Review into vaginal mesh and other products reveals much patient harm was ‘avoidable’
Hannah Devlin Science correspondent – The Guardian
Many women who were given vaginal mesh implants were left with traumatic complications after surgery. Photograph: BBC
An arrogant culture in which serious medical complications were dismissed as “women’s problems” contributed to a string of healthcare scandals over several decades, an inquiry ordered by the government has found.
The review of vaginal mesh, hormonal pregnancy tests and an anti-epilepsy medicine that harmed unborn babies paints a damning picture of a medical establishment that failed to acknowledge problems even in the face of mounting safety concerns, leading to avoidable harm to patients.
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.
“For the women concerned, this was tantamount to a complete denial of their concerns and being written off by a system that was supposed to care,” the review, chaired by Baroness Julia Cumberlege, concluded.
The Independent Medicines and Medical Devices Safety Review was ordered by the then health secretary, Jeremy Hunt, in 2018 amid concerns about vaginal mesh operations. The implants were marketed as a less invasive treatment for urinary incontinence and prolapse – conditions that are commonly linked to childbirth – but the Guardian revealed that many women were left with traumatic complications following the surgery.
The review also focused on Primodos, a hormone pregnancy test taken by women between the 1950s and 1978, associated with damage to children born to mothers who took it, and sodium valproate, a treatment for epilepsy known to cause harm to babies if taken during pregnancy.
Cumberlege said the pain experienced by so many women and their families was beyond anything she had previously encountered. “Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself,” she said. “We couldn’t believe that people had gone through so much agony and suffering and had been ignored. We did believe them.”
It was notable that all three cases primarily affected women, 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.”
The report makes wide-ranging recommendations, including the appointment of an independent patient safety commissioner, an overhaul of the Medicines and Healthcare products Regulatory Agency and the expansion of the General Medical Council register to include a list of financial interests for all doctors.
A common theme was the systemic failure to collect data on patient outcomes. The inquiry could not establish rates of mesh complications or how many women had taken sodium valproate while pregnant.
The review recommends the establishment of a central medical device database and a registry of all women of child-bearing age who are taking sodium valproate. A recent survey by the Epilepsy Society found that one in 10 women currently taking the drug remain unaware of the risk of birth defects.
The report stops short of recommending a ban on the use of pelvic mesh, but says that such surgery should take place within specialist centres, and only in rare circumstances, after other conservative treatments have been tried.
Kath Sansom, who founded the Sling the Mesh campaign in 2015, welcomed the recommendations, saying: “The report is hard-hitting, harrowing 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.”
Sansom, whose group has more than 8,000 members, said women had consistently had their voices ignored and medical complications downplayed. “At every step of this campaign I’ve been treated as though I’m overhyping something that really isn’t that bad,” she said.
Prof Derek Alderson, president of the Royal College of Surgeons of England, said the government should act swiftly to mandate a new central database for devices by including it in the medicines and medical devices bill that is going through parliament and will regulate medical implants after Brexit.
“Most people would be astonished to know that when they have an operation and a medical device or implant is used, there is no systematic way of tracking that implant over the following months and years,” he said.
Alderson said the surgical profession was working to improve its culture on equality and diversity, including through training to surgeons. “We cannot under any circumstances ever support surgeons who are dismissive of their patients’ complaints,” he said. “If that was a prevalent attitude at the time of most of the surgery, I’d hope there’s a lesson that is being learned as we speak.”
The 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”.
“While the NHS is a beacon of brilliant care and safety in the majority of cases, as this report demonstrates, we must do better,” she said. “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 “full and careful consideration”, Dorries said.