Enmeshed in Controversy: Locating and Regulating Risk

• In Event: 192 - Regular Session. Risk

Abstract

Female urinary incontinence has been a hidden issue until vaginal mesh lawsuits brought it into the public sphere over the last few years. This issue has been medicalized through surgical interventions, most recently through the use of polypropolene mesh. Vaginal mesh was introduced to the market circuitously, through the FDA’s 510(k) process. This process allows devices that are “substantially equivalent” to existing marketed devices to be used for additional, novel applications. After the introduction of vaginal mesh, and in the face of increasing reported adverse events, the FDA held special hearings to consider the safety and efficacy of these devices. This paper analyzes the claims that key stakeholders made during those meetings, comparing perspectives across stakeholder constituencies, and demonstrating which claims “won” in terms of FDA action or inaction. We find that responsibility for the risks associated with vaginal mesh were deflected away from the mesh itself, and pinned instead on the surgeons who implant the device.

Authors

• Valerie R. Leiter, Simmons College

• Michelle K. White, Chestnut Health Systems