High vigilance restrictions on use of vaginal mesh
On 10 July 2018, NHS Improvement and NHS England wrote to all acute trusts advising of the immediate implementation of a high vigilance restriction period regarding vaginal mesh.
For the majority of patients, mesh surgery should not be performed during this period of high vigilance restriction.
For some patients, mesh procedures may be the only viable treatment option. This includes cases where clinicians judge there is clinical urgency to carry out the procedure and no suitable alternative exists, and/or where delay would risk harm to the patient. However, this treatment should only be used in carefully selected patients who understand the risks and have given fully informed consent.
For more detail please see the mesh safety alert issued by the College on 10 July 2018.
About mesh
‘Mesh’ is a broad term used to describe a number of different types of manufactured biological or synthetic implantable devices. Mesh is used in a range of surgical procedures to support tissues. In obstetrics and gynaecology (O&G), mesh is one option for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
For many women, surgical procedures using mesh provide an effective form of treatment for the distressing effects of SUI and POP. However, some women experience serious complications and there are a number of patient communities who campaign to raise awareness of these concerns.
As of 10 July 2018, a period of high vigilance restriction is in place regarding use of vaginal mesh in England (see above).
Information for healthcare professionals
High vigilance restrictions on use of vaginal mesh
A period of high vigilance restriction regarding vaginal mesh is currently in place in England – read the College’s safety alert for more information.
Clinical guidance
The NICE guideline on urinary incontinence is currently being updated to take account of recent research into mesh, and expanded to include pelvic organ prolapse. The draft guideline is now out for consultation and can be accessed on the NICE website.
NICE has also updated (in 2017-18) its interventional procedures guidance related to mesh:
Consent
The RCOG’s consent hub provides guidance on how to:
- Support women to make decisions about their healthcare
- Obtain consent for procedures
- Discuss risks
Complications
All complications must be reported via the MHRA Yellow Card Scheme. More information about how to report mesh complications is available on the British Society of Urogynaecology (BSUG) website.
A number of units are able to see women who have significant mesh problems following surgery for SUI or POP where mesh was inserted. The clinical lead for each named unit has confirmed that they will:
- Comply with set criteria for discussing all women requiring surgery at a joint meeting to help determine best treatment options
- Submit data on all women undergoing surgery onto the national database and report them to MHRA
Information about these units is available from BSUG and the British Association of Urological Surgeons (BAUS).
Information for women and the public
High vigilance restrictions on use of vaginal mesh
A period of high vigilance restriction regarding vaginal mesh is currently in place in England – read the College’s safety alert for more information.
Information about procedures using mesh
If you have been diagnosed with SUI or POP, you may be offered a number of different procedures to treat or manage your condition. If you are considering a procedure using mesh, you should have a detailed discussion with an expert healthcare professional about the benefits and risks of the surgery for you. If you decide to go ahead with a procedure using mesh, the operation should only be performed by a specialist with expertise in this technique.
NHS England has developed two information leaflets to support women’s decision-making. These look at the benefits and risks of mesh surgery to help you decide whether this is the best option for you. You should discuss this information with your healthcare team and ask any questions you need answering to help you make your decision:
The RCOG menopause hub provides additional information about alternative treatments for:
Complications
If you experience any complications, you must inform your healthcare professional. There is a central database of units that can see women who are experiencing significant problems following mesh surgery for SUI or POP. Your healthcare professional will be able to refer you to one of these units.
Your doctor should report the complication to a national registry – this is to ensure the NHS has full details of the number and type of complications experienced by women across the country in order to make informed decisions about future guidance. You can also report complications yourself, directly to the Medicines and Healthcare products Regulatory Agency via their website, which also includes FAQs for members of the public.
Support groups
There are a number of patient groups who will be able to provide information and support:
Further information
There have been a number of national reports into the use of mesh which provide more detail about the current debate around use of mesh. The reports also provide a number of recommendations: