As Minister for Health I am committed to putting in place the measures necessary to ensure that both the current use of Transvaginal mesh implants (TVMIs) in surgical procedures in Ireland, and the ongoing clinical management of women who have had these procedures in the past are in line with international best practice and emerging evidence. At my request, the Chief Medical Officer (CMO) is preparing a report which will make recommendations in relation to the clinical and technical issues involved. I am informed that the CMO’s Report is close to finalisation with an anticipated publication date in the first two weeks of November.
Pending finalisation of the CMO's report, a number of significant system actions in relation to mesh implants have already been advanced on foot of priority recommendations which were identified in the course of preparation of that report.
The CMO wrote to the Acting Director General of the Health Service Executive on 20 July 2018 to request that the Executive put immediate measures in place to:
1. Pause the use of all procedures involving uro-gynaecological/transvaginal mesh implants for the management of Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP) in HSE funded hospitals, in cases where it is clinically appropriate and safe to do so.
2. Ensure that in situations where expert clinical judgment is that there is an urgency to carry out the procedure and no suitable alternative exists, surgery should proceed only if a delay would risk harm to the patient and should be based on multidisciplinary team decision and fully informed consent.
This pause is to remain in place pending confirmation of implementation by the Health Service Executive, working in conjunction with the Institute of Obstetricians and Gynaecologists (IOG) and the Royal College of Surgeons in Ireland (RCSI), of three urgent recommendations relating to:
(i) Surgical Training,
(ii) Informed Consent and
(iii) the Development of an agreed Dataset of Mesh Procedures.
The Department also wrote to the Institute of Obstetricians and Gynaecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland on requesting that they assist the HSE in progressing these recommendations on an urgent basis.
It is anticipated that the Executive will be in a position to indicate to the Department that these recommendations have been implemented within a number of months. The HSE has published information concerning the pause on its website for patients affected.
The provision of appropriate aftercare for women suffering from mesh complications, including appropriate diagnostic facilities, has also been identified as a priority recommendation for immediate advancement by the Executive in the course of preparation of the CMO’s report. The CMO wrote to the Acting Director General of the HSE, and to the Institute of Obstetricians and Gynaecologists (IOG), the Royal College of Surgeons in Ireland (RCSI), and the Continence Foundation of Ireland (CFI) on May 28 2018, requesting that the Executive commence work on (i) the development of appropriate patient information resources and consent materials and (ii) clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications, in conjunction with the IOG, the RCSI and the CFI.
The HSE has confirmed that work has commenced by the National Women and Infants Health Programme (NWIHP) in the HSE to progress all the recommendations above. A Learning Notice concerning mesh devices in uro-gynaecological procedures was circulated by the NWIHP on 26 June 2018 to all maternity hospitals and acute hospitals with gynaecological services to highlight the importance of appropriate patient selection, adequate information and consent and also to inform the service providers that a Response Group has been convened to propose remedies for and address the provision of aftercare for complications. This learning notice has been posted on the NWIHP website.
The HSE has informed the Department of Health that a Synthetic Mesh Devices Advisory Group has been convened by the NWIHP which includes three patient representatives, as well as representatives of the HPRA, the IOG, the RCSI, the CFI and all Hospital Groups to advise on and action all of the recommendations above.
The HSE advice is that all patients who have experienced complications due to mesh devices are advised to contact their consultant’s clinic in the first instance. Each hospital group has nominated an individual to coordinate a response to this group of patients. If patients are having trouble accessing information they can contact the National Women & Infants Health Programme at firstname.lastname@example.org. for help.