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Medical Inquiries

Dáil Éireann Debate, Tuesday - 15 September 2020

Tuesday, 15 September 2020

Ceisteanna (89, 626)

David Cullinane

Ceist:

89. Deputy David Cullinane asked the Minister for Health his plans to advance an inquiry into mesh implants and sodium valproate; his further plans to gather better data to understand the extent of the impact of same; if an expert panel will review the UK report on the matter; and if he will make a statement on the matter. [23647/20]

Amharc ar fhreagra

David Cullinane

Ceist:

626. Deputy David Cullinane asked the Minister for Health his plans to advance an inquiry into mesh implants and sodium valproate; his further plans to gather better data to understand the extent of the impact of same; if an expert panel will review the UK report on the matter; and if he will make a statement on the matter. [23642/20]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 89 and 626 together.

Considerable work has been done and continues to progress in Ireland in relation to the safe use of mesh implants and sodium valproate; and the patient voice is central to our understanding of these, and similar, issues. With regards to the specific details, I will first deal with mesh implants and then consider sodium valproate.

Over the past two decades, Uro-Gynaecological Mesh has been widely used in the surgical treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse 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.

I am aware that in response to concerns raised in Ireland regarding complications associated with the use of mesh devices in late 2017, the then Minister for Health requested the Chief Medical Officer (CMO) to prepare a report on the matter. The 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 was instigated pending implementation of initial recommendations regarding (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 was published in November 2018. Four of the 19 recommendations relate to data gathering to support the development of information resources to permit long-term research and audit of practice, ensuring the reporting of mesh related complications, and ensuring timely, appropriate arrangements for the management of women with complications.

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 Health Products Regulatory Authority (HPRA) receives adverse incidents reported in Ireland with respect to mesh products.  It is working with the National Women and Infants Health Programme on a national reporting guidance document, for adverse incident reporting associated with uro-gynaecological mesh. This new guidance is expected to be finalised and published in the coming weeks.  It requests that Healthcare Professionals including consultants, GPs and national mesh administrators report adverse events associated with vaginal mesh implants to the HPRA. 

The HPRA is also involved other related areas of work. It is leading work in Europe to create a device specific vigilance guidance with respect to mesh products to standardise reporting with respect to these products. It is conducting a market surveillance review into transvaginal mesh products used for stress urinary incontinence or pelvic organ prolapse, in addition to supporting a European taskforce relating to mesh products.

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. 

With regard to the medicine, sodium valproate, I am aware of historical and current issues surrounding the use of sodium valproate by women during pregnancy. I am also aware of the significant work carried out by the HSE and the HPRA over the last two years to implement European Medicines Agency (EMA) recommendations from 2018 and to provide support to families who may have concerns about previous exposure to sodium valproate and the possible impact on their children.

 As I understand it, the HSE has improved the structures in place to support families affected by foetal valproate syndrome (FVS), including the establishment of a dedicated genetics clinic in Our Lady’s Hospital, Crumlin. This means that families now have access to a clear diagnostic pathway if they feel their child may be affected by FVS.

As regards the UK report referred to by the Deputy, any relevant learnings from that review will be taken into account as my Department continues to work with the HSE, the HPRA, and other stakeholders to support successful implementation of the current regulatory framework and risk mitigation measures for valproate and implementation of the recommendations of the CMO’s report on the use of use of Uro-Gynaecological Mesh in Surgical Procedures.

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