In accordance with Medical Devices Directive 93/42/EEC (as amended), the Health Products Regulatory Authority (HPRA) does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. The HPRA has a post market role where they monitor the medical devices on the market. As Minister for Health, I have no role in the approval, licensing and certification process for medical devices.
To place a medical device such as a vaginal mesh implant on the Irish or EU market, the manufacturer must be authorised to do so following an assessment conducted by a notified body for medical devices. There are currently just over fifty such notified bodies based in Europe (one in Ireland – NSAI) and the manufacturer can choose any designated notified body to which it can apply for assessment and the award of a CE mark. Following its assessment and once satisfied that the device meets the relevant requirements, the notified body will issue a certificate for the medical device. This entitles the manufacturer to affix a CE mark to the device and thereafter market the product throughout Europe. The HPRA has advised that, to their knowledge, the NSAI has not certified a transvaginal mesh device at any time.
No regulatory action has been taken to date by Competent Authorities in any European country in respect of these devices. 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.
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, including the issues raised by the Deputy.
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 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.