The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland.
The HPRA does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as the HPRA does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. They have a post market role where they monitor the medical devices on the market.
The HPRA strongly encourages those who have experienced a safety issue with a medical device, including transvaginal mesh devices or implants, to report it through its medical device adverse incident reporting system. The system is accessible to patients, healthcare professionals or any person who identifies a medical device safety issue. Issues or concerns about a medical device can be submitted through the HPRA website’s online reporting system or by downloading and completing an incident report form which is also available from its website, www.hpra.ie .
It is important to note that these devices continue to be certified as compliant with relevant EU legislation and have not been subject to specific recall.
The use of transvaginal mesh in a procedure is a clinical decision made by the consultant with the patient, at which point possible complications would be brought to the patients attention
