Cumberlege Inquiry: Report published after patients’ fight for answers

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The Government needs to offer a full apology to victims of three separate healthcare failings, according to the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege.

The report “First Do No Harm” which has just been published, comes after a two-year review of harrowing patient testimony and a large volume of evidence concerning three medical treatments:

  1. A hormone pregnancy test called Primodos
  2. The anti-epileptic drug sodium valproate
  3. Use of vaginal mesh in surgery

 What Is Primodos?

Campaigners have long said that the hormone-based pregnancy test Primodos taken in early pregnancy causes a range of devastating and life-long congenital disabilities such as shortened limbs, spina bifida, heart defects, and miscarriages. Its use started in the 1950s until 1978.

What Is Sodium Valproate?

Sodium valproate, used to control epilepsy, has been linked to a significant risk of physical malformations, autism and developmental delay in many children when taken by their mothers during pregnancy. According to The Times, an estimated 20,000 people in the UK are affected. The report says that babies are still being born to mothers taking the drug.

What Is Vaginal Mesh?

Vaginal (or pelvic) mesh, used in surgery to repair pelvic organ prolapses or cure stress urinary incontinence, has left women in chronic pain, with many suffering from infections and loss of libido. It is now not used in the UK, until such time that safety measures are developed.

Evidence from the Cumberlege report

The Cumberlege report runs to 277 pages and includes additional, downloadable documents. The review team’s approach was to “listen, learn and recommend”. They heard from hundreds of affected patients and their families whose lives had been catastrophically affected, and written evidence from many more was taken during the two-year investigation.

Evidence from the healthcare sector, including the NHS, private healthcare providers, regulators and professional bodies, manufacturers, and policymakers were also taken into consideration.

The inquiry found evidence of institutional and professional resistance to changing practice even in the face of mounting safety concerns, including a culture of “dismissive and arrogant attitudes” and “gross under-reporting” of safety concerns.

While healthcare providers, overall, provide first-class care and are dedicated to meeting patients’ needs safely and effectively, the inquiry makes for uncomfortable reading.

Review demands action for those affected by negligent medical interventions

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.”

The Review’s recommendations include:

  1. The Government should issue an immediate and 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. An independent public leader with statutory responsibility who champions the value of listening to patients, being their advocate and holding the system to account.
  3. The creation of “costs of care” schemes for hormone pregnancy tests, sodium 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.
  4. The creation of a new independent Redress Agency for those harmed by medicines and medical devices with the administration of decisions based on non-adversarial processes with determinations based on avoidable harm looking at systemic failings.
  5. To set up the establishment of two types of regionally located specialist centres to provide comprehensive treatment, care and advice for those affected by mesh and those separately affected by medications taken during pregnancy.
  6. A substantial revision of the Medicines and Healthcare products Regulatory Agency (MHRA), particularly concerning adverse event reporting and medical device regulation, putting patients at the heart of its activity.
  7. The creation of a central patient-identifiable database which collects crucial details, including key features of all devices and the surgeon.
  8. The expansion of the register of the General Medical Council (GMC) to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialists.
  9. The immediate creation of a task force to implement the Review’s recommendations.

Our specialist medical negligence and patient safety solicitors welcome the Cumberlege “First Do No Harm” recommendations for shining a light on “systemic failings”.

The experiences of patients and their families detailed in the report are shocking and harrowing. It is thanks to their fight for their tragic stories to be heard that changes will now be made in the healthcare sector to offer protection from avoidable harm in the future.

The challenge now, of course, will be to ensure the robust recommendations are implemented effectively.

If you or a family member has suffered due to negligent medical treatment or surgery, then please get in touch. Call Novum Law’s specialist team on Freephone 0800 884 0777, email: or complete the enquiry form on this page.

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