Patrick O'Donovan
Question:175. Deputy Patrick O'Donovan asked the Minister for Health the status of the resolution of the issue concerning women who had vaginal mesh implants; and when progress will be made on same. [52300/18]
View answerWednesday, 12 December 2018
Questions (175)
Written answers
As Minister for Health, I requested Dr Tony Holohan, Chief Medical Officer (CMO) to draft a report on the use of Uro-Gynaecological in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. The report covers 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 report has now been completed and 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. However, 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.
Preparation of the report has involved consultation and engagement with national and international bodies. The report has been informed by review of international reports and safety reviews of mesh surgery which 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.
I acknowledge 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 what were harrowing, 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. However, mesh devices 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.
The HSE was also asked by the Chief Medical Officer on 24 July to pause all mesh procedures where clinically safe to do so, until a number of key recommendations are implemented.
Following the publication of the report, the Department wrote to the HSE to request that it prepare a detailed Implementation Plan for the complete set of recommendations set out in the CMO’s Report, working in conjunction with other stakeholders.
The HSE has a 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 at:
hse.ie/eng/about/who/acute-hospitals-division/woman-infants/vaginal-mesh-implants/vaginal-mesh-implants.html.
Question No. 176 answered with Question No. 158.