Mesh For Stress Urinary Incontinence Research Articles

Natural electrospun scaffold fabrication as an alternative to surgical mesh for stress urinary incontinence

Natural electrospun scaffold fabrication as an alternative to surgical mesh for stress urinary incontinence

Development and in vitro investigation of a biodegradable mesh for the treatment of stress urinary incontinence

Introduction and hypothesisThe use of polypropylene (PP) mesh for stress urinary incontinence (SUI) surgery has declined because of safety concerns. The aim of this study is to evaluate a biodegradable polycaprolactone (PCL) mesh and a PCL composite mesh tissue engineered with human uterine fibroblasts (HUFs) for SUI surgery by comparing mechanical properties and in vitro biocompatibility to commercially available PP and porcine dermis (PD).MethodsThe mechanical properties of four scaffold materials were evaluated: PCL, PCL-collagen-hyaluronic acid composite, acellular porcine dermal collagen (PD) (Pelvicol™) and polypropylene (Gynecare TVT™ Exact®). HUFs were seeded on separate scaffolds. After 7 and 14 days scaffolds were assessed for metabolic activity and cell proliferation using Alamar Blue, Live/Dead and PicoGreen assays. Soluble collagen production was evaluated using a Sircol assay.ResultsPCL and the composite scaffold reached ultimate tensile strength (UTS) values closest to healthy pelvic floor tissue (PCL = 1.19 MPa; composite = 1.13 MPa; pelvic floor = 0.79 MPa; Lei et al. Int Urogynecol J Pelvic Floor Dysfunct. 18(6):603-7, 2007). Cells on PCL showed significantly greater cell viability than PP at day 7 (p < 0.0001). At D14 the composite scaffold showed significantly greater cell viability than PP (p = 0.0006). PCL was the best performing scaffold for soluble collagen production at day 14 (106.1 μg versus 13.04 μg for PP, p = 0.0173).ConclusionsWe have designed a biodegradable PCL mesh and a composite mesh which demonstrate better biocompatibility than PP and mechanical properties closer to that of healthy pelvic floor tissue. This in vitro study provides promising evidence that these two implants should be evaluated in animal and human trials.

Media coverage of the 2019 United States Food and Drug Administration ordered withdrawal of vaginal mesh products for pelvic organ prolapse.

On April 16, 2019, the United States Food and Drug Administration announced a withdrawal on sales and distribution of transvaginal mesh products for pelvic organ prolapse. The aim of this study was to asses online user behavior on pelvic-mesh related articles after the withdrawal and to evaluate article accuracy. We used Google Trends© to identify the terms related to pelvic mesh that experienced increased activity after the FDA announcement. The terms were analyzed for worldwide social media engagement (Facebook, Twitter, Pinterest, and Reddit) between April 16-19, 2019. The top ten lay press articles shared for each term were evaluated. We also examined the top ten Google search results for each term on June 6, 2019, in the US to evaluate what information was available after peak interest subsided. During peak activity in April, 30 unique articles were identified after the FDA announcement. Two (6.7%) did not mention the April 2019 FDA announcement. Seven (23%) discussed mesh for stress urinary incontinence. After peak interest on June 6, 2019, Google identified 26 unique articles for the four terms. Seven (27%) did not mention the FDA announcement, and 3 (12%) mentioned mesh for incontinence. Internet search patterns and social media behavior following the April 2019 ordered withdrawal on transvaginal mesh for pelvic organ prolapse reveal that some of the most disseminated information did not accurately or thoroughly distinguish the type of mesh discussed. This could lead to negative consequences for other mesh indications in female pelvic medicine and reconstructive surgery.

Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration.

To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

MP05-09 SOURCES OF CONFUSION: MEDIA COVERAGE OF THE 2019 UNITED STATES FOOD AND DRUG ADMINISTRATION BAN ON VAGINAL MESH FOR PELVIC ORGAN PROLAPSE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (MP05)1 Apr 2020MP05-09 SOURCES OF CONFUSION: MEDIA COVERAGE OF THE 2019 UNITED STATES FOOD AND DRUG ADMINISTRATION BAN ON VAGINAL MESH FOR PELVIC ORGAN PROLAPSE Poone Shoureshi*, Wai Lee, Kathleen Kobashi, and Kamran P. Sajadi Poone Shoureshi*Poone Shoureshi* More articles by this author , Wai LeeWai Lee More articles by this author , Kathleen KobashiKathleen Kobashi More articles by this author , and Kamran P. SajadiKamran P. Sajadi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000819.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: On April 16th, 2019, the United States Food and Drug Administration (FDA) announced a ban on transvaginal mesh for the treatment of pelvic organ prolapse (POP). The aim of this study was to asses online user behavior on pelvic-mesh related articles after the ban. METHODS: We used Google Trends© to identify the terms related to pelvic mesh that experienced increased activity after the FDA ban. The terms were analyzed for worldwide social media engagement (Facebook, Twitter, Pinterest, and Reddit) between April 16-19, 2019. The top ten lay press articles shared for each term were evaluated. We also examined the top ten Google search results for each term on June 6th, 2019 in the United States to evaluate what information was available after peak interest subsided. RESULTS: Thirty unique articles with peak activity after the FDA ban were identified. Two (6.7%) did not mention the April 2019 FDA announcement. Seven (23%) discussed mesh for stress urinary incontinence. Eighteen (69%) mentioned lawsuits or negative individual experiences without clarifying the type of pelvic mesh used. Twelve (40%) included a photo of mesh in the article, six (50%) were accurate in depicting a transvaginal POP mesh implant. The other six (50%) depicted photographs of slings for stress urinary incontinence (SUI) or abdominal wall mesh. Google identified 26 unique articles for the four terms when searched on June 6, 2019. Seven (27%) did not mention the FDA announcement, 3 (12%) mentioned mesh for incontinence, and 11 (42%) discussed lawsuits or negative individual experiences. Seven articles included a mesh photo, and three (43%) were of the correct type of mesh. The other 4 photographs were of mesh slings for SUI for abdominal wall mesh. CONCLUSIONS: Internet search patterns and social media behavior following the April 2019 ban on transvaginal mesh for pelvic organ prolapse reveal that some of the most disseminated information did not accurately or thoroughly distinguish the type of mesh discussed. This emphasizes the importance of preoperative counseling and focused educational materials for patients who may be or think they are affected by the FDA ban. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e44-e44 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Poone Shoureshi* More articles by this author Wai Lee More articles by this author Kathleen Kobashi More articles by this author Kamran P. Sajadi More articles by this author Expand All Advertisement PDF downloadLoading ...

Midurethral slings: evidence-based medicine vs the medicolegal system

Midurethral sling procedures are minimally invasive surgeries for stress urinary incontinence that use a trocar system to place a narrow ribbon of polypropylene mesh under the midurethra. The peer-reviewed scientific literature on these procedures is abundant and midurethral slings are the most well-studied incontinence procedure ever. Systematic reviews of the literature demonstrate that midurethral slings are safer and more (or equally) effective as traditional procedures. The midurethral sling is the worldwide standard for the treatment of female stress urinary incontinence and >3 million procedures have been performed. The Food and Drug Administration and international scientific review agencies have consistently differentiated transvaginal mesh for stress urinary incontinence from transvaginal mesh for prolapse. In the recruitment of patients to participate in transvaginal mesh litigation, plaintiff lawyers have not made the distinction between stress urinary incontinence and prolapse procedures because more women have received midurethral slings than transvaginal mesh for prolapse by an order of magnitude. The litigation costs of defending their products have forced several companies that manufactured midurethral slings to leave the marketplace. It is not inconceivable that midurethral slings could become absent from the US market. If that happens, then US women with stress urinary incontinence will be harmed because they will not have access in this country to the best and safest stress urinary incontinence surgical procedure ever developed. It may be time for the Institute of Medicine or another comparable national agency to provide evidence-based recommendations on the midurethral sling.

Outcomes of Autologous Fascia Pubovaginal Sling for Patients with Transvaginal Mesh Related Complications Requiring Mesh Removal

We reviewed the outcomes of the autologous fascial pubovaginal sling as a salvage procedure for recurrent stress incontinence after intervention for polypropylene mesh erosion/exposure and/or bladder outlet obstruction in patients treated with prior transvaginal synthetic mesh for stress urinary incontinence. In a review of surgical databases at 2 institutions between January 2007 and June 2013 we identified 46 patients who underwent autologous fascial pubovaginal sling following removal of transvaginal synthetic mesh in simultaneous or staged fashion. This cohort of patients was evaluated for outcomes, including subjective and objective success, change in quality of life and complications between those who underwent staged vs concomitant synthetic mesh removal with autologous fascial pubovaginal sling placement. All 46 patients had received at least 1 prior mesh sling for incontinence and 8 (17%) had received prior transvaginal polypropylene mesh for pelvic organ prolapse repair. A total of 30 patients underwent concomitant mesh incision with or without partial excision and autologous sling placement while 16 underwent staged autologous sling placement. Mean followup was 16 months. Of the patients 22% required a mean of 1.8 subsequent interventions an average of 6.5months after autologous sling placement with no difference in median quality of life at final followup. At last followup 42 of 46 patients (91%) and 35 of 46 (76%) had achieved objective and subjective success, respectively. There was no difference in subjective success between patients treated with a staged vs a concomitant approach (69% vs 80%, p = 0.48). Autologous fascial pubovaginal sling placement after synthetic mesh removal can be performed successfully in patients with stress urinary incontinence as a single or staged procedure.

Incidence of Placement and Removal or Revision of Transvaginal Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence in the Ambulatory Setting before and after the 2011 Food and Drug Administration Notification

In July 2011 the FDA issued a notification stating that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. This statement did not include any conclusions on mesh for stress urinary incontinence. The notification was reported widely in the popular media and public opinion appeared to turn against transvaginal mesh of all types not specific to pelvic organ prolapse. We evaluated changes in practice that occurred after the notification. We used the California, South Carolina, Illinois and Maryland SASD to determine the incidence of transvaginal mesh implantation procedures for pelvic organ prolapse and stress urinary incontinence as well as the incidence of mesh revision or removal procedures for these indications. A total of 20,323 mesh related procedures were performed for pelvic organ prolapse and stress urinary incontinence in 2011. The total number of transvaginal mesh implantations for prolapse decreased from early to late 2011. The total number of revision or removal procedures increased by 49.1% and 15% for prolapse mesh and slings, respectively. There was an increase in revision or removal procedures for slings as well as for all mesh (each p <0.001). The FDA notification was associated with increased revision or removal procedures for mesh placed for stress urinary incontinence despite the notification warning only against mesh for pelvic organ prolapse. Patients may rely on popular media for medical knowledge. Better patient education may help patients make choices regarding surgery in accordance with the FDA notification.

The Role of Mid-urethral Slings in 2014: Analysis of the Impact of Litigation on Practice

Over 90,000 legal claims for complications related to transvaginal mesh have been filed to date. Safety issues specifically related to the use of transvaginal mesh for pelvic organ prolapse have not been appropriately differentiated from the use of mesh for stress urinary incontinence by either attorneys or the media. This litigious environment and nebulous communication on the safety issues have led to patient and physician concern regarding mesh slings for the treatment of stress urinary incontinence. The ultimate result is likely to be a decrease in use of the gold standard of care for stress urinary incontinence—the mid-urethral synthetic sling.

110 Development of tissue engineered bio-absorbable cellularised mesh for stress urinary incontinence and pelvic organ prolapse: The effect of chemical and mechanical stimulation on improving tensile properties

110 Development of tissue engineered bio-absorbable cellularised mesh for stress urinary incontinence and pelvic organ prolapse: The effect of chemical and mechanical stimulation on improving tensile properties

A modified inexpensive transobturator vaginal tape inside-out procedure versus tension-free vaginal tape for the treatment of SUI: a prospective comparative study

To prospectively compare, in terms of efficacy and safety, the tension-free vaginal tape (TVT) and our modified transobturator vaginal tape inside-out (TVT-O) procedure with self-tailored monofilament macroporous polypropylene mesh for stress urinary incontinence (SUI). A total of 150 women with SUI were assigned to modified TVT-O (n = 95) and TVT (n = 55), respectively, the surgical outcomes compared 1 year later. A cough stress test was applied to the objective outcomes, while urinary incontinence specific quality of life (IQoL) questionnaire, to the subjective outcomes. The objective success rates defined as a negative stress test were found to be 95% in the TVT group and 96% in the modified TVT-O group, respectively. No significant difference was found between these two groups in the cure, improvement and failure rates (all P > 0.05), with significant improvement in quality of life (QoL) and no significant difference in patient satisfaction rates in two groups. In the TVT group were found three cases of bladder injuries. In the modified TVT-O group, operative duration, blood loss and medical cost were significantly reduced compared with those in the TVT one (P < 0.01). In the study, the modified TVT-O procedure could be defined to be quicker, more economic with fewer bladder complications than the TVT approach while both were found to be manually simple and clinically mini-invasive with similar efficacy.

The surgical results of the pubovaginal sling procedure using polypropylene mesh for stress urinary incontinence

To investigate the surgical results after a pubovaginal sling procedure using polypropylene mesh in women with stress urinary incontinence (SUI). Sixty-four women with different types of SUI underwent a pubovaginal sling procedure, using polypropylene mesh. The sling was placed at the level of the proximal half of the urethra and tied with adequate tension, but not obstructing the bladder outlet. A video-urodynamic study and transrectal ultrasonography were undertaken before and after surgery. The surgical results were assessed and the urodynamic changes compared at different stages. At a median follow-up of 24 months, 52 patients (81%) were completely continent, 10 (16%) had an improvement but with mild SUI, and two had persistent SUI requiring a second sling procedure. The treatment result was considered satisfactory by 55 patients (86%). The video-urodynamic study showed no significant change in voiding pressure, cystometric capacity and residual urine volume after surgery. The bladder neck opening time was increased at 7 days and the maximum flow rate increased at 3 months after surgery. Transrectal ultrasonography showed that all the polypropylene mesh slings were located beneath the bladder neck and proximal urethra, with no notable granuloma formation around the sling. The pubovaginal sling procedure is effective in treating female SUI, using polypropylene mesh as the sling material. The video-urodynamic results showed that a pubovaginal sling of polypropylene mesh causes no bladder outlet obstruction when the correct surgical technique is used.