The United Kingdom has ordered a review of whether “systemic failures” led the regulatory system to respond too slowly to patient concerns about the safety of vaginal mesh implants. Mesh will stay on the market in the U.K. while the government implements near- and long-term changes to protect patient safety.
Officials already know some of the near-term actions. Announcing the medical device safety review, U.K. health secretary Jeremy Hunt said the government is initiating a retrospective audit of patient data and investing $1.5 million in a database designed to improve clinical practice and spot issues. Those actions are intended to ensure mesh remains available to patients who need it while reducing the risk of harm.
In the longer term, the government hopes to learn from the vaginal mesh case to ensure regulators listen to patients and respond “in a rapid, open and compassionate way.” Hunt thinks the system fell short of this ideal in the vaginal mesh case.
“The truth is that we have a system that has not treated patients’ concerns with the seriousness that it should have done,” the health secretary said during a parliamentary debate.
Hunt has tasked Baroness Julia Cumberlege with reviewing where the regulatory system went wrong. Cumberlege will look at the speed, coordination and patient engagement shown by U.K. regulators and other healthcare officials when reports of adverse events tied to mesh implants started to come to light. Hunt wants Cumberlege to assess whether a “fuller, or even statutory, public inquiry” needs to take place when reports of adverse events arise in the future.
Cumberlege has freedom to propose how this will work in practice, but Hunt has provided her with some guideposts. The health secretary is encouraging Cumberlege to consider how best to support patients who have suffered harm despite overall evidence suggesting there isn’t a legitimate concern with the safety of the device in question.