Enmeshed in controversy: claims about the risks of vaginal mesh devices

Urinary incontinence is a hidden, private issue that affects over 40% of women. Its experience has been medicalised, mainly through urogynaecological surgery, more recently using implanted synthetic vaginal mesh. In this article, we analyse the power dynamics at play in the US Food and Drug Administration's public hearings on the regulation of mesh. We use grounded theory to analyse verbatim transcripts of two days' hearings in 2011 of a Food and Drug Administration medical devices advisory panel regarding the risks and benefits of the mesh. Applying the concept of language games to the transcripts, we found that mesh manufacturers and physicians expanded perceptions of the locations of risk, thereby diffusing responsibility for mesh-associated claims of adverse effects. This resulted in 'organised irresponsibility' where accountability for the risks reported by patients was deflected away from the mesh to other issues such as inadequacies of surgeons' training. Patients in turn questioned the Food and Drug Administration's regulation of mesh safety. In this article, we reflect on the ways in which medical device regulation may become more pressing and contested in the future.