Of all the questions that a patient might ask before treatment, three of the most important, surely, are:
- “Will this help me?”
- “If it helps me, how long will it help?”
- “Whether or not this treatment helps me, what risks—in the short-term and over the long-term—does it present?”
Until we can provide our patients with answers that are supported by evidence, products that lack such evidence should be considered experimental, and patients should be counseled accordingly.
Some patients may accept what they’ve been advised are new and unproven treatments—in the way that some physicians are early adopters. Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.
Now, more than ever and above all else, we must stand between marketing and our patients’ safety. We are familiar with the toll that prolapse and incontinence, as chronic conditions, take on our patients; yet it’s that very chronic nature that should lead us to adopt patience and caution in accepting new treatments before they have been adequately studied.
If we cannot always rely on industry to provide clear information about the risks and benefits of new devices, neither can we routinely look to our professional organizations for unbiased information. Often, professional organizations accept cash contributions from industry, raising the question of conflict of interest that may undermine their actions when the priorities of industry do not align with the goal of safeguarding patients’ well-being.
In an unprecedented example of how a professional association can interfere with its own, expert-authored clinical practice guidelines, the American College of Obstetricians and Gynecologists (ACOG) more than a year ago rescinded one of its published guidelines on POP (Issue 79, February 20073 ) and replaced it with a new guideline (Issue 85, September 20074 ). The new guideline is nearly identical to the prior one—save for one sentence, in which “experimental” is deleted in a discussion of kits of trocar-based synthetic materials sold for the surgical treatment of pelvic organ prolapse (see the EXCERPT ).
The deletion is crucial because offering informed consent for surgery requires a patient to accept risks in balance with an expectation of benefit. A patient cannot be appropriately informed when no evidence of benefit exists and evidence of postoperative risk is extremely limited.
Now, I am not declaring that ACOG acted with bias because of a financial conflict of interest with industry in this instance; the fact that a financial conflict of interest exists for ACOG, however, cannot be disputed if one examines the College’s Annual Report, where contributors are listed. (For a comprehensive, if disillusioning, treatise on the many effects of financial conflict of interest within medicine, I recommend the book On The Take.5 )
How ACOG revised a section of its Clinical Practice Bulletin on pelvic organ prolapse
Differences between the two bulletins are marked in boldface
Bulletin #79 (original wording): “Given the limited data and frequent changes in the marketed products (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks especially mesh erosion), if clinicians recommend these procedures before evidence of their risk-benefit is fully understood, the procedures should be considered experimental and patients consented for surgery with that understanding.”
Bulletin #84 (revised wording): “Given the limited data and frequent changes in the marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks especially mesh erosion), patients should consent to surgery with an understanding of the post-operative risks and lack of long-term outcomes data.”
Case: Radiofrequency therapy. Even when clinical experience demonstrates lack of effectiveness or an unacceptable rate of complications associated with certain techniques or devices, unequivocal evidence of such problems does not always appear in the literature. One example of this is how a technique was translated into a treatment for incontinence by way of its use in other fields.
Radiofrequency has, among other uses, been used to ablate nerves in intractable chronic pain and to address joint instability in orthopedic surgery. Radiofrequency energy was then, by extension, applied transvaginally to tissue (known as “endopelvic” fascia, of a distinctly different nature than parietal fascia involved in orthopedic procedures) surrounding the urethra. The goal was to coagulate “supporting” tissues and “correct” urethral hypermobility that purportedly causes stress incontinence.