Safety and efficacy of non-absorbable mesh in contemporary gynaecological surgery

Mesh-augmented pelvic floor surgery evolved to address the limitations of native tissue repair in reconstructive surgery. The development of the synthetic mid-urethral tape signalled a revolution in the treatment of stress urinary incontinence, whilst the use of mesh in abdominal apical prolapse repair may confer benefits over native tissue alternatives. However, these procedures can be associated with mesh-specific complications, underlining the need for shared decision-making between physicians and patients prior to mesh surgery. Transvaginal non-absorbable mesh implants for pelvic organ prolapse are associated with a high risk of serious adverse events, leading to withdrawal or restricted use in many countries. Increased scrutiny has led to growing concerns about complications associated with all types of mesh-augmented reconstructive surgery, attracting widespread media attention. National and international reports have been commissioned examining the safety and efficacy of mesh surgery in gynaecology. They have all highlighted systemic failures in the development, regulation and clinical adoption of medical devices. The widespread application of novel devices prior to the availability of reliable safety and efficacy data, and delayed recognition of adverse events, is of serious concern. Notwithstanding, the available data continue to support a role for mesh augmentation. This review outlines the evolution of gynaecological mesh, the safety and efficacy of pelvic floor surgery using non-absorbable mesh materials, and an overview of specific complications

Risk of thrombosis and bleeding in gynecologic cancer surgery: systematic review and meta-analysis

Objective: This study aimed to provide procedure-specific estimates of the risk of symptomatic venous thromboembolism and major bleeding in the absence of thromboprophylaxis, following gynecologic cancer surgery.Data sources: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar for observational studies. We also reviewed reference lists of eligible studies and review articles. We performed separate searches for randomized trials addressing effects of thromboprophylaxis and conducted a web-based survey on thromboprophylaxis practice.Study eligibility criteria: Observational studies enrolling ≥50 adult patients undergoing gynecologic cancer surgery procedures reporting absolute incidence for at least 1 of the following were included: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding requiring reintervention (including reexploration and angioembolization), bleeding leading to transfusion, or postoperative hemoglobin <70 g/L.Methods: Two reviewers independently assessed eligibility, performed data extraction, and evaluated risk of bias of eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors. The GRADE approach was applied to rate evidence certainty.Results: We included 188 studies (398,167 patients) reporting on 37 gynecologic cancer surgery procedures. The evidence certainty was generally low to very low. Median symptomatic venous thromboembolism risk (in the absence of prophylaxis) was <1% in 13 of 37 (35%) procedures, 1% to 2% in 11 of 37 (30%), and >2.0% in 13 of 37 (35%). The risks of venous thromboembolism varied from 0.1% in low venous thromboembolism risk patients undergoing cervical conization to 33.5% in high venous thromboembolism risk patients undergoing pelvic exenteration. Estimates of bleeding requiring reintervention varied from <0.1% to 1.3%. Median risks of bleeding requiring reintervention were <1% in 22 of 29 (76%) and 1% to 2% in 7 of 29 (24%) procedures.Conclusion: Venous thromboembolism reduction with thromboprophylaxis likely outweighs the increase in bleeding requiring reintervention in many gynecologic cancer procedures (eg, open surgery for ovarian cancer and pelvic exenteration). In some procedures (eg, laparoscopic total hysterectomy without lymphadenectomy), thromboembolism and bleeding risks are similar, and decisions depend on individual risk prediction and values and preferences regarding venous thromboembolism and bleeding

Host–biomaterial interactions in mesh complications after pelvic floor reconstructive surgery

Polypropylene (PPL) mesh is widely used in pelvic floor reconstructive surgery for prolapse and stress urinary incontinence. However, some women, particularly those treated using transvaginal PPL mesh placement for prolapse, experience intractable pain and mesh exposure or extrusion. Explanted tissue from patients with complications following transvaginal implantation of mesh is typified by a dense fibrous capsule with an immune cell-rich infiltrate, suggesting that the host immune response has a role in transvaginal PPL mesh complications through the separate contributions of the host (patient), the biological niche within which the material is implanted and biomaterial properties of the mesh. This immune response might be strongly influenced by both the baseline inflammatory status of the patient, surgical technique and experience, and the unique hormonal, immune and microbial tissue niche of the vagina. Mesh porosity, surface area and stiffness also might have an effect on the immune and tissue response to transvaginal mesh placement. Thus, a regulatory pathway is needed for mesh development that recognizes the roles of host and biological factors in driving the immune response to mesh, as well as mandatory mesh registries and the longitudinal surveillance of patients

'What research was carried out on this vaginal mesh?' Health-related concerns in women following mesh-augmented prolapse surgery: a thematic analysis

Objective: To understand health-related issues in women following mesh-augmented prolapse surgery. / Design: Inductive thematic analysis of free-text comments from participants in a cross-sectional study of laparoscopic mesh sacrohysteropexy. / Setting: Tertiary urogynaecology centres, United Kingdom. Population Women who underwent laparoscopic mesh sacrohysteropexy by surgeons based at two tertiary urogynaecology centres between 2010 and 2018. / Methods: A total of 1766 potential participants were contacted by post and invited to complete paper, online or telephone questionnaires containing a free-text comments section. Of 1121 participants (response proportion 63.5%), 752 (67.1%) provided such comments. These were analysed with a six-stage inductive thematic analysis, using NVIVO 11� software. Main outcome measures Themes developed from free-text comments. / Results: Following familiarisation, 29 codes and 189 sub-codes were identified. These defined six themes: pelvic floor symptoms, health status, treatment success, mesh, pain and care received. The majority of comments centred on the first of these six themes. There were concerns about mesh use and a desire for more information. A range of pain symptoms were mentioned, often associated with pelvic floor symptoms, prolapse surgery or mesh. / Conclusions: Despite the mesh controversy, pelvic floor symptoms and their impact on quality of life remain the principle concern of women following mesh-augmented prolapse surgery. There is a need for quality, accessible and evidence-based information sources for those women with concerns, and for those considering such surgery in the future, particularly regarding mesh safety and postoperative recovery. The relationships between pain, prolapse, mesh and pelvic floor surgery require further stud

Long-term mesh complications and reoperation after laparoscopic mesh sacrohysteropexy: a cross-sectional study

Introduction and hypothesis The paucity of long-term safety and efficacy data to support laparoscopic mesh sacrohysteropexy is noteworthy given concerns about the use of polypropylene mesh in pelvic floor surgery. This study is aimed at determining the incidence of mesh-associated complications and reoperation following this procedure. Methods This was a cross-sectional postal questionnaire study of women who underwent laparoscopic mesh sacrohysteropexy between 2010 and 2018. Potential participants were identified from surgical databases of five surgeons at two tertiary urogynaecology centres in the UK. The primary outcome was patient-reported mesh complication requiring removal of hysteropexy mesh. Secondary outcomes included other mesh-associated complications, reoperation rates and Patient Global Impression of Improvement (PGI-I) in prolapse symptoms. Descriptive statistics and Kaplan–Meier survival analyses were used. Results Of 1,766 eligible participants, 1,121 women responded (response proportion 63.5%), at a median follow-up of 46 months. The incidence of mesh complications requiring removal of hysteropexy mesh was 0.4% (4 out of 1,121). The rate of chronic pain service use was 1.8%, and newly diagnosed systemic autoimmune disorders was 5.8%. The rate of reoperation for apical prolapse was 3.7%, and for any form of pelvic organ prolapse it was 13.6%. For PGI-I, 81.4% of patients were “much better” or “very much better”. Conclusions Laparoscopic mesh sacrohysteropexy has a low incidence of reoperation for mesh complications and apical prolapse, and a high rate of patient-reported improvement in prolapse symptoms. With appropriate clinical governance measures, the procedure offers an alternative to vaginal hysterectomy with apical suspension. However, long-term comparative studies are still required

Fission track dating and provenience of archaeological obsidian artefacts in Colombia and Ecuador

International audienceWe dated by the fission track method eighteen samples of obsidian glass. Of these, seventeen were artefacts collected in prehispanic archaeological sites from Ecuador and Colombia and one comes from a secondary obsidian source located in southern Colombia. When our data are compared to (i) the fission track ages of obsidian from volcanic sources and (ii) the PIXE chemical composition of the same artefacts and of samples from obsidian sources, eight discrete age/composition groups appear.Fifteen artefacts might come from a single unknown source: three others from sources in the Sierra de Guamani (East of Quito): one from the Mullumica rhyolitic flow and two from the Quiscatola/Yanaurcu sources. A fourth artefact migh come from the South Colombia source of Rio Hondo. At least five other sources are necessary to account for thr variety of ages and compositions found in the arefact collection studied