Mesh For Incontinence Research Articles

Efficacy of the Sub-Urethral Transobturator KIM System® for Female Urinary Incontinence: Long Term Results.

Background/Objectives: Female stress urinary incontinence (SUI) surgical treatment has changed since its beginning. Selecting materials that promote constructive tissue remodelling helps to maintain continence after surgery and minimizes complications. To analyze the long-term urinary continence results in women who underwent SUI surgical correction using the transobturator mid-urethral sling KIM system® (Knotless Incontinence Mesh) and analyze the complications associated with this SUI treatment. Materials and Methods: Prospective study of the first 1000 patients undergoing SUI surgery with the Contasure KIM® sling between April 2007 and December 2018. Results and complications were recorded. Group A represented 94.2% of the sample and were the continent patients after surgery (GA = 942), while Group B accounted for incontinent patients after surgery (5.8%) (GB = 58). Results: The mean age at operation was 60 years. Eutocic deliveries (p = 0.0022), high blood pressure (p = 0.0190), anxiety (p = 0.0084), hemorrhoidectomies (p = 0.0016) and hysterectomies (p = 0.0002) were higher in GB. No differences between groups were found regarding body mass index (GA 26.50; GB 26.93) (p = 0.220649), food or drug allergies (p = 0.0.6547), dystocia (p = 0.2365), diabetes mellitus (p = 0.1715), pelvic surgery (p = 0.8842), other surgery (p = 0.8801) or concomitant treatments that would have an impact on bladder function. Correction of SUI was achieved in 94.2% of cases. Continence persisted over time in 97.98% of continent patients at 4-year follow-up and 90.90% of patients at last follow-up. Mesh caused erosion of the urethra in 0.3% of patients and extruded to the vagina in 0.42%. De novo urinary urgency (2.8%), significant chronic pain (3.6%) and urinary tract infections (3.0%) after surgery were lower than complications reported in reviewed publications. Pain was treated with medication, and all patients were pain-free at the one-year follow-up visit. Conclusions: The mid-urethral transobturator sling KIM system® has good initial and long-term results in patients with stress urinary incontinence, with a low recurrence rate and minimal complications.

Transvaginal mesh for incontinence and prolapse: Where are we now and how did we get here?

Transvaginal mesh for incontinence and prolapse: Where are we now and how did we get here?

Improvement in dyspareunia after vaginal mesh removal measured by a validated questionnaire.

The objective was to examine the effect of the surgical removal of vaginally placed prolapse and incontinence mesh on sexual function. We hypothesize that patients with painful complications of mesh will experience improvement in dyspareunia and sexual function after mesh removal. The eligible cohort consisted of 133 women who presented with a new onset of pain attributed to mesh-augmented incontinence or prolapse surgery and who elected to undergo mesh removal between 1 August 2012 and 1 July 2013. Sexual function symptoms were assessed before and after mesh removal surgery using the Pelvic Organ Prolapse and Urinary Incontinence Sexual Function Questionnaire short form (PISQ-12). Multivariate analysis was performed to identify predictors of improvement in dyspareunia. Ninety-four patients undergoing mesh removal completed a pre-operative questionnaire, 63 of whom also completed a post-operative questionnaire. After mesh removal, there was a nearly 50% reduction in the proportion of women reporting always experiencing post-operative pain with intercourse among those experiencing pre-operative pain. There was a statistically significant quantitative improvement in pain with intercourse after mesh removal based on mean change score of PISQ-12 question 5 "How often do you experience pain with intercourse?". In multivariate analysis, only history of vaginal delivery was associated with symptom improvement. Removal of transvaginal prolapse mesh is associated with improvement in self-reported dyspareunia based on a standardized question on a validated instrument in a small cohort of women. Although larger studies are needed to confirm the relationship between mesh-augmented surgeries and post-procedural dyspareunia, these data suggest that consideration of mesh removal is a reasonable step for patients with painful intercourse attributed to mesh-augmented prolapse and incontinence surgeries.

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.

Inaccuracies in News Media Reporting About the 2019 US Food and Drug Administration Ban on Transvaginal Mesh for Pelvic Organ Prolapse Repair

ObjectiveTo analyze inaccuracies in the news media reporting of the 2019 US Food and Drug Administration (FDA) ban on surgical mesh for transvaginal repair of pelvic organ prolapse (POP). MethodsWe queried the NexisUni media database for English-language news articles about “transvaginal mesh” or “FDA” published before and after the ban. Content analysis was based on discussion of the ban, indications for surgical mesh, and assessment of bias. We characterized public interest in transvaginal mesh using Google Trends. ResultsOf 290 news articles reviewed, 42 articles were included for analysis. Public interest in transvaginal mesh increased 4-fold after the FDA announcement. While 15 articles (38%) accurately reported that mesh was used in both POP and incontinence repairs, a plurality (18, 43%) only described using mesh for POP. The majority (30, 71%) of articles did not specify that the FDA ban applied to only transvaginal repair of POP and not to incontinence. Despite multiple professional societies affirming the use of mesh for incontinence, only 2 (5%) articles cited these evidence-based recommendations. About half of the articles had an overtly biased tone; articles with an anti-mesh bias were significantly less likely to identify the mesh indications relevant to the ban (P <.01). ConclusionSeventy percent of news reports about the 2019 FDA ban on transvaginal mesh for POP failed to distinguish between the clinical indications for mesh impacted by the ban. The findings raise concern about patient perceptions of and future access to mesh surgery, regardless of indication.

Real story behind transvaginal mesh.

Much of the debate over the use of transvaginal mesh for incontinence and prolapse has been conducted on social media, in the tabloid press and through a very public Senate inquiry. It has been a very emotionally charged debate with surgeons variously accused of scandalous behavior, financial impropriety, surgical experimentation and misogyny. What really happened, how did we get here and what can we learn from these complex events?

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 ...

Recurrent Urinary Tract Infections in the Setting of Mesh Implants

Mid-urethral polypropylene mesh slings are widely accepted as a standard for surgical management of stress urinary incontinence due to a low complication rate and superior efficacy. Synthetic mesh implants used to augment female pelvic prolapse repairs gained popularity following introduction of these slings. Mesh implants for prolapse have been under increased scrutiny after the FDA safety notification was published in 2008 due to a higher than anticipated complication rate. While the complication rate of mesh slings used for incontinence is low, both incontinence mesh and prolapse mesh are associated with similar types of complications. These include mesh exposure, pain, voiding dysfunction, and infections. The majority of available literature describes the incidence of acute urinary tract infections in the immediate postoperative period, specifically after mid-urethral sling procedures for incontinence. The rates of de novo recurrent urinary tract infections and risk factors for these infections after polypropylene mesh placement are not well-characterized. The incidence of recurrent urinary tract infections after polypropylene mesh-augmented surgery for stress urinary incontinence and for pelvic organ prolapse is low. Risk factors for recurrent urinary tract infections after surgery include urinary retention, need for indwelling or intermittent catheterization, and preoperative history of recurrent urinary tract infections. While multiple theories exist, the current literature has not been able to determine risk factors for de novo recurrent urinary tract infections after mesh-augmented surgery in women without urinary retention or prior history of recurrent urinary tract infections. While some have suggested that the implant is coated with a bacterial biofilm resulting in chronic low levels of bacterial shedding, and thus predisposing certain individuals to chronic recurrent urinary tract infections, this theory remains unproven. It is also not known if revision of the mid-urethral slings or if removal of the mesh implant in women in this subgroup will result in the resolution of recurrent infections.

The mesh controversy

Pelvic organ prolapse and stress urinary incontinence are common conditions for which approximately 11% of women will undergo surgical intervention in their lifetime. The use of vaginal mesh for pelvic organ prolapse and stress urinary incontinence rose rapidly in the early 2000s as over 100 mesh products were introduced into the clinical armamentarium with little regulatory oversight for their use. US Food and Drug Administration Public Health Notifications in 2008 and 2011, as well as reclassification of transvaginal mesh for prolapse to class III in early 2016, were a response to debilitating complications associated with transvaginal mesh placement in many women. The midurethral sling has not been subject to the same reclassification and continues to be endorsed as the “gold standard” for surgical management of stress urinary incontinence by subspecialty societies. However, litigators have not differentiated between mesh for prolapse and mesh for incontinence. As such, all mesh, including that placed for stress urinary incontinence, faces continued controversy amidst an uncertain future. In this article, we review the background of the mesh controversy, recent developments, and the anticipated role of mesh in surgery for prolapse and stress urinary incontinence going forward.

PD28-09 A POPULATION BASED ASSESSMENT OF THE RISK FACTORS FOR MESH REMOVAL OR REVISION AFTER FEMALE INCONTINENCE PROCEDURES

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Incontinence - Therapy II1 Apr 2015PD28-09 A POPULATION BASED ASSESSMENT OF THE RISK FACTORS FOR MESH REMOVAL OR REVISION AFTER FEMALE INCONTINENCE PROCEDURES Blayne Welk, Hana'a Al-Hothi, and Jennifer Winick-Ng Blayne WelkBlayne Welk More articles by this author , Hana'a Al-HothiHana'a Al-Hothi More articles by this author , and Jennifer Winick-NgJennifer Winick-Ng More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1906AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The public is increasingly aware of incontinence mesh complications. Our objective was to determine the incidence and risk factors associated with surgical revision or removal of incontinence mesh. METHODS We conducted a retrospective, population-based study using administrative data. Our study population consisted of all women who underwent a stress incontinence procedure with mesh between 2002-2012 in Ontario, Canada. Patients who had mesh based prolapse repairs at any point were excluded. Our primary outcome was a composite of any surgical invention resulting in operative manipulation of the mesh (division, removal). Our primary exposure was surgeon volume; high volume surgeons were defined as the top 25th percentile of mesh implanters in a given year. Secondary exposures were multiple incontinence mesh procedures, and the presence of potential risk factors for mesh complications (pelvic radiation, fistula, urethral diverticulum, urethral injury). Other covariates included age, obesity, diabetes, health care utilization, comorbidity, socioeconomic status, surgical specialty and simultaneous surgical procedures. Primary analysis was an adjusted Cox proportional hazards model. RESULTS We identified 59,887 women with a median age of 52 (IQR 45-63) years. Median followup was 4.4 (IQR 2.4-6.9) years. A hysterectomy was done simultaneously in 13% of cases and non-mesh based prolapse repairs in 30% of cases. Within our cohort, 0.1% had risk factors for mesh complications, and 2.3% had multiple mesh slings placed. Our primary outcome was identified in 1307 patients (2.18%), and our overall event rate was 4.62/1000 person-years of followup. The cumulative incidence of mesh removal or revision increased from 1.2% after 1 year of followup to 2.5% after 10 years of followup. In our adjusted Cox regression analysis, high volume surgeons were significantly less likely to have patients with mesh removal or revision (HR 0.74, p<0.0001), and patients with multiple slings placed had a much higher rate of revision or removal (HR 6.57, p<0.0001). The presence of potential risk factors for mesh complications was not a significant risk factor (HR 0.55, p=0.5552). CONCLUSIONS The risk of surgical revision or removal of incontinence mesh is relatively rare, but does increase with time to 2.5% after 10 years of followup. Patients of high volume surgeons are significantly less likely to experience this complication, and women who have undergone multiple sling placements are at much higher risk of experiencing these complications. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e647 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Blayne Welk More articles by this author Hana'a Al-Hothi More articles by this author Jennifer Winick-Ng More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Vaginal mesh for incontinence and/or prolapse: caution required!

Vaginal mesh for incontinence and/or prolapse: caution required!

TVA y TOA. Nuevas mallas ajustables de tensión en el tratamiento de la incontinencia urinaria de esfuerzo. Resultados preliminares

ObjectivesEvaluation of a new mesh for incontinence (TVA/TOA) which enables the degree of tension applied during surgery to be readjusted at the post-operative stage. Patients and Method62 patients treated with the TVA mesh and monitored over a 14-month period (SD 7.8, range 6-38). In 33 patients (53%) some other pelvic prolapse was corrected. Evaluation was carried out by clinical report, examination of bladder full of 250 saline solution, flowmetry and urinary residue. 40 patients filled in 4 quality of life questionnaires (QoL; ICIQ-SF; PGI-S; PGI-I). Results42 patients were found to be objectively continent in the post-operative evaluation. Of these, it was necessary to reduce tension in 7 cases (11%) due to urinary obstruction (flow < 10 ml/sec and/or residue). The tension of the mesh was tightened in 20 patients (32%) due to continue with a certain degree of incontinence. All patients were discharged as continent and with no residue. In the last revision, 58 patients (93%) proved to be objectively continent and 4 (6.5%) showed a notable improvement in their incontinence. The QMAX is 19.8 ml/sec (SD 9.8). The mictional urgency had disappeared or improved in 32 of the patients who had this prior to operation (76%) and had appeared in 3 of the patients who didn’t (15%). The clinical report showed a high level of consensus with the ICIQ-SF survey (Kappa = 0.89) regarding stress incontinence, diminishing clearly (Kappa= 0.13) when urge incontinence was taken into account. 34 (85%) patients scored over 95 out of 110 in the QoL. 30 (75%) scored less than 6 in ICIQ-SF. 32 (80%) showed a perception of normality and 4 (10%) slight illness in the PGI-S. In the PGI-I 29 (72.5%) were much better and 11 (27.5%) quite a lot better. A relation exists between urgency and dismissed quality of life. ConclusionWith the TVA (trans-vaginal adjustable) mesh it is possible to adjust the tension originally applied during surgery at the post-operative stage, so that any defects or excesses can be corrected.