Clare Daly (Dublin Fingal, Independent)
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346. To ask the Minister for Health his plans to institute a ban on the use of transvaginal mesh in view of the permanent and debilitating side effects of same and in further view of full or partial bans in the UK, New Zealand and Australia. [4879/18]

Clare Daly (Dublin Fingal, Independent)
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347. To ask the Minister for Health his plans to launch a public awareness campaign in regard to the severe and lifelong side effects of transvaginal mesh in some cases and in view of the fact that many women suffering such side effects have been disbelieved or ignored over many years (details supplied). [4881/18]

Clare Daly (Dublin Fingal, Independent)
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348. To ask the Minister for Health if his attention has been drawn to the findings of the PROSPECT study which concluded that transvaginal mesh is of no benefit in pelvic organ prolapse repair; and if he will make a statement on the matter. [4882/18]

Catherine Connolly (Galway West, Independent)
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441. To ask the Minister for Health further to Parliamentary Question Nos. 165 to 167, inclusive, of 23 November 2017, if consideration has been given to the suspension of the use of transvaginal mesh while the report of the Chief Medial Officer is awaiting completion; and if he will make a statement on the matter. [4404/18]

Catherine Connolly (Galway West, Independent)
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442. To ask the Minister for Health further to parliamentary questions numbers 165, 166 and 167 of 23 November, 2017, when the report of the Chief Medical Officer in relation to transvaginal mesh implants will be available; and if he will make a statement on the matter. [4405/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 346 to 348, inclusive, 441 and 442 together.

As Minister for Health, I want to ensure that both the current use of mesh implants in urogynaecological procedures in Ireland, and the on-going 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 is preparing a report on the many clinical and technical issues involved.

This work involves engagement with national and international bodies, the professional colleges and others. This work is underway and will take a number of months to complete.

The advice from the Health Products Regulatory Authority (HPRA) continues to be that it is not aware of scientific evidence which concludes these devices are unsafe when used in line with their intended use. The Health Products Regulatory Authority (HPRA) continues to liaise closely with European Competent Authorities, the European Commission and with International regulatory agencies in relation to the international evidence relating to these devices. To date, no regulatory action has been taken by Competent Authorities in any European country in respect of the use of transvaginal mesh.

The safety of surgical meshes used in urogynecological surgery has been reviewed in Europe by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). SCENIHR was requested to provide a scientific opinion on the safety of surgical meshes used in contemporary pelvic surgery. The Opinion of the SCENIHR was approved in December 2015 and is available, together with a summary of the outcome, on the website of the European Commission

.

SCENIHR states that ‘synthetic sling SUI surgery is an accepted procedure with proven efficacy and safety in the majority of patients with moderate to severe SUI, when used by an experienced and appropriately trained surgeon. Therefore, the SCENIHR supports continuing synthetic sling use for SUI, but emphasises the importance of appropriately trained surgeons and detailed counselling of patients about the associated risk/benefits’. SCENIHR also highlights that “the implantation of any mesh for the treatment of POP via the vaginal route should only be considered in complex cases, in particular, after failed primary repair surgery”.

The Department strongly advises that any woman who experiences or suspects that she has experienced a complication associated with TVMI surgery should discuss this with her GP or with the hospital from which she received the implant. The Department also advises that women considering surgery involving TVMIs should thoroughly discuss with their doctors the indications, alternatives (surgical and non-surgical), benefits and risks involved in their personal circumstances.

Timmy Dooley (Clare, Fianna Fail)
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349. To ask the Minister for Health when a person (details supplied) will have additional surgery carried out; and if he will make a statement on the matter. [3932/18]

Simon Harris (Wicklow, Fine Gael)
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Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, A standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014,has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.