Nuffield Council on Bioethics welcomes Independent Medicines and Medical Devices Safety Review

Today, the Independent Medicines and Medical Devices Safety Review published their report titled First do no harm. We welcome the recommendations of this report, which aim to reduce the risk of avoidable harm to patients in future, to better the patient experience, and to help restore trust in the system. We commend the work of the Review team in listening to and engaging people and patients and making their voices heard.

This independent Review into the safety of medicines and medical devices was triggered by concerns about the effects of three medical interventions: Primidos, sodium valproate and vaginal mesh.

The Review team, led by Baroness Cumberlege, travelled across the UK to listen to hundreds of affected patients and their families, and received written evidence from many more over its two-year investigation. The team heard from people, mainly women, whose lives had been catastrophically affected and whose families had suffered terribly as a consequence.

Today’s report echoes many of the themes in our bioethics briefing note on the ethical issues raised by the use of medical implants, including:

• the responsibilities of healthcare professionals to report adverse events
• conflicts of interests
• uncertainty about the long-term effects of implants
• challenges around informed consent
• liability when something goes wrong.

We highlighted that registries can play an important role in monitoring the safety of implants.

Director of the Nuffield Council on Bioethics, Hugh Whittall, says:

“This Review shines a light on the patients affected by these medical interventions, many of whom have been left with serious pain and suffering, often over long periods of time, and have experienced dismissal of that pain by the medical profession. This is unacceptable.

Manufacturers, regulatory bodies, and healthcare professionals have responsibilities to ensure that medical interventions are used in a responsible and trustworthy manner, and are carefully monitored to ensure that any problems are discovered early. This clearly is not happening in all cases, and the impact on patients and their families is deep and far-reaching. We look forward to seeing the recommendations of this Review swiftly implemented.”