The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, was published yesterday (8th July). Its report, titled ‘First Do No Harm’ – a phrase that the report hopes will serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of the healthcare system.
The two-year review has considered patient testimony from 700 women and their families along with evidence concerning three medical interventions:
- Primodos – a hormonal pregnancy test, which was withdrawn from the market in 1978 and thought to be associated with birth defects and miscarriages.
- Sodium valproate – an epilepsy drug, that can be harmful when taken during pregnancy and cause physical abnormalities in babies as well as developmental delay and autism.
- Pelvic mesh – used to treat prolapse and incontinence, it has left some women with internal damage and chronic pain.
The report sets out nine major recommendations to bring support and help to the mothers, children and families who have suffered as a result of these interventions.
Cumberlege Review’s nine major recommendations
- The Government to issue a fulsome apology immediately on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- 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 medicine 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 medicine 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, 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 specialism.
- Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.
Sadly, one of the key findings in the report was that complaints and worries were often dismissed as “women’s problems”, which has left many women traumatised, intimidated and confused. When calling for a UK Government apology, Baroness Cumberlege said, “I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”
Following the report, it is hoped that lessons can be learned to prevent avoidable harm from medicines and medical devices happening in the future.
Peter Walsh, Chief Executive of AvMA said, “AvMA welcomes the Cumberlege Review recommendations and would like to pay tribute to the women and their families who have fought so hard for this…The challenge now will be to ensure that the recommendation are implemented well.”
The report in full can be viewed here.
Partner and Solicitor, Sara Westwood has previously acted on behalf of women who have suffered an injury following a mesh tape procedure. She is highly experienced in these claims and handles them with sensitivity and compassion.
Contact Sara for a confidential consultation if you think that you or a loved one may have a case.
T: 01603 660 811