The work by Huerta et al1 in this issue of JAMA Surgery highlights a fundamental problem in surgery: balancing the need for innovation with the practicalities of demonstrating clinical benefit for novel ideas. This issue is particularly timely given an unsustainable trajectory of health care spending in the United States.2 The authors link the use of high-cost biological meshes with a regulatory approval process based on the predicate device concept. The premarket notification (510k process) is used to obtain marketing clearance for a device that is largely equivalent in safety and effectiveness to another marketed device or to a standard recognized by the US Food and Drug Administration (FDA) when used for the same intended purpose. However, most hernia mesh products are marketed aggressively, purporting individual advantages with generally poor data to substantiate these claims. The current fiscal climate of hospitals (who bear the brunt of additional mesh costs) will likely limit the use of products that have no potential benefit to patients compared with less costly alternatives. This is a reasonable fiscal approach, but potential clinical benefits of innovative technologies may go undiscovered.
Poulose BK, Matthews BD, Rosen MJ. Balancing Innovation and Value of Biological Meshes in HerniaWho Is in Charge?. JAMA Surg. 2016;151(4):381-382. doi:10.1001/jamasurg.2015.5236