Calls for Urgent MHRA Reforms Over Safety Failings

An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has raised calls for urgent reforms at the agency, including how it deals with adverse event reports.

The agency failed to adequately respond to serious adverse events reported by women implanted with pelvic mesh for treatment of stress urinary incontinence (SUI), according to a report by the Independent Medicines and Medical Devices Safety Review.

One of the biggest downfalls of the MHRA during the pelvic mesh failure was not listening to patient concerns and responding too slowly, the report found.