I propose to take Questions Nos. 672, 674 and 711 together.
I note the recent publication in England of the report of the Independent Medicines and Medical Devices Safety (IMMDS) review, “First Do No Harm” which was chaired by Baroness Cumberlege.
International evidence and learning play an important role in health policy considerations to promote safe, high quality care for patients. This report may add to that evidence and learning.
Over the past two decades, Uro-Gynaecological (Transvaginal) Mesh has been widely used in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women. Mesh devices are certified as compliant with relevant EU legislation, and as such, European regulatory competent authorities consider that the benefits outweigh the risks for these devices.
In Ireland, considerable work has been done to date and continues to progress on patient safety in relation to mesh implants; and the patient voice is central to our understanding of these, and similar, issues. As part of the ongoing policy response, my department officials are examining options to establish a process for an independent, compassionate engagement for women affected by mesh to have their voices heard; and will make proposals to me in this regard. Any engagement process will need to take account of the wider context relating to the COVID-19 pandemic.
Concerns were raised in Ireland regarding complications associated with the use of mesh devices in late 2017, including a number of Ministerial representations from the women affected or on their behalf. At that time, the Minister for Health requested the Chief Medical Officer (CMO) to prepare a report on 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 CMO Report was published in November 2018.
Importantly, the CMO report was informed by the available national and international evidence and the personal experiences of women who have suffered complications following mesh surgery.
Since July 2018, the HSE has paused all mesh procedures where clinically safe to do so. This was at the request of the CMO and undertaken in advance of completion of the final CMO report. The pause was instigated pending confirmation by the HSE of the implementation of initial 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.
The CMO 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 procedures. However, mesh devices are associated with significant and severe complications in a minority of women, which are of concern given the difficulties of mesh implant removal.
The CMO report made a number of recommendations, the implementation of which will provide significant assurance that both women presenting for treatment and who develop mesh-related complications, receive high quality, multi-disciplinary patient centred care in accordance with the evidence and supported by robust clinical governance mechanisms.
The HSE published a detailed Implementation Plan for the recommendations in the report in April 2019. The HSE’s National Women & Infants Health Programme (NWIHP) is progressing treatment pathways and referral services for women suffering from mesh-related complications.
A multidisciplinary National Specialist Centre is being developed over 2 sites at Cork University Maternity Hospital (CUMH) and the National Maternity Hospital (NMH) Dublin. In addition, two translabial scanners, were procured by the HSE in late 2019, and are now onsite in both hospitals. However, the first scanning clinic, which was due to take place last March had to be postponed, due to the pandemic.
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.