Treatments caused ‘avoidable suffering’, concludes UK’s medical review

“We are therefore recommending that 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,” said Cumberlege as part of the recommendations. In response, NHS England has issued a new poster detailing the impact of the three treatments.

The UK's state-funded National Health Service (NHS) ignored serious concerns raised about the side effects of some treatments, causing many women and their babies "avoidable suffering", an independent review concluded on Wednesday. The Independent Medicines and Medical Devices Safety Review, Chaired by Baroness Julia Cumberlege, looked into how the NHS responds to reports from patients about harmful side effects from medicines and medical devices. More than 700 women and their families shared "harrowing" details of three particular treatments – vaginal mesh, pregnancy test Primodos and epilepsy drug sodium valproate – but the review found that too often worries and complaints were dismissed as "women's problems".

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

She said even now the exact numbers of women affected by the three issues was still not known and praised campaigners for fighting to raise the problems. The cases span decades and are thought to affect hundreds of thousands of women and babies. The review, launched in 2018, set out the missed opportunities when something could or should have been done to prevent harm.

Cumberlege found that sodium valproate, considered an effective medication for epilepsy, still today causes harm to unborn children when their mother, unaware of the risks, takes it when she is pregnant. The pelvic mesh, used to treat pelvic organ prolapse and urinary incontinence, could lead to terrible complications in some cases. Primodos, a hormone pregnancy test taken by women between the 1950s and the late 1970s, was associated with damage to children.

Her review found that there was a culture of denial by a disjointed and defensive healthcare system that failed to listen to patients' concerns. Hundreds of babies are being born each year to mothers "unaware" of the risks that sodium valproate can pose in pregnancy, it said. "We are therefore recommending that 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," said Cumberlege as part of the recommendations.

In response, NHS England has issued a new poster detailing the impact of the three treatments. "NHS England supports the Independent Medicines and Medical Devices Safety Review and encourages General Practitioners and community pharmacies to display the poster to encourage those people affected to have their say," NHS England said in a statement.

UK Health Minister Nadine Dorries said 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," she said.

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