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Issues uncovered by review ‘suggest system-wide problems’ in healthcare system

The review was tasked with looking into the use of surgical mesh, the anti-epileptic drug sodium valproate and the hormone pregnancy test Primodos.

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The review concluded that thousands had come to ‘avoidable harm’ (Peter Byrne/PA)

The review concluded that thousands had come to ‘avoidable harm’ (Peter Byrne/PA)

The review concluded that thousands had come to ‘avoidable harm’ (Peter Byrne/PA)

Additional “problems, mistakes and tragedies” may have occurred in the healthcare system, the authors of a damning review into the care of tens of thousands of people have said.

The scathing review into surgical mesh, the anti-epileptic drug sodium valproate and the hormone pregnancy test Primodos concluded that thousands had come to “avoidable harm” and their concerns were “dismissed and overlooked”.

But the review team said the issues indicated “system-wide problems” and that the issues uncovered were “unlikely to be unique to those three areas”.

The Independent Medicines and Medical Devices Safety Review concluded that the healthcare system had a “glacial” and “defensive” response when patients raised concerns over treatments.

It detailed “heart-wrenching stories” of how treatments provided on the NHS had “damaged lives” and highlighted how campaigners had fought for decades to achieve acknowledgement of their suffering.

The review team made a series of wide-reaching recommendations and warned that the Government “should not be forgiven” if similar mistakes were allowed to happen again.

Baroness Julia Cumberlege, chair of the review, said she had heard “harrowing” stories from patients which she would take to her grave.

“We were invited by Jeremy Hunt when he was secretary of state for health, to review three medications and a medical device, because these interventions had caused avoidable harm to thousands of people, tens of thousands of people,” she said.

“If this Government and the healthcare system ignores our review, and another medication, a medical device damages people, to the extent that we have witnessed, they will and should not be forgiven.”

She added: “We travelled around the UK and met over 700 women and their families and I have to say, it made such a lasting impression on us.

“And some of those stories, I will certainly take to my grave.

“Their experiences were harrowing.

“We learnt about damaged families under immense strain, relationships that have been destroyed and careers broken. And as a result, financial ruin.”

The report details how patients with concerns about other medical devices and treatment contacted the review team in the hope they could broaden the scope of the inquiry.

It states: “We know that there are many who contacted us during the course of our work and who were disappointed that we could not also consider their concerns about other medications and devices on the market.”

Concerns were raised about a contraceptive device called Essure, a treatment for severe acne called Roaccutane, Poly Implant Prostheses (PIP) breast implants, cervical cancer vaccination, in utero exposure to hormones, valproate use in children and hernia mesh, which was not in the scope of the inquiry.

“Neither hernia mesh nor the other medications and devices listed above were within our remit,” the report added.

“Concerns about these taken together, however, point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns.”

When asked whether the other issues highlighted were of concern, Simon Whale – a member of the review panel – said: “What we feel is that the problems that we have identified in relation to mesh, valproate and Primodos suggests system-wide problems.

“And it suggests that the issues that we’ve uncovered are unlikely to be unique to those three areas.

“So sadly, it is quite likely that there are other areas where similar problems, mistakes and tragedies have occurred.”

Baroness Cumberlege described how women’s lives had been turned “upside down” by surgical mesh, adding: “They told us about experiencing splintered glass inside them, razors inside them, in their bodies. And that gave them permanent, unremitting pain.”

On sodium valproate, she added: “Even today, this medication causes harm to unborn children and pregnancy mothers continue to be unaware of that fact and the risks involved.

“Women told us that when they were pregnant and controlling their epilepsy with sodium valproate, they were never told that the unborn baby could be seriously damaged. They didn’t know, but the chances are one in two. What a tragedy.”

She continued: “We met women who told us that they were given two little pills called Primodos to confirm whether they were pregnant or not.

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A surgical mesh kit (Handout/Kath Sansom/PA)

A surgical mesh kit (Handout/Kath Sansom/PA)

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A surgical mesh kit (Handout/Kath Sansom/PA)

“And we learned that because of these medications, these pills they were given, that some of them lost their babies. And others gave birth to babies who were seriously disabled.

“Now, in their seventies, these parents agonise, who is going to care for that disabled offspring when they no longer can.”

She said she had “never encountered anything like this”, adding: “The intensity of the suffering. The fact that these conditions lasted for decades. And the sheer scale that these interventions have done to women and their families.

“And what is truly shocking, no-one knows, exact numbers affected by these three interventions, but it’s in the thousands, tens of thousands.

“These families have to fight, fight to be listened to and fight to be taken seriously.”

Our health system must learn from those it has failed, ensure those who have felt unheard have a voice and, ultimately, that patients are better protected in futureNadine Dorries, health minister

She added: “We were astonished to find how the health system is disjointed, it is siloed, unresponsive and defensive.

“It doesn’t recognise that the patients are the very purpose of the healthcare system.

“And it fails to listen to their concerns.”

She said the team were “astounded” to discover that the healthcare system did not know the scale of the problems they were investigating, adding: “It is flying blind.”

She added: “It fails to acknowledge when things go wrong. It fails to take action, for fear of blame, and litigation.”

Health minister Nadine Dorries said: “While the NHS is a beacon of brilliant care and safety in the majority of cases, as this report demonstrates, we must do better.

“Our health system must learn from those it has failed, ensure those who have felt unheard have a voice and, ultimately, that patients are better protected in future.

“I want to thank Baroness Cumberlege and the review team for their comprehensive recommendations. We will now give this independent review the full and careful consideration it deserves before setting out our full response.”

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