Vaginal Mesh Implants

Background

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions that can have a negative impact on a person’s quality of life. A surgical mesh is a medical device made from a synthetic (absorbable, partially absorbable or non-absorbable) material that is used to support weakened tissues. In urology / urogynaecology procedures they are permanently implanted with the aim to repair POP or to support the urethra or bladder neck in case of SUI. These devices may be supplied in a variety of forms depending on their intended purpose.

User Reporting 

The HPRA continues to encourage reporting of adverse incidents relating to these devices both from patients who have experienced complications with these devices and from healthcare practitioners who have used these devices. We understand how issues relating to these medical devices are of a highly personal nature and assure anyone providing information to us that your report will be treated with the utmost confidentiality. Your reporting of issues to us is very important and we will respect the privacy of this personal information and treat it with utmost sensitivity. Please note however that during the course of reviewing the information provided, the HPRA may seek to follow up on your report with the device manufacturer or healthcare practitioner. This can be an important step in the review process, however please be assured this will not happen unless you provide us with consent to do so during initial reporting and/or subsequent correspondence with the HPRA.

Reports can be made online through our user reporting system. However, if you have any reservations or if you are uncertain about completing the online report form, you can contact the medical devices team at HPRA directly between 09:00 and 13:00 Monday to Friday by calling 01 6343380. Your call will be directed to a member of the medical devices vigilance team.The user report can also be submitted to the HPRA by post

European Review

At European level, the safety of surgical meshes used in urogynecological surgery was reviewed by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). 

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’.

Link to Full report here

The SCENIHR also published an ‘easy to read science fact sheet’ relating to this topic. 

Recent Activity

The HPRA notes the recommendations from the Chief Medical Officer (24 July 2018) that a pause be put in place on the use of procedures involving synthetic mesh for treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The regulatory status of synthetic mesh implants remains unchanged and they continue to be CE marked as medical devices. The HPRA does not issue CE marks or approve medical devices for market. However, we are conducting a review of the regulatory aspects of these products as a matter of priority.

The HPRA has also provided advice to the Chief Medical Officer who is currently preparing a report for the Minister for Health concerning the use of vaginal mesh in Ireland.

The HSE has previously provided advice (26 June 2018) to hospitals and practitioners in the form of a Learning Notice.