Announced recently, Johnson and Johnson will no longer manufacturer four mesh kits designed to repair vaginal prolapse (Prolift, Prolift M, Prosima) and urinary incontinence (TVT-S). While not a recall, this action highlights the trouble these kinds products have had since the FDA’s July 2011 safety communication (http://tinyurl.com/3kzd6zd). In case you missed that report, the FDA announced that two mesh complications - mesh erosion and mesh contraction - had persistently high rates of occurrence and were associated with “severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse.” Furthermore, relative to traditional repairs (that ironically could include the use of mesh, although placed abdominally) the FDA did not identify globally improved treatment outcomes associated with the use of these transvaginally placed mesh kits designed to repair vaginal prolapse. Herein lies a treasure trove of topics to discuss for anyone interested in bioethics, medical innovation and health care delivery. One such topic is the implications of medical innovation on surgeon supply.
According to researchers at The Dartmouth Institute, all health care treatments can be lumped into one of three buckets. One bucket is care that is evidence-based to demonstrate improved therapy outcomes. Using a beta-blocker after a heart attack would be an example. Another bucket is preference sensitive care where no singular best therapy has been identified as superior to another. An example of this sort of care would be lumpectomy or mastectomy for the treatment of breast cancer. In this situation either therapy has been evidenced to render equivalent outcomes and the choice of one over another hinges on patient preference. The last therapy bucket is supply sensitive care. This sort of care is the great majority what Medicare and Medicaid spends money on and it is a kind of care that medical innovation might just accelerate. Supply sensitive care is where the supply of the care, not the burden of disease, defines the amount of care delivered. More cardiologists are associated with more cardiology visits even if the burden of heart disease is held constant.
Drooping vaginal organs is a curious disease. The FDA cites that while the prevalence of this disease is high (upwards of 50%) attributable symptoms are only found in a handful of affected women (one study estimates this rate at 2%). Consistent with this fact is the curious reality U.S. women living in the South are nearly twice as likely to have surgery for lost vaginal support relative to women living in the Northeast. This sort variation is even more disturbing when examined over smaller geographic regions. Variations in care can suggest that features outside of a patient’s symptom burden drive the care delivered. If industry surgical devices, like a vaginal prolapse repair kit, increase the supply of physicians ‘capable’ of treating a given disease then per a supply sensitive paradigm surgery for that disease increases even if the disease burden stays the same. This sort of arrangement challenges the notion of informed consent in care delivery. Is the woman who has an asymptomatic vaginal bulge truly giving informed consent for a surgery that is being propelled by the availability of a care option? Coercion, albeit subtle and likely innocently unrecognized by the surgeon, is the ethical concern with supply driven care.
What if, however, women suffer in silence and these industry options are the only realistic treatment for women in a given community? Fair question. This sort of question raises the issue of justice. Communities with surgeons more familiar with complex benign gynecologic surgery may have an unfair advantage over communities without such a surgeon population. This thinking has some legitimacy and it is a poor assumption to believe that surgeons skill (that is at least a product of inborn skill and experience) is uniform across geographic region or age or year of training or any of the host of other factors that have been linked to this quality. So how should surgeons be trained? How does industry develop needed health technologies yet not feed into the care supply trap? How does formal surgeon training accommodate new technologies since to introduce such necessarily impinges on training for already accepted treatment options? How do surgeons who have completed their training maintain their skills and learn new technologies? I could go on but the happy days when what a surgeon learned in residency would be all they ever needed to know are gone. Gone too are those days when medical innovation primarily arose from within the clinician community avoiding the pressures that can propel vexing ethical challenges. The mesh mess is just part of larger problems in modern healthcare that strains the familiar tensions between respecting persons and distributive justice and between what is innovation and what is reckless.
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