I propose to take Questions Nos. 666 to 668, inclusive, together.
I understand that complications from a mesh implant are very distressing and painful for those women involved. Ensuring that all women who develop mesh-related complications receive high quality, multi-disciplinary and patient-centred care is a priority for me and my Department. I would assure the Deputy that considerable work has been done to date in this country and continues to progress on patient safety in relation to mesh implants.
Uro-Gynaecological (Transvaginal) Mesh is used in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women and such mesh devices have been widely used for this over the past two decades. Mesh devices continue to be placed on the market for use within the EU as they continue to be certified by European device regulatory competent authorities as being compliant with relevant EU legislation.
I am aware that in response to concerns raised in late 2017, the then Minister for Health requested the Chief Medical Officer (CMO) to prepare a report 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 complications. Published in November 2018, this report was informed by the available national and international evidence and the personal experiences of women who have suffered complications following mesh surgery.
In July 2018, in advance of publication of the full report, the CMO requested the HSE to pause all mesh procedures where clinically safe to do so. This pause remains in place.
The HSE published a detailed Implementation Plan for the recommendations in the report in April 2019. The National Women and Infants Health Programme is leading on this work. The HSE has created a dedicated webpage about vaginal mesh implants, including contact information regarding the pathways for women suffering complications. In addition, multidisciplinary specialist services are now available for women suffering from mesh complications across two sites at Cork University Hospital (CUMH) and National Maternity Hospital (NMH) Dublin . Both centres currently treat women suffering with post mesh complications and have been accepting referrals from the national pathway since it was set up in November 2018. Women referred to these centres are generally being seen within 3 months of referral, sometimes sooner. I am informed that it has been necessary for these clinics to be cognisant of the current COVID-19 public health guidance.
Funding has been provided in Budget 2021 to enhance and improve gynaecology services; this includes funding to further develop the multidisciplinary National Mesh Specialist Service, and to implement additional pelvic floor physiotherapy and clinical nurse specialist services in each maternity network. The development funding will support the ongoing work to implement the recommendations from the CMO’s Report.
Since the emergence of this matter, the ongoing priority focus for the Department and the HSE has been to meet the care needs of women experiencing mesh complications. I strongly encourage all women affected by mesh to engage with the relevant HSE contact points and the associated care pathways, to ensure that their service needs can be identified and provided for.
With regard to Baroness Cumberlege report, I am aware that in the UK, the Independent Medicines and Medical Devices Safety (IMMDS) Review chaired by Baroness Cumberlege, was established to examine how the UK healthcare system has responded to concerns raised by patients and families about three medical interventions, one of which was mesh.
The safety of mesh devices has been the focus of considerable regulatory, policy, clinical, and political scrutiny in many jurisdictions in recent years including the United States of America (USA), England, Scotland, Northern Ireland, Australia and other European countries, resulting in several safety reviews by regulatory bodies and other national health systems.
International evidence and learning play an important role in health policy considerations to promote safe, high quality care for patients. Any relevant learnings from the review will be taken into account as my Department continues to work with the HSE, the HPRA, and other stakeholders to support implementation of the recommendations of the CMO’s report on the use of use of Uro-Gynaecological Mesh in Surgical Procedures.
Women's health is a priority for this Government, as outlined in the Programme for Government. In relation to the wider work of my Department, Budget 2021 will provide a significant investment in services that are important to women, including gynaecology services. It will also provide a Women’s Health Fund which will support proposals arising from the work of the women’s health taskforce to improve women’s health outcomes and experiences of healthcare.