Debate on pelvic mesh and the Cumberlege review
A general debate has been scheduled in the Commons Chamber for 5 December on pelvic mesh and the Cumberlege review. The subject of this debate was chosen by the Backbench Business Committee and the debate will be opened by Chris Vince MP.
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 leakage of urine during effort or exertion) and pelvic organ prolapse (when body organs in the pelvic area move out of position and bulge into the vagina).
A range of complications can result from the use of pelvic mesh, including the erosion (breaking down) of mesh, protrusion of mesh into the vagina or other organs, pain, urinary problems, infection and bleeding.
The Independent Medicines and Medical Devices Safety Review (Cumberlege review)The Independent Medicines and Medical Devices Safety (IMMDS) review examined safety concerns about the medicine Primodos (a hormone pregnancy test), the use of the anti-epileptic drug sodium valproate during pregnancy, and the use of vaginal mesh.
The review published its final report, First Do No Harm, in July 2020. It made nine recommendations, including that the government appoint a Patient Safety Commissioner for England and establish specialist centres for the care of those affected by mesh complications. The then government accepted these recommendations, but it did not accept a recommendation to establish an independent redress agency or a specific redress scheme for those harmed by mesh implants.
The Library briefing The Independent Medicines and Medical Devices Safety Review provides more information about the review, its recommendations and the then government’s response.
In December 2022, the government published an update report on its implementation of the IMMDS review recommendations.
The Hughes ReportOn 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.
On 5 September 2024, the House of Lords debated the matter of compensation for vaginal mesh implants. The Chair of the IMMDS review, Baroness Cumberlege, opened the debate by asking the government about its progress in ensuring that people affected by vaginal mesh implants receive compensation.
The Parliamentary Under-Secretary of State for Health and Social Care, Baroness Merron, responded for the government. She highlighted NHS England’s specialist mesh centres and work to improve how information about mesh complications is recorded. On compensation, she said that the government were carefully considering the Hughes report before coming to a decision and did not set out a specific timetable for doing so.
New regulations for medical devicesThe IMMDS review included recommendations about the regulation of medical devices. It said that the Medicines and Healthcare products Regulatory Agency (MHRA) should make changes to the regulation of devices and improve its engagement with patients (recommendation 6).
As part of its response to this recommendation, in October 2024, the government laid the Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024. These regulations introduce new requirements for medical device manufacturers to monitor the safety and performance of devices after they have been placed on the market and report this information to the MHRA.
These regulations were subject to the draft affirmative procedure, meaning that they required approval in Parliament before they can be signed into law. They were considered by the House of Lords Secondary Legislation Scrutiny Committee on 5 November 2024. The committee asked the MHRA for an update on the implementation of IMMDS review recommendations. It responded:
The MHRA is currently developing legislation that will bring further improvements to the safety of medical devices by introducing additional measures that must be taken before a product can be put on the market, including introducing unique device identifiers and implant cards, amongst other things.
The regulations were also considered by the House of Commons Delegated Legislation Committee on 26 November 2024 and by the House of Lords Grand Committee on 28 November 2024.
The instrument was approved in the House of Commons on 27 November 2024 and in the House of Lords on 2 December 2024. They will come into force in six months’ time.
Library briefings- House of Lords Library briefing Vaginal mesh implants: Financial compensation (2 September 2024)
- House of Commons Library briefing Medical technology regulations and the NHS (27 March 2023)
- House of Commons Library briefing The Independent Medicines and Medical Devices Safety Review (2 February 2022)
- House of Commons Library briefing Surgical mesh implants (5 September 2019)
Royal College of Obstetricians and Gynaecologists, About mesh (accessed 27 November 2024)