The Independent Medicines and Medical Devices safety review chaired by Baroness Julia Cumberlege has published its report entitled “First Do No Harm” which highlights wide-ranging and radical recommendations relating to improvement across the healthcare system in relation to the administration of medicines and medical devices. 

The report is set out here and took over 2 years to compile with more than 700 people consulted about their experiences of pelvic mesh, Primodos and an epilepsy drug called Sodium Valproate. Importantly, the review team also collated information and data from the healthcare system including the NHS, manufacturers and policymakers. Sadly, the review confirmed that people’s lives had been catastrophically affected as a result of avoidable harm from these medicines and medical devices. 

Baroness Julia Cumberlege said:

“The first duty of any health system is to do no harm to those in its care but I am sorry to say that in too many cases concerning Primodos, Sodium Valproate and pelvic mesh our system has failed in its responsibilities. We met with people more often than not women, whose worlds have been turned upside down, their whole lives and often their children’s lives shaped by the pain, anguish and guilt they feel as a result of Primodos, Sodium Valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings and to thousands of future patients to do better.”

Some of the review’s key recommendations include:

  • That the government immediately issue an apology to the affected families.
  • That the government immediately set up a task force to implement the report’s recommendations.
  • That a Patient Safety Commissioner is appointed who would hold the system to account.
  • Separate schemes should be set up for Primodos, pelvic mesh and Sodium Valproate to meet the costs of providing additional care and support.
  • A redress agency for those harmed by medicines and medical devices in the future should be established.
  • That a central database should be created which would collect key data including details of that patient, the implanted device/medicine and the surgeon.

Having been involved in catastrophic injury claims for a number of years and seen the trauma that is caused by defective treatment, we fully support this review and the recommendations that have been put forward by the report. The effects of the 3 treatments were life-changing for many people and most were women. Primodos was a hormonal pregnancy test withdrawn from the market in 1978 which was thought to be associated with birth defects and miscarriages. Sodium Valproate was an epilepsy drug which could be harmful if taken during pregnancy, potentially causing abnormalities to the baby. Pelvic mesh implants were used to treat prolapse and incontinence but could cause agonising chronic pain described by many of the people who were interviewed for the report as “like razors inside the body”. The report concluded that the patients in question were not really listened to and were complaining of their difficulties within a defensive system.

We hope that the recommendations will be put in place as soon as possible in order to ensure there is improvement for the future.

For more information

If you would like more information about this article or may have been affected by any of the above medicines/medical devices or others, please contact Rankeshwar Batta.