Medical Device Marketing and the Ethics of Vaginal Mesh Kit Marketing
The marketing of vaginal mesh kits raises ethical concerns related to the kit marketers, to the US Food and Drug Administration (FDA), and even to the surgeons who implanted them in patients. Had there been a better understanding of the marketing practices of the mesh kit manufacturers, a more informed perspective on the FDA’s clearance protocols and ability to police medical devices, and a recognition of the range of behaviors taken by surgeons whose patient outcomes did not meet expectations, thousands of patients might have been spared harm. An analysis of the ethical choices of kit manufacturers and their sales reps, often well intended but incentivized to achieve business objectives over service to the patient, combined with the uncertainties related to the causes of suboptimal patient outcomes reveals a complicated set of factors. A particularly troublesome outcome of this analysis is the recognition that surgeons in all likelihood were not fully informed regarding approval or clearance process by which these devices came to market, raising the ethical question: how are surgeons to provide this fair, impartial, and complete information to the patient for informed consent when the primary source of data for the surgeon are the medical device representatives who finds themselves challenged to act ethically?
KeywordsEthics Marketing Informed consent Consumer behavior Primum non nocere FDA clearance vs. approval Business vs. ethical decisions
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