Despite advances in all areas of medical technology, there continue to be few choices for women in American with stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). The options available often fail to represent complete cures, or elimination of symptoms.
Although for years, doctors considered the abdominal colposuspension (Burch) procedure to be the "gold standard" for treating SUI with surgery, a recent multi-center, randomized clinical trial comparing the Burch to the sling using a patient's own tissue revealed when clinical assessment was coupled with patient assessment much lower success rates than often shared previously with patients. At two years, complete success without any urine leakage with the Burch was only witnessed by half, or 49%, of patients, whereas with the non-mesh sling it was a higher, but still disappointing, 66%. In 2010, the researchers tabulated results at five years post-operatively, and success rates had tumbled still further to 22% for the Burch group and 30% for the sling group. Nearly a decade ago, researches had documented from the literature that over the lifetime of women, one in nine, or 11.1%, will have surgery for prolapse or SUI, and that nearly one in three, or 29.2%, of them will undergo repeat surgery. The durability of the procedures we put so much faith in simply isn't there.
Twenty years ago, a vaginal approach using synthetic, tension-free mesh was introduced in Europe, becoming available in the U.S. five years later, with the goal of increasing the durability of surgical treatment for SUI. Thus far, research outcomes suggest at least comparable efficacy to the Burch procedure. We continue to await high quality, long term data. Within the last decade, synthetic mesh has been used in pelvic reconstructive surgery for prolapse repair, but here too we lack high quality, long term data. One large comparative study between a commercial mesh "kit" and a traditional colporrhaphy using sectioning and suturing of tissue revealed a 61% success rate for mesh compared to 34% for the traditional repair after one year and enduring results deteriorated further a year later for both. Improving the capability of these procedures to last remains a primary goal of biomedical engineers and surgeons alike. The use of mesh has continued to advance through research and innovation, as women undergoing pelvic surgery (and both genders undergoing hernia repair with synthetic mesh) have benefited from the evolution toward lightweight mesh with larger pores to achieve less scar tissue formation and better blood flow.
The challenge for any new procedure, with or without mesh, whose durability trumps a longstanding, traditional procedure such as the Burch procedure for SUI or the colporrhaphy for prolapse is to reduce the incidence of complications, both immediate and persisting. With vaginal mesh used in pelvic surgery, the most serious of complications have involved erosion and chronic pelvic pain. There are also frequent urinary tract infections. Complications appear to be more prevalent during the months immediately following the surgery because the body is accommodating the foreign material and responding with inflammation. The marketers of synthetic mesh and the surgeons who use them are equally committed to undertake efforts to reduce such adverse events.
If you have had surgery for SUI or prolapse, with or without mesh, we welcome hearing about your experiences - good and bad - especially those over the years. If you have opinions on this topic, we want to hear from you so we can represent your voice as patients. Contact us through our web site at www.nafc.org.
NAFC will be speaking on this in a hearing before the FDA September 8-9, 2011 near Baltimore. For more information, visit our web site and read our position statement.
Nancy Muller, PhD, MBA