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.

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. 

Clinical Perspective

The HPRA has consulted with a number of clinical experts in this field. Dr. Suzanne O’Sullivan, President Continence Foundation of Ireland (www.continence.ie) and Consultant Obstetrician and Urogynaecologist in Cork University Maternity Hospital confirms “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.”

User Reporting

The HPRA continue to encourage reports of adverse incidents relating to these devicesthrough our user reporting system.