The practice of gynecological surgery is being reshaped by commercial interests that are promoting the use of trochar-and-mesh surgical kits for the treatment of stress incontinence and pelvic organ prolapse. In this article, we review the recent history of these surgical innovations and discuss the implications of changes in surgical practice that are driven by commercial interests of this kind. We situate this phenomenon within the general “life cycle” of surgical innovation and point out the dangers inherent in the adoption of new procedures without adequate evidence to support their safety and efficacy. We highlight the ethical responsibilities surgeons and their professional organizations have in making sure such innovations are safe and effective before they come into widespread use. Finally, we offer some policy suggestions to ensure that this process has proper oversight.
Conflicts of interest are commonplace in all areas of life. From time to time, everyone finds himself or herself forced to choose between potential self-interest or personal advantage and other obligations. Physicians are no exception to this rule. “Physicians have a conflict of interest when their interests or commitments compromise their independent judgment or their loyalty to patients.” Surgeons face particularly challenging conflicts of interest, since they determine both who needs surgery and also who performs the operations once that decision is made. As the Irish playwright George Bernard Shaw wrote sardonically in The Doctor’s Dilemma , “That any sane nation, having observed that you could provide for the supply of bread by giving bakers a pecuniary interest in baking for you, should go on to give a surgeon a pecuniary interest in cutting off your leg, is enough to make one despair of political humanity.”
This reality raises important ethical questions for individual surgeons as well as for their professional associations. Are there appropriate indications for surgery? If so, is an operation in the patient’s best interest rather than just in the financial interest of the surgeon? Which operation should be performed?
There is a constant tension in the practice of surgery around these issues. For the most part, surgeons handle these tensions well. Unfortunately, there are egregious examples of surgeons who have gone ethically awry when faced with competing interests of this sort. Perhaps the most notable recent example is the cardiothoracic surgeon in California who (in collusion with a local cardiologist who performed coronary angiography on nearly every patient he saw with even minimal complaints of chest pain) conspired to make false diagnoses of coronary artery disease and performed cardiac bypass surgery on hundreds of patients with normal hearts. (It goes without saying that most of these patients “did well” after surgery, having had no coronary pathology in the first place!)
These ethical problems have accelerated recently in gynecologic surgery, as commercial interests that have previously paid little attention to the details of gynecologic operations have become intensely interested in the details of specific surgical procedures. The reason for this reversal has been the development of operation-specific “kits” for surgical use, which provide everything you need to operate (except technical skill and good clinical judgment) right in the box. These kits hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer. What could be better?
This trend toward prepackaged surgical procedures originated with operations for urinary stress incontinence but has now expanded into the related field of surgery for vaginal prolapse. A wide variety of “trochar-and-mesh” kits for repositioning prolapsed female genitalia are now available, with new variations attempting to elbow their way into the medical marketplace almost every month. As long as you have a strong right arm and a long enough spike, you can thread an artificial mesh through almost any cavity in the female pelvis. What remains to be seen is whether or not this trend is good for patients and not just for the balance sheets of medical device manufacturers and the surgeons who use their products. As yet, there have been very few appropriately powered clinical trials with follow-up long enough to judge the outcomes. Nevertheless, it is clear that powerful commercial interests are reshaping the field of pelvic surgery. These surgical procedures are being promoted by groups that stand to benefit directly from their increasing use. As yet, we do not know if these procedures are better than the operations they are replacing and whether or not this trend is in the best long-term interests of the patients who undergo them. We contend that these issues are not being adequately addressed by the community of pelvic surgeons, by their professional organizations, or by the federal government.
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 the back of the pubic symphysis. The ProteGen sling turned out to be a disastrous marriage of 2 bad ideas and produced catastrophic consequences in many patients who underwent this operation. The product was conceived in haste and rushed to market for financial reasons without adequate premarket clinical trials.
Two investigative journalists who wrote about this fiasco several years later recorded that the manufacturer of the ProteGen Sling (Boston Scientific/Urology) anticipated sales of over 35,000 kits in the first year of use, with an annual sales growth of 80-100% per year over the next 5 years. In 1997, the Food and Drug Administration cleared the ProteGen Sling for marketing as being “substantially equivalent” to other devices already on the market. After receiving permission to introduce the device, Boston Scientific sales representatives aggressively marketed the device and uncritical surgeons adopted it rapidly.
Unlike drugs—which must be shown by clinical trials to be both safe and effective prior to their release—current regulations in the United States do not require medical devices such as the ProteGen Sling to meet this burden of proof. The collagen-injected polyester mesh from which the sling was manufactured had never been used in urological operations or implanted in a human vagina prior to its clearance, release, and marketing. Boston Scientific relied on a 90-day study in rats and the fact that the mesh was already being used for cardiovascular grafting to gain approval from the FDA. The results were disastrous.
The ProteGen Sling turned out to have an extremely high erosion rate within 8 months of implantation. Anecdotes concerning eroded slings, bleeding ulcers, and infections quickly spread among the community of pelvic surgeons who specialized in the treatment of incontinence, and eventually this experience made its way into the peer-reviewed urological literature. Less than 2 years after its introduction, the ProteGen Sling was withdrawn from the market by Boston Scientific in January 1999. The FDA found that the product was associated with a “higher than expected rate of vaginal erosion and dehiscence” and did “not appear to function as intended.” Over 23,000 unused (unimplanted) kits were recalled, but patients who had already had a ProteGen Sling implanted were “left to their own devices.” At the time of the recall, the ProteGen Sling had not been the subject of a single randomized, controlled clinical trial published in a peer-reviewed journal. The fact that no data on the product’s safety and efficacy as a suburethral sling existed prior to its sale and marketing did not deter commercial exuberance. Boston Scientific executive Bill Martin enthusiastically wrote to a colleague in March 1996 that, “We need to continue moving quickly and steadily on this project so we can begin realizing our market potential very soon.” However, the financial bonanza that resulted from the ProteGen Sling largely fell to trial lawyers, who have been aggressively pursuing malpractice claims over the device and who continue to solicit cases from the general public over the Internet (eg, www.protegen-vaginal-sling.com ).
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 ). Anyone familiar with the history of the surgical treatment of urinary incontinence can recognize this pattern, perhaps most notably in the life history of the multitude of needle-suspension procedures that were commonly performed on women for stress incontinence until they fell out of favor a decade ago. As McKinlay lamented “… it is wasteful and perhaps unethical that proper evaluations of innovations should be postponed until the penultimate stages in their career. Imagine the potential for harm that could be avoided, and the resources saved, if innovations were routinely evaluated during earlier stages in their careers— certainly well before they become ‘standard procedures.’” Nonetheless, this “extraordinarily wasteful” process still continues as “innovation after innovation begins its slow, costly journey through the stages described only to end up—in the overwhelming majority of cases—either discarded or discredited.”
