| February 2009 · Vol. 21, No. 02 COMMENTARY
Are new tools for correcting prolapse and incontinence better just because they’re new?
How economics intersects with the management of urinary incontinence
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Fast Track
“Fluidity” in the marketplace of products for treating stress UI surgically makes it nearly impossible to conduct clinical trials of those devices
Clinicians may mistake the FDA’s 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process
An apparent lack of immediate complications cannot be equated with safety. We need long-term studies.
If manufacturers tested their products, patients would benefit—by being able to make informed choices about risk and value
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Anne
M.
Weber,
MD, MSDr. Weber is on sabbatical from her position as Program Officer in the Female Pelvic Floor Disorders Program, Contraception and Reproductive Health Branch, Center for Population Research, at the National Institute of Child Health and Human Development, National Institutes of Health, in Bethesda, Md. She is an author of OBG Management Update articles on urinary incontinence.
The author reports no financial relationships relevant to this article.
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.
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