“Systemic failings” by the health service have ruined the lives of untold numbers of women and their children.
A review into three damaging treatments given to women found that risks were known but hidden. Patients were ridiculed, dismissed or not believed when they complained.
The review found evidence of conflicts of interest and financial links between the pharmaceutical industry and healthcare services. And it said the problems uncovered may be the tip of the iceberg.
“All that we have heard leads us to conclude the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques,” it said.
“The issue is not one of a single or a few rogue medical practitioners, or differences in regional practice. It is system-wide.
“And, while we have looked in detail at only three interventions, we have heard nothing that would lead us to believe that things are different for other surgical procedures and devices or other medications.”
The review was announced in 2018 following years of struggle by victims and patient groups. It investigated the impact of medications hormone pregnancy tests (HPTs) and sodium valproate—a drug used to treat epilepsy—and the medical device pelvic mesh.
They would tell you there is nothing wrong with you and that you are just an hysterical womanTeresa Hughes
Many women who were given HPTs or took sodium valproate while pregnant had children with a wide range of disabilities. And many treated with mesh, which is used to treat prolapse or incontinence, have been left permanently disabled.
The review found that all three “caused avoidable psychological harm”. Mesh caused “significant physical harm” and valproate “physical and neurodevelopmental harm”.
Women who have had mesh implants described “excruciating chronic pain feeling like razors inside their body, damage to organs, the loss of mobility and sex life and depression and suicidal thoughts”.
Yet one victim, Teresa Hughes, said, “They would tell you there is nothing wrong with you and that you are just an hysterical woman.”
The inquiry was “appalled” by how many women said they never knew they had had mesh inserted. “They did not know because no one told them, let alone sought their properly documented informed consent,” it said.
No wonder one patient said, “I feel as though I am an unsuspecting, unwilling participant in a cruel experiment that has gone wrong. This is how many of us feel.”
Symptoms were routinely attributed to “women’s issues” or the menopause. A defensive, sexist system and a “culture of denial” stopped women from being heard.
And some women who underwent procedures to have mesh removed, later found that much of it remained.
“Women have told us they were treated as ‘guinea pigs’ at implantation and are now being treated as ‘guinea pigs’ again over mesh removal,” said the review.
It feels like we are the forgotten ones. We want justice
Victims of the treatments suffered “life-changing consequences” not just for them but for family and friends too. Some lost jobs, suffered financially, lost homes, or saw relationships break down.
Mothers are “burdened by guilt” that their children have disabilities because of the drugs they took. They are “deeply anxious about what will happen to their adult child when they are no longer there for them”.
The review couldn’t say how many people have been affected because there has been no proper monitoring of the outcomes of treatments. It said this is “dangerous” and made it impossible to spot problems early, and so prevent others from suffering.
The inquiry found “inaccurate or altered patient records”. And private firms influenced what it could say.
Bayer took over Schering, which manufactured hormone pregnancy tests. The review said “legal reasons asserted by Bayer” meant it was “limited” in the information it could publicly provide.
A parent of children affected by problems linked to the tests said the scandal had “rocked my faith in those in authority”. A mesh survivor added, “It feels like we are the forgotten ones. We want justice.”
Hormone Pregnancy Tests
HPTs were used in Britain from the 1950s to the 1970s. By 1978, all had been withdrawn. The leading HPTs were Primodos made by Schering and Amenerone Forte made by Roussel.
Concerns that HPTs may be teratogens—drugs that can cause abnormalities in foetuses—have been raised for decades.
The review listed adverse conditions that have followed its use. They include spina bifida, paralysis, limb defects, deformed digits, sensory deficits such as deafness, sensory-motor disorders, congenital heart defects and seizures.
Miscarriages, stillbirths and baby deaths have also been linked to HPTs.
The use of HPTs has caused “continuing psychological suffering”. It said authorities should have recommended their withdrawal for use as a pregnancy test in 1967. This was eventually recommended in 1977.
The review described a “lack of premarket testing” by manufacturer Schering. The firm kept the product on the market after safety concerns were raised.
When sodium valproate was licensed in 1972, it was known to be teratogenic—harmful to a foetus—in animals. Doctors were told this and that it should only be used in “severe and resistant” cases of epilepsy.
Yet around 27,000 women of childbearing age still take it today.
“Women are still becoming pregnant whilst on valproate without any knowledge of the risks,” it said. “This means that babies are still being born today—estimates suggest hundreds a year—exposed to sodium valproate despite the teratogenic risk being well recognised and undisputed.”
The medicine is used to treat epilepsy and bipolar disorder. But the review said it “causes physical malformations, autism and development delay in many children when it is taken by their mothers during pregnancy”.
One parent who was affected said, “I felt so guilty. I felt it was my fault for his problems and disability.” Another said, “All our hopes and dreams were destroyed by this. We weep for the child who could have been and the man who never was.”
There was no full clinical trial carried out in Britain before the drug was licensed for use in treating epilepsy in 1972. The Medicines and Healthcare products Regulatory Agency (MHRA) was “unable to locate” a number of documents relating to decisions made on the licensing of the drug.
One woman who took the drug said she was lied to about the risks to the foetus. “Even when I asked the doctors I was told it was perfectly safe, nothing to worry about,” she said.
The risks of the drug during pregnancy were first raised in parliament in 1983, and several times since. The review asked for the government to provide evidence of any historic actions taken. It provided none.
Pelvic mesh is inserted during surgery to support pelvic organ prolapse and treat incontinence. Prolapse occurs when one or more organs drop and often push into the vagina.
The review listed some of the adverse effects women have suffered. Some women “require strong opioid painkillers just to function” due to severe pain. They can’t sit or stand comfortably.
Some experience “recurrent infections” and “mobility issues”. “Women have described how restricted their lives are,” it said. “Some rely on crutches or are confined to a wheelchair.”
Other problems include incontinence, new prolapse, haemorrhage, bowel problems, painful sex and autoimmune issues. The health problems can cause relationship and family breakdown, loss of jobs and homes, and poverty.
Women have also suffered “suicidal feelings, attempted suicide and death”.
“This is not a life,” said one woman affected. “It is an existence.”
Support for women affected “is hard to access and variable”. And the review noted “concerns” about mesh removal services including that consent to it “may not always be fully informed”.
Another victim said, “I feel that I have been lied to, and not taken seriously. I felt completely let down.”
In whose interest?
The review heard “concerns about potential conflicts that arise as part of the financial links between drugs and medical device companies and consultants, hospitals or other organisations”.
Some conflicts of interests “arose as part of the personal and professional interests of clinicians”.
“This concern is not limited to the interventions under review, or to this country,” it added.
“We have heard particular concerns that clinicians have been paid or otherwise incentivised by manufacturers. This may influence their practice, and the course of action they recommend to patients.”
The MHRA is responsible for ensuring that medicines and medical devices are safe.
But campaign group Sling the Mesh told the review that MHRA “has been too close to the industry”. They share “common policy objectives” and have “frequent contact, consultation and interchange of staff”.
The review said patient groups have a “major concern” about “the role of industry funding” of regulators.
“The activities of the MHRA are currently funded primarily through the pharmaceutical industry on the medicines side,” it said. The Department for Health and Social Care mostly funds its activities on devices.
Around 11 percent of workers in the medical devices division of the MHRA previously worked in the industry. This “leaves the MHRA open to influences from industry”.
“Of those working in the medical devices division who previously worked in industry, many are in decision-making roles,” said the review.
“Across the three interventions we have come across conflicts of interest in the selection of experts to form part of expert working groups, advisory committees or to agree guidelines.”
An inquiry into transvaginal mesh implants in Scotland in 2017 found “a number of conflicts of interests”. This included “clinical members being paid by pharmaceutical companies”.
The MHRA said it relied on “self-declaration and honesty” instead of investigating people before they joined the group. The review found, “The system of self-declaration has not been sufficient.”
How many more scandals?
The review said many people contacted it to express disappointment that its scope was limited to two medications and one device. Concerns raised about others include Essure, a contraceptive device, and Roaccutane, a treatment for severe acne.
People also described similarities between pelvic mesh and mesh used for hernia procedures. The review heard from “a number of people adversely affected following hernia mesh procedures”.
It said such concerns “point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns”.