In light of the recently released review by Baroness Cumberlege into the use of Primodos, Sodium Valproate and mesh in gynaecological procedures, Christian Beadell; our Head of Medical Negligence Fast Track (Southport), has summarised the key Recommendations and Actions for Improvement Recommendations of the IMMDS Review:

1: The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.

2: The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.

3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

4: Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.

5: Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.

6: The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.

7: A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures

8: Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.

9: The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.

On reflection of Baroness Cumberlege’s review, Christian also believes that the continued pain and suffering of victims as a result of mesh surgery cannot continue:

“The Review by Baroness Cumberlege has cast a light upon the inequities that have faced the many people affected by Primodos, Sodium Valproate and the use of mesh in gynaecological procedures. We hope that the recommendations will be implemented swiftly; and that in particular, the creation of an independent redress agency and cost recovery scheme will help to ensure the future treatment and support that is so crucial, is provided to those for whom legal redress has not been possible.

“It is important in situations like these with historic, systemic advice based upon an evolving understanding of problems, that the true victims of that ‘lack of understanding’ receive the help they urgently require; and that adequate resources are put in place to ensure accessibility to all. Many of our clients have had to live with years of pain, discomfort and embarrassing conditions and have had little or no definitive help. This cannot be allowed to continue, and we commend the recommendations from the Review.”

See the full report here and keep an eye on our social media for a breakdown of the main findings.


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