Women’s Healthcare Scandals ‘Ruined Lives’ Says Report

A report into scandals involving failures in women’s healthcare has blamed ‘arrogant’ attitudes which dismissed complaints as ‘women’s problems’.

The report, The Independent Medicines and Medical Devices Safety Review chaired by former Junior Health Minister Baroness Julia Cumberlege, looked in particular at three women’s healthcare cases, the drugs Primodos and sodium valproate, and plastic mesh used in vaginal reconstruction.

The report, titled First Do No Harm, concludes that many lives have been ruined because officials failed to listen to the concerns of women given drugs and procedures that caused them or their babies considerable harm.

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Instead, women routinely had symptoms attributed to psychological issues or it being “that time of life”, with “anything and everything women suffer perceived as a natural precursor to, part of, or a post-symptomatic phase of, the menopause”, the inquiry heard.

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Harrowing details

More than 700 women and their families shared “harrowing” details about vaginal mesh, implanted to repair the pelvic area after birth problems or in cases of incontinence, Primodos, a hormone-based pregnancy test which caused foetal deformation, and the epilepsy drug sodium valproate which can also cause birth defects.

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Many patients with vaginal mesh implants experienced crippling pain, and they and mothers of children born with limb deformities have fought for many years for an enquiry into the circumstances surrounding their treatment.

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The chairwoman of the highly critical review into women’s healthcare, Baroness Julia Cumberlege, said the families affected deserved apologies and compensation from the government.

She 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 first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities.

Acute suffering

“We met with people, more often than not women, whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel as the result of Primodos, sodium valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better.

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“That is why, having spent two years listening to these stories of acute suffering, “First Do No Harm” is an appropriate title and a necessary reminder not just to doctors but to the whole healthcare system. We are urging the system to do what it should have done years ago, to help those who have suffered and put in place the processes that will enable it to learn from past mistakes so that we spare other families from such anguish.

“The system’s response – or lack of one – has added to the pain – both physical and mental – of those affected. The system and its leaders need to acknowledge what has gone so badly wrong. Our major recommendations, together with a number of actions for improvement we call for in our report, are wide ranging and radical. Given what we have witnessed, we are clear that is what is needed now.”

It was notable that all three cases primarily affected women’s healthcare, she added. “As women, we know when things are not right with our bodies,” she said. “We are the first to know. When that information is ignored, it is simply belittling and adds to the suffering.”

Great sadness

Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said she welcomed the conclusions of the report into women’s healthcare, but that there was “great sadness” that many of the original campaign members were not alive to see the result.

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The cases span several decades and may have affected hundreds of thousands of women and babies.

The review looked at three treatments:

  • Primodos was a hormonal pregnancy test, marketed from the 1950s and withdrawn from the market in the 1978. It is thought to be associated with birth defects and miscarriages, but the manufacturer Schering, now part of Bayer, has always denied a link between the drug and deformities in babies.
  • Sodium valproate is an epilepsy drug which is effective for preventing seizures but can be harmful if taken during pregnancy, causing physical abnormalities to the baby in the womb, as well as developmental delay and autism. The report concludes that patients are not being given sufficient warnings against becoming pregnant while using the drug.
  • Pelvic mesh implants were used as a surgical option to treat women’s healthcare issues such as prolapse and incontinence. Some patients said they had been left with internal damage and agonising chronic pain “like razors inside the body”.

    In recent years the procedure has been used only under exceptional circumstances and with close monitoring.

    In the USA, litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars.

    Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.

The Cumberlege report into women’s healthcare concludes that there was “a culture of denial by a disjointed and defensive healthcare system that failed to listen to patients’ concerns” and says: “The system, and those that oversee it, need to acknowledge what has gone so badly wrong.”

The review warns against pushing innovative treatments without enough long-term monitoring, and criticises manufacturers for being motivated by sales ahead of safety.

Safety commissioner

Its recommendations include :

  • Appointing an independent patient safety commissioner to talk and act from the perspective of the patient and hold the healthcare system to account
  • Setting up discretionary payment schemes to meet the financial care costs of those already affected
  • Creating a redress agency to help resolve future disputes
  • Transparency of payments made to doctors by pharmaceutical and medical device companies

Kath Sansom, founder of the Sling the Mesh campaign which has over 8,000 members, 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.

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“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.”

The Independent Medicines and Medical Devices Safety Review of women’s healthcare was ordered by the then Health Secretary, Jeremy Hunt, in 2018 amid concerns about vaginal mesh operations.

Vital reading

Health Minister Nadine Dorries said the experiences of patients and families affected by mesh, sodium valproate and Primodos made for “harrowing but vital reading, and have left me determined to make the changes that are needed to protect women in the future”.

Of the ways in which women’s healthcare might have to change, she 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.”

The government would set out its full response after giving the review of women’s healthcare “full and careful consideration”, Nadine Dorries said.

You can read here the full report into scandals involving failures in women’s healthcare which blames ‘arrogant’ attitudes which dismissed complaints as ‘women’s problems’.

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