David Cullinane
Ceist:937. Deputy David Cullinane asked the Minister for Health his plans for advancing an inquiry into the use of mesh implants and sodium valproate; and if he will make a statement on the matter. [8811/21]
Amharc ar fhreagraWednesday, 17 February 2021
Ceisteanna (937)
Freagraí scríofa
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 regard 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, which was published in November 2018. 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 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.
In line with good practice internationally, the establishment of an independent, compassionate process for women affected by mesh to have their voices heard is currently being scoped and this may help to drive learning across the health service and ensure that the healthcare system has appropriate responses in place.
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.
I have recently committed to holding an inquiry into the historical licensing and use of sodium valproate in Ireland and have asked officials in my department to examine a number of different options for the structure of this inquiry.
Question No. 938 answered with Question No. 804.