Seanad debates

Tuesday, 4 December 2018

2:30 pm

Photo of Jennifer Murnane O'ConnorJennifer Murnane O'Connor (Fianna Fail)
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I thank the Minister of State for coming to the House at a very busy time. I appreciate the time he is giving me today for this important issue. I have been contacted by a number of my constituents regarding uro-gynaecological transvaginal mesh implants for the management of stress urinary incontinence or pelvic organ prolapse and the many and often severe complications following these procedures. My understanding was that the Chief Medical Officer was to prepare a report which was expected to make recommendations in respect of the clinical and technical issues involved. I am informed that this report had an anticipated publication time of the first two weeks in November, yet we are currently in December.

While we awaited this report, a number of significant system actions on mesh implants were advanced on foot of priority recommendations identified during the course of the preparation of that report. I am aware of this and welcome the swift action in this matter. I understand all procedures in HSE-funded hospitals involving mesh implants for the management of stress urinary incontinence, a common condition in women following childbirth or at menopause, or of pelvic organ prolapse, where a pelvic organ moves out of place, have been suspended in cases where it is clinically appropriate and safe to do so.

There was also a recommendation to ensure that in situations where expert clinical judgment was such that there was an urgency to carry out the procedure and no suitable alternative existed, surgery should have proceeded only if a delay would risk harm to the patient and should be based on multidisciplinary team decisions and fully informed consent.

I would like clarification that the suspension of these procedures has actually taken place pending publication of the report, and that no woman is enduring this procedure unless there is an identified risk associated with not carrying it out. The pause in this procedure was to remain in place pending confirmation of implementation by the HSE, working in conjunction with the Institute of Obstetricians and Gynaecologists and the Royal College of Surgeons in Ireland, of three urgent recommendations in respect of surgical training, informed consent and development of an agreed dataset of mesh procedures. The HSE has published information concerning the pause on its website for patients affected. This is no doubt due to pressure applied by the Department and must be welcomed. When this procedure was introduced in the early 2000s, clinical trials found efficacy and low complication rates for mesh implants used for incontinence. However, there soon grew to be a body of evidence indicating that efficacy was lower and complication rates higher in cases of pelvic organ prolapse. In 2012, the mesh was reclassified as high risk, and the United Kingdom has banned this procedure.

I would like to know what we in Ireland are doing for these women. Their lives were changed utterly and they have felt forgotten and left in pain. The preliminary recommendations of the report identify as urgent the provision of appropriate aftercare for women suffering from mesh complications including appropriate diagnosis facilities. Can the Minister of State clarify whether these provisions have been put in place? A learning notice concerning mesh devices in uro-gynaecological procedures was circulated on 26 June 2018 to all maternity hospitals and acute hospitals with gynaecological services to highlight the importance of appropriate patient selection. Under adequate information and consent, it was also recommended to inform service providers that a response group has been arranged to propose remedies for and address the provision of aftercare for complications.This is also available online. I am concerned, however, that this information has not been made widely available and without discrimination to all women who may be affected. The HSE advises that all patients who have experienced complications due to mesh devices should contact their consultant's clinic in the first instance. This advice is not getting to women. Women have contacted my office and I have sent them to their own doctors. Each hospital group was to have nominated an individual to co-ordinate a response to this group of patients. Can the Minister of State confirm if this has happened? Will there be greater awareness made of any recommendations made, and the steps being taken for aftercare and the future patients? This is such a serious issue. I have had women coming into my clinics, crying, who are in a very bad situation. I hope the Minister of State has good news for me on this. It is unacceptable.

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent)
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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.

Photo of Jennifer Murnane O'ConnorJennifer Murnane O'Connor (Fianna Fail)
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The Minister of State is aware of the seriousness of this issue. The people I have been dealing with have been trying to go England because the mesh itself cannot be taken out in full, once one has it. That is a concern. Evidently, part of the mesh can be taken out. This is a crucial issue and I ask the Minister of State to convey to the Minister for Health that this cannot happen to anybody else, in particular given the way people have been affected by this. Their whole lives have changed. This is an important issue. I have seen the 19 recommendations and I will return to this issue. I hope this can be sorted and that no one else will be left in the situation of some of the people I have dealt with over the last few months.

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent)
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I take the Senator's point. The Minister for Health is committed to ensuring the safe and effective use of mesh implants and an appropriately and a timely response to women suffering mesh complications. Last week the Department wrote to the HSE again 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. On another level, the Minister intends to meet with the Mesh Survivors Ireland group in the coming weeks to discuss the report. I will certainly convey the Senator's genuine concerns to the Minister, Deputy Harris.