Regulatory Scripting: Embodied, Scientific, and Medical Knowledges on Vaginal Mesh

• In Event: 034 - Section on Science, Knowledge and Technology Paper Session. Bodies and Sexualities in Science and Technology Studies (co-sponsored by the Section on Body and Embodiment)

Abstract

This article examines how the voices of different constituency groups are shaped within regulatory spaces where women's health issues are debated. We analyze over 350 pages of transcripts of a 2-day hearing in September 2011, wherein the FDA reviewed the safety and efficacy of vaginal mesh devices. We analyze the claims each group made and their basis of knowledge, and consider how the hearing’s structure shaped participation. The claimants, women injured by mesh, rely on embodied knowledge, using the voice of the lifeworld to convey meanings of mesh-induced adverse events and to critique regulatory lapses. Physicians use the voice of medicine, which, rather than being strictly scientific, is shaped by clinical knowledge and patient interactions. Industry and FDA representatives rely on scientific knowledge, which makes a claim to objective authority, but which also serves a commercial functionality. We find that the structure of the proceedings privileges the voice of science above all others, and results in a regulatory scripting that ultimately silences the voice of the lifeworld.

Authors

• Shelley K. White, Worcester State University

• Valerie R. Leiter, Simmons College