Clinical opinionGeneral gynecologyThe perils of commercially driven surgical innovation
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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A surefire profit-maker could cost its maker dearly
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Cite this article as: Wall LL, Brown D. The perils of commercially driven surgical innovation. Am J Obstet Gynecol 2010;202:30.e1-4.
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