The impact of the 2011 U.S. Food and Drug Administration transvaginal mesh communication on utilization of synthetic midurethral sling procedures for stress urinary incontinence

Alexander B1, Jasmine T2, Shawn M2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 693
Urogynaecology 6 - Mesh / Sling Complications
Scientific Podium Short Oral Session 33
Friday 6th September 2019
15:37 - 15:45
Hall G3
Grafts: Synthetic Stress Urinary Incontinence Surgery
1.University of California/Kaiser-San Diego, 2.Kaiser-San Diego
Presenter
B

Berger Alexander

Links

Abstract

Hypothesis / aims of study
Our aim was to examine the change in utilization of the midurethral sling for the treatment of stress urinary incontinence after the 2011 U.S. Food and Drug Administration (FDA) communication for transvaginal mesh for prolapse.  Midurethral slings were developed in the 1990's as a minimally invasive surgery for stress urinary incontinence, replacing the more invasive autologous fascial sling and retropubic urethropexy (Burch colposuspension). Midurethral slings have shorter hospital stays, quicker return to function, and less complications compared to the more invasive surgical options. Subsequently the midurethral sling has become the gold-standard for the treatment of stress urinary incontinence. While the FDA warning in 2011 explicitly excluding midurethral sling mesh, litigation groups, public interest groups, and many countries have targeted midurethral sling mesh for stress urinary incontinence along with transvaginal mesh for prolapse. We hypothesized that midurethral sling utilization would decrease after the FDA communication
Study design, materials and methods
This is a retrospective cohort study evaluating surgical utilization of the midurethral sling for stress urinary incontinence at a large multi-centered managed care organization of 4.6 million patients from 2005 to 2016. The primary outcome was the change in utilization of midurethral sling with synthetic mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in utilization by medical center sites. Midurethral sling rates were compared using generalized linear models and multivariate analysis.
Results
Over the study period 17,030 midurethral slings were performed at 11 medical centers throughout the managed care organization. Midurethral sling procedures decreased from 131 to 116 per 100,000 women with a decrease of 11.5% from 2010 to 2012 (Figure 1). Year over year utilization of midurethral sling was rapidly increasing prior the FDA communication from 19 (in 2006) to 131 (in 2010) per 100,000 women, and then significantly declined after its release from 135 (in 2011) to 75 (in 2016) per 100,000 women (224% increase vs 44% decrease).  Individual sites within the system showed similar trends.
Interpretation of results
Within our large managed-care organization, after the 2011 FDA communication, the midurethral sling is being used much less often for the treatment of stress urinary incontinence. While quickly adopted internationally and within our system in the late 2000s,  the years following 2011 revealed a equally drastic decrease in utilization of midurethral slings for the treatment of women with stress urinary incontinence. Despite explicit exclusion of MUS mesh in the FDA communication, litigation efforts have included MUS mesh with POP mesh and more than 50,000 women have joined class action lawsuits alleging mesh complications from both types of procedures. These financial and public concerns related to safety have increased awareness of synthetic mesh use in pelvic floor disorders including SUI.   Over the past decade, concerns over the safety of synthetic midurethral sling mesh has led several countries (United Kingdom, Australia, New Zealand) to ban or put a hold on midurethral slings, and many of the companies (Endo International, Bard, Astora) that supply midurethral slings to stopped producing them. Our results reveal that those same pressures are being seen in the United States.
Concluding message
Midurethral sling surgery for stress urinary incontinence drastically declined after the 2011 FDA communication. Despite the 2011 FDA communication concerning only transvaginal mesh, there was a significant decrease in midurethral sling mesh utilization within our large managed-care organization. Our findings support the importance of continued long-term outcome data regarding the safety and efficacy of midurethral sling and highlight the impact of the FDA warning on midurethral sling utilization.  The climate surrounding the treatment of stress urinary incontinence with a synthetic mesh midurethral sling is a dynamic one, and further data is needed to provide reassurance to patients, providers, and the public at large.
Disclosures
<span class="text-strong">Funding</span> Grant from the Regional Research Committee of Kaiser Permanente Southern California, Grant No. KP-RRC-20171101. <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Kaiser Southern California IRB <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> No