This page contains resources to inform and support decision-making by women in Northern Ireland who are concerned about the use of vaginal mesh.
**Update July 2018: A pause in some procedures using vaginal mesh is currently in place. If you have any concerns, you should approach your GP in the first instance who will refer you to your local health and social care trust. If you have previously had mesh-related surgery and are concerned, you should also see your GP and ask to be referred to the Trust where you had your procedure**
1) What conditions is vaginal mesh used to commonly treat?
2) Is there a difference between using mesh to treat stress urinary incontinence and pelvic organ prolapse?
3) What are the different types of mesh procedures to treat stress urinary incontinence?
4) Are people still being treated with mesh for stress urinary incontinence?
5) What are the different types of mesh procedures to repair pelvic organ prolapse?
6) How many mesh procedures have been carried out in Northern Ireland and how many have had complications?
7) How many women in Northern Ireland are likely to be affected by this?
8) Why has mesh continued to be used here, when the complications have been known for some time?
9) Does draft NICE guidance mean all mesh operations will be banned?
10) Why won’t you ban the use of vaginal mesh?
11) How do I know if I need my mesh removed?
12) Who should I contact if I am experiencing problems?
13) What happens after I am assessed by a consultant?
14) What does the assessment of whether I need treatment for mesh complications involve?
15) How long will my treatment take?
16) Is translabial ultrasound available in Northern Ireland?
17) Do we have the expertise in Northern Ireland to remove mesh partially and to remove mesh completely?
18) What are the different types of mesh removal?
19) If mesh is removed, what do you provide to replace it to ensure women are treated for their original problem?
20) Who will look after me here in Northern Ireland if I decide to seek private assessment and/ or treatment elsewhere?
21) How often have surgeons been brought over from England to perform removals here?
22) What is an ECR?
23) How many women have travelled to England to have their mesh removed?
24) If women want their mesh removed, how long will they have to wait for the procedure?
25) Are women who are affected by this being offered counselling and other support aside from surgery?
26) What are you doing for men who experience pain from mesh surgery?
Vaginal mesh is used to treat two different health issues in women:
The same material (Type 1 polypropylene mesh) is used for both, but the operations differ in the method and site of mesh placement, amount of mesh used and risks.
The amount of mesh used in a tape operation for stress urinary incontinence is less than in vaginal mesh operations for pelvic organ prolapse. The risk of complications during and after the operation is much higher with vaginal mesh for prolapse repairs than with tapes used to treat stress urinary incontinence.
The differences in complications mean that vaginally placed mesh is no longer recommended by NICE in the treatment of pelvic organ prolapse. It has not been used in Northern Ireland for several years.
There is also an operation using abdominally placed mesh (sacrocolpopexy) for prolapse that has been used for decades and has a good safety record.
There are two types of mesh tape to treat stress urinary incontinence with different routes of insertion:
Retropubic tape (TVT) remains a treatment option for women with stress urinary incontinence, so long as they are fully informed of the risks and complications and offered a ‘non-mesh’ alternative procedure such as colposuspension, autologous fascial sling or urethral bulking injections, all of which have their own risks and complications. Transobturator tape (TVT-O) is more likely to cause long term pain and is rarely used.
Between 2007 and 2015 in Northern Ireland, 5,255 women had vaginal tapes inserted for stress urinary incontinence, and there were 200 tape removals (3.8%).
Most of these were partial rather than total mesh removals.
There were 409 vaginal mesh implants for pelvic organ prolapse during the same period in Northern Ireland. We do not have robust data for the removal of mesh implants for pelvic organ prolapse as yet, because this is an emerging issue and we only started to collect data on it in 2017. It is a difficult operation and other UK mesh centres find it as challenging to deal with as we do.
Vaginal mesh repair is no longer recommended by NICE for routine surgery for pelvic organ prolapse due to an unacceptably high complication rate. It has not been used in Northern Ireland for several years.
Several thousand operations using vaginal tapes and mesh have been performed in Northern Ireland, and most of these women are doing well with good results from their surgery. A small number of women experience problems immediately after the procedure, while a significant and growing number may do so many years later. All surgical procedures carry risks, and these vary depending on a number of factors. Long term complications are particularly difficult to identify.
It is therefore impossible to give exact figures, but reasonably accurate estimates tell us that approximately 4% of women having had a vaginal mesh tape inserted for stress urinary incontinence in Northern Ireland have undergone some form of tape removal. This is similar to findings from audits here, elsewhere in the UK and beyond.
All surgical procedures carry risks and these vary depending on a number of factors.
The mesh complication rate for retropubic (TVT) and transobturator (TVT-O) tape is around 5%, much lower than the complication rate for vaginally placed mesh for prolapse. Some women deem this level of risk acceptable, when they have been advised about the risks and success rates of ‘non-mesh’ alternatives. The transobturator (TVT-O)tape procedure is more likely to cause long-term pain and is now rarely performed.
In 2011, the United States Federal Drugs Agency recognised that complications from vaginally placed mesh for pelvic organ prolapse are ‘not rare’. A number of reports reviewed the available evidence and made recommendations, but did not ban mesh for prolapse.The PROSPECT study published in 2016 provided robust evidence that vaginal mesh procedures for pelvic organ prolapse do not provide any benefit over alternative operations like abdominal mesh procedures and ‘non mesh’ alternatives.
Vaginally placed mesh for pelvic organ prolapse was not commonly used at any time in Northern Ireland and has not been used at all in recent years.
Some of the latest NICE guidance remains under consultation and refers to vaginally placed mesh used in pelvic organ prolapse only. It does not suggest a change to existing practice for abdominally placed mesh for pelvic organ prolapse or mesh tape operations for stress urinary incontinence.
Vaginal mesh repair is no longer recommended for routine surgery for pelvic organ prolapse. It has not been used in Northern Ireland for several years.
NICE does not have the authority to approve or ban any medical equipment; it can only make recommendations about its use. The responsibility for regulating medical equipment in the UK lies with the Medicines and Healthcare Products Regulatory Authority (MRHA). If any kind of medical equipment including mesh containing ones are to be banned in the UK, the decision to do so needs to be taken by MRHA.
NICE has other guidance on how patients needing surgery involving mesh should be treated, and health and social care trusts in Northern Ireland follow this guidance.
All health and social care trusts, the Health and Social Care Board, the Public Health Agency and the Department of Health are working together to make better use of the skills and resources we have here through a Northern Ireland wide urogynaecological network to ensure every woman receives the best possible service regardless of where she lives.
The body responsible for governing the use of medical devices in the UK is the Medicines & Healthcare Products Regulatory Agency (MHRA), while the National Institute for Health and Care Excellence (NICE) provides national guidance and advice to all health and social care organisations.
Any decision to ban the use of vaginal mesh would be dependent on guidance and advice from both these bodies and would not be a decision for individual health and social care organisations in Northern Ireland.
The majority of women who have had any of these procedures do not experience complications. If you are not experiencing problems after your procedure, there is no need to do anything.
However, if you are among the women who are experiencing complications, which you think may be caused in part or wholly by mesh, you need to be medically assessed by a consultant with experience in this area. This expertise is available in every health and social care trust in Northern Ireland.
Depending on the outcomes of your assessment, and if a decision is made to remove the mesh, you can be treated in your local health and social care trust, another health and social care trust in Northern Ireland or at a hospital in Great Britain.
The first step is to speak to your GP, who will refer you to the health and social care trust where you had your most recent mesh procedure, because this is where your most recent records are held. Letters were sent to GPs and health and social care trusts in July 2017, advising them about the referral process. These have been updated and reissued in June 2018.
Depending on the outcomes of your assessment, and if a decision is made that you do need treatment for mesh complications, you can be treated in your local health and social care trust, another health and social care trust in Northern Ireland or at a hospital in Great Britain, depending on the kind of procedure you need.
Some women may be asked to go to the Mesh Centre in Belfast for further tests or second opinions after seeing clinicians in their local health and social care trust. This does not mean women will necessarily be treated in Belfast.
Some will be treated at the Mesh Centre in Belfast and some will return to their local health and social care trusts if clinicians there have the necessary skills, experience and team available to carry out the required treatment.
If a woman cannot be treated in Northern Ireland, arrangements can be made by her consultant through the Extra Contractual Referral (ECR) process for her to be treated abroad, usually at an NHS hospital in GB.
The consultant will ask you about the problems you have and will review your medical record to get a full understanding of what has happened in the past. You need to be examined and, depending on the findings, tests will be done.
These may include keeping a record of your symptoms in a diary or on a chart, urine tests, ultrasound scanning, computer assisted tomography (CT) or magnetic resonance imaging (MRI), cystoscopy (looking into the bladder with a telescope), urodynamics (studying bladder movements), colonoscopy, EUA (examination under anaesthesia) and nerve tests.
There isn’t a standard set of investigative tests, as these are dependent on individual circumstances and may include a variety of invasive and non-invasive procedures to both confirm that mesh is causing symptoms and to rule out other causes.
The results of these tests are usually discussed by your consultant at a multidisciplinary team meeting with colleagues to consider options for treating you. Based on this, you and your consultant agree next steps.
While patients presenting with mesh complications are given priority and longer initial appointments, many other investigations cannot be fast tracked, because this would disadvantage other patients with equally urgent problems. At this point in time, unfortunately waiting lists for these investigations can be very long.
Belfast Trust has placed an order for a transvaginal scanner and it is expected to be fully operational in 2019. This is a positive step in the further development of the Mesh Centre in Belfast Trust. The centre, when fully operational, will offer enhanced patient services including transvaginal and translabial ultrasound. These services will also include psychological support and a pain management clinic.
There are several specialists working in health and social care trusts here who can remove vaginal mesh.
Cutting or releasing mesh tapes is relatively straightforward and can be done in every health and social care trust after a patient has been assessed and a conclusion reached that this is the most appropriate procedure.
Partial removal of mesh is referred to as trimming if only a small amount of mesh needs to be removed. This tends to be a relatively simple procedure, but removing larger proportions of mesh is more complex so is performed in some Northern Ireland health and social care trusts by specialists who work with one another to achieve the best possible result for each patient.
Total mesh removal has been performed for a small number of women by surgeons in Northern Ireland. Further expertise in total mesh removal is currently being developed in all mesh centres in the UK.
Northern Ireland has a Mesh Centre in Belfast, which is recognised by the Royal College of Obstetrics and Gynaecologists, but needs additional resources to increase its capacity to assess and treat women with complex mesh problems and recurrent incontinence. This mesh centre has a multidisciplinary team (MDT) of experts, which is growing to meet the needs of women from across Northern Ireland.
We are also developing a network of mesh specialists from each health and social care trust. Patient pathways have been developed to ensure that women in Northern Ireland have access to the most appropriate treatment for their condition either in their local health and social care trust or at the mesh centre. More information about the mesh centre is available here.
The type of mesh removal depends on the reason for surgery and type of mesh. Some operations for removal involve a minor procedure (trimming or release of tape) and others are more complex operations (partial or complete removal of mesh).
The most common reason for removal of mesh is mesh that has eroded into the vagina and less commonly for removal of a tight tape, which protrudes into the vagina leading to painful sex or vaginal pain. On rare occasions, mesh can erode into a neighbouring organ such as the urethra, bladder or bowel, which makes removal necessary. There are different types of removal:
Removal of vaginal mesh used to treat pelvic organ prolapse is the most technically difficult due to the larger amount of mesh used and its position close to important organs like the urethra, bladder and bowel. This to a lesser degree also applies to total removal of transobturator (TVT-O) tape, which can be close to large blood vessels and nerves in the inner thigh, making removal difficult with potentially greater risk of complications. The removal of retropubic (TVT) tape is technically more straightforward due its position behind the pubic bone.
For all types of removal, the original health problem that the mesh was used to treat might recur or get worse, regardless of whether the mesh is cut, partially or completely removed.
If a patient is in pain, the decision to cut or remove mesh must be considered very carefully and take into account every woman’s individual circumstances. There are other causes for pelvic pain in women, many of which are more common than mesh related ones, and it can be difficult to tell them apart. This is why a good assessment to identify and treat other problems if possible is so important.
If the mesh was used to treat incontinence, and this recurs after mesh removal surgery, a ‘non-mesh’ operation may be offered such as colposuspension, fascial sling or urethral bulking injection, but each of these carries its own risks. Such surgery may be performed at the same time as the mesh removal or later.
If the mesh was used to treat pelvic organ prolapse, and this recurs after mesh removal, a hysterectomy or native (using the woman’s own) tissue repair may be offered, or a non-surgical approach using a vaginal pessary may be an option.
Other non-surgical options include pelvic floor muscle exercises, which are effective and avoid the need for surgery in many women, especially if supervised by a physiotherapist, and weight loss for overweight women with stress urinary incontinence. Medication can also help, and some women might prefer to do nothing other than use incontinence pants or pads.
After being assessed and / or treated privately elsewhere and assuming you are a Northern Ireland resident, you remain entitled to emergency, urgent and routine treatment for your original health problem here in as far as this is available.
However, difficulties can arise if communication between your private health care provider outside Northern Ireland and your GP or hospital here is poor.
If you have sought private assessment or treatment elsewhere against the advice of your GP or hospital here, and if complications arise that cannot be treated in Northern Ireland or which are not urgent nor an emergency, you might need to return to and pay your private health care provider for further treatment.
It may therefore be prudent in advance of deciding to seek private assessment and/ or treatment to consider arrangements for follow up.
No surgeons have been brought over from England to perform removals here, but surgeons from Northern Ireland have observed colleagues at work in England and are now reassured that the expertise is available here to offer women the same level of service as anywhere else in the UK.
It is likely that in future surgeons from Northern Ireland and GB will work together to exchange examples of good practice and experiences of mutual benefit and to continually improve practice. Such UK wide collaborations are commonly used in many areas of clinical practice to continually improve services here and elsewhere.
Unfortunately to date, because of increasing numbers of women needing mesh centre services everywhere in the UK, it has not been possible to establish a formal partnership with any mesh centre in GB.
An Extra Contractual Referral (ECR) becomes necessary when the Health and Social Care Board approves a consultant’s request to transfer a patient temporarily to a colleague outside Northern Ireland for a second opinion, assessment or treatment, which the consultant considers necessary, but which is not available here.
This is normally to a service provider in Great Britain, but rarely may also be outside the UK, where this is clinically justified.
There have been no changes to the ECR criteria, which Northern Ireland clinicians and patients need to fulfil but finding mesh centres in Great Britain that can accept patients from Northern Ireland is difficult, because all of them are busy treating patients from their own catchment area and have long waiting lists. This situation has to date also hampered plans to establish a formal visiting relationship with a mesh centre in Great Britain.
Since June 2017, over 10 ECRs made by consultants in Northern Ireland for women with mesh related problems living here have been approved. Records indicate that only a few of these women have travelled to England, but we do not have information on patients who travel and pay for treatment privately.
Women waiting for mesh-related and other gynaecological operations will be treated depending on how urgent the operation is and when they went on the waiting list. This applies in Northern Ireland as it does in Great Britain.
Women needing support will be offered it either by their GP, their gynaecologists or by other members of the multidisciplinary teams that exist in every health and social care trust.
Complications after mesh surgery in men are not as often caused by the mesh itself, because it is used very differently in women compared with men. Surgery in men is usually done close to the surface of the body to strengthen the abdominal wall or other superficial structures. This makes it more straightforward and less likely to interfere with how the body functions after surgery.
Mesh in men was in use decades before its introduction into surgery for women. Mesh surgery for hernias in men continues to be recommended by NICE and remains routine practice in the UK, because alternatives have unacceptably high failure rates.
As with any surgery, there are men who experience problems after mesh surgery. These can be related to problems the mesh surgery was intended to treat but could not cure, the surgery itself or the mesh used. As in women, these problems can be difficult to tell apart.
Therefore, any men who have problems after mesh surgery should consult with their GP and be directed to the health and social care trust where the surgery was performed if this is necessary to get the appropriate care and treatment.