgery to treat symptomatic pelvic organ prolapse, stage III/IV according to the POP-Q (Pelvic Organ Quantification System).InterventionAnterior armed transobturator collagen-coated mesh.Measurement and Main Results: Morphologic findings and clinical outcome were measured. Morphologic features were assessed via 2-dimensional introital ultrasonography and Doppler studies. Clinical outcome was measured via subjective and objective outcome. Objective outcome was assessed via the 9-point site-specific staging method of the International Continence Society Pelvic Organ Prolapse Quantification before the operation and at 1-year postoperative follow-up. Subjective outcome was based on 4 validated questionnaires: the 6-item UDI-6 (Urogenital Distress Inventory), the 7-item IIQ-7 (Incontinence Impact Questionnaire), the 6-item POPDI-6 (Pelvic Organ Prolapse Distress Inventory 6), and the 12-item PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire), at baseline and at 12 months after the operation. Data were obtained for 65 patients who underwent the combined surgery and were able to comply with follow-up for >1 year. Ultrasound studies reveal that mesh length tends to shorten and decrease in thickness over the 1-year follow-up. Vagina thickness also was reduced. Neovascularization through the mesh was observed in <8.5% of patients in the first month and at 1 year, and was evident in approximately 83%. The mesh exposure rate was 6.4%. The recorded objective cure was 90.8% (59 of 65 patients), and subjective cure was 89.2% (58 of 65 patients) at mean (SD) follow-up of 19.40 (10.98) months. At 2 years, UDI-6, IIQ-7, and POPDI-6 scores were all significantly decreased (p < .001), whereas the PISQ-12 score was significantly increased (p = .01).ConclusionsUltrasound features suggest that the degeneration of collagen barrier may be longer than expected and that integration of collagen-coated mesh could occur up to 1 year. A substantially good clinical outcome was noted.     

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。     

Use of Prolene Mesh in surgical treatment of tissue defects after radical inguinal and pelvic lymph node dissection in vulvar cancer—a brief report

Surgery is still the procedure of choice in treatment of advanced vulvar cancer. Radical vulvar surgery is often associated with severe vulvar and inguinal skin and fat-tissue deficits resulting from wide "butterfly" shape resection. Primary closure of large vulvar and inguinal defects is hampered by lack of tissue. The study presents the case of using prolene mesh in filling up the tissue defects over femoral vein and artery after radical excision of enlarged inguinal superficial, femoral, and pelvic nodes to prevent vessels in hiatus saphenus. It is the first report describing the use of prolene mesh in such a procedure.     

A comparative study of laparoscopic sacrocolpopexy and total vaginal mesh procedure using lightweight polypropylene meshes for prolapse repair

ObjectiveUse of vaginal meshes for treatment of pelvic organ prolapse (POP) remains controversial. A trend toward abdominal approaches and the development of new meshes has been noted. We compared the 1-year results of two different approaches using new lightweight meshes.Materials and methodsSixty-nine (95.8%) of 72 women with POP Stage ≥ 2, who underwent laparoscopic sacrocolpopexy (LSC) (n = 39) or a total vaginal mesh (TVM) procedure (n = 30) using lightweight polypropylene meshes, were studied. Baseline and follow-up assessments included a pelvic examination and a composite condition-specific questionnaire. A detailed comparison of 1-year outcomes was made. Data were analyzed using appropriate statistical methods.ResultsCompared to the TVM group, the LSC group was characterized by a younger age (53.7 years vs. 64.1 years, p < 0.001) and a longer operating time (264 minutes vs. 177.6 minutes, p < 0.001). Objective anatomic success (POP Stage ≤ 1) rates were similar between groups after statistical adjustment, i.e., 84.6% (33/39) and 86.7% (26/30) after LSC and TVM (p = 0.94), respectively. However, the dominant recurrence sites were different with anterior (n = 6) most frequent after LSC and apical (n = 4) most frequent after TVM. Reoperations were needed for the four (13.3%) apical recurrences in the TVM group. No serious complications were noted. We found “cystocele as the dominant prolapse” (p = 0.016; odds ratio = 6.94) and “suspension of prolapsed (POP Stage ≥ 2) uterus” (p = 0.025; odds ratio = 7.00) significantly affected recurrence after LSC and TVM, respectively.ConclusionPOP repair by LSC or TVM using the new lightweight polypropylene meshes seems to be safe and has comparable outcomes, but limitations may vary.