The Minister for Health, Simon Harris TD, has announced today (Tuesday 24th July 2018) that the department’s Chief Medical Officer (CMO) has requested the Health Service Executive (HSE) to pause the use of all procedures involving transvaginal mesh devices 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. This announcement follows a review by the Department of Health together with the HSE and the Health Products Regulatory Agency (HPRA), of the decision by health authorities in England and Northern Ireland to pause the use of mesh in those countries on the recommendation of the Independent Medicines and Medical Devices Safety Review (IMMDS) until a set of conditions to mitigate the risks of injury are met.
Minister Harris said:
There is no concurrent change in the evidence base concerning these devices. It is widely accepted that for many women suffering the distressing symptoms of SUI in particular, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures. The recommendations of the IMMDS to NHS England arose because of a lack of certainty or confidence that critical clinical governance measures to assure the safety of mesh procedures are demonstrably in place. The department considers that similar concerns in relation to the visibility and consistency of such measures apply equally in the public health system here.
This pause should remain in place until the HSE confirms implementation of recommendations relating to (i) Surgical Training, (ii) Informed Consent and (iii) the Development of an agreed Dataset of Mesh Procedures. The department has also written to the Institute of Obstetricians and Gynaecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland requesting that they assist the HSE in progressing these recommendations on an urgent basis.
Patients affected by the cancellation will be contacted by the HSE as soon as possible to advise them that their surgery has been postponed. The duration of their cancellation will be related to the duration of the pause and every effort will be made to keep this to a minimum. Patients with concerns are advised in the first instance to contact their Consultant’s clinic.
Transvaginal mesh implant devices (TVMIs) have been widely used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women over the past two decades. It is widely accepted that for many women suffering these distressing conditions, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures. However, controversy about mesh devices has arisen owing to concerns about the frequency and severity of complications associated with their use in some women.
The regulatory status of uro-gynaecological mesh implants at a European level remains unchanged in that they are CE marked medical devices. As such, the benefit-risk profile for the devices is considered positive. Ensuring that the use of transvaginal mesh is appropriate and as safe as possible requires, not only that the device is safe and performs as intended, but also that the healthcare system has appropriate measures for patient selection, treatment and follow-up. The HPRA welcomes the proposed pause and is supportive of the measures recommended being introduced in a timely and effective manner.
The HPRA remains fully committed to ensuring that from a regulatory perspective the status of these medical devices is appropriate and is prioritising a review of all aspects of these devices. The outcome of this review will establish whether there are grounds for future regulatory action in relation to the use and/or status of these medical devices.
The Minister for Health is committed to putting in place the measures necessary to ensure that both the current use of 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 the request of the Minister, the CMO is preparing a report for him on the clinical and technical issues involved.
In light of the recent policy developments in the NHS and in Northern Ireland, further engagements with stakeholders and with colleagues in other jurisdictions will be needed to review these developments and their implications for practice here before the report is finalised. Engagement is ongoing with the HSE, the Health Products Regulatory Agency and the professional bodies for the purpose of completing the report to the Minister and in progression of the two Priority Recommendations signalled to the Executive in May, as described below. It is now anticipated that the Report to the Minister will be completed by late August or early September.
In advance of finalisation of the report by the CMO, two priority recommendations have already been identified for immediate advancement. These are (i) the development of appropriate patient information resources and consent materials and (ii) the clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications.
The HSE has confirmed that work has commenced by the National Women and Infants Health Programme (NWIHP) in the HSE to progress these recommendations, and the experiences of the women concerned will be an essential element to informing the assessment of need and identifying the aftercare services required. This work will include identifying the appropriate specialist clinical expertise and facilities required at hospital group level and nationally to provide comprehensive aftercare services. It will also include an examination of the role of and requirement for specialist diagnostic services such as translabial scanning.
A Learning Notice concerning mesh devices in uro-gynaecological procedures was circulated by the NWIHP on 26th 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 to address the provision of aftercare for complications. This learning notice has been posted on the NWIHP website.
The decision on Tuesday 10th July to institute a pause in vaginal mesh procedures in NHS England followed a recommendation by the Independent Medicines and Medical Devices Safety (IMMDS) Review established in February 2018 by the Secretary of State for Health and Social Care, the Rt. Hon Jeremy Hunt MP. On Wednesday July 11th, a similar pause was instigated by health authorities in Northern Ireland. It is not a blanket ban of the relevant procedures, and it is anticipated that there will need to be some exceptions within the pause, within a high vigilance programme of restricted practice. For some patients, mesh procedures may be the only viable treatment option for a debilitating condition.
It is reported that the high vigilance restriction in the NHS will remain in place until conditions concerning surgical training, reporting and registration of procedures, reporting of complications, identification of specialist centres for mesh surgery and publication of guidelines are met (estimated date March 2019).