I propose to take Questions Nos. 153, 154 and 245 together.
As Minister for Health, I requested Dr Tony Holohan, Chief Medical Officer (CMO), to draft a report on the use of Uro-Gynaecological Mesh in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. The report covers the clinical and technical issues involved in ensuring both:
1. the safe and effective provision of mesh procedures in urogynaecology and
2. an appropriate response to women who suffer complications as a result of undergoing such procedures.
This report was published on the Department of Health website on 21 November 2018.
The CMO’s Report identifies that for many women, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional SUI and POP procedures. However, mesh devices are associated with significant and severe complications in a minority of women. These are of concern given the difficulties of mesh implant removal.
The CMO's Report makes 19 recommendations including:
- the development of patient information and informed consent materials;
- surgical professional training and multidisciplinary expertise in units carrying out mesh procedures;
- the development of clinical guidance;
- the development of information systems to monitor the ongoing use of mesh devices;
- ensuring the reporting of mesh related complications; and
- ensuring timely, appropriate and accessible care pathways for the management of women with complications.
In advance of the report’s completion, the HSE was requested in May 2018 to begin work immediately on the development of national standardised patient information and informed consent materials and the clarification and development of treatment pathways and appropriate referral services for women suffering serious complications.
The HSE was also asked by the Chief Medical Officer on 24 July 2018 to pause all mesh procedures where clinically safe to do so, pending confirmation by the HSE of the implementation of recommendations relating to (i) professional training requirements, (ii) patient information and consent and (iii) the development and maintenance of a national data set for all mesh procedures carried out in HSE funded hospitals.
A Synthetic Mesh Devices Advisory Group was convened by the HSE, to advise on and progress all of the recommendations which included three patient representatives, as well as representatives of the HPRA, the IOG, the RCSI, the CFI and all Hospital Groups to advise on and action all of the recommendations above.
I am informed that an ongoing work programme for the clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications is being progressed by the HSE. This work includes identifying the appropriate specialist clinical expertise and facilities required at hospital group level and nationally to provide comprehensive aftercare services.
Pending the completion of this work, I am informed that work to identify and progress service options for women with immediate or urgent needs is nearing completion.
As was requested by the Secretary General of my Department in November 2018, the HSE prepared an Implementation Plan for the complete set of recommendations set out in the CMO’s Report, which was approved by the Leadership Team in the HSE and published on the HSE website on 26 April 2019.
I am informed that the HSE has advised that a further detailed progress report on implementation of the recommendations will be provided to my Department in the coming weeks.
The HSE has published a dedicated webpage about vaginal mesh implants, including contact information for women suffering complications, which I hope is a useful resource. This can be found on the HSE website.
I would strongly encourage all women affected by mesh to engage with the relevant HSE contact points provided, to ensure that their service needs can be identified and provided for.
At my meeting with the Mesh Survivors Ireland Group on 7 March 2019 I agreed to continue engagement with them on a pathway forward, to ensure that the ongoing clinical management of this patient group is in line with international best practice and emerging evidence. It is my intention to meet again with the Mesh Survivors Ireland group in the coming weeks.
Mesh devices are regulated medical devices and the overall risk benefit profile associated with their use is considered positive. There is no basis for the introduction of a general redress scheme for women who have suffered mesh complications.