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Mesh

President’s response to the Independent Medicines and Medical Devices Safety Review

Earlier this week, I welcomed the publication of Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The review highlights harrowing stories of women to whom we should have listened sooner, including their concerns about the effects of drugs on their unborn child and adverse effects for those who have undergone surgical treatment of incontinence and prolapse with mesh. For this I apologise on behalf of the Royal College of Obstetricians and Gynaecologists (RCOG) and personally.

The RCOG has a long and valued history of listening to women’s voices, so to those whose stories have not been heeded, we could and should have done better.

I am grateful to the women who have had the courage to come forward and share their most painful and distressing accounts. It is essential that we as a profession learn from each and every story.

The RCOG exists to pursue the highest standards of care for women and to advocate for their health around the globe. We achieve this in part by training and supporting our members and by inspiring young doctors to enter the specialty of obstetrics and gynaecology.

To this end I pledge that the College will act on the detailed recommendations of the review, while working with the Secretary of State for Health and Social Care to implement the system-wide and regulatory recommendations. We will also work to the highest standards with our profession and the NHS to protect the health and wellbeing of women and their families and guide them through the complex treatment options for incontinence and prolapse. We will work with healthcare providers to ensure that women who have experienced complications have access to appropriate and safe treatment.

We are also responsible for training the doctors of the future. They will be the professionals developing, researching, teaching and learning new treatments, both surgical and non-surgical, for these distressing conditions. My final undertaking, therefore, is that we will incorporate learning from this review, including the importance of listening to our patients’ voices, into the teaching and training of future generations of obstetricians and gynaecologists.

Mr Edward Morris PRCOG
RCOG President

High vigilance restrictions on use of vaginal mesh

Update April 2019

On 29 March 2019, NHS Improvement and NHS England issued a letter to all acute trusts (PDF) to extend the period of high vigilance restriction on the use of vaginal mesh. The pause and same restrictions, as outlined below, will remain in place until a set of conditions have been met. For more information, visit the mesh safety alert page.

Update July 2018

On 10 July 2018, NHS Improvement and NHS England wrote to all acute trusts (PDF) 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 page.

 

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 was reviewed in 2019 to take account of recent research into mesh, and expanded to include pelvic organ prolapse. The updated NICE guideline on urinary incontinence and pelvic organ prolapse in women: management was first published in April 2019 and last updated in June 2019.

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:

 

Elsewhere on the site

Clincal guidelines
See all clinical guidance developed by the RCOG
Patient information
See all information developed by the RCOG for women and their families