The Independent Medicines and Medical Devices Safety Review: Regulatory Reform and Remedies

Abstract

For years, groups of patients and their families in the United Kingdom raised their concerns about three medical interventions. The first was a possible link between hormone pregnancy tests and fetal malformations and deaths; the second was the physical and neurodevelopmental impacts of in utero valproate exposure; and the third was life-changing adverse events caused by pelvic mesh implants for pelvic organ prolapse repair and stress urinary incontinence management. In response to their tireless campaigning, the Independent Medicines and Medical Devices Safety (IMMDS) Review was commissioned by the Secretary of State for Health and Social Care in 2018. The review, chaired by Baroness Cumberlege, found a catalogue of institutional, systems and structural failures within both the medical establishment and healthcare system more broadly. Drawing on the IMMDS Review findings on pelvic mesh, in this article, I consider the dire consequences when medical devices go wrong. Drawing on firsthand experience as lead researcher for the IMMDS Review, I examine some of the background, outline some key findings and reflect on the strategic changes recommended to medical device regulation and the redress prompted by the pelvic mesh scandal. In so doing, I contextualise and consider the relevant regulatory frameworks, the fundamental systems failures and the other issues identified. Three years on, this article also provides an opportunity to assess the extent to which the IMMDS Review recommendations have been successfully operationalised, as well as to take stock of the improvements that still need to be made.