Debate on the first anniversary of the Hughes report on valproate and pelvic mesh

A Westminster Hall debate has been scheduled for Thursday 27 March on the first anniversary of the Hughes report on valproate and pelvic mesh. The subject of this debate was chosen by the Backbench Business Committee and the debate was proposed by Sharon Hodgson MP.

What are pelvic mesh and sodium valproate?

Pelvic mesh and sodium valproate are two medical products that were considered by the Independent Medicines and Medical Devices Safety Review (the Cumberlege review). The review also considered the hormone pregnancy test, Primodos. The Library briefing Hormone pregnancy tests provides more information about these medicines.

Mesh is a medical device that can be surgically implanted into the body to support organs and other tissues. Pelvic mesh (also known as vaginal mesh) has been commonly used in the treatment of stress urinary incontinence (the involuntary leaking of urine during effort or exertion) and pelvic organ prolapse (when body organs in the pelvis move out of position and bulge into the vagina). Pelvic mesh can cause a range of complications, including erosion (when mesh breaks down in body tissues), protrusion of mesh into the vagina or other organs, pain, urinary problems, infection and bleeding.

Sodium valproate is a medicine that is used to treat epilepsy and bipolar disorder. It is known to cause foetal abnormalities when it is used during pregnancy, including neurodevelopmental disorders and congenital malformations (birth defects).

The Independent Medicines and Medical Devices Safety Review (Cumberlege review)

The Independent Medicines and Medical Devices Safety (IMMDS) review published its final report, First Do No Harm, in July 2020. It made nine recommendations, including that the government should establish an independent redress agency and specific redress schemes for patients harmed by pelvic mesh and sodium valproate.

The government did not accept the report’s recommendations in relation to redress, but in December 2022, it announced that it had asked the Patient Safety Commissioner (for England) to explore options for a redress scheme for people affected by sodium valproate and mesh.

The Patient Safety Commissioner (Dr Henrietta Hughes) agreed terms of reference for the PSC Redress Project in Spring 2023 and work began in Summer 2023.

The Hughes Report

On 7 February 2024, the Patient Safety Commissioner published The Hughes Report, setting out further recommendations for redress for those harmed by sodium valproate and pelvic mesh. The report calls for the establishment of an independent two-stage redress scheme to provide both financial and non-financial redress for affected patients.

The government has not yet responded to the report. It has repeatedly stated that it is carefully considering the report and its recommendations.