Dr Tony Holohan, Chief Medical Officer, has published his report on the clinical and technical issues associated with the use of Uro-Gynaecological Mesh (also referred to as Transvaginal Mesh Implants (TVMIs)).
Dr Holohan prepared the 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.