Written answers

Friday, 7 September 2018

Photo of Seán HaugheySeán Haughey (Dublin Bay North, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

662. To ask the Minister for Health if a ban on the use of mesh for prolapse and urinary incontinence will be considered in view of the severe difficulties it has caused many women; and if he will make a statement on the matter. [35741/18]

Photo of Seán HaugheySeán Haughey (Dublin Bay North, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

708. To ask the Minister for Health his plans to ensure that medical facilities for the removal of transvaginal mesh are put in place here, including the appointment of surgeons; and if he will make a statement on the matter. [35855/18]

Photo of Seán FlemingSeán Fleming (Laois, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

859. To ask the Minister for Health his views in regard to the mesh implant that many women have used for prolapsed bladder; if he is satisfied with its continued use here; and if he will make a statement on the matter. [36428/18]

Photo of Seán HaugheySeán Haughey (Dublin Bay North, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

861. To ask the Minister for Health if the necessary arrangements will be made to allow a person (details supplied) to carry out full removal operations in a hospital here for a six-week period in January and February 2019; if his attention has been drawn to the fact that the treatment abroad scheme and the EU Cross-Border Healthcare Directive are not available to women requiring such full removal surgery; and if he will make a statement on the matter. [36430/18]

Photo of John CurranJohn Curran (Dublin Mid West, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

908. To ask the Minister for Health if a full audit by hospital of all transvaginal mesh implants will be arranged; if so, if the audit will include details of all known defective devices; and if he will make a statement on the matter. [36625/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 662, 708, 859, 861 and 908 together.

As Minister for Health I am committed to putting in place the measures necessary to ensure that both the current use of Transvaginal mesh implants (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 my request, the Chief Medical Officer (CMO) is preparing a report which will make recommendations in relation to the clinical and technical issues involved. I am informed that following policy actions in relation to mesh by health authorities in the NHS and in Northern Ireland in July 2018, as set out below, further engagements with the HSE, the Health Products Regulatory Agency, the professional bodies and colleagues in other jurisdictions were needed for the purpose of finalising the report. I am informed that the CMO’s Report is anticipated to be completed in the coming weeks.

Pending finalisation of the report, a number of significant system actions in relation to mesh implants have already been advanced.

The CMO wrote to the Acting Director General of the Health Service Executive on 20 July 2018 to request that the Executive put immediate measures in place to:

  1. Pause the use of all procedures involving uro-gynaecological/transvaginal mesh implants 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.
  2. Ensure that in situations where expert clinical judgment is that there is an urgency to carry out the procedure and no suitable alternative exists, surgery should proceed only if a delay would risk harm to the patient and should be based on multidisciplinary team decision and fully informed consent.
This pause is to remain in place pending confirmation of implementation by the Health Service Executive, working in conjunction with the Institute of Obstetricians and Gynaecologists (IOG) and the Royal College of Surgeons in Ireland (RCSI), of three urgent recommendations relating to:

(i)Surgical Training,

(ii) Informed Consent and

(iii) the Development of an agreed Dataset of Mesh Procedures.

The Department also wrote to the Institute of Obstetricians and Gynaecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland on requesting that they assist the HSE in progressing these recommendations on an urgent basis.

The HSE has published information for patients on its website concerning the pause.

It is acknowledged that there may be concerns that restricting the availability of mesh procedures, particularly SUI mesh procedures, which are widely accepted to be less invasive and more effective than non-mesh alternatives will delay access to treatment procedures for distressing symptoms. Advice received in relation to this is that uro-gynaecological mesh procedures are largely elective procedures and it is not anticipated that a postponement of weeks / months will materially affect health outcomes for the majority of women affected. Given the limited number of surgeons and units carrying out these procedures in HSE funded hospitals, it is anticipated that the Executive will be in a position to indicate to the Department that these recommendations have been implemented within a number of months.

The decision to institute a pause in vaginal mesh procedures in HSE funded hospitals followed a review by Department officials, together with representatives of the HSE and the Health Products Regulatory Authority (HPRA), of the NHS England decision of Tuesday 10 July to institute a similar ‘pause’ in their use. This decision in the NHS 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 11, a pause was instigated by health authorities in Northern Ireland.

It has been clarified by the NHS that there is no concurrent change in the evidence base concerning these devices. 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.

There is understandable public and patient anxiety about the ongoing safety of mesh devices in light of 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 recommendations as set out above have been implemented, is considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.

The advice of the HPRA to the Department is that it is supports a temporary restriction on all procedures involving uro-gynaecological/transvaginal mesh implants, pending the introduction of the further clinical mechanisms proposed relating to the delivery of care for patients. 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 in place.

In relation to the provision of appropriate aftercare for women suffering from mesh complications, including appropriate diagnostic facilities, this has already been identified as one of two priority recommendations for immediate advancement by the Executive in the course of preparation of the CMO’s report. The CMO wrote to the Acting Director General of the HSE, and to the Institute of Obstetricians and Gynaecologists (IOG), the Royal College of Surgeons in Ireland (RCSI), and the Continence Foundation of Ireland (CFI) on May 28 2018, requesting that the Executive commence work on (i) the development of appropriate patient information resources and consent materials and (ii) clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications, in conjunction with the IOG, the RCSI and the CFI.

The HSE has confirmed that work has commenced by the National Women and Infants Health Programme (NWIHP) in the HSE to progress all of the recommendations above. A Learning Notice concerning mesh devices in uro-gynaecological procedures was circulated by the NWIHP on 26 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 address the provision of aftercare for complications. This learning notice has been posted on the NWIHP website.

The experiences of women concerned will be an essential element to informing the assessment of need and identifying the aftercare services required. I am informed that a Synthetic Mesh Devices Advisory Group has been convened by the NWIHP which includes three patient representatives, as well as representatives of the HPRA, the IOG, the RCSI, the CFI and all Hospital Groups to advise on and action all of the recommendations.

This work is ongoing and 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. The outcome of this work will clarify if there is a need to look at sourcing services from abroad to address any shortfalls identified at national level, either through utilisation of the treatment abroad scheme or by commissioning services from abroad.

The HSE advice is that all patients who have experienced complications due to mesh devices are advised to contact their consultant’s clinic in the first instance. Each hospital group has nominated an individual to coordinate a response to this group of patients. If patients are having trouble accessing information they can contact the National Women & Infants Health Programme at smi.nwihp@hse.ie for help.

For all patients wishing to access services abroad there are two potential schemes which may be available to patients, namely the Treatment Abroad Scheme and the Cross-Border Directive. Details of the qualifying criteria for both schemes may be found on the HSE website - details below.

It is important to note that both schemes are only applicable for patients accessing care via the public patient pathway. Referrals of private patients or from private hospital consultants are not eligible for consideration under TAS for example, nor can an outpatient appointment in a private capacity be accepted for the purposes of access healthcare under the Cross-Border Directive, however, for the purposes of the Cross-Border Directive, a GP may refer a patient for an out-patient appointment abroad.

It is open to private patients to apply their private health insurance provider in relation to accessing funding towards the cost of treatment abroad. However, if this request for assistance is declined a patient can seek to access treatment through either of the above schemes if they follow the public patient pathway.

Details of both the TAS and CBD can be accessed on the HSE’s website or by contacting the office on 056 778 4551.

Comments

No comments

Log in or join to post a public comment.