John Brassil (Kerry, Fianna Fail)
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428. To ask the Minister for Health if he is satisfied the necessary provisions are available here, including doctors who have undergone specialist training, to allow full removal for all women affected by transvaginal mesh complications within a reasonable timeframe; when the chief medical officer's report will be available; if he will consider making the treatment abroad scheme available for this treatment; and if he will make a statement on the matter. [49300/18]

Simon Harris (Wicklow, Fine Gael)
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In late 2017, concerns were brought to my attention about the frequency and severity of complications associated with the use of mesh devices in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women in Ireland; the regulation and audit of their use; the extent of use of these devices in Ireland and the availability of services for women affected by mesh-associated complications, including through the tabling of several Parliamentary Questions.

In responding to these questions and in recognition of the complexity of the matters arising, I requested the Chief Medical Officer (CMO) to prepare a report for me on the clinical and technical issues involved in ensuring both:

a) the safe and effective provision of mesh procedures in urogynaecology and

b) an appropriate response to women who suffer complications as a result of undergoing such procedures.

The Report, entitledThe Use of Uro-gynaecological Mesh in Surgical Procedures, has now been presented to me and was published on the 21 November 2018 on the Department of Health website.

The report provides a brief background description of mesh implant devices, including the complications associated with their use; and summarises international best practice in the use of mesh procedures in the clinical management of SUI and POP. A range of recommendations for action by the HSE in collaboration with other stakeholders is identified, to provide assurance that the use of mesh implants and the care of women requiring aftercare in Irish hospitals is in line with emerging evidence and best practice internationally, based on expert advice received and review of international experience.

Methodology

Preparation of the report has involved consultation and engagement with national and international bodies, including the Health Products Regulatory Agency (HPRA); the relevant professional training bodies, the Institute of Obstetricians and Gynaecology (IOG) and the Royal College of Surgeons in Ireland (RCSI); the Continence Foundation of Ireland (CFI) and the Health Service Executive (HSE), as well as colleagues in other jurisdictions. The report has been informed by review of international reports and safety reviews of mesh surgery which have been published in recent years. The report has also been informed by the personal experiences of women who have suffered complications following mesh surgery.

I wish to acknowledge the bravery, commitment and dignity shown, by the women that met with me and by those women who have written to me concerning this issue, in sharing what were harrowing, deeply personal experiences.

It is important to note that the views of the many women who have undergone mesh procedures and have had satisfactory outcomes, with minor or no complications, have not been formally sought and so are not reflected in this report. Also, following the implementation of a pause in mesh procedures by the HSE in July 2018, as described in Section 2, a number of women whose procedures were postponed made representations to the Department expressing concern at the impact that this has on them personally as they await treatment for the distressing symptoms of SUI, reflecting another important group of women affected directly by this issue.

Report Findings

The report makes a number of overall findings, in addition findings are presented which relate to informed consent, aftercare of women with complications, clinical and professional issues and information issues. The findings are:

Overall Findings

- Mesh implant devices are certified as compliant with relevant European Union (EU) legislation and no market action against mesh devices for the treatment of SUI or POP has been taken by any of the European device regulatory competent authorities.

- There is an extensive evidence base supporting (i) the use of the mid-urethral sling (MUS) devices in the treatment of SUI and (ii) the use of abdominally placed mesh in the management of POP. A significant majority of patients benefit greatly from these procedures, with reduced long-term complications and improved functional outcomes compared to non-mesh procedures.

- Mesh procedures should be performed by trained personnel, in patients who are appropriately selected and counselled and when appropriate multidisciplinary expertise and clinical governance mechanisms are in place.

- Transvaginal placement of mesh for the treatment of POP is no longer regarded as appropriate first line treatment. Its use is restricted by clinical guidance in some jurisdictions. Regulatory restrictions on its use are in place in Australia and New Zealand.

- Mesh devices are associated with significant and severe complications in a minority of women, which are of concern given the difficulties of mesh implant removal.

- Many other health systems, including the United Kingdom (UK), Australia and the Netherlands have implemented specific measures in recent years to ensure appropriate use of mesh procedures in the treatment of SUI and POP and to ensure appropriate aftercare for women suffering mesh complications.

Informed Consent

- As would be usual with many surgical conditions, standardised information resources were not available at national level to ensure that all patients receive consistent information about the benefits and risks of mesh devices, to advise of other treatment options and to support informed consent processes.

- Many women reported that they were not informed of other treatment options; they had not been informed that their surgeries involved the use of mesh; they were not informed of mesh complications; and they were not made aware of the difficulties associated with mesh removal or with the treatment of long-term mesh complications.

Aftercare of Women with Complications

- Structured treatment or referral pathways were not evidently in place for the minority of women requiring specialist, multidisciplinary care for serious complications following mesh surgery.

- Some women reported considerable difficulty in accessing timely, compassionate and appropriate specialist aftercare for complications.

- Some women reported that individual clinicians responded to their personal concerns in an inappropriate manner which greatly added to their distress. Women also reported feeling that they were not believed, or that their clinicians minimised or did not understand the severity of their complications.

Clinical and Professional Issues

- Governance mechanisms are not in place at national level to provide assurance that mesh surgeries are carried out in accordance with agreed international best practice and clinical guidance.

- There is no mandated professional clinical guidance at national level to guide the use of mesh implants in the management of SUI or POP or to guide the management of women with complications.

- Communication mechanisms currently in place at national level between the HPRA, healthcare providers and professional bodies do not provide assurance that the findings and recommendations of safety reviews such as those circulated by the HPRA in recent years regarding mesh implants are systematically analysed and acted upon where appropriate.

Information

- There are significant gaps in knowledge about current practice in Ireland regarding the use of urogynaecological mesh implants.

- Routinely collected clinical information at national level does not provide the capacity for monitoring or audit of mesh surgeries for the treatment of SUI and POP.

- Based on international experience, there is under-reporting of adverse events relating to mesh surgeries by clinicians to both the HPRA and to the National Incident Management System (NIMS) operated by the State Claims Agency (SCA).

Recommendations

Nineteen recommendations in total are identified throughout the report in response to the findings above:

- Patient Information and Consent - 2 recommendations;

- Aftercare for Women Suffering Complications - 5 recommendations;

- Clinical and Professional Recommendations - 8 recommendations;

- Information Recommendations - 5 recommendations.

These include recommendations about the development of patient information and informed consent materials to ensure appropriate patient selection and counselling, ensuring clinical and professional standards of practice are met by ensuring that all surgeons have undergone appropriate surgical professional training and ensuring that appropriate multidisciplinary expertise is available in units carrying out mesh procedures, the development of clinical guidance for the management of SUI and POP, the development of information resources to monitor the ongoing use of mesh devices and to permit long-term research and audit of practice, ensuring the reporting of mesh related complications, and ensuring timely, appropriate and accessible care pathways for the management of women with complications.

Full implementation of the report’s recommendations will provide significant assurance that all patients presenting for treatment for SUI and POP and all women who develop mesh-related complications receive high quality, patient centred care in accordance with accepted evidence and supported by robust clinical governance mechanisms.

Actions to date

A number of important interim system actions to address the safety and effectiveness of mesh implant use have been progressed in advance of completion of the report.

1. Pause on all uro-gynaecological mesh procedures

On 24 July 2018, the HSE was requested by the CMO to pause all uro-gynaecological mesh procedures, in cases where it is clinically appropriate and safe to do so, pending confirmation by the HSE of the implementation of recommendations relating to (i) professional training requirements, (ii) patient information and consent and (iii) the development and maintenance of a national data set for all mesh procedures carried out in HSE funded hospitals. The request to institute a pause in vaginal mesh procedures was considered proportionate and necessary to address public and patient concern about the ongoing safety of mesh devices as comprehensively as possible.

2. Development of patient information and consent materials

Prior to this request, in May 2018, the HSE had been requested to begin work immediately on the development of national standardised patient information and informed consent materials and the clarification and development of treatment pathways and appropriate referral services for women suffering serious complications.

3. Learning Notice on mesh devices

A Learning Notice concerning mesh devices in uro-gynaecological procedures was circulated by the National Women and Infants’ Health Programme (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.

3. Synthetic Mesh Devices Group

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 progress all the interim recommendations as advised to the HSE in May 2018 and in July 2018. To ensure that the spectrum of views of women affected by mesh safety concerns is represented, the three patient representatives include Ms Melanie Power, representative of Mesh Survivors Ireland; as well as a woman who has had a successful outcome of mesh surgery for the treatment of SUI and a woman who is on the waiting list for surgery (currently paused).

I am informed that a work programme for the development of appropriate patient information resources and consent materials, the clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications including access to specialist diagnostic facilities such as translabial scanning is being progressed through this Group. The work being progressed by the HSE will include identifying the appropriate specialist clinical expertise and facilities required at hospital group level and nationally to provide comprehensive aftercare services. Pending the completion of this, the HSE will also examine the need to look at sourcing services from abroad to address any immediate shortfalls identified, either through utilisation of the treatment abroad scheme or by commissioning services from abroad.

Next Steps

As requested by the CMO in July 2018, the pause in the use of mesh procedures for the management of SUI and POP in HSE-funded hospitals is ongoing, in cases where it is clinically appropriate and safe to do so, pending confirmation by the HSE of the implementation of recommendations.

The Department will be writing to the HSE to request that it prepare a detailed Implementation Plan for the complete set of recommendations set out in the CMO’s Report, working in conjunction with other stakeholders.

As promised at my meeting with Mesh Survivors Ireland on 14 June 2018, I provided the group with a copy of the CMO’s Report on the date of publication and a date has been arranged for a further meeting with the group in coming weeks.