Minister for Health Simon Harris TD has today published the report from Dr Tony Holohan, Chief Medical Officer, on the clinical and technical issues associated with the use of Uro-Gynaecological Mesh (also referred to as Transvaginal Mesh Implants (TVMIs)).
Minister Harris had asked Dr Holohan to prepare a report in response to a number of concerns raised about the frequency and severity of complications associated with the use of TVMIs in some women. TVMIs have been widely used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. It is widely accepted that for many women suffering the distressing symptoms of SUI in particular, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures. However, 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.
A key conclusion of the report is that there is an evidence base to support (i) the use of mid-urethral sling (MUS) mesh devices in the treatment of SUI and (ii) the use of abdominally placed mesh in the management of POP.
The report states all TVMIs should only be offered following assessment and after detailed discussion with the patient about the associated risks and benefits and alternative treatment options.
The report also concludes that the use of TVMIs for the treatment of POP specifically is no longer regarded as appropriate first line treatment internationally and recommends that the HSE develop protocols to ensure its use is restricted to the management of complex POP cases, where other treatment options have failed or are not appropriate, and where patients are fully informed.
The Report makes 19 recommendations in all, including the necessity to develop patient information and informed consent materials; surgical professional training and multi-disciplinary expertise in units carrying out mesh procedures, and ensuring timely, appropriate and accessible care pathways for the management of women with complications.
A significant number of these recommendations are already underway by the HSE.
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 Report, working in conjunction with other stakeholders.
The HSE was also asked by the Chief Medical Officer on 24th July to pause all mesh procedures where clinically safe to do so. That pause remains in place until a number of key recommendations are implemented.
Minister Harris said: “The bravery, commitment and dignity shown by these women in sharing what were harrowing, deeply personal experiences are acknowledged and appreciated. The telling of their stories makes public what heretofore was often a private suffering.
“Their stories and their courage caused me to act and I want to thank the Chief Medical Officer for his work in addressing the understandable public and patient anxiety about this issue.
“A pause remains on the use of mesh procedures, pending confirmation by the Health Service Executive that the key recommendations have been implemented. I have already committed to meeting again with Mesh Survivors Ireland to discuss the report and I look forward to doing that in the coming weeks.”
Notes to the Editor
Synthetic mesh devices 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. For many women suffering the distressing symptoms of SUI and POP, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional surgical procedures. However, controversy about the safety of mesh devices has arisen in many countries because of concerns about the frequency and severity of complications associated with their use.
In late 2017, concerns arose about the frequency and severity of complications associated with the use of mesh devices in the surgical treatment of SUI and 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 to the Minister for Health.
In responding to these questions and in recognition of the complexity of the matters arising, the Minister requested the Chief Medical Officer (CMO) to prepare a report for him 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 full report is available to download from the Department of Health website.
The HSE have a dedicated webpage which is available here.
The HPRA have a dedicated webpage which is available here.