Independent Medicines and Medical Devices Safety Review publishes its recommendations

After years of campaigning by patient groups and a two-year review of devastating evidence from patients and families together with a large volume of other evidence, the Independent Medicines and Medical Devices Safety Review chaired by Baroness Julia Cumberlege has today published its long awaited report. The Review closely examined the circumstances and avoidable harm caused to patients as a result of three public health scandals: Pelvic Mesh, the epilepsy drug Sodium Valproate and the hormone-based pregnancy test Primodos.

Nexus Chambers’ Michael Mansfield KC has been actively involved in the campaign work of Mashed up by Mesh in respect of the use of Pelvic Mesh in the treatment of patients. Michael gave evidence to the Review Team with his wife Yvette Greenway-Mansfield in respect of the unimaginable debilitating physical and emotional damage the use of pelvic mesh has personally caused her as a mesh damaged woman and the continuing impact it has had on them as they live with the consequences every day.

In addition to his personal involvement in the Mashed up by Mesh campaign, alongside Chambers’ Alan Barker, Michael drafted submissions on behalf of INFACT (The Independent Fetal Anti Convulsant Trust) in respect of the Government’s response to the harm caused by Sodium Valproate during pregnancy. Those submissions were forwarded for the consideration of the review team and called for a public apology from the Government together with the establishment of care plan and redress schemes.

Aptly titled “First Do No Harm”, the Report sets out nine major recommendations to bring overdue and desperately needed help and support to the many victims and families who have avoidably suffered as a result of these clinical interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future.

A copy of the report can be accessed here.

The Review’s major recommendations include:

• That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Pelvic Mesh, Sodium Valproate and Primodos.
• That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
• Separate schemes should be set up for Hormone Pregnancy Tests, 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.
• A Redress Agency for those harmed by medicines and medical devices in future should be established.
• The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
• The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
• That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
• That 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’ clinical interests and specialisms.
• Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.

The publication of these recommendations marks the latest step towards securing accountability, redress, accessible support and long-term patient safety. However, it is important to recognise that as matters stand they are not legally binding and there has yet to be any commitment to implementing these recommendations from the Government.

Response from Mashed up by Mesh in respect of Pelvic Mesh

“MUBM would firstly like to thank Baroness Cumberlege and the rest of the Review Team for their hard work since 2018 when Jeremy Hunt sanctioned this review. There can be no doubt that the whole team fully empathised with the avoidable physical and emotional damage inflicted upon patients across all 3 disciplines – Pelvic Mesh, Sodium Valproate and Primodos.

We would also like to thank all our members for their support as well as sharing of experiences and knowledge. MUBM is proud to say it is a cohesive and supportive group with members that genuinely reach out to each other.  It has been a long journey and the impact of re-living, in minute detail, our personal experiences through evidence or via our group page has been extremely upsetting and unsettling at times.  But we have all persisted and this report acknowledges, and, to a degree, rewards our resilience.

It is also only right to acknowledge the vital role each and every support group, campaigner and individual has played in achieving an overall positive report from the team.

It is significant to note that due to serious concerns, the Review had already called for a suspension in the use of mesh for SUI in July 2018, which NICE duly agreed and that it shouldn’t be lifted until certain pre-conditions were met. 2 years on, these conditions have still not been met, and no one has any idea when they will be…

We have listed our thoughts against each Recommendation and identified 2 other missed opportunities where recommendations could, and ought to have been made:

*Ban on SUI mesh

*Or at least a moratorium on SUI mesh until robust research producing substantial qualitative and quantitative data on the properties of polypropylene has been undertaken, analysed and understood.

Where there is mesh, there is risk, where there is risk, there is potential danger.”

You can access the full response to the recommendations from Mashed up by Mesh here.

If you have been affected by pelvic mesh or have any queries or concerns you can access further support, information and/or contact Yvette Greenway-Mansfield in confidence using the following details:

Telephone: 07802 884984

Email: missyvettegreenway@gmail.com

Facebook: https://www.facebook.com/groups/MashedUpByMesh

Twitter: @AnnaCCampaigns

Response from INFACT in respect of Sodium Valproate:

“After 8 years of Campaigning at Parliament we are delighted with the recommendations made by the Independent Medicine and Medical Devices Review.

We are pleased to see that the Review not only took on board the shocking evidence we discovered in the National Archives in 2015 that the teratogenic properties of Sodium Valproate were known to the then Committee on Safety of Medicines when it was licensed in 1973 yet the decision was taken to actively withhold that information from patients, 
but most importantly acknowledged the many heart-breaking stories from families that have been affected by Sodium Valproate, which highlighted how women in particular have felt ignored and dismissed by healthcare professionals, despite them knowing something was wrong with their child.

An apology has been a long time coming. We now look forward to the statement from the Government and their acknowledgment of what has happened before thereafter working with them as recommended by Baroness Cumberlege for prompt action.”

If you have been affected by sodium valproate or have any queries or concerns you can access further support, information and/or contact Janet Williams or Emma Murphy at INFACT in confidence using the following details:

Telephone: 01253 799161

Email: janet.infact@btinternet.com

Website: https://infactuk.com

Facebook: https://www.facebook.com/ValproateNationalCampaign

Twitter: @Infactuk