This is not a ‘ban’ but rather a ‘pause’
On the 24th July 2018, The Minister for Health Simon Harris TD announced that his Department’s Chief Medical Officer (CMO) 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). The pause applies to HSE funded hospitals and to cases where it is clinically appropriate and safe to do so.
What are transvaginal mesh implant devices?
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.
What about the regulation and certification of mesh implants?
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. At the same time, the Health Products Regulatory Authority (HPRA) has said it welcomes the proposed pause and is supportive of the measures recommended being introduced in a timely and effective manner.