Transvaginal Mesh Placement Research Articles

Factors associated with exposure of transvaginally placed polypropylene mesh for pelvic organ prolapse

This study evaluates potential risk factors for mesh exposure following transvaginal placement of polypropylene mesh for pelvic organ prolapse requiring reoperation. We performed a case-control study. Cases had mesh exposure requiring surgical revision; controls had no mesh exposures and were chosen for similar surgical date and type of mesh. We identified 48 cases and 48 controls. The adjusted odds ratio of having a bleeding complication at the time of mesh implantation was 7.25 [95% confidence interval (CI) 1.47-35.66], smokers versus nonsmokers was 3.17 (95% CI 0.59-17.12), and being 1 year older was 0.96 (95% CI 0.92-1.0), among women with mesh exposure. We identified bleeding complications at the time of mesh implantation as a risk factor for mesh exposure requiring reoperation. Despite being one of the largest studies on this topic, our data were inconclusive regarding the impact of other possible factors on mesh exposure.

Credentialing for transvaginal mesh placement—a case for “added qualification” in competency

A process of added qualification of transvaginal mesh (TVM) placement is desirable. Through a physician-led partnership of specialty societies, centers of excellence, and industry, a core curriculum encompassing mesh/graft biology, technical skills, and safety can be coupled with current educational endeavors instructing surgeons in the use of TVM. A posttest process can verify a knowledge-based competency in mesh/graft safety. An auditing process after implementation would be optimal. We recommend implementation of a five-step process in order to accomplish these goals. It is hoped through these efforts, the ultimate goal of patient safety may be reached.

Perioperative Complications and Reoperations After Incontinence and Prolapse Surgeries Using Prosthetic Implants

To estimate the perioperative complication and reoperation rates associated with slings and prolapse repairs using mesh and biologic grafts. Analysis of all female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent sling procedures or pelvic organ prolapse surgeries using implanted grafts or mesh between September 1, 2008, and May 31, 2010. Physicians' Current Procedural Terminology Coding System, 4th edition, International Classification of Diseases, 9th Revision, and surgical implant logs were used to identify the procedures performed, implants used, perioperative complications, and readmissions and reoperations within 12 months of the index surgery. During the 21-month period, 4,142 women (mean age 57 years [standard deviation 12.2], median parity 3 [interquartile range 1-4], median body mass index 28 [interquartile range 25-32]) underwent 3,747 (71%) slings and 1,508 (29%) prolapse repair procedures using implanted prostheses. Trocar-related bladder perforations (51 of 3,747 [1.4%]) occurred more commonly than urethral perforations (2 of 3,747 [0.05%]) in sling procedures (P<.001). There were no trocar-related injuries for prolapse repair kit procedures. Mesh-related reoperations after sling procedures were performed for voiding dysfunction or urinary retention (49 of 3,747 [1.3%]), vaginal mesh erosion (30 of 3,747 [0.8%]), and urethral erosion (3 of 3,747 [0.08%]). Reoperations after prolapse procedures were performed more often for vaginal mesh erosion (29 of 858 [3%]) than for biologic graft infection (2 of 650 [0.3%]; P=.01) and were performed more commonly after anterior (19 of 307 [6%]) compared with apical (9 of 487 [2%]) or posterior vaginal mesh repairs (1 of 64 [2%]; P=.018). Reoperations for mesh-related complications occurred most often after transvaginal mesh placement in the anterior vagina.

Incidence of Extrusion Following Type I Polypropylene Mesh “Kit” Repairs in the Correction of Pelvic Organ Prolapse

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh “kit” repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Do we need meshes in pelvic floor reconstruction?

Transvaginally placed mesh in pelvic reconstructive surgery for women with pelvic organ prolapse has gained popularity because of excellent anatomical outcomes, but postoperative mesh-related complications have lead to a number of cautious reviews and warnings. This review focuses on functional outcomes after synthetic transvaginal mesh placement. MEDLINE database was searched from 2010 to August 2011 for original articles on transvaginal mesh surgery for pelvic organ prolapse not included in recent reviews. The following search terms were used: pelvic organ prolapse, genital prolapse, cystocele, rectocele and mesh, synthetic graft, and repair. Studies were assessed and appropriate data extracted and tabularized. Studies were excluded if the follow-up time was less than 12months and if studies did not contain original data or data on subjective outcome. Eleven studies irregularly reported functional outcomes. After trocar-guided transobturator vaginal mesh surgery, symptomatic recurrence of pelvic organ prolapse was reported between 7 and 33%. If analyzed cumulatively, 76 of 370 patients (21%) complained of prolapse symptoms postoperatively. De novo stress urinary incontinence occurred in 12-17% and persisted in up to 68% after trocar-guided mesh surgery. De novo dyspareunia was present between 2 and 15%, worsened or de novo dyspareunia between 25 and 44%. Deteriorating coital incontinence was described in 6 of 16 women after anterior Prolift in one trial. When counseling women for pelvic reconstructive surgery, we should provide them with evidence-based information on functional outcomes and subsequently take the patient's concerns and preferences into account. Pelvic floor symptoms were scarcely reported in reviewed trials, but demonstrated a worse scenario than anatomical outcomes.

Interventional Radiology Used To Treat Pelvic Hemorrhage after Reconstructive Pelvic Surgery

In order to illustrate the successful use of pelvic artery embolization we report on a patient who underwent transvaginal mesh placement presenting with pelvic hematomas in the obturator space. The wide-spread adoption reconstructive pelvic surgery has brought with it the prospect of challenging vascular morbidity. A thorough understanding of pelvic anatomy is essential for management of vascular complications from mesh kits, sacrospinous ligament fixation, and retropubic surgery.

Pelvic organ prolapse (POP) surgery: the evidence for the repairs

What is known on the subject? and What does the study add? Substantial experience of the outcomes has been gathered regarding the acute and sub-acute experience with various types of corrective procedures for POP. These include long-term POP correction as well as more recent recognition of improvement in functional disorders associated with POP such as UI, colorectal dysfunction, and sexual dysfunction. Long-term follow-up is available for some of the older types of interventions and current multicentre trials are being accrued with longer term follow-up for new interventions including mesh-type repairs. The study adds a condensed and summarized version of the current literature regarding the various interventions for POP and also provides an overview of the current controversies and areas where knowledge is incomplete and in need of further elaboration for definitive answers regarding optimization of surgical care for POP. Our aim is to summarise the available data on the transvaginal placement of synthetic mesh for pelvic organ prolapse (POP) repair, with a focus on the outcomes and complications of commercial POP-repair kits. As the stability and durability of autologous tissues may be questionable, nonabsorbable, synthetic materials are an attractive alternative for providing additional support during POP surgery. These materials are not novel, and most have been used for many years in surgical applications, e.g. hernia repairs. While theoretically appealing, the implantation of synthetic mesh in the pelvis may be associated with inherent adverse consequences, such as erosion, extrusion, and infection. Additionally, the routine use of these materials may carry potential long-term complications, such as dyspareunia, chronic pelvic pain, and vaginal distortion. The success and failure of mesh-augmented POP repair is related not only to the synthetic material itself, but also to patient- and surgeon-related factors. Recent warnings by the USA Food and Drug Administration and other groups regarding adverse events further complicate the decision to use synthetic mesh.

V677 PURE TRANSVAGINAL EXCISION OF MESH EROSION INVOLVING THE BLADDER

Introduction and hypothesis We present a pure transvaginal approach to the removal of eroded mesh involving the bladder secondary to placement of transvaginal mesh for management of pelvic organ prolapse (POP) using a mesh kit.

Novel Hybrid Mesh Surgery Combines Sacrocolpopexy with Transvaginal Mesh Placement for Pelvic Organ Prolapse

Mesh surgeries, such as sacrocolpopexy and transvaginal mesh surgery, are commonly used to treat pelvic organ prolapse. Although mesh surgeries have a high success rate, they are unsuitable for some patients. For a patient with pelvic organ prolapse and highly calcified multiple fibroids, we performed hybrid sacrocolpopexy combined with transvaginal mesh surgery with a method modified for the patient's condition. Three months after surgery, the results were highly satisfactory. This approach is simple, secure, and versatile for patients who are not good candidates for conventional mesh surgeries. This novel hybrid mesh surgery is an option for treating various types of pelvic organ prolapse.

Vaginal Hysterectomy at the Time of Transvaginal Mesh Placement

: Previous investigations have shown an increased risk of mesh erosion when concomitant vaginal hysterectomy is performed at the time of transvaginal reconstruction with mesh. We hypothesize that vaginal hysterectomy can be performed without a high risk of erosion. : This is a retrospective, repeated-measures study of women with uterovaginal prolapse who underwent vaginal hysterectomy and pelvic reconstruction with a transvaginal mesh technique using the Prolift system. Mesh was never placed behind the cuff closure and "T" incisions were not used. We compared preoperative quality-of-life and Pelvic Organ Prolapse Quantification values to postoperative values. : Forty women met the study criteria. The median length of follow-up was 12 months (range 4-43 months). Thirty-two (80%) of the women had at least 1 year of follow-up. Significant improvements were found in all quality-of-life measures. Except for genital hiatus and perineal body length, a significant change was seen in all Pelvic Organ Prolapse Quantification measures. The greatest mean change found was for point "C" going from +2.4 to -6.8 cm (P < 0.001). There was 1 (2.5%) mesh erosion. : When incisions for mesh placement are kept separate from the vaginal cuff, transvaginal mesh reconstruction can be safely performed at the time of hysterectomy.

Use of vaginal mesh in the face of recent FDA warnings and litigation

Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.

Création d’un registre des complications du traitement chirurgical des prolapsus génitaux

ObjectiveData about serious adverse events can be particularly useful when assessing surgical procedures. However, spontaneous reporting of adverse events does not generally provide sufficient or highly accurate data on incidence and prevalence. In order to provide the most complete and accurate data, a postoperative surveillance program for pelvic organ prolapse (POP) surgery was conducted in the region Île-de-France from June through December 2007.Material and methodsThe program included 200 patients who have undergone POP surgery from nine test centers.Serious adverse events were defined following WHO recommendations (mortality, increased hospital stay, reintervention, rehospitalization, unexpected postoperative hospitalization in intensive care unit).ResultsIn 184 cases, it was a primary surgery for POP: laparoscopic sacrocolpopexy (N = 52), sacrocolpopexy by laparotomy (N = 12), and surgical treatment by vaginal approach without mesh (N = 87), with synthetic macroporous monofilament polypropylene mesh (N = 19) or with absorbable biological mesh (N = 14). Furthermore, 16 women have undergone surgery for POP recurrence. Eighteen serious adverse events have been reported between June 2007 and December 2007. Median latency between surgery and observation of a serious adverse event was 18months (IQR: 5–45). The most common adverse events were vaginal extrusion of non absorbable suture following sacrospinous fixation (N = 3), vaginal extrusion of synthetic mesh following the transvaginal placement of nonabsorbable mesh between the bladder and the vagina (N = 6), or vaginal extrusion of a syntheticmesh following sacrocolpopexy (N = 2).ConclusionThe pattern of occurrence of serious adverse events indicates that most complications occur after 6-month follow-up. Furthermore, this study shows that the frequency of serious adverse event commonly reported following POP surgery is probably underestimated. These discrepancies may be explained by the method of monitoring used in the current register study, which reported clinically relevant adverse events.

Pure transvaginal removal of eroded mesh and retained foreign body in the bladder

We present a pure transvaginal approach to the removal of eroded mesh and a retained foreign body involving the bladder secondary to placement of transvaginal mesh for management of pelvic organ prolapse (POP) using a mesh kit. Transvaginal excision of mesh erosion involving the bladder after mesh placement using a prolapse kit was performed. A U-shaped incision was made in the anterior vaginal wall; mesh was identified, divided in the midline, and then dissected from the bladder. Additionally, a retained foreign body was removed from the bladder. The bladder was closed in three layers transvaginally. Removal of eroded mesh and foreign body within the bladder was completed with all operative steps performed transvaginally. Follow-up cystogram was normal. There were no postoperative complications. Transvaginal removal of mesh erosion and retained foreign body involving the bladder is feasible and allows for rapid return to normal function.

Transvaginal Repair of a Large Chronic Porcine Ventral Hernia with Synthetic Mesh Using NOTES

Ventral incisional hernias still remain a common surgical problem. We tested the feasibility of transvaginal placement of a large synthetic mesh to repair a porcine hernia. Seven pigs were used in this survival model. Each animal had creation of a 5-cm hernia defect and underwent a transvaginal repair of the defect with synthetic mesh. A single colpotomy was made using a 12-cm trocar for an overtube. The mesh was cut to size and placed through the trocar. A single-channel gastroscope with an endoscopic atraumatic grasper was used for grasping sutures. Further fascial sutures were placed every 5 cm. Mesh repair was feasible in all 7 animals. Mean operative time was 133 minutes. Technical difficulties were encountered. No gross contamination was seen at the time of necropsy. However, 5 animals had positive mesh cultures; 7 had positive cultures in the rectouterine space in enrichment broth or on direct culture. Transvaginal placement of synthetic mesh to repair a large porcine hernia using NOTES is challenging but feasible. Future studies need to be conducted to develop better techniques and determine the significance of mesh contamination.

Mesh removal following transvaginal mesh placement: a case series of 104 operations

The objective of the study was to reveal the way we treat vaginal mesh complications in a trained referral center. This is a retrospective review of all patients who underwent surgical removal of transvaginal mesh for mesh-related complications during a 5-year period. Eighty-three patients underwent 104 operations including 61 complete mesh removal, 14 partial excision, 15 section of sub-urethral sling, and five laparoscopies. Main indications were erosion, infection, granuloma, incomplete voiding, and pain. Fifty-eight removals occurred more than 2 years after the primary mesh placement. Mean operation time was 21 min, and there were two intraoperative and ten minor postoperative complications. Stress urinary incontinence (SUI) recurred in 38% and cystocele in 19% of patients. In a trained center, mesh removal was found to be a quick and safe procedure. Mesh-related complications may frequently occur more than 2 years after the primary operation. Recurrence was mostly associated with SUI and less with genital prolapse.

Transvaginal Excision of Mesh Erosion Involving the Bladder After Mesh Placement Using a Prolapse Kit: A Novel Technique

To present our initial experience with a pure transvaginal approach for the removal of mesh erosion involving the bladder secondary to placement of transvaginal mesh for management of pelvic organ prolapse using a prolapse kit. Transvaginal excision of mesh erosion involving the bladder after mesh placement using a prolapse kit was performed in 2 patients. A U-shaped incision is made in the anterior vaginal wall forming a vaginal wall flap. Mesh is identified, divided in the midline, and then dissected from the bladder. The bladder is closed via a transvaginal approach in 3 layers. Removal of mesh erosion within the bladder was completed, with all operative steps performed transvaginally in 2 patients. No intraoperative complications occurred. Both patients were discharged with bilateral JJ stents and an 18F Foley catheter. Follow-up cystogram was normal in both patients. There were no major postoperative complications. Transvaginal removal of mesh erosion involving the bladder is technically feasible. Additional experience is needed to better define patient selection criteria and indications for transvaginal excision of mesh erosion involving pelvic structures.

Four Month and One Year Results of Transvaginal Mesh Placement (Prolift Procedure) in the Treatment of Pelvic Organ Prolapse

Study Objective: To report perioperative and anatomical outcome data following the surgical placement of transvaginal mesh, the Prolift TM procedure, in the treatment of pelvic organ prolapse among patients with 4 months and 1 year or greater follow-up.

New Considerations in the Use of Vaginal Mesh for Prolapse Repair

The proliferation of mesh-based transvaginal prolapse surgical repair methods and products has generated increased scrutiny of the evidence-based foundation in support of these techniques. Recent developments in this arena include the publication of the Society of Gynecologic Surgeons Systematic Review Group, which concluded that supportive evidence for transvaginal mesh is limited, and a Public Health Notification from the Food and Drug Administration (FDA), regarding “serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.” This article reviews available literature regarding transvaginal mesh use, specifically regarding material, technique, and patient characteristics that may influence the rates of iatrogenic complications of transvaginal mesh prolapse repairs. Compliance with the FDA Public Health Notification is encouraged, and additional clinical practice guidelines are provided.