First Do No Harm – Independent Medicines and Medical Devices Safety Review, July 2020

Responding to reports from patients about harmful side effects from medicines and medical devices


On 8 July, the Independent Medicines and Medical Devices Safety Review in the UK, published its report into the use and effect of certain medical interventions.

In 2018, following patient-led campaigns, the review, titled ‘First Do No Harm’, was commissioned to examine how the health system responds to reports from patients about harmful side effects from medicines and medical devices.

It covers three interventions, two medications and one medical device:

  • Hormone pregnancy tests (HPTs) such as Primodos, associated with damage to children (available in Ireland until the late 1970s)
  • Sodium Valporate (an anti-epileptic drug that causes harm to the unborn child if taken during pregnanct)
  • and Pelvic Mesh Implants (used in the surgical repair of pelvic organ prolapse)

The report is critical of the healthcare system noting “innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”

The report makes 9 key recommendations to improve patient safety in future.

These include a government issued full apology; schemes for additional care and support; the Medicines and Healthcare products Regulatory Agency (MHRA) be overhauled to improve the way that concerns about medicines and devices are detected and acted upon, engaging with patients to track over time how well they improve health and quality of life and a central database to collect this data.

Following publication of the report, there are fresh calls on the government here to establish an independent inquiry to examine the licencing and use of valproate in Ireland and to examine the use of vaginal mesh treatment.

A copy of the full report can be found here

To read more about pelvic and vaginal mesh claims click here



Please contact a member of our team should you wish to discuss this topic further.