Are new tools for correcting prolapse and incontinence better just because they’re new?

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How economics intersects with the management of urinary incontinence



From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries“FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

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