I propose to take Questions Nos. 306 and 454 together.
I am aware of the safety concerns that have been raised surrounding the use of Transvaginal mesh procedures. As Minister for Health, I want to ensure that both the current use of mesh implants in uro-gynaecological 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, including the issues raised at Leader’s Questions and in previous Parliamentary Questions on this topic. I am informed that 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 and I would ask the Deputy to await the outcome of that work.
I would have no objection to meeting with women affected and their representatives once this report to me is completed.
The Health Products Regulatory Authority (HPRA) advises that they are not aware of scientific evidence which concludes these devices are unsafe when used in line with their intended use. The 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. No regulatory action has been taken to date by Competent Authorities in any European country in respect of these devices.
The HPRA has also consulted with a number of clinical experts in this field. The advice of Dr. Suzanne O’Sullivan, President Continence Foundation of Ireland (www.continence.ie) and Consultant Obstetrician and Urogynaecologist in Cork University Maternity Hospital is that “The MUS [mid-urethral sling] has become the operation of choice in Europe, Asia, North and South America and Australasia for treatment of stress urinary incontinence with several million procedures performed worldwide. Whilst each patient differs in terms of symptoms, background medical history, optimal treatment approaches may differ. Relative to other procedures mid urethral slings have been shown, in large studies from all over the world, to be no less safe (and usually more safe) than other procedures and with improved short, medium and longterm outcomes. These mesh slings have major advantages of shorter operating and admission times, and a quicker return to normal activities together with lower rates of complications”.
The safety of surgical meshes used in urogynecological surgery has also 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.
The SCENIHR summary outlines that ‘clinical outcome following mesh implantation is influenced by material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and the surgeon’s experience’.
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.