Mesh Kits Research Articles

Risk Factors for Mesh Complications After Trocar Guided Transvaginal Mesh Kit Repair of Anterior Vaginal Wall Prolapse

Risk Factors for Mesh Complications After Trocar Guided Transvaginal Mesh Kit Repair of Anterior Vaginal Wall Prolapse

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In the span of a few years, the field of vaginal POP repair has come full circle. Mesh kits were celebrated for their ease of use and safety and as methods to improve a patient's quality of life. Now, after several series of complications, 2 FDA notifications, and the decision from Ethicon to withdraw some prostheses, interest seems to be growing in refocusing the message. Proponents of mesh repairs suggest that vaginal mesh kits or meshes “tailored by the surgeon” can be useful at times under very strict criteria, as outlined in the accompanying editorial. This common sense approach is certainly reasonable. Editorial CommentUrologyVol. 81Issue 1PreviewIn this retrospective analysis of women referred for TM complications, the authors try to highlight the FDA statements “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” Full-Text PDF

Transvaginal Mesh Kits—How “Serious” Are the Complications and Are They Reversible?

To review the merit of the U.S. Food and Drug Administration-issued warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications. On institutional review board approval, we reviewed the data from 2 tertiary institutions managing complications of transvaginal mesh. The data recorded included mesh type, details of surgical removal, and patient-reported clinical outcomes. From 2006 to March 2011, 58 women were evaluated. Their mean age was 54.6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution. Most women presented with multiple complaints, with mesh extrusion the most frequently reported (n=43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms. As outlined in the Food and Drug Administration notifications, patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.

Mesh in prolapse surgery: an imaging perspective

Mesh in prolapse surgery: an imaging perspective

Pudendal Neuralgia after Posterior Vaginal Wall Repair with Mesh Kits: An Anatomical Study and Case Series

Pudendal Neuralgia after Posterior Vaginal Wall Repair with Mesh Kits: An Anatomical Study and Case Series

Ureteral injury during vaginal mesh excision: role of prevention and treatment options

Vaginal mesh kits are increasingly used in vaginal prolapse repair. Mesh erosion, infection, and pain may necessitate removal, which can lead to urinary tract injury. We describe 2 cases of ureteral injury at the time of mesh excision. Surgeons must recognize the possibility of ureteral injury and treatment modalities available.

Laparoscopic sacrocolpopexy for recurrent pelvic organ prolapse after failed transvaginal polypropylene mesh surgery

A prospective case series to assess the safety and efficacy of laparoscopic sacrocolpopexy for the surgical management of recurrent pelvic organ prolapse (POP) after transvaginal polypropylene mesh prolapse surgery. Between January and December 2010, women with post-hysterectomy recurrent prolapse (≥ stage 2 POP-Q) after transvaginal polypropylene mesh prolapse surgery were included. Perioperative morbidity and short-term complications were recorded and evaluated. Surgical outcomes were objectively assessed utilising the Pelvic Organ Prolapse Quantification system (POP-Q), the validated, condition-specific Australian Pelvic Floor Questionnaire (APFQ) and the Patient Global Impression of Improvement (PGI-I) at 12 months. All 16 women in this study had undergone surgery with trocar-guided transvaginal polypropylene mesh kits. In 75% the recurrent prolapse affected the compartment of prior mesh surgery with the anterior (81%) and apical (75%) compartment prolapse predominating. At a mean follow-up of 12 months, all women had resolution of awareness of prolapse, had < stage 2 POP-Q on examination and high levels of satisfaction on PGI-I post surgery. There were no serious peri- or postoperative complications. This preliminary study suggests that laparoscopic sacrocolpopexy for recurrent prolapse after failed transvaginal mesh surgery is feasible and safe. Further widespread evaluation is required.

Laparoscopic sacrocolpopexy versus transvaginal mesh for recurrent pelvic organ prolapse

Both expert surgeons agree with the following: (1) Surgical mesh, whether placed laparoscopically or transvaginally, is indicated for pelvic floor reconstruction in cases involving recurrent advanced pelvic organ prolapse. (2) Procedural expertise and experience gained from performing a high volume of cases is fundamentally necessary. Knowledge of outcomes and complications from an individual surgeon's audit of cases is also needed when discussing the risks and benefits of procedures and alternatives. Yet controversy still exists on how best to teach new surgical techniques and optimal ways to efficiently track outcomes, including subjective and objective cure of prolapse as well as perioperative complications. A mesh registry will be useful in providing data needed for surgeons. Cost factors are also a consideration since laparoscopic and especially robotic surgical mesh procedures are generally more costly than transvaginal mesh kits when operative time, extra instrumentation and length of stay are included. Long-term outcomes, particularly for transvaginal mesh procedures, are lacking. In conclusion, all surgery poses risks; however, patients should be made aware of the pros and cons of various routes of surgery as well as the potential risks and benefits of using mesh. Surgeons should provide patients with honest information about their own experience implanting mesh and also their experience dealing with mesh-related complications.

Vaginal mesh repair: is it appropriate for pelvic organ prolapse in a nulliparous female following pelvic ring fracture?

Pelvic organ prolapse (POP) in a nulliparous woman is a rare sequela of high-energy pelvic trauma. We report a case of a 26-year-old nulliparous woman who developed stage III pelvic organ prolapse two decades after pelvic ring disruption. Abdominal wall cervicopexy was performed as a primary procedure by her attending local gynecologist. Recurrence occurred in early postoperative period following which she was referred to our institute. Examination revealed 5-cm pubic symphysis widening and stage III pelvic organ prolapse with deficient perineal body. Widened levator hiatus with atrophic pelvic floor muscles were confirmed on MRI. The patient was successfully managed by sacrospinous hysteropexy using predesigned vaginal mesh kit along with anterior colporrhaphy and colpoperineorrhaphy. Mesh exposure detected at the 6th year of follow-up required partial excision of the exposed mesh.

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This review will focus on the strengths of transvaginal mesh-augmented repairs over traditional native tissue repairs with an emphasis on the more recent literature. Recent attention from the Food and Drug Administration has prompted a re-evaluation of the use of commercial mesh kits in pelvic organ prolapse (POP) repair. Mesh kits for POP repair were recently reclassified from Class 2 medical devices to Class 3 medical devices, a policy change that will prompt additional trials for POP repair in the future. The statements published by the FDA and the reclassification of mesh kits have generated a debate regarding the use of mesh in POP repairs. Higher complication rates involving mesh exposures have been documented in the past leading to the recent controversy; however, current mesh studies with longer term follow-up show lower and acceptable exposures with improved objective and subjective outcomes.

Mesh for Anterior Pelvic Organ Prolapse: Where Do We Go Now?

Pelvic organ prolapse (POP) repair using native tissue has a significant risk of failure, especially for anterior compartment repair. Surgical techniques using a variety of mesh grafts and approaches have been developed to decrease the risk of recurrence and improve overall outcomes. Some, but not all, studies have demonstrated that synthetic mesh grafts and mesh kits improve objective outcomes. However, reports of complications with the use of synthetic mesh grafts and mesh kits have been emerging. Such reports have stirred the interests of physicians, medical societies, the media, and regulatory agencies such as the US Food and Drug Administration (FDA), which in July 2011 issued a Safety Communication updating a 2008 statement warning about synthetic mesh and mesh kit complications associated with POP repair. This article discusses current and future directions using synthetic mesh for anterior compartment POP repair in the context of the recent FDA communication.

Clinical efficacy of a trocar-guided mesh kit for repairing lateral defects

The optimal surgery for lateral defects is not well defined. Our objective was to assess the effects of anterior trocar-guided transvaginal mesh repair versus anterior colporrhaphy in women with lateral defects. This subanalysis from a randomized controlled trial of mesh kit versus anterior colporrhaphy assessed 99 patient diagnosed at baseline with lateral defects in the anterior vaginal wall. Thirty-nine patients underwent anterior colporrhaphy and 60 anterior trocar-guided transvaginal mesh surgery. One year after surgery, a persistent lateral defect was significantly more common after colporrhaphy compared with transvaginal mesh [11/32 (34.4 %) vs 1/42 (2.4 %), risk ratio (RR) 14.4, 95 % confidence interval (CI) 2.0-106.1; P < 0.001)] However, there were no significant differences between treatment groups with regard to subjective symptoms as reflected by the overall Urogenital Distress Inventory scores, with mean difference from baseline 37.3 ± 50.6 in the colporrhaphy group vs 39.0 ± 45.8 in the mesh group (p = 0.61). Use of a transvaginal mesh kit increases the odds for anatomical correction of lateral defects compared with anterior colporrhaphy but does not necessarily improve lower urinary tract symptoms.

Pregnancy and delivery after anterior vaginal mesh replacement: a case presentation

A 36-year-old para 2 woman with Pelvic Organ Prolapse Quantification (POP-Q) stage III anterior prolapse and stress urinary incontinence (SUI) was treated using Polypropylene monofilament anterior vaginal mesh kit. She conceived 3 months after mesh replacement. During pregnancy and after delivery, patient satisfaction was achieved in terms of symptom relief, and surgeon satisfaction was obtained in terms of anatomical results. Three years after cesarean section, she had no incontinence, and on exam, POP-Q score was Ba -2 cm. No mesh complication was noted, and no sexual dysfunction was declared. In summary, vaginal mesh kits can be used satisfactorily for patients with anterior prolapse and SUI who want to be pregnant.

Central Compartment and Apical Defect Repair Using Synthetic Mesh

Pelvic organ prolapse is an increasingly common condition for women that has been challenging to treat due to high recurrence rates after surgical repair. The introduction of mesh-augmented prolapse repairs as a means to achieve more robust repairs had great initial promise. As more data emerge on outcomes and novel mesh complications, the when and where of mesh augmentation has become much less clear. This article reviews the relevant literature on the use of mesh in central and apical repairs. This includes a detailed look at the available data for vaginal mesh kits and several recent trials comparing mesh kits to traditional repairs. The article ends with a discussion of the recent U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh in pelvic organ prolapse and the authors' views of how practice may change in this new environment.

Magnetic resonance imaging of abdominal versus vaginal prolapse surgery with mesh

We compared two surgical approaches in patients with symptomatic prolapse of the vaginal apex with normal controls by analyzing pelvic landmark relationships measured using magnetic resonance imaging (MRI) before and after surgery. In this prospective multicenter pilot study involving 16 participants, nulliparous controls (n = 6) were compared with ten parous (3.0 ± 1.0) women with uterine apical prolapse equal to or greater than stage 2. Group A (n = 5) underwent abdominal sacral colpopexy with monofilament polypropylene mesh and group B (n = 5) with vaginal mesh kit repair (Total ProLift). Subtotal hysterectomy was performed in all group A and no group B women. All patients underwent preoperative and 3-month postoperative Pelvic Organ Prolapse Quantification (POP-Q) and dynamic MRI. Comparison of MRI pelvic angles and distances was performed and analyzed by Mann-Whitney rank sum test and chi-square test. Vaginal apical support is similar at 3 months for abdominal sacral colpopexy (ASCP) and ProLift by POP-Q examination and MRI analysis. In both treatment groups, the postoperative POP-Q point C and MRI parameters were similar to nulliparous controls at 3 months. Anatomic outcomes for ASCP compared with ProLift were similar at 3 months in terms of vaginal apical support by POP-Q and MRI analysis. Continued comparative analysis of postoperative support with objective imaging seems warranted.

Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse

To identify risk factors for mesh exposures after anterior pelvic organ prolapse repair using a standardized trocar guided polypropylene mesh kit. A secondary risk analysis combining patients from two prospective multicenter studies. Main outcome was clinical host-vs-implant reactions one year after surgery using a macroscopic inflammatory scale. 353 patients were included in the study. Mean age at surgery was 65.3 (± 9.6 SD) years and surgery was performed as a primary procedure in 224/353 (63.5%) patients. Mesh exposures, of which the majority were mild-moderate, occurred in a total of 30/349 patients (8.6%). Multivariate logistic regression showed increased odds for mesh exposures for women who smoked before surgery (OR 3.48, 95% CI 1.18-10.28), who had given birth to more than two children (OR 2.64, 95% CI 1.07-6.51) and those with somatic inflammatory disease (OR 5.11, 95% CI 1.17-22.23). Age, body mass index, and menopausal status showed no significant association with clinical mesh exposures. Smoking, multiple childbirth, and somatic inflammatory disease are possible risk factors for mesh exposure after trocar guided mesh kit surgery for anterior pelvic organ prolapse. Preoperative smoking cessation may decrease the risk for exposures.

What is the Gold Standard for Posterior Vaginal Wall Prolapse Repair: Mesh or Native Tissue?

Reports in the literature of high recurrence rates after native tissue repair for pelvic organ prolapse led to the development of alternative techniques, such as those using synthetic mesh. Transvaginal mesh (TVM) delivery systems were implemented in search of better outcomes. Despite reported recurrence as low as 7.1 % after posterior colporrhaphy, mesh kits were developed to correct posterior compartment prolapse. There is a paucity of data to substantiate better results with TVM for rectocele repair. Three randomized controlled trials comparing native tissue repair to synthetic mesh reported posterior compartment outcomes and two of these failed to show a significant difference between groups. Complications of TVM placement are not insignificant and mesh extrusion was reported in up to 16.9 %. Based on currently available data, native tissue repairs have similar outcomes to synthetic mesh without the risks inherent in mesh use and remain the standard of care for the typical patient.

2145 ANTERIOR TRANSVAGINAL MESH- HOW “SERIOUS” ARE THE COMPLICATIONS AND ARE THEY REVERSIBLE?

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Pelvic Prolapse1 Apr 20122145 ANTERIOR TRANSVAGINAL MESH- HOW “SERIOUS” ARE THE COMPLICATIONS AND ARE THEY REVERSIBLE? Dominic Lee, Benjamin Dillon, Gary Lemack, Alexander Gomelsky, and Philippe Zimmern Dominic LeeDominic Lee Dallas, TX More articles by this author , Benjamin DillonBenjamin Dillon Dallas, TX More articles by this author , Gary LemackGary Lemack Dallas, TX More articles by this author , Alexander GomelskyAlexander Gomelsky Shreveport, LA More articles by this author , and Philippe ZimmernPhilippe Zimmern Dallas, TX More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.2316AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Following two FDA warnings on the use of trans-vaginal mesh in women with pelvic organ prolapse, we reviewed our series of patients referred with anterior mesh related complications. METHODS Following IRB approval, a retrospective analysis of pooled data from 2 tertiary institutions managing complications of anterior transvaginal mesh (ATM) from 2006 to March 2011 was conducted. Data recorded included mesh type, symptoms leading to surgical removal, and clinical outcome. Minimal follow-up was 6 months. RESULTS Fifty-eight women underwent anterior vaginal wall mesh removal. Mean age was 54.6 years (range: 32-80) and duration of follow-up 13.3 months (range: 6-67.3). Time from original surgery to mesh excision was 20.9 months (range: 2.2-59.8). Overall, 44 patients had removal of ATM mesh only, while 31 of 44 had mid urethral sling (MUS) takedown as well. Fourteen patients had ATM removal combined with apical and/or posterior mesh removal and of these, 9 also had MUS takedown. ProliftTM was the predominant mesh kit material (28), followed by PerigeeTM (14), AvaultaTM (10) and various others (8). Nineteen of 58 patients (32.7%) had prior mesh removal attempts. Vaginal mesh extrusion (75%), dyspareunia (73%) and pelvic pain (41%) were the commonest presenting complaint, in addition to one case of vesico-vaginal fistula. Three cases required an abdominal approach. Seventy-four surgeries were required for maximal anterior mesh excision. Thirteen additional procedures were required for recurrent cystocele (4) and secondary stress urinary incontinence (9). Forty-two of 58 were women remained sexually active (73%) postoperatively and reported improvement in dyspareunia with 18 having no pain (42.8%), 12 mild pain (28.6%) and 3 moderate pain (7.1%). Chronic pelvic pain was improved in most patients with 7 women reporting no pain (30.4%), 9 mild pain (39.1%) and 5 moderate pain (21.7%). Two patients had mesh erosion recurrence, and 1 intra-operative ureteric injury was successfully repaired primarily on mesh removal. CONCLUSIONS : In this combined series, ATM removal provided symptom relief in over 75% of women. Residual issues of dyspareunia, chronic pelvic pain, prolapse recurrence, and recurrent mesh extrusion remain in a substantial minority. Some ATM complications are life-altering and intervention “may or may not correct the complication” [FDA October 2008]. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e866 Peer Review Report Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dominic Lee Dallas, TX More articles by this author Benjamin Dillon Dallas, TX More articles by this author Gary Lemack Dallas, TX More articles by this author Alexander Gomelsky Shreveport, LA More articles by this author Philippe Zimmern Dallas, TX More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

V249 THE USE OF MESH IN FEMALE PELVIC SURGERY AN EDUCATIONAL VIDEO

You have accessJournal of UrologyFemale Voiding Dysfunction (Pelvic Reconstruction and Incontinence)1 Apr 2012V249 THE USE OF MESH IN FEMALE PELVIC SURGERY AN EDUCATIONAL VIDEO Sarah Kane, Adonis Hijaz, and Firouz Daneshgari Sarah KaneSarah Kane Cleveland, OH More articles by this author , Adonis HijazAdonis Hijaz Cleveland, OH More articles by this author , and Firouz DaneshgariFirouz Daneshgari Cleveland, OH More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.305AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The July 13th, 2011 FDA warning statement on surgical mesh used for pelvic organ prolapse and stress incontinence surgery caused much anxiety for patients and for Female Pelvic Surgeons. In this video, our objectives are to show the evolution of prolapse and incontinence repair surgery. This includes showing how prolapse repair incorporating mesh has been used in the past and more recently, and also how the surgical treatment of stress incontinence has evolved to include mesh as the standard of care. We also review the FDA's warning and what it means for patients contemplating surgery. METHODS We highlight the progression of Female Pelvic Surgery from abdominal to minimally invasive surgery and the incorporation of surgical mesh. We then demonstrate the evolution of mesh from the initial midurethral slings to the vaginal mesh kits available today in a timeline, and the slings are compared to the vaginal mesh kits. Surgical treatment of pelvic organ prolapse using mesh and non-mesh techniques is then discussed, giving risks and benefits of each option. The FDA warning statement on mesh is then explained to help patients make informed decisions. RESULTS The FDA review concluded that transvaginal prolapse repair with mesh does not improve symptomatic results or quality of life when compared to the traditional sutured tissue repair, and mesh used in transvaginal prolapse repair introduces risks not present in traditional non-mesh surgery prolapse repair. They added that abdominal or robotic sacral colpopexy has a lower risk of mesh complication than transvaginal use of mesh in prolapse treatment. The review of the use of mesh for the treatment of stress incontinence is still in progress, with no final recommendations having been made for its use. CONCLUSIONS We hope that patients watching this video will have a better understanding of the use of mesh in Female Pelvic Surgery, and that this knowledge will help them make informed decisions regarding their surgical treatment. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e101 Peer Review Report Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sarah Kane Cleveland, OH More articles by this author Adonis Hijaz Cleveland, OH More articles by this author Firouz Daneshgari Cleveland, OH More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

2147 EDUCATIONAL EXPERIENCE AND PRACTICE PATTERNS OF SYNTHETIC MESH USE

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Pelvic Prolapse1 Apr 20122147 EDUCATIONAL EXPERIENCE AND PRACTICE PATTERNS OF SYNTHETIC MESH USE Tristan Keys and Gopal Badlani Tristan KeysTristan Keys Winston-Salem, NC More articles by this author and Gopal BadlaniGopal Badlani Winston-Salem, NC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.2318AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In light of the U.S. Food and Drug Administration's safety update in July 2011 warning of the complications associated with trans-vaginal mesh repair of Pelvic Organ Prolapse (POP), we sought to assess current trends in mesh use by practicing urologists, as well as evaluate their training methodology. Approaches to the surgical management of Stress Urinary Incontinence (SUI) and POP have experienced several recent paradigm shifts with the introduction of synthetic mesh-based repair procedures. The subsequent advent of commercialized mesh kits has allowed for wide-spread use, and there has been an associated significant increase in the application of these kits for treating POP. Experience of the surgeon has been shown to impact success and complication rates of mesh procedures, but the rapid incorporation of commercial kits into clinical practice may hinder appropriate training and education, leading to higher complication rates. METHODS Current members of the American Urological Association in the United States were sent an anonymous questionnaire in September 2011. The questionnaire evaluated each member's incorporation of mesh in their daily practice, their sources of training for mesh-based procedures, and their opinion on educational programs. RESULTS The questionnaire was sent to 8,008 practicing urologists in the United States, and 1,329 (16.6%) responded. A majority of urologists (86.8%) currently perform synthetic mesh-based procedures, with an average of 5 procedures performed per month (range 0–100). Most of the procedures are surgical correction of SUI, averaging 4.27 procedures per month (range 0-100), as compared to 1.34 procedures per month for POP (range 0–35). Concerning training modalities, 74.4% have received training through an industry-sponsored course, while only 13% have trained at a specialty society course. One-third (31.9%) indicated self-training as an educational source, whereas another third (32.2%) indicated training received primarily during residency and/or fellowship. Lastly, 75.9% believe the AUA should conduct educational courses regarding surgical mesh use for SUI/POP repair, with the highest percentile of responders (19.3%) being “Extremely Interested” in taking such a course. CONCLUSIONS A majority of responders have received training directly from a surgical device company course, demonstrating the large influence held by the manufacturing sector. Complications vary based on training and patient selection. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e867 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tristan Keys Winston-Salem, NC More articles by this author Gopal Badlani Winston-Salem, NC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...