John McGuinness (Carlow-Kilkenny, Fianna Fail)
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1188. To ask the Minister for Health if matters raised in correspondence (details supplied) will be addressed; and if he will make a statement on the matter. [21513/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

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. It 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. The HSE has published a dedicated webpage about vaginal mesh implants, including contact information regarding the pathways for women suffering complications. This can be found on the HSE website.

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 pathways for women experiencing mesh complications, established by the HSE, have been in place for over a year. All appointments offered to women through these pathways have been to the public system. 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.

The Treatment Abroad Scheme is not available for patients wishing to have mesh related surgery for SUI or POP as there is currently a pause on mesh surgeries for these specific ailments. The TAS scheme is not available for mesh removal, full or partial, as the treatment is available publicly in Irish hospitals.

On an interim basis, Translabial Scanning has been made available under the Treatment Abroad Scheme until the two scanners which have been purchased by the HSE are operational in the two Mesh Complications Centres. As Translabial scanning is a diagnostic tool and not a “treatment” it does not normally qualify for this scheme however having listened to the requests from women for this specific type of scanning to be made available this interim measure was taken.

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.