Health

Ministers are urged to pay thousands victims of sodium valproate and vaginal mesh scandals £25,000 each in £600million compensation scheme

Thousands of women butchered by mesh and families of children left disabled by epilepsy drugs should be given pay-outs in the region of £25,000 each, ministers were told today.

In a landmark compensation scheme which could be worth £600m, patient safety watchdogs ruled there is a ‘clear case for redress’ for victims of both scandals.

At least 10,000 women are estimated to have been harmed by vaginal mesh, with some left in agony and wheelchair-bound because of the ‘quick fix’ to treat urinary incontinence and prolapse. The brittle plastic – designed to stay in the body forever – can pierce through skin.

Sodium valproate, a powerful drug that prevents epileptic seizures, can cause birth defects, autism and learning difficulties in children when taken in pregnancy. Campaigners have condemned the medication — thought to have injured tens of thousands — as the ‘new thalidomide’ due to its risks.

Dr Henrietta Hughes, the Patient Safety Commissioner, recommended a two-stage scheme which could see an estimated 24,000 victims handed interim payments of around £25,000 as early as 2025.

But, if accepted, the final sum paid out to victims could be even greater because Dr Hughes advised an additional payment based on individual circumstances.

However, victims affected by a third scandal, which saw GPs advise women to take hormone pregnancy tests in the 60s and 70s that have been linked to miscarriages and birth defects, will not be eligible for the scheme.

Marie Lyon, chairwoman of the Association For Children Damaged by Hormone Pregnancy Tests, said many were never told of the risks of Primodos and were advised to take the drug by their GPs to find out if they were pregnant. Pictured left, with MP Yasmin Qureshi

The report found that 315 women have been prescribed sodium valproate during pregnancy since April 2018 and 30 started taking the drug when already pregnant, suggesting that expectant mothers are still not receiving full details of the risks

The report found that 315 women have been prescribed sodium valproate during pregnancy since April 2018 and 30 started taking the drug when already pregnant, suggesting that expectant mothers are still not receiving full details of the risks

The report states that between April 2008 and March 2017, 100,516 patients had a reported tape insertion procedure for urinary incontinence, while 27,016 had it for a prolapse

The report states that between April 2008 and March 2017, 100,516 patients had a reported tape insertion procedure for urinary incontinence, while 27,016 had it for a prolapse

Campaign groups representing women affected by Primodos, which equates to the strength of 13 morning after pills or 40 oral contraceptives, said they feel ‘betrayed’ and ‘left out in the cold’.

Dr Hughes said that the Department of Health prevented her from including these victims in the scheme despite her belief that they should also be eligible.

The recommended £25,000 interim payment for sodium valproate and mesh victims is the ‘median amount patients said would be appropriate’.

Mesh patients suggested a median interim sum of £20,000 while those affected by valproate said they should initially receive £100,000. However, some called for more than £340,000 to be paid out initially. 

For comparison, victims of the infected blood scandal, who were given blood transfusions contaminated with hepatitis C or HIV, have been given £100,000 in interim compensation.

The thalidomide scandal, which saw tens of thousands of babies maimed after their mothers were prescribed the morning sickness drug in the 1950s and 60s, has seen sufferers receive annual payments up to £50,000. 

To be eligible for the payment, victims would need to meet cut-off dates, which would be set by the Government, and have suffered a ‘qualifying injury’, which have not yet been detailed. 

Patients could then apply for the main scheme, which would see payouts based on injury criteria set by an expert panel. 

The compensation process should be run by an independent body and the application process should be ‘straightforward, accessible and non-adversarial’ with patients presumed to be telling the truth. 

Dr Hughes, who was asked by ministers to look at costing a redress scheme, said: ‘My report could not be clearer — the case for redress has been made.

‘It highlights in detail the daily problems that impact on those who have been harmed, who have seen their lives destroyed by pelvic mesh, and the children who will never be able to live independent lives.’

She told Sky News: ‘The need for redress is now. I want the Government to get on with it, to set up a scheme for patients and start making payments in 2025.’

The Government has previously rejected calls for such a scheme, which Dr Hughes said is ‘unsustainable and is causing immense anxiety for harmed patients’.

Maria Caulfield, the women’s health minister, said the Government is ‘carefully considering’ the recommendations and will respond in due course. 

She said: ‘Our sympathies remain with those affected by sodium valproate and pelvic mesh and we are focused on improving how the system listens to patients and healthcare professionals, as well as introducing measures to make medicines and devices safer.

‘I commissioned this work to see what a redress scheme could look like and I am hugely grateful to the Patient Safety Commissioner and her team for their work on this important issue.’

How the Primodos, sodium valproate and mesh scandals unfolded – and the stories of the patients whose lives have been ‘taken away’

Primodos

Primodos is an oral hormonal pregnancy test that was prescribed to women in the UK between 1958 and 1978. 

The test involved taking two tablets on consecutive days. If a woman was not pregnant, they would experience a period three to 10 days later.

Primodos contained norethisterone, a synthetic progesterone, and ethinyl estradiol, an artificial oestrogen in high concentrations, equating to the strength of 13 morning after pills or 40 oral contraceptives.

In 1967, research by Dr Isabel Gal, a scientist at Queen Mary’s hospital for children in Carshalton, Surrey, published in the prestigious Nature medical journal, suggested that Primodos caused birth defects.

However, it wasn’t until 1975 that a review by the now defunct Committee on Safety of Medicines concluded that Primodos shouldn’t be used by pregnant women. A warning about its risk for unborn babies was stuck on the packaging that year.

Marie Lyon with her daughter Sarah in 1971. Sarah was born with a partially formed arm, which Ms Lyon believes was the result of taking Primodos

Marie Lyon with her daughter Sarah in 1971. Sarah was born with a partially formed arm, which Ms Lyon believes was the result of taking Primodos

The drug was eventually taken off the market in 1978.

Research suggests women who took Primodos were five times more likely to have a disabled child.

Bayer, the German manufacturer, has faced claims for decades that the tests led to malformations in the womb but has denied its tests are to blame.

But 2020 report by Baroness Julia Cumberlege into Primodos, sodium valproate and vaginal mesh, found that there was a link between Primodos and adverse effects.

She concluded that Primodos should have been removed from the market in 1967, immediately after the publication of Dr Gal’s study.

Dr Hughes said that the Department of Health did not include hormone pregnancy tests in its the scope of her review despite her desire for these victims to be included.

She told Sky News: ‘I said right from the start that if you have an independent review, the Government should accept all the recommendations. 

‘[Baroness] Cumberlege recommended redress for victims of Primodos and I believe the same.’

Marie Lyon, whose daughter Sarah was born with a partially formed arm in 1971 after she took Primodos, is chairwoman of the Association For Children Damaged by Hormone Pregnancy Tests. She said many were never told of the risks of Primodos and were advised to take the drug by their GPs to find out if they were pregnant. 

The 77-year-old said that families who took hormone pregnancy tests feel ‘betrayed’ and as though they have been ‘left out in the cold’.

An advert for Primodos in 1961. Before the drug became available, pregnancy tests were slow. One method relied on a woman's urine being injected into a live toad, which would produce eggs if the woman was pregnant

An advert for Primodos in 1961. Before the drug became available, pregnancy tests were slow. One method relied on a woman’s urine being injected into a live toad, which would produce eggs if the woman was pregnant

She said: ‘I feel betrayed by the Patient Safety Commissioner, by the IMMDS review (Independent Medicines and Medical Devices Safety Review) and by the Secretary of State for Health.

‘All three have betrayed our families because basically they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’.’

Labour MP Yasmin Qureshi, a long-time campaigner on the issue, said: ‘It is deeply disappointing that the Government has ensured families affected by Primodos are sidelined from this report.

‘Many of those who would benefit from redress are on borrowed time, they do not have the luxury of waiting for the Government to do the right thing, they urgently need financial support.’

The new Patient Safety Commissioner report states: ‘Our terms of reference did not include the issue of hormone pregnancy tests.

‘This was a decision taken by DHSC and should not be interpreted as representing the views of the Commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this.

‘The Patient Safety Commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.’

A group of 172 claimants attempted to bring legal action against Primodos’ makers and the Government in a bid for compensation, but their claims were thrown out by a High Court last year.

Sodium valproate

The report highlights how thousands of children ‘will never be able to live independent lives’ after being exposed to sodium valproate.

The drug prevents epileptic seizures by reducing excessive electrical activity in the brain. It is still dished out on the NHS but is no longer recommended to women if there is a chance they could become pregnant. 

The epilepsy treatment has been linked to physical malformations, autism and developmental delay in some children whose mothers took it while pregnant.

Patricia Alexander, 46, took the medication during both of her pregnancies. She was completely unaware that it would cause her daughter Amelie, 14, and son Joseph, 23, to have autism and life-long learning difficulties

Patricia Alexander, 46, took the medication during both of her pregnancies. She was completely unaware that it would cause her daughter Amelie, 14, and son Joseph, 23, to have autism and life-long learning difficulties

The report today estimated that 14,000 children were affected between 1973 and 2017.

However, the report states that 315 women have been prescribed the drug during pregnancy since April 2018 and 30 started taking the drug when already pregnant, suggesting that expectant mothers are still not receiving full details of the risks.

Patricia Alexander, 46, took the medication during both of her pregnancies.

She was completely unaware that it would cause her daughter Amelie, 14, and son Joseph, 23, to have autism and life-long learning difficulties.

Ms Alexander told Sky News: ‘We’re talking about reminding them how to use the toilet properly, washing their hands, drying their hands, having a wash, brushing their teeth… things like this that children would have learned when they’re very small, we’re still having to do every day.’

She added: ‘Our biggest worry is what will happen to children when the time comes that we’re not here to look after them.’

Clare Pelham, chief executive of the Epilepsy Society, said: ‘The recommendations within The Hughes Report are frank, fair and long overdue.’ 

Vaginal mesh 

Vaginal mesh implants were widely used to treat stress urinary incontinence and pelvic organ prolapse.

The net-like piece of material is made from polypropylene — a plastic also used to make packaging and drinks bottles — and is supposed to work like a scaffold to ease bladder leaks or keep the pelvic organs in the correct position. 

Between April 2008 and March 2017, the dates NHS Digital has released figures for, more than 100,000 SUI implants were performed, while 27,000 were done for POP.

However, women came forward suffering from complications, including extrusion — when the mesh pokes through the vaginal wall or cuts through internal tissue — as well as vaginal scarring, painful sex, bladder infections and perforations, nerve trauma, pelvic, back and leg pain and even injury to nearby organs.

Dr Hughes estimated that at least 10,000 women have suffered such complications. However, campaigners say the figure is the ‘tip of the iceberg’ as many women don’t know that mesh was used to treat their incontinence or prolapse.

Natasha Brown, who now has to walk with a crutch, described the pain as 'like there is a piece of wood, a pencil, wedged in there.' The 49-year-old, who had her own cleaning business, had to give up work and now depends on her two young daughters for care

Natasha Brown, who now has to walk with a crutch, described the pain as ‘like there is a piece of wood, a pencil, wedged in there.’ The 49-year-old, who had her own cleaning business, had to give up work and now depends on her two young daughters for care

The net-like piece of material is made from polypropylene — a plastic also used to make packaging and drinks bottles — and is supposed to work like a scaffold to ease bladder leaks or keep the pelvic organs in the correct position

The net-like piece of material is made from polypropylene — a plastic also used to make packaging and drinks bottles — and is supposed to work like a scaffold to ease bladder leaks or keep the pelvic organs in the correct position 

Natasha Brown, who now has to walk with a crutch, described the pain as ‘like there is a piece of wood, a pencil, wedged in there.’

The 49-year-old, who had her own cleaning business, had to give up work and now depends on her two young daughters for care. 

She told Sky News: ‘I don’t want them to be my carers. 

‘It’s really hard when you’re cooking tea and you have to get your 12-year-old to lift something out of the oven for you, and seeing my neighbours take them on long walks or taking them kayaking, and all I get is the photographs at the end. 

‘I want to be doing that. I’m only 49. I’m supposed to be doing those things for them, and with them. It has taken our lives away, and that’s wrong.’ 

Kath Sansom, founder of the Sling The Mesh campaign group, said: ‘While we are pleased that this report validates the suffering of thousands of women many who have lost jobs, pensions, homes, partners, and live in constant pain, there are also concerning elements to it.

‘Most notably, the initial sum of £25,000 for mesh is disappointingly low. We hope second stage payments for women directly harmed will compensate for that.

‘All women harmed by pelvic mesh trusted they were having a gold standard surgery, with little to no warning of risks from their surgeon, and as a result experienced irreversible, life altering complications.

‘Many were then gaslit for years, and, just like the Post Office scandal, told they were the only one suffering, forcing them to suffer in silence.’

She said her heart goes out to those affected by Primodos, who ‘have no positive financial redress news at all in this report’.

MP Sharon Hodgson, co-chair of the First Do No Harm All Party Parliamentary Group, said the report highlighted the ‘magnitude of suffering of women and families maimed by pelvic mesh and sodium valproate’.

How the Primodos scandal unfolded 

Primodos, a hormone pregnancy tests, was widely prescribed to women in the UK from 1958.

The test involved taking two tablets on consecutive days. If a woman was not pregnant, they would trigger a period three to 10 days later.

Primodos contained norethisterone, a synthetic progesterone, and ethinyl estradiol, an artificial oestrogen in high concentrations, equating to the strength of 13 morning after pills or 40 oral contraceptives.

It triggered a rapid spike in progesterone levels, which were expected to balance out in expectant mothers. However, it is thought that foetus’ livers cannot process the hormones, leading to disabilities.

In 1967, research by Dr Isabel Gal, a scientist at Queen Mary’s hospital for children in Carshalton, Surrey, published in the prestigious Nature medical journal, suggested that Primodos caused birth defects.

However, it wasn’t until 1975 that a review by the now defunct Committee on Safety of Medicines concluded that Primodos shouldn’t be used by pregnant women. A warning about its risk for unborn babies was stuck on the packaging that year.

The drug was eventually taken off the market in 1978.

In 2017, a study by Professor William Inman, a Government medical officer, was unearthed from the Berlin National Archives. It found that women who took hormone pregnancy tests were five-times more likely to give birth to a disabled child.

Later that year, a Government-commissioned review concluded that there was no link between Primodos and malformations, stillbirths or miscarriage.

However, an Oxford University paper in 2018 added further weight to the link between Primodos and malformations. Researchers said there was a clear association, especially for heart, musculoskeletal and neurological problems.

A 2020 report by Baroness Julia Cumberlege into Primodos, sodium valproate and vaginal mesh, found that there was a link between Primodos and adverse effects.

She concluded that Primodos should have been removed from the market in 1967, immediately after the publication of Dr Gal’s study.

Bayer, the German-based pharma company that took over Schering-Plough, which originally made the tests, has always denied that the tests could be damaging.

Victims of Primodos have unsuccessfully brought legal action against Bayer and the Government over the decades.

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