I propose to take Questions Nos. 440 to 442, inclusive, and 461 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 has been completed and was published on the Department of Health website on 21 November 2018. Preparation of the report involved consultation and engagement with national and international bodies, including the Health Products Regulatory Agency (HPRA); the relevant professional training bodies, the Institute of Obstetricians and Gynaecology (IOG) and the Royal College of Surgeons in Ireland (RCSI); the Continence Foundation of Ireland (CFI) and the Health Service Executive (HSE), as well as colleagues in other jurisdictions. The report was informed by review of international reports and safety reviews of mesh surgery which have been published in recent years.
The report was informed by the personal experiences and concerns of women who have suffered complications following mesh surgery, including through written representations to me and my Department, those concerns raised in Parliamentary Questions on this subject, and the issues raised by the Mesh Survivors Ireland group at its meeting with me on 14 June 2018. I acknowledge the bravery, commitment and dignity shown by the women I met and by those women who have written to me concerning this issue, in sharing what were often harrowing, deeply personal experiences.
The priority issues relating to patient care which were raised by women suffering complications and by others on their behalf are addressed in the report recommendations and are being addressed by the HSE.
It is important to note that the views of the many women who have undergone mesh procedures and have had satisfactory outcomes, with minor or no complications, were not formally sought and so are not reflected in this report. Also, following the implementation of a pause in mesh procedures by the HSE in July 2018, a number of women whose procedures were postponed wrote to me and my Department expressing concern at the impact that this is having on them personally as they await treatment for the distressing symptoms of SUI, reflecting another important group of women affected directly by this issue.
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 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 to pause all mesh procedures where clinically safe to do so, until a number of key recommendations are implemented.
A Synthetic Mesh Devices Advisory Group has been convened by the HSE, to advise on and progress all of the recommendations. The Group includes 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. The HSE has advised that it is unable to facilitate membership on the Advisory Group to every patient or patient group who has a mesh experience. The NWIHP has sought to have a range of mesh experiences from the patient’s perspective represented by a patient advocate on the Group – including patients who have had mesh with post-operative problems, patients who have had successful mesh surgery and patients who are on the waiting list for a mesh procedure. The HSE advises that women who wish to submit views or submissions to the overall work of the Group should contact the National Women & Infants Health Programme at email@example.com.
I am informed that an ongoing work programme for the development of appropriate patient information resources and consent materials, and the clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications is being progressed through this Group. The work being progressed by the HSE will include 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, the HSE will also examine the need to look at sourcing services from abroad to address any immediate shortfalls identified, either through utilisation of the treatment abroad scheme or by commissioning services from abroad.
The HSE has advised that many women have already engaged with this pathway system and have attended centres for second opinion and follow up appointments. 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.
The Secretary General of my Department wrote to the HSE on November 27 2018 to request that it prepare a detailed Implementation Plan for the complete set of recommendations set out in the CMO’s Report, to be approved by the Leadership Team in the HSE and published on the HSE website within three months of receipt of the report, or sooner if completed. It was also requested that a copy of the Implementation Plan, together with an interim report on the implementation of those recommendations on which work has already commenced, should be submitted to the Department at the time of publication of the Implementation Plan.
I am informed that the HSE has advised that the final version of the Implementation Plan will be published on its website and submitted to my Department in coming weeks.
At my recent 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.