Seanad debates

Tuesday, 4 December 2018

Commencement Matters

Medical Products

2:30 pm

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent) | Oireachtas source

I thank the Senator for raising this important issue. I am taking this Commencement matter on behalf of the Minister for Health, Deputy Simon Harris.

The report to the Minister from Dr. Tony Holohan, Chief Medical Officer, CMO, on the use of urogynaecological mesh in the surgical treatment of stress urinary incontinence, SUI, and pelvic organ prolapse, POP, in women was published on the Department of Health website on 21 November 2018. Synthetic mesh devices have been widely used in the surgical treatment of SUI and POP in women over the past two decades. I accept the Senator's point but controversy about the safety of mesh devices has arisen in many countries because of concerns about the frequency and severity of complications associated with their use. In responding to these questions and in recognition of the complexity of the matters arising, the Minister requested the CMO to prepare a report for him on the clinical and technical issues involved in ensuring the safe and effective provision of mesh procedures in urogynaecology and an appropriate response to women who suffer complications as a result of undergoing such procedures.

Preparation of the report has involved consultation and engagement with national and international bodies. The report has been informed by reviews of international reports and safety reviews of mesh surgeries that have been published in recent years. The report has also been informed by the personal experiences of women who have suffered complications following mesh surgery. The Minister acknowledges the bravery, commitment and dignity shown by the women he met and by those women who have written to him concerning this issue, in sharing their harrowing and deeply personal experiences.

The 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 SUI and POP procedures. Mesh devices, however, are associated with significant and severe complications in a minority of women. These are of concern given the difficulties of mesh implant removal. The report makes 19 recommendations, including the development of patient information and informed consent materials; surgical professional training and multidisciplinary expertise in units carrying out mesh procedures; the development of clinical guidance; the development of information systems to monitor the ongoing use of mesh devices; ensuring the reporting of mesh-related complications; and ensuring timely, appropriate and accessible care pathways for the management of women with complications.

At the CMO's request, a programme of work to advance some of the report's more important recommendations has commenced in the HSE in advance of completion of the report. The HSE was also asked by the CMO on 24 July to pause all mesh procedures where clinically safe to do so until a number of key recommendations are implemented. The HSE has a published a dedicated web page about vaginal mesh implants, including contact information for women suffering complications, which I hope is a useful resource and for which we can make the link available.

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