This is not a ‘ban’ but rather a ‘pause’

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  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.

The health authorities in England and Northern Ireland decision prior to this to pause the use of mesh in those countries and so the announcement in Ireland came after the Department of Health, the HSE and the Health Products Regulatory Agency (HPRA) considered this move by them.

It is important to note that this is not a ‘ban’ but rather a ‘pause’ which was driven by the understandable public and patient anxiety about the ongoing safety of mesh devices. There are a number of key recommendations that the HSE has confirmed implementation of, namely (i) Surgical Training, (ii) Informed Consent and (iii) the Development of an agreed Dataset of Mesh Procedures. The pause will remain on the mesh procedures until such time as the Executive is satisfied that these recommendations have in fact been implemented. At the same time, the Minister wishes to provide public assurance that the mesh procedures are being carried out in accordance with internationally accepted good practice.

While this ‘pause’ has been put in place, there has been no change in the evidence gathered about the devices themselves. The government, in its press release on 24 July 2018 said that it is widely accepted that for many women suffering the distressing symptoms of stress urinary incontinence, surgery using synthetic mesh devices has proved more effective and less invasive than traditional surgical procedures. The government instead pointed out that the similar recommendations that were issued in England came about because of a lack of certainty or confidence that critical clinical governance measures to assure the safety of mesh procedures were clearly in place. The Department of Health considered that similar concerns in relation to the visibility and consistency of such measures apply equally in the public health system in Ireland.

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.

For further information regarding vaginal mesh implants and how you can seek advice if you have been affected by this procedure, please refer to our page about Vaginal Mesh Implants.

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RELEVANT LINKS

• Press Release – Department of Health
• The Journal – 24/07/2018 – Ireland to pause use of transvaginal mesh after ‘understandable public anxiety’