This paper provides an overview on the use and regulation of mesh implants, concerns relating to use of these implants in urogynaecological surgical procedures, recent reviews and parliamentary debate on this subject.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 urogynaecological 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. There has been an acknowledgement from the NHS England mesh working group that there is a lack of comprehensive data on these complications. Work is ongoing to ensure that patients are encouraged to report complications and clinicians report adverse events.
There have been a number of recent reviews looking at the use of mesh. Departments of Health in both England and Scotland have undertaken work in this area, as have the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission. The Welsh Government have set up a group to review the use of mesh implants.
NHS England have led the most recent review on the use of mesh implants in urogynaecological surgery, with the Mesh Oversight group publishing its final report of the review in July 2017. This stated that the use of mesh to treat women with stress urinary incontinence and pelvic organ prolapse is a safe option, but there is a “need for better information for women experiencing SUI and POP, better data and a multi-disciplinary approach to caring for women.” The report provided information on action in a number of areas:
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 recent NHS England review did not looked at this issue. 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 Under-Secretary of State for Health, Jackie Doyle-Price, responded to a Westminster Hall debate on the risk of surgical mesh implants in October 2017. She said that the issues with mesh implants were related to clinical practice and not to the devices themselves and that the Government needed to ensure that clinicians have the most up to date advice. Ms Doyle Price also set out that it was important that women were given the information to make an informed choice, and that the evidence on mesh implants would be reviewed to keep guidance up to date.
It has been reported that a number of UK patients are pursuing legal action against the mesh implant manufacturers and the NHS. There has also been legal action on this issue in other countries.
There has been some international regulatory activity in this area. Recent announcements by medicines and device regulators in Australia and New Zealand have meant that certain mesh products will be removed from sale there and producers are being required to provide safety information on their products.
Commons Briefing papers CBP-8108
Authors: Sarah Barber; Rachael Harker