Urinary Incontinence affects 18 million women in the United States with those under the age of 60 accounting for more than half of the cases. (NAFC website). Treatment options for women with SUI encompass lifestyle/behavioral modification, physical therapy, biofeedback, vaginal insert devices, and surgery. Over 100 procedures have been described to treat SUI leading to broad regional, specialty and provider variability in the delivery of care. Since its introduction in the late 1990s, the midurethral slings has been broadly adopted because of its superior effectiveness, its minimally invasive approach which enables it to be performed in an outpatient setting and its associated short convalescence and relatively quick return to work and activities of daily living. A large, population-based cohort of over 10 million women found the cumulative risk for undergoing stress incontinence surgery was 13.6% (95%CI 13.5, 13.7) between 2002-2011 (Wu 2014).

This risk is in the range of breast cancer!

In 2008, increasing frequency of reports on adverse events, prompted the FDA to issue a Public Health Notification directed to vaginal mesh used in prolapse repair and stress urinary incontinence. In 2011 the FDA convened a conference with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. The group concluded that the data on adverse events and the absence of data on safety and benefit warranted reclassification of transvaginal mesh kits for prolapse repair from Class II to Class III devices. The panel was clear in its consensus that the safety and effectiveness of mesh midurethral slings was well established. They recommended that efforts should be made to better characterize low frequency life-altering adverse events.

Although there was no mesh or product recall, many manufacturers ceased production and sale of their mesh kits for POP repair citing their liability exposure with individual and class action litigation.

This decision was predictable given our current legal and business environment; however, few healthcare providers expected this to translate to an attack on the midurethral sling which is widely recognized as a major advance in the treatment of SUI in women.

Physicians who care for women with SUI are gravely concerned that the current litigious environment will lead to the withdrawal from the market of midurethral slings. The impact of this business decision on women with SUI will be profound. Indeed, Bard in 2012 and Astora, in Feb 2016 both US manufacturers of midurethral slings, withdrew from the market.

The midurethral sling is the most scrutinized procedure in the portfolios of gynecologic and urologic surgeons. Despite this level of research, public confusion fostered by misinformation and bundling of prolapse associated adverse outcomes has fueled anxiety and fear in women, surgeons and manufacturers. Only 4 manufacturers market slings in the US as of June 2016. Their commitment to continue manufacturing slings is uncertain. Providers are concerned that the fate of the midurethral sling will follow that of the uterine morcellator or silicone breast implants both of which were removed from contemporary medical care by unfounded concerns of adverse consequences.

Physicians and their patients urgently need an independent, unbiased, authoritative systematic review of the literature to fully appreciate the risks and benefits of the midurethral sling. We are seeking a review similar to that conducted by the Institute of Medicine on silicone breast implants which showed no link between these implants and autoimmune diseases.

Lifetime Risk of Stress Incontinence or Pelvic Organ Prolapse Surgery. Jennifer M. Wu, MD, MPH, Catherine A. Matthews, MD, Mitchell M. Conover, BS, Virginia Pate, MS, and Michele Jonsson Funk, PhD, Obstet Gynecol. 2014 June; 123(6): 1201 1206.

If midurethral slings are universally withdrawn from the market, women in the US seeking relief from SUI will be offered less effective and non-standardized procedures. It will be a tremendous setback to the advances in continence, and reclamation of productivity and quality of life for the over 100,000 women undergoing surgery for stress incontinence each year.

A recent Cochrane review on midurethral slings concluded their efficacy for SUI but acknowledged that long term outcomes (beyond 3 years) are lacking. The Cochrane review was limited to data from randomized clinical trials and excluded a trove of outcome data from prospective cohort studies which detailed adverse outcomes of mesh exposure, mesh erosion, pelvic pain, and dyspareunia. The latter have become the focus of litigation as well as patient and provider concerns. We fully recognize that there are risks with all procedures and that some women have been harmed during or after placement of midurethral slings. However, the overall positive impact these devices have had on women warrants a comprehensive and fair review on this topic.

We envision that AHRQ s rigorous review of the literature on the midurethral sling will provide a sound basis for clinician counselling and patient s decisions regarding the expected long-term outcomes and adverse consequences of the midurethral sling to counterbalance the current emphasis on personal experiences and second hand rumors of associated morbidities.

Trends in Stress Urinary Incontinence Inpatient Procedures in the United States, 1979 2004 Sallie S. Oliphant, MD, Li Wang, MS, Clareann H. Bunker, PhD, and Jerry L. Lowder, MD, MSc Am J Obstet Gynecol. 2009 May; 200(5): 521.e1 521.e6. doi: 10.1016/j.ajog.2009.01.007.

Mid-urethral sling operations for stress urinary incontinence in women. Ford AA, Rogerson L, Cody JD, Ogah J. Cochrane Database Syst Rev. 2015 Jul 1;(7):CD006375. doi: 10.1002/14651858.CD006375.pub3.

The outcomes of this unbiased, authoritative review will enable physicians to provide their patients with stress urinary incontinence a reliable informed consent on the expected outcomes and potential complications of midurethral slings in the context of expectant management or other historic procedures which would be the default interventions.

We anticipate that the conclusions of this rigorous review will be respected and will provide balance to the tsunami of fear and misinformation currently fostered by litigation attorneys. There is an immediate and urgent need to combat the forces threatening access to a cost-effective, minimally invasive treatment option for women with SUI.

The American Urogyncologic Society and other organizations in the field will disseminate the findings of the systematic review broadly through publication, web links, membership blog, as well as sponsored patient advocacy and education websites. The information acquired by the AHRQ review and summary report will serve as a tool in the discussion of treatment options that occurs between the patient and her physician. We anticipate the findings will result in updates to AUGS clinical guidelines and quality outcomes measures.

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Professional society representing physicians, nurse practitioners, physical therapists, nurses and scientists all dedicated to treating women with pelvic floor disorders.

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The American Urogynecologic Society (AUGS), founded in 1979, is the premier non-profit organization representing more than 1,900 members including practicing physicians, nurse practitioners, physical therapists, nurses and health care professionals, as well as researchers from many disciplines, all dedicated to treating female pelvic floor disorders. As the leader in Female Pelvic Medicine and Reconstructive Surgery, AUGS promotes the highest quality patient care through excellence in education, research and advocacy.

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