Barry Ward (Dún Laoghaire, Fine Gael)
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This is an important issue. The irony of two men discussing a women's health issue is not lost on me. I thank Dr. Gerry Agnew, a consultant gynaecologist at St. Michael's Hospital in Dún Laoghaire, and Dr. Suzanne O'Sullivan, president of the Institute of Obstetricians and Gynaecologists in Ireland, for bringing this to my attention.

The issue I want to raise regards treatment for stress urinary incontinence, which affects one in three women over the age of 45. It is a substantial issue. It is solved by the insertion of a thing called the mid-urethral mesh sling, which has been used extensively around the world for treatment of this condition in women since the late 1990s.

There are essentially two ways to treat the condition. One is a conservative way that is non-surgical and involves physiotherapy. It involves urinary pessaries, for example. The other way is surgery, and the surgery involves the insertion of this mesh sling. The reality is that where the conservative treatments fail, the surgical treatments are much more effective, and they are not available in this country. The mid-urethral mesh is just one of the solutions that can be put forward but it offers shorter operating time to perform, shorter recovery time for the women who undergo the surgery because of its minimally invasive nature, lower rates of subsequent repeat incontinence surgery, and lower rates of complication. It is something that has worked.

In the late 2000s, the idea was taken that they would expand the use of these meshes into other areas, including prolapse surgery. That did not work. It had complications and it did not have the same rate of success. Throughout the world, relevant authorities rowed back on that but Ireland blindly followed the UK surgeon general and withdrew these mesh slings from the market. All of the meshes used in surgeries were withdrawn from the market in July 2018 and they have not been put back on the market since then. This means that meshes being used in all vaginal surgeries have been removed from the market. It is now seven years later, and they still have not restored it despite the fact that although it does not work for prolapse surgery, it works very well for the stress urinary incontinence surgery. Specialists in Ireland have been offering all the services they can but ultimately not the surgery, and the extraordinary thing is that the surgery is available throughout the European Union, just not in Ireland or the UK. It seems to me that this does not make sense at all.

The worst thing about that is that doctors here - gynaecologists, urogynaecologists and surgeons - were performing this operation in Ireland with enormous success for years. Since 2018, they have not been able to do that, with the result that they refer their patients abroad to hospitals in the rest of the European Union. A constituent contacted me regarding the one in Amsterdam.

That hospital provides a very successful service. The Irish women who need to undergo this surgery now find themselves having to go abroad. They are supported in that regard by the HSE but not in every respect. There are additional costs involved, including travel, accommodation, etc. It is tremendously unfair that they should have to go abroad for this surgery when it would make much more sense to deliver it in this jurisdiction.

The persistence in providing inferior options for treating this condition leads to multiple attendances at urogynaecology and urology clinics. It has a devastating effect on waiting times for appointments for patients, who, in previous times, were successfully treated and discharged back to their GPs. They now must continue to attend those services, which takes up time and resources. If we are in favour of choice for women, we should be in favour of giving them this choice in this jurisdiction, rather than relying on exporting the problem to other countries around the European Union. It defies explanation as to why that is happening. The removal of this product from the market is not supported by the international organisations representing physicians who practise in this area. They all want to see it restored. The medical evidence is that it should be restored. However, there appears to be a bureaucratic and certainly nonsensical block on its restoration. Can this situation please be fixed?

Jerry Buttimer (Cork South-Central, Fine Gael)
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I am taking this matter on behalf of the Minister for Health. I congratulate Deputy Ward on his appointment as Chair of the European affairs committee and wish him well in the role.

He has raised a very important matter regarding women's health and the healthcare provided to them. The urogynaecological transvaginal mesh is used in the surgical treatment of stress urinary incontinence and pelvic organ prolapse in women. Such mesh devices have been widely used to treat those conditions over the past two decades. For many women suffering the distressing symptoms of stress urinary incontinence and pelvic organ prolapse, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures.

However, as the Deputy noted, concerns about the safety of mesh devices have arisen in many countries because of the frequency and severity of complications associated with their use. In November 2017, in response to public and patient concern about the ongoing safety of mesh devices, the then Minister for Health, Deputy Harris, requested the Chief Medical Officer to prepare a report for him on the clinical and technical issues involved in ensuring both the safe and effective provision of mesh procedures in urogynaecology and an appropriate response to women who suffer mesh complications.

In July 2018, the CMO asked the HSE to pause all mesh procedures where clinically safe to do so, pending confirmation of the implementation of specific recommendations in the CMO's report. In November 2018, the CMO's report on the use of urogynaecological mesh in surgical procedures was published. It contains a number of recommendations regarding the safe and effective provision of mesh procedures in urogynaecology and an appropriate response to women who suffer complications as a result of undergoing such procedures. The CMO's report included 19 recommendations across four key areas, namely, patient information and consent, aftercare for women suffering complications, clinical and professional recommendations, and information systems.

In 2018, the HSE commissioned a review of the CMO's recommendations. In 2019, it began work on the recommendations, providing regular progress updates. The Covid-19 pandemic subsequently delayed that work. Implementation of the report's recommendations will provide significant assurance that all patients presenting for treatment for stress urinary incontinence and pelvic organ prolapse, and all women who develop mesh-related complications, receive high-quality, patient-centred care in accordance with accepted evidence and supported by robust clinical governance mechanisms.

In 2023, the HSE established a national vaginal mesh implant oversight group to oversee vaginal mesh implants in HSE acute hospitals in terms of both primary implant surgery and tertiary complications services. The focus of the group was to review and assess implementation of the recommendations as set out in the CMO's report and assess the appropriateness of resuming urogynaecological mesh procedures, cognisant of international developments and approaches in this complex area. I have noted the Deputy's comments regarding services in other jurisdictions. The Department recently received a report from the HSE's national vaginal mesh implant oversight group. Officials are actively liaising with the HSE on all aspects of this work to ensure comprehensive implementation of the CMO's recommendations.

I again thank the Deputy for raising this very important matter. I will convey the points he raised to the Minister for Health.