Jennifer Murnane O'Connor (Fianna Fail) | Oireachtas source

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.