Marketing of the SURx Transvaginal System (CooperSurgical, Inc.) began in 2002, followed by reports of success. One industry-sponsored study, for example, reported a 73% rate of either continence or improvement after 12 months.6
Despite such favorable early results, however, in 2006 CooperSurgical decided to abandon this system, citing “technique-dependent” results of the procedure. Since then, independent research has shown a very low initial success rate that declines rapidly—within weeks or months—of treatment.7,8
A different radiofrequency technique continues to be marketed—the Renessa System™ (NovaSys Medical), which uses a urethral catheter-mounted system to deliver radiofrequency energy through the urethral mucosa to the submucosa and adjacent tissues. Once again, initial reports of industry-sponsored research showed promising results; one study of 110 patients reported 74% achieved continence or improvement after 1 year.9 In a follow-up report of 21 of the original 110 patients, “improvement” was reported in 74% after 3 years.10 Independent research has yet to be reported in the literature.
Of particular concern, no data exist on the long-term effect of denaturing collagen in the urethra and adjacent tissues in relation to UI, other aspects of bladder function, or sexual function. An apparent lack of immediate complications cannot be equated with safety; we need long-term studies to determine whether urethral function is affected adversely compared with that in untreated women and women treated with surgery.
Bring on innovation—in context!
For those who consider my argument anti-innovation, let me repeat: I believe strongly in innovation to improve care for our patients. Am I anti-industry? Only when there is an unbridled race to profit from marketing products without safeguards to ensure, first and foremost, the safety of our patients and, second, their long-term effectiveness. Knowingly or unknowingly, patients then become the guinea pigs on whom these products are tested—just not in the appropriate context of clinical research and informed consent for participation.
Instead (as happened in the US Public Health Service’s Tuskegee syphilis experiments), patients serve as research subjects without their consent when they receive untested products and undergo unproven treatments. And because clinicians are the conduit through which patients receive untested and unproven treatments, who is ultimately responsible for the outcome?
Industry brings innovation to clinical practice. But it is incumbent on clinicians to recognize, with unflinching honesty, the bottom line on which industry operates. Prolapse and incontinence are deeply distressing for our patients, but these chronic conditions are not life-threatening; virtually all women who suffer these conditions have been symptomatic for years before they come for care. I see no need, except to increase that bottom line, to rush products to market before they have been evaluated sufficiently to determine whether “new” is actually “better.”
For clinicians who style themselves as early adopters, remember: It’s not you, but your patient, who is “adopting” a foreign material and having it placed deep in the most intimate area of her body—a foreign material intended to stay for life (except for those unfortunate patients who must have it removed). Above all, we must do no harm—an elusive goal when some of us try to attract patients by being the first to use a product before evidence of its risk and utility have been established in practice.
Does this kind of talk encourage litigation?
Does a commentary like this one provide fodder for plaintiff attorneys who are seeking grounds for product liability lawsuits against manufacturers and malpractice claims against clinicians? Please! Spend a moment on the Web, and you will see that the lawyers are already busy—especially since the FDA’s October 2008 alert about complications with surgical mesh for prolapse and incontinence. [See “FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management, at www.obgmanagement.com.] 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.