International Urogynecology Journal

, Volume 23, Issue 1, pp 3–4

A perfect storm

Authors

    • Female Pelvic Medicine and Reconstructive SurgeryLoyola University Medical Center
  • Bob Shull
    • Department of OB/GYNScott & White Clinic
Debate: Transvaginal Mesh for POP - The Recent FDA Update

DOI: 10.1007/s00192-011-1596-8

Cite this article as:
Brubaker, L. & Shull, B. Int Urogynecol J (2012) 23: 3. doi:10.1007/s00192-011-1596-8

We are in the midst of a perfect storm. How did we get here?

More women than ever will need prolapse surgery. The fastest growing segment of our female population is over 60 years old, physically active, and at greatest risk for developing pelvic organ prolapse. Several reports in our peer-reviewed literature have been cited repeatedly as evidence that not only are women at risk for developing disorders of the pelvic floor as they grow older, but in fact there may be an epidemic occurring. Those women who have unsuccessful surgery may undergo repeat surgery to achieve a satisfactory prolapse outcome. Some surgeons debate various aspects of these truths—How common is “surgical failure”? Who determines the “need” for second surgery? What are the risks of subsequent surgery?

These uncertainties, plus the prospects of such an enormous business opportunity, have been a fertile ground for a coalition of doctors and industry groups to collaborate with the intention of finding a “solution” to benefit patients, surgeons, and the businesses themselves. The transvaginal mesh solution was proposed and came onto the surgical market, often as unique surgical kits. Regretfully, basic research into the risks and benefits of the products has been sorely lacking due to gaps in regulation of these products such that clinical evidence of efficacy or safety was not required. While it is true that other surgical procedures for prolapse have entered our surgical practice without large clinical trials, individual and/or corporate profits were not in potential conflict with patient benefit. The use of transvaginal mesh, with strong industry support and surgeons as inventors and consultants, poses a new and challenging ethical dilemma—a perfect storm.

As this storm approaches, we have an aging population of women at risk for disorders of the pelvic floor, a group of surgeons who want to treat them, well-meaning surgical “thought leaders” and business people who think they can offer assistance, a lax regulatory environment, and patients who cannot make an informed decision about what to do. Add to that the failure of organized medical and surgical societies to assert leadership roles, to review and question the underlying premise that traditional surgery has unacceptably poor outcomes, to develop innovative educational programs to enhance surgical skills, to require more vigorous evaluation of products not only for their indications but just as importantly for their potentially unintended consequences, and finally to help patients make informed decisions about their options for treatment.

As the winds grow stronger, and the voices of dissent grow louder, we cannot afford to lose the patient voice. Reconstructive pelvic surgeons have had difficult discussions with patients who have experienced recurrent prolapse following a primary operation. Once the disappointment, frustration, and—sometimes—anger subside, a treatment plan is selected and repeat surgery is typically successful. The episode resolves uneventfully after a second operation. Unsuccessful transvaginal mesh surgery does not typically resolve with a second surgery. Multiple procedures may be necessary to deal with misbehaving mesh, and, in some cases, it may not be possible to fully restore a patient’s pelvic wellbeing. We should thoughtfully consider comparison of the consequences of unsuccessful interventions. For native tissue vagina repairs, a well-known set of problems can occur, including dyspareunia, new-onset incontinence, and recurrent prolapse. None of these are desirable, but they are relatively treatable compared to refractory mesh-incited pain, apareunia and difficult mesh removal surgery.

Assumeg for a moment that transvaginal mesh-based procedures can be done reliably by only a few surgeons and that in their hands, harms are minimal. Is there a role for such a surgery when the epidemiology of prolapse suggests that such surgery will be needed by many women? Perhaps the debate should be centered on whether those highly skilled surgeons, with an outstanding understanding of anatomy could improve existing native tissue procedures rather than invoke the need for transvaginal mesh-based procedures that appear associated with harm outside the hands of these few surgeons.

The FDA stepped into this storm in 2008 and advised us about its concerns. In the ensuing 3 years the storm has gained strength and become more ominous. The FDA has rightfully interjected itself into “our business” because we have not successfully steered ourselves away from this storm. The storm is still gathering now. It will require all our efforts to withstand this onslaught, to address our concerns collegially, and to work together for the benefit of all the women who entrust themselves to our care.

Copyright information

© The International Urogynecological Association 2011