Clinical opinion
General gynecology
The perils of commercially driven surgical innovation

https://doi.org/10.1016/j.ajog.2009.05.031Get rights and content

The practice of gynecological surgery is being reshaped by commercial interests that are promoting the use of trochar-and-mesh surgical kits for the treatment of stress incontinence and pelvic organ prolapse. In this article, we review the recent history of these surgical innovations and discuss the implications of changes in surgical practice that are driven by commercial interests of this kind. We situate this phenomenon within the general “life cycle” of surgical innovation and point out the dangers inherent in the adoption of new procedures without adequate evidence to support their safety and efficacy. We highlight the ethical responsibilities surgeons and their professional organizations have in making sure such innovations are safe and effective before they come into widespread use. Finally, we offer some policy suggestions to ensure that this process has proper oversight.

Section snippets

The ProteGen Sling: prototype of a continuing problem

The ProteGen pubovaginal sling was 1 of the earliest “kit” operations to make its way onto the market. It was a woven polyester mesh impregnated with pressure-injected bovine collagen that was intended for use in treating women with urinary stress incontinence. The product was implanted underneath the affected woman's urethra through a transvaginal incision using a surgical kit that included the Vesica bone-anchor system for fixing the sling in place with surgical screws that were drilled into

Seven stages in the life of a medical or surgical innovation

The unfortunate case of the ProteGen Sling was not an anomaly; rather, it was typical of the life cycle of most surgical procedures. In a classic but underappreciated article, J. B. McKinlay described the 7 stages in the career of a medical or surgical innovation as it moves from initial “promising report” to become a “standard procedure,” then on to ultimate abandonment once critical data have finally been collected from randomized controlled trials of the procedure's effectiveness (Table 1).9

History repeats itself: the mentor ObTape

The life-cycle fiasco of the ProteGen Sling is not a unique event. The same process was repeated again within the ensuing decade. Following the success of the trochar-and-mesh operation developed by Ulmsten (“intravaginal slingplasty”),16 which was marketed as the Tension-Free Vaginal Tape or “TVT” procedure,17 hordes of imitators rushed to market “equivalent” products by creating new, potentially lucrative variations on the same theme. The Mentor Corporation of Santa Barbara, CA, offered up

Solving the problem

There are clear differences between what is legal and what is ethical with regard to the use of surgical devices such as the ProteGen Sling, the Mentor ObTape, or the ever-expanding number of trochar-and-mesh kits now being marketed for the surgical treatment of prolapse and urinary incontinence. A regulatory body such as the FDA grants legal permission to introduce a drug or device into the marketplace. This is largely a political decision, with no guarantee that such decisions are based on

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  • Cited by (0)

    Cite this article as: Wall LL, Brown D. The perils of commercially driven surgical innovation. Am J Obstet Gynecol 2010;202:30.e1-4.

    Reprints not available from the authors.

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