Cath Lab Digest

  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.