In late 2017, concerns arose about the frequency and severity of complications associated with the use of mesh devices in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women in Ireland. In responding to these questions and in recognition of the complexity of the matters arising, I requested the Chief Medical Officer (CMO) to prepare a report on the clinical and technical issues involved in ensuring both:
a) the safe and effective provision of mesh procedures in urogynaecology; andb) an appropriate response to women who suffer complications as a result of undergoing such procedures.
Preparation of the report has involved consultation and engagement with national and international bodies. The report has been informed by review of international reports and safety reviews of mesh surgery which have been published in recent years. The report has also been informed by the personal experiences of women who have suffered complications following mesh surgery.
The 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.
The report was completed and published on the Department of Health website on 21 November 2018.
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. 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 HSE has advised that many women have already engaged with this pathway system and have attended centres for second opinion and follow up appointments.
I am informed that work is ongoing by the HSE to examine options for sourcing services from abroad to address any immediate shortfalls identified, either through utilisation of the treatment abroad scheme or through agreement with relevant centres.
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.