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
http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_27_en.
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.