This briefing paper provides an overview on mesh implant use in surgery to treat pelvic organ prolapse and stress urinary incontinence, and recent action to halt these procedures. It also briefly discusses the use of mesh in hernia repair surgery.Jump to full report >>
Mesh implants may be used in a number of surgical procedures to provide additional support when repairing weakened or damaged tissue. Over recent years attention has increased on complications that can occur with the use of this mesh in urogynaecology procedures to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
These complications can include persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel. It is acknowledged by NHS England, NICE and others that there is limited evidence on the long-term adverse effects following these procedures.
In February 2018, the then Secretary of State for Health and Social Care, Jeremy Hunt announced the establishment of a medicines and medical devices safety review in February 2018. This review is being led by Baroness Cumberlege and has taken evidence from patients, patient groups, and clinicians on three areas of concerns in relation to medicines and medical devices – Sodium valproate, primodos (the hormone pregnancy test) and surgical mesh.
In July 2018, following the evidence it had heard, the Independent Medicines and Medical Devices Safety Review called for the immediate halt of the use of surgical mesh in stress urinary incontinence procedures. The use of mesh in procedures to treat pelvic organ prolapse had only been undertaken as part of research following NICE guidance in 2017.
The Government accepted this recommendation and said the pause should also apply to vaginally inserted mesh to treat pelvic organ prolapse. This high vigilance restriction period means that for most women, there will be a delay in having procedures or alternative treatment would be offered but does not mean that a blanket ban is in place. Halts in the use of mesh in Scotland, Wales and Northern Ireland are also currently in place.
This halt in procedures remains in place at the time of writing
Concerns have been raised about the safety of the mesh implants themselves and the regulatory process used to assess them. There has been disappointment that the 2017 NHS England review did not look at this issue.
Mesh implants are regulated as medical devices, under EU legislation. In response to concerns relating to mesh implants, new EU regulations have changed the medical device classification of mesh implants. This will mean that they will be subject to greater scrutiny during the pre-approval process. These changes will come into force in 2020. The Government have said when the UK leaves the EU, it will still implement the new EU Medical Devices Regulations.
In response to a debate on medical devices in February 2019, the then Under-Secretary of State for Health, Jacqui Doyle-Price acknowledged that improvements were needed to the existing system of regulation for devices. She said that the Government would implement the changes introduced by the EU regulations and were confident that this would drive system-wide improvement. She also said, that in advance of this the Government were taking actions to ensure the existing legislation is working as effectively as possible.
There has also been international action on the regulation of mesh devices.
Another use of mesh that has received recent attention is in hernia repair procedures. Complications due to this mesh use were raised in a BBC investigation in September 2018. This briefing paper mainly focuses on mesh procedures for stress urinary incontinence and pelvic organ prolapse but hernia repair using mesh is discussed in Section 8. There is a Westminster Hall debate on hernia mesh in men on 5 September 2019.
Commons Briefing papers CBP-8108
Authors: Sarah Barber; Rachael Harker