England’s patient safety commissioner has expressed disappointment over the “continued absence of visible and timely progress” on compensation for people harmed by pelvic mesh and the epilepsy drug sodium valproate, more than two years after she recommended a two‑stage redress scheme.
Professor Henrietta Hughes, author of the Hughes Report published in February 2024, said the government had still not provided a “substantive response” to her recommendations. She has written to No. 10 under the Medicines and Medical Devices Act 2021, requesting information on the government’s deliberations. A response deadline of 16 July has been set, and she has indicated she will approach Downing Street directly to press for financial redress.
“Given the seriousness of these findings, and the continued impact on patients and their families, it is disappointing that the Government still hasn’t provided a substantive response,” Professor Hughes said. “The recommendations in the Hughes Report are direct and actionable. They address fundamental issues … including the need for timely acknowledgement, fair and accessible routes to compensation, and a more coordinated, compassionate response from government and public bodies.”
The harm caused by pelvic mesh
Transvaginal mesh implants were used for pelvic organ prolapse and stress urinary incontinence after childbirth between 1998 and 2020. The polypropylene mesh has caused debilitating injuries including chronic pain, nerve damage, infection, depression, anxiety and sexual dysfunction. In severe cases women have required the removal of their bladders or bowels. Studies suggest that between 15 % and 25 % of women experience complications.
Research from the University of Sheffield has shown that polypropylene mesh fibres can become stiffer and begin degrading within 60 days of implantation, with particles found in surrounding tissue. The NHS restricted the use of transvaginal mesh in 2018, now employing it only as a last resort. NICE had effectively suspended vaginal prolapse mesh in December 2017 and later recommended mesh should not be routinely used for stress urinary incontinence. A “high vigilance restriction” was announced in July 2018.
Globally, more than 100,000 women are reportedly taking legal action against manufacturers. In the UK, over 1,200 women had submitted claims against the NHS by January 2019. In August 2024, more than 100 women received compensation for complications arising from vaginal mesh implants.
Kath Sansom, founder of the campaign group Sling the Mesh, said the “evidence has been undeniable about the thousands of women living with devastating, irreversible injuries caused by treatments they trusted”. She added: “These women did everything right. They trusted their doctors. And for that trust, they’ve paid with their health, their jobs, their savings, and for some their marriages, but moreover their sense of self. … The Government must act now. Full, fair and urgent financial compensation is not optional, it is long overdue.”
The harm caused by sodium valproate
Sodium valproate, used to treat epilepsy and bipolar disorder, is now known to cause significant birth defects and lifelong learning difficulties when taken during pregnancy. An estimated 20,000 babies in the UK have been harmed. Physical malformations occur in about 10 % of exposed infants, while neurodevelopmental disorders — including autism, ADHD and reduced IQ — affect 30–40 %. The Epilepsy Society estimates the lifetime cost of severe autism for a child affected by epilepsy medication can reach £2.5 million.
Evidence of the drug’s teratogenicity has existed since the 1970s, yet this information was not consistently passed on to women. The Cumberlege Review in 2020 highlighted systemic failures in this regard. Since the MHRA issued warnings in 2017 and 2018, prescribing has declined, but in 2020/21 around 50 women in England were still prescribed sodium valproate during pregnancy. Stricter guidelines introduced in 2018 require a pregnancy prevention programme for women of childbearing potential unless no alternative is available. Research is also examining possible transgenerational effects, with behavioural changes observed in mice exposed to sodium valproate seen in subsequent generations.
Tom Shillito, health improvement and research manager at Epilepsy Action, said it was “extremely worrying” that Professor Hughes was still pushing for answers. “For the families affected, this is not about government process or policy discussions, it’s about the reality of living with the consequences of harm every single day,” he said. “Many parents and carers have spent years seeking recognition … For some families, more than 40 years have passed since the harm occurred and they are now reaching an age where they are increasingly worried about who will be there to provide support when they no longer can.” He added that families “need the confidence that the recommendations made on their behalf will be acted upon and not simply left to gather dust”.
The Hughes Report had recommended interim compensation payments of £25,000 — the median amount patients said would be appropriate — to begin in 2025, followed by a main scheme offering more personalised support. The estimated cost of initial payments alone was half a billion pounds. The report also called for non‑financial redress, including improved access to public services. Professor Hughes said the recommendations were “not new concerns” but continued to have “significant consequences for those who have been harmed”.
A Department of Health and Social Care spokesperson said: “We recognise the significant impact that sodium valproate and pelvic mesh have had on people and their families. This is a complex issue and our priority is to ensure any response is fair, balanced and sensitive to those affected. We are carefully considering the recommendations within the Hughes Report, in collaboration with relevant departments, and we aim to provide an update in due course.” The department has noted that the authority to deliver financial compensation rests with the Treasury and No. 10, rather than the Department of Health itself.