Continence Coach: Controversies Regarding Pelvic Surgery Using Vaginal Mesh

  As a sequel to “Informed Decisions for Improved Patient Safety” (Ostomy Wound Manage. 2011;57[9]:22-23), it is timely to make the case for a patient-centered process that focuses on expectations, effective intervention and care, and desired outcomes regarding vaginal mesh.

  Vaginal mesh used in pelvic surgery for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP) has received increasing attention, largely because of growing vocal complaints from patients (including men with hernia repair) experiencing chronic pain, urinary tract infections, and other discomfort following surgery. This attention influenced the Food and Drug Administration’s¹ (FDA) 2008 decision to issue a public warning about mesh, most of which utilizes polypropylene, a common biocompatible material used widely for sutures and other implanted devices. When complaints continued to increase and attorneys swarmed to file wrongful injury lawsuits, the FDA issued a stronger communication² on July 13, 2011, regarding complications from prolapse surgery using mesh “kits.”   A public hearing was held in September to air the evidence supporting the safety and effectiveness of mesh procedures in women for SUI and POP. At the hearing, which spanned 2 days and was attended by more than 100 people, FDA staff presented their recommendations, industry provided its analysis of published research, and various individuals and organizations offered their views and personal experiences with mesh. Most of the dozen or so women who spoke about their SUI or POP called for the removal of all surgical mesh from use, but others expressed gratitude for access to a procedure that remedied their troubling symptoms without adverse events.

  The topic deserves attention because SUI and POP prevalence is widespread and likely on the increase. One fourth (24%) of all women 19 years or older have SUI, 12% of whom have severe or very severe symptoms (continuous leakage) and an additional 46% have moderate (daily but intermittent) episodes of SUI.³ Minor degrees of POP affect up to 50% of women who have delivered babies vaginally, yet only one in 10 with symptomatic POP seeks care,⁴ perhaps influenced by barriers of stigma, lack of health insurance, a fragmented healthcare system, and poor public health literacy impeding health-seeking activity.

  Before the advent of vaginal mesh used in pelvic surgery for SUI, suspension procedures performed either through the vagina (fascial sling) or through the abdomen (Burch colposuspension) used only sutures and were considered well-established standards until the midurethral slings with mesh were introduced. In the fascial sling procedure, a harvested strip of tissue is placed transvaginally and secured with permanent sutures to the rectus fascia. In the Burch colposuspension, the anterior vaginal wall is suspended with permanent sutures tied to the iliopectineal ligament. Two-year data on the fascial sling versus Burch colposuspension using the most stringent definition of success reveal low success rates of 66% versus 49%, respectively,⁵ deteriorating to 30% versus 22%, respectively at 5 years out.⁶ Overall treatment success was defined as no self-reported symptoms of urinary incontinence, an increase of <15 g in pad weight during a 24-hour pad test, no incontinent episodes recorded in a 3-day diary, no leakage noted during clinical examination, and no retreatment of any kind for urinary incontinence. Patient satisfaction also was assessed at 24 months. Multiple requirements for determining success are considered stringent because success rates based on reporting by patients are consistently lower than those based on physician-reported measures alone.⁵

  Based on research and experience using midurethral slings with mesh over 15 years in the US and longer abroad, the consensus among surgeons is that midurethral slings now are considered the standard of care and represent a considerable advance over traditional suspension procedures for SUI, with fewer postoperative complications — ie, less pain, less urinary retention, and less bleeding — and shorter hospital stays. Success rates typically are quoted 15% to 20% points higher for standard midurethral slings with mesh compared to the Burch colposuspension. Data are less conclusive on newer “mini” slings using one rather than three incisions and a smaller strip of mesh compared to standard midurethral slings.

  Limited research suggests higher durability from a mesh kit for prolapse (eg, 61% with a mesh kit versus 34% with colporrhaphy for anterior repair), but rates for both deteriorate over time and complications are higher with a mesh kit (2% for mesh versus <1% for colporrhaphy) in the first 2 months.⁷ Although mesh exposure (mesh exposed in the vagina) is less serious than mesh erosion (perforation into a hollow organ such as bladder or urethra) and typically treated in-office, it occurs more frequently, and some patients are at greater risk of mesh exposure — eg, older patients, smokers, patients with diabetes, and those with a prior hysterectomy. Prolapse patients are typically more complex, may have multiple comorbidities and multiple compartments experiencing prolapse; patients must rely on physician judgment for choice of procedure. Surgeon training and experience appear to carry greater weight in determining both success and the rate of complications in prolapse repair than with SUI surgery.

  Along with the American Urogynecologic Society, the Society of Urodynamics and Female Urology, and the American Urological Association, I presented the position statement of the National Association For Continence (NAFC) in addressing this controversy, making the following points very much in sync with the societies:

    • In applying principles of evidence-based healthcare in caring for patients, the individuality of the patient and his/her input must be considered.
    • To participate fully in shared decision-making, the public’s health literacy concerning SUI and POP — and especially that of patients — must be elevated. Conversational, informed consent between the patient and her physician must be central to the process and take place well in advance of jointly reaching a decision about intervention and a care plan. Physicians should be transparent with patients regarding influential relationships with companies.
    • The medical societies must take responsibility for establishing standard protocols for surgery and insist on consistent, specialized training of physicians treating POP and SUI. Patients should be educated to demand evidence of such training and be offered options in care.
    • Based on outcomes research to date, the NAFC does not support the arbitrary withdrawal of mesh products from the marketplace. Instead, the NAFC advocates for the encouragement and reward of innovation that advances knowledge, science, and treatment modalities. The dynamic nature of discovery must always place a priority on safe-guarding patients, appropriately balancing benefits over risks.
    • Especially in light of the poor success rates associated with nonmesh procedures for SUI and POP and their lack of durability over time, coupled with the limited treatment options available to women, the NAFC advocates for a long-term registry for analyzing all outcomes from intervention, including analysis of the data to determine a science-based means of optimizing patient selection for particular procedures and devices.

  The NAFC encourages the FDA to maintain open dialogue with all parties — industry, providers, payors, and patient advocacy groups — on issues affecting patient safety and patient access to innovation for continuously improved quality outcomes in care.

  Final recommendations from the Obstetrics and Gynecology Devices Panel of the FDA are forthcoming. Suffice it to say, nurses have an ever-important role as health educators and ombudsmen of patients with SUI and POP to equip patients to frame their expectations as participants in shared decision-making and not be discouraged from seeking treatment.

  The National Association For Continence is a national, private, non-profit organization dedicated to improving the quality of life of people with incontinence. The NAFC’s purpose is to be the leading source for public education and advocacy about the causes, prevention, diagnosis, treatments, and management alternatives for incontinence. This article was not subject to the Ostomy Wound Management peer-review process.

Correction

  In the article Ichioka S, Yokogawa H, Nakagami G, Sekiya N, Sanada H. In vivo analysis of skin microcirculation and the role of nitric oxide during vibration (Ostomy Wound Manage. 2011;57[9]:40–47), dosing information was inadvertently omitted. On page 44, the text should read, L-NAME was intraperitoneally injected (20 mg/kg). The Editors apologize for the error.

1. FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, October 20, 2008. Available at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed September 21, 2011.

2. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011. Available at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed September 21, 2011.

3. Ebbesen MH, Hunskaar S, Hannestad YS. Prevalence of UI in the Norwegian Epincont (Epidemiology of Incontinence in the County of Nord – Trøndelag) population 10 years after. J Neurourol Urodynam. 2011;30(6): 1163–1165.

4. Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol. 2000;183(2):277–285.

5. Albo ME, Richter HE, Brubaker L, Norton PA, Kraus SR, Zimmern PE, et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007;356:2143–2155.

6. Brubaker, L. Baseline and time-varying factors associated with long-term continence outcomes up to 7 years after surgery for stress urinary incontinence. American Urological Association Meeting, May 16, 2011. Unpublished abstract presentation, Washington, DC.

7. Altman D, Väyrynen T, Ellström-Engh M, Axelsen S, Falconer C. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011;364(19):32–42.