Explaining the Absence of Surgical Procedure Regulation

Systematic evaluation of both existing and innovative surgical procedures is needed to make important safety and efficacy data available to surgeons, facilitating optimal treatment decisions. High quality risk-benefit data is also essential if the healthcare system is to honor its obligation to inform patients of relevant benefits and risks prior to obtaining their consent to treatment. Yet for a variety of reasons, surgical procedures are not subject to direct regulation. As a result, surgeons consulting the available literature may find it inadequate to answer fundamental questions about optimal treatment choices. This failure of information increases the chance that, for years or even generations, patients will undergo painful or risky surgeries until further study eventually exposes them as either inferior to alternatives, or worse, as causing more harm than good. Unfortunately, history has repeatedly borne witness to such medical embarrassments, from the centuries-old practice of bloodletting to the disconcertingly recent examples of radical mastectomies and autologous bone marrow transplants, among many others. The federal government is well-positioned to support needed surgical research activities at the national level, both through the identification of evidence gaps and the funding of studies to fill those gaps. The government is also well-positioned to coordinate the private surgical research marketplace through activities such as the aggregation of country-level adverse event data and the setting of standards for medical terminology and guidelines for study protocols. In partnership with state governments and private organizations, the federal government can contribute to appropriate regulation that improves evidence development without imposing disproportionate burdens on surgeons or others