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Theresa May orders review into three controversial issues

The Prime Minister has today ordered a review into three public health scandals that have made headlines in recent months.

Theresa May announced the Government will look into vaginal mesh implants, epilepsy drug sodium valproate and pregnancy test Primodos.

Thousands of furious victims have been affected by the controversial issues, which have left women on the brink of suicide and caused serious birth defects.

Baroness Julia Cumberlege will lead the review, which was announced by Mrs May during Prime Minister’s Questions this morning.

Mrs May told MPs that she wanted to see a ‘faster, more understanding response to patients when they raise concerns’.

While Health and Social Care Secretary Jeremy Hunt has admitted the reaction to the scandals has ‘not always been good enough’.

The review will delve into how the authorities responded to concerns raised by those affected and establish whether fears were raised upon.

Public inquiries into each of the three issues – which MailOnline has repeatedly raised awareness of – could be undertaken, if the Government sees fit.

Campaigners have announced their ‘delight’ over the news, which has come after years of relentless fights for justice and ‘often being dismissed as mad’.

Mrs May announced the Government will look into vaginal mesh implants, epilepsy drug sodium valproate and pregnancy test Primodos

Mrs May was asked about Primodos specifically by Tory former minister Sir Mike Penning, who has campaigned on the issue.

The Prime Minister replied: ‘I recognise that there are many individuals whose lives have been affected by this. There are very powerful stories of these individuals.

‘I know this has been of concern across the whole of this House and the concerns raised by campaign groups, not just about Primodos but some other issues like vaginal mesh and sodium valproate, I think have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it.

‘I’ve been clear that we need to do better. I was very struck by the stories, the powerful stories I heard.

‘We do need to see a faster, more understanding response to patients when they raise concerns.

‘If [Sir Mike] can be a little patient, [Health Secretary Jeremy Hunt] will be making a statement this afternoon setting out his plans to the House for a review on these issues.’

Mr Hunt said: ‘Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS.

Health and Social Care Secretary Jeremy Hunt has admitted the response to the scandals has 'not always been good enough'

Health and Social Care Secretary Jeremy Hunt has admitted the response to the scandals has ‘not always been good enough’

WHAT IS PRIMODOS?

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

It was withdrawn amid fears the test was linked to cleft palates, limb defects and heart problems in babies.

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

Primodos’ two key components, Norethisterone acetate and Ethinyl estradiol, are included in period delayers today, but at a much lower dose.

How did the test work? 

A controversial hormonal pregnancy test from the 1960s-70s may have caused  birth defects

A controversial hormonal pregnancy test from the 1960s-70s may have caused birth defects

Primodos worked by causing a rapid spike in progesterone levels, which resulted in a small menstrual-like bleed in non-expectant women.

Due to pregnant women producing higher amounts of progesterone to maintain their gestation periods, it was assumed these excess hormone levels would be balanced out in expectant mothers.

Primodos is thought to have caused infant disabilities due to foetuses’ livers not being sufficiently developed to process excess progesterone.

Complications swept under the carpet 

In May last year, Health Minister Lord O’Shaughnessy announced the Government had ordered medical chiefs to investigate the HPT scandal, saying: ‘It’s vital we take concerns such as these seriously. That’s why we’ve asked the Medicines and Healthcare products Regulatory Agency to conduct a thorough scientific review of the evidence.’

Professor Bill Inman, who established the Drug Research Safety unit, carried out research in 1975 demonstrating Primodos’ risks.

Yet these findings were only passed to the drug’s manufacturer, German pharmaceutical firm Schering, and not made public.

Investigations also reveal the potent hormone pills were never tested, even on animals, before being given to women.

Safety alarms were first raised in 1967, however, it was eight years before warnings were placed on packaging.

A damages claim was launched in 1982 but dropped over fears that victims would struggle to prove Primodos caused the malformations. 

Campaigners want justice 

A recent review concluded scientific evidence ‘does not support a causal association’ between the use of HPTs, such as Primodos, and birth defects or miscarriage. 

Campaigners called the review by the Commission on Human Medicines a ‘whitewash’, saying the expert working group did not examine all of the available evidence on the use of the drugs. 

Before Primodos was introduced, pregnancies were confirmed by sending samples from women to a laboratory  where it was injected into a toad.

If the toad produced eggs in response to the high levels of hormones, it suggested the patient was expecting.

Baroness Julia Cumberlege will lead the review, which was announced by Mrs May during Prime Minister's Questions this morning

Baroness Julia Cumberlege will lead the review, which was announced by Mrs May during Prime Minister’s Questions this morning

‘The response they have received from those in positions of authority has not always been good enough.

‘From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many.

‘I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.’

Mr Hunt also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.

Baroness Cumberlege said: ‘I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.

‘It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.’  

Commenting on the news, chair of the All Party Parliamentary Group on Surgical Mesh Implants, MP Owen Smith said he was ‘delighted’.

‘Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future.

‘The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary. 

WHAT IS SODIUM VALPROATE?

Sodium valproate controls electrical functions in the brain to prevent life-threatening seizures, with Epilim typically being a go-to brand in the UK and Ireland.

Around 20,000 children in the UK have been affected by the drug, according to campaigners. 

NICE data reveals the drug raises the risk of babies suffering serious developmental disorders by up to 40 per cent and malformations, such as cleft palates or lips, by 11 per cent, if it is taken during pregnancy.

An estimated 20,000 British children have been severely harmed because their mothers took the drug sodium valproate during pregnancy

An estimated 20,000 British children have been severely harmed because their mothers took the drug sodium valproate during pregnancy

In September last year, campaigners presented evidence to a hearing of the European Medicines Agency in London, revealing that drug regulators knew of the problems as far back as 1973 but did not add warnings to packaging until 2015.

Last week it emerged a professor from the University of Liverpool is studying a boy affected by sodium valproate syndrome to determine if he developed the condition as a result of his grandmother taking the drug during pregnancy.

HOW MANY PEOPLE SUFFER? 

Out of around 35,000 women aged 14-to-45 taking sodium valproate between 2010 and 2012, at least 1,125 were pregnant.

If 450 babies are born every year to mothers taking the drug, up to 45 could have a physical disability and up to 180 may suffer from learning difficulties. 

Between 1993 and 2008, there was a 20 per cent reduction in the number of women aged 15-to-55 who were taking sodium valproate due to new treatments being available.

The Medicines and Healthcare products Regulatory Agency says sodium valproate should not be given to women of a childbearing age or during pregnancy unless alternative treatments are ineffective or not tolerated. 

Yet, in 2016, around 450 babies were born to mothers taking the drug during pregnancy.

‘Mesh devices should be seen against that history of medicalisation and miss-selling and should be subject to the most stringent clinical trials before being deployed in surgery.’  

Kath Sansom, founder of Sling The Mesh, a campaign group calling for a ban on mesh, said: ‘We are delighted that at last a review is to be carried out but also deeply saddened that so many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally. 

‘We were the human guinea pigs. These are three huge women’s health disasters. 

‘The people who benefited most were the share holders and big CEOs. It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering. 

‘Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence. 

‘Every woman affected by Primodos, valproate or mesh implants have suffered personal tragedies that can never be compensated for.’

But Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said: ‘We are disappointed that the three campaigns are being reviewed together.

‘We are not prepared to support this proposal without consultation and agreed terms of reference.’

WHAT ARE VAGINAL MESH IMPLANTS? THE CONTROVERSIAL DEVICES THAT HAVE BEEN COMPARED TO THALIDOMIDE

WHAT ARE VAGINAL MESH IMPLANTS? 

Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women.

Usually made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall.

Other fabrics include polyester, human tissue and absorbable synthetic materials.

Some women report severe and constant abdominal and vaginal pain after the surgery. In some, the pain is so severe they are unable to have sex.

Infections, bleeding and even organ erosion has also been reported.

Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women

Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women

WHAT ARE THE DIFFERENT TYPES OF MESH? 

Mini-sling: This implant is embedded with a metallic inserter. It sits close to the mid-section of a woman’s urethra. The use of an inserter is thought to lower the risk of cutting during the procedure.

TVT sling: Such a sling is held in place by the patient’s body. It is inserted with a plastic tape by cutting the vagina and making two incisions in the abdomen. The mesh sits beneath the urethra.

TVTO sling: Inserted through the groin and sits under the urethra. This sling was intended to prevent bladder perforation.

TOT sling: Involves forming a ‘hammock’ of fibrous tissue in the urethra. Surgeons often claim this form of implant gives them the most control during implantation.

Kath Samson, a journalist, is the founder of Sling The Mesh

Kath Samson, a journalist, is the founder of Sling The Mesh

Ventral mesh rectopexy: Releases the rectum from the back of the vagina or bladder. A mesh is then fitted to the back of the rectum to prevent prolapse.

HOW MANY WOMEN SUFFER?  

According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.

But a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.

Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.

Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.

Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life. 

Kath Samson, founder of the Sling The Mesh campaign, said surgeons often refuse to accept vaginal mesh implants are causing pain.

She warned that they are not obligated to report such complications anyway, and as a result, less than 40 per cent of surgeons do.   



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