Drug Administration Public Health Notification Research Articles

What to do after a mid-urethral sling fails.

After the Food and Drug Administration Public Health Notification in 2011 regarding transvaginal mesh, there has been a decline in the use of mid-urethral slings (MUS). However, they are an effective treatment option for stress urinary incontinence (SUI) with minimal complications. The management of recurrent SUI after sling continues to be debated. Long-term follow-up after primary MUS confirms its efficacy and safety. There remains no level 1 evidence for the best next step after a failed MUS. Preferred treatment strategies include placing a repeat MUS with more recent evidence demonstrating no difference in cure rates between transobturator tape and retropubic approach. Pubovaginal slings (PVS) and urethral bulking agents are also acceptable treatment options. A newer bulking agent, polyacrylamide hydrogel, demonstrated excellent short-term success rates in patients after a failed sling. MUS is an effective treatment option for SUI. Patients who develop recurrent urinary incontinence are a heterogeneous population who must be evaluated for detrusor overactivity, misplaced sling, unrecognized ISD. Patients with ISD are more likely to benefit by a PVS. Other patients with demonstrated recurrent SUI will likely do well with a repeat MUS.

Trends in Stress Urinary Incontinence Surgery at a Tertiary Center: Midurethral Sling Use Following the AUGS/SUFU Position Statement

ObjectiveTo investigate trends in stress urinary incontinence (SUI) surgery before and after the 2011 Foods and Drug Administration notification and the 2014 (American Urogynecologic Society [AUGS]/Society for Urodynamics Female Pelvic Medicine and Urogenital Reconstruction [SUFU]) position statement. MethodsA retrospective chart review was performed to identify patients presenting for evaluation of SUI by 2 Female Pelvic Medicine and Reconstructive Surgery specialists between June 1, 2010 and May 31, 2017. Rates of surgical treatment modality (synthetic midurethral slings [MUS] versus autologous fascial pubovaginal sling versus bulking agents) were analyzed at 6-month intervals. ResultsOver fourteen 6-month intervals, the number of new patients presenting for evaluation of SUI increased consistently. There was a decrease in the proportion of new patients who underwent antiincontinence surgical procedures, specifically MUS, between December 2011 and December 2013. After the integration of the 2014 AUGS/SUFU position statement in patient counseling, this trend reverted and we noted a sustained increase in the proportion of patients electing surgical management. This paralleled an increase in new patient visits for SUI and MUS. The number autologous fascial pubovaginal sling remained stable throughout the study period. Conversely, MUS composed the highest proportion of procedures performed, accounting for 60 %-87.2% off all antiincontinence procedures. ConclusionAfter the Foods and Drug Administration Public Health Notification in 2011, we observed a decline in the number of new patients presenting with SUI electing surgical management, specifically MUS. However, after the AUGS/SUFU position statement publication and integration into counseling, we observed a reversal in the previous year's trends, noting a resurgence of MUS utilization.

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.

Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the food and drug administration public health notifications.

To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013. SAS statistical software was used to assess for trends in the data. There was a decrease in the use of synthetic mesh sling for the treatment of SUI at academic tertiary care centers over the past 7 years; however, this was not statistically significant. While the total number of surgical interventions for SUI remained stable, there was an increase in the utilization of autologous fascia pubovaginal slings (AFPVS). The number of mesh sling revision surgeries, including urethrolysis and removal or revision of slings, increased almost three-fold at these centers. These observed trends suggest a possible effect of the FDA Public Health Notifications regarding TVM on surgical practice for SUI in academic centers, even though they did not specifically warn against the use of synthetic mesh for this indication. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study. However, such data may provide alternative insights into reasons for the observed trends. Neurourol. Urodynam. 36:1155-1160, 2017. © 2016 Wiley Periodicals, Inc.

Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications

To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers. Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods. There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases. Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends.

Transvaginal mesh in the media following the 2011 US food and drug administration public health notification update.

Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notification about the use of mesh in the treatment of pelvic organ prolapse. Two national newspaper databases were queried for articles discussing transvaginal mesh published within 3 years of the FDA announcement. Content analysis included headline subjects, mesh-related complications, quoted sources, and the FDA recommendations. To determine whether more widely read sources publish higher quality reporting, a subgroup analysis was conducted based on newspaper circulation. Ninety-five articles met inclusion criteria. Mesh-related litigation was the most common headline subject (36 articles, 38%), and 54% of all articles referenced legal action. Fifty-seven articles (60%) cited at least one mesh-related complication. Only 18 articles (19%) quoted surgeons who use transvaginal mesh. For the FDA update, 40% of articles that first reported the announcement accurately specified that it applies to mesh for prolapse, not incontinence. This ambiguity persisted: half of all articles cited the warning, but only 23% distinguished between prolapse and incontinence. Higher newspaper circulation did not significantly improve the quality of reporting about the content or context of the FDA's recommendations. Despite frequent media coverage of transvaginal mesh and its complications since 2011, very few news sources that cited the FDA warning distinguished between prolapse and incontinence. Given prevalent reporting of mesh-related litigation, the findings raise concern about how patients perceive the safety and efficacy of transvaginal mesh, regardless of indication. Neurourol. Urodynam. 36:329-332, 2017. © 2015 Wiley Periodicals, Inc.

Current Trends in Demographics, Practice, and In-Hospital Outcomes in Cervical Spine Surgery

Retrospective database analysis. To investigate national trends of cervical spine surgical procedures from 2002 to 2011. There is a paucity of literature assessing the current practice trends and outcomes of cervical spine surgery following the 2008 Food and Drug Administration public health notifications regarding bone morphogenetic protein (BMP) utilization in cervical spine surgical procedures. The National Inpatient Sample database was accessed for each year across 2002 to 2011. Patients undergoing anterior cervical fusion, posterior cervical fusion, and posterior cervical decompression were identified. Patient and hospitalization parameters including demographics, BMP utilization, costs, early postoperative outcomes, and mortality were assessed for each surgical cohort. A Pearson correlation coefficient with a 95% confidence interval (P < 0.05) was used to analyze trends in patient and hospital outcome parameters during this 10-year period. A total of 307,188 cervical spine procedures were performed from 2002 to 2011. Both the anterior cervical fusion and posterior cervical fusion cohort demonstrated a statistically significant increase in the number of procedures performed over time (r = +0.9, P < 0.001). A significant uptrend in patient age (r = +1.0, P < 0.001) and comorbidity burden (r = +0.9, P < 0.001) was demonstrated during the studied decade. Overall, BMP utilization (r = +0.7, P = 0.02) also demonstrated a significant increase during this time period, but demonstrated a decline after peaking in 2007. The posterior cervical fusion cohort demonstrated the greatest comorbidity, length of stay, costs, and mortality. This study demonstrates that the number of cervical spine procedures has increased between 2002 and 2011, irrespective of the change in BMP utilization after the 2008 Food and Drug Administration warning. Despite an older patient population with greater comorbidities undergoing cervical spine surgeries, hospital length of stay and mortality has not significantly changed. However, we did note a significant increase in costs during this time period. These findings may be related to advances in surgical technology and instrumentation that may be associated with rising hospital costs.