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Independent Medicines and Medical Devices Safety Review

  • 13.07.2020
  • JessicaMG
  • Clinical-negligence
  • Clinical negligence NHS medical negligence vaginal mesh surgery Independent Medicines and Medical Devices Safety Review sling the mesh Primodos Sodium valproate

A review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices has found that a culture of denial - in which serious medical complications were dismissed as "women's problems" - contributed to a number of healthcare scandals affecting women and babies which date back decades.

Independent review

The review came about following growing concerns about vaginal mesh operations and various awareness campaigns pushed by the public, such as 'Sling the 'Mesh'. The mesh implants were initially marketed as a less invasive treatment for issues linked to childbirth, such as urinary incontinence and prolapse. However, figures obtained by the Guardian in 2017 revealed that many women were left with traumatic complications following the surgery. 

Jeremy Hunt, Health and Social Care Secretary at the time, announced The Independent Medicines and Medical Devices Safety Review the following year, which focused on three NHS treatments: 

Primodos

A hormone pregnancy test which was used up until 1978. The test has been associated with birth defects and miscarriages, however the manufacturer, Schering, now part of Bayer, has always denied a link between the drug and deformities in babies.

Sodium valproate

An anti-epileptic drug which is effective in reducing seizures, but if taken whilst pregnant it can cause physical abnormalities to the baby in the womb, as well as developmental delay and autism.

Vaginal mesh implants

While some women have benefited from mesh implants, others have been left with internal damage and in chronic agonising pain with some claiming it feel like ‘razors inside the body’. In recent years, vaginal mesh surgery has only been offered on the NHS under exceptional circumstances and high vigilance.

Led by Baroness Julia Cumberlege, the review considered:

  • If any further action is needed relating to the complaints around the three treatments
  • The processes the NHS and its regulators follow when patients report a problem
  • Ways to ensure good communication between the different groups involved

Findings

Over 700 women and their families shared "harrowing" details about the treatments. It was found that their worries and complaints were dismissed as "women's problems", and that arrogant attitudes had left women confused, traumatised and intimidated.

The review added that a disjointed and defensive healthcare system failed to listen to patients' concerns. Furthermore, it was found that hundreds of babies are being born each year to mothers who are "unaware" of the risks that sodium valproate can pose during pregnancy.

Baroness Cumberlege said she was shocked by the "sheer scale" and "intensity of suffering". She said: 

"I have conducted many reviews and inquiries over the years, but I have never encountered anything like this. 
"Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself."

Unfortunately, the exact number of women affected by the three issues is still not known – but the cases span decades and are thought to affect hundreds of thousands of women and babies.

Recommendations

The review criticised manufacturers for putting sales ahead of patient safety and warned against the promotion of new treatments before any long-term monitoring has taken place. The report recommended:

  • The appointment of an independent patient safety commissioner to hold the health system to account
  • Creating discretionary payment schemes to meet the financial care costs of those already affected
  • Setting up a redress agency to help resolve future disputes
  • Increased transparency of payments made to doctors by pharmaceutical and medical device companies

Founder of Sling the Mesh campaign and mother of two, Kath Sansom, said:

"The report is hard hitting and recognises the total failure in patient safety, regulation and oversight in the UK. It also makes it very clear that our medical establishment is deeply entrenched in institutional denial and misogyny.
"While we welcome all of the recommendations, there is no glory in knowing thousands of women have been maimed by mesh since the late 1990s then ignored when they asked for help suffering debilitating, life altering and irreversible pain."

While Health Minister Nadine Dorries stated that she was determined to make the changes needed to protect women in the future:

"Our health system must learn from those it has failed. We will now give this independent review the full and careful consideration it deserves before setting out our full response."