The Minister for Health Simon Harris TD has announced that the Department’s Chief Medical Officer (CMO) Dr. Tom O’Connell 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 understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS.
“It is important that this be addressed as comprehensively as possible. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.”
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 has welcomed the proposed pause and is supportive of the measures recommended being introduced in a timely and effective manner.