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January 12, 2026
Approximately 5 minutes
Adverse Event Reports for Surgical Mesh in New Zealand
Adverse Event Reports for Surgical Mesh in New Zealand
1. Background on Surgical Mesh Monitoring
Surgical mesh has been used in New Zealand for procedures such as pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) treatment. Medsafe has been monitoring adverse events associated with these devices since 2005, following international concerns about complications including chronic pain, mesh erosion/exposure, infection, and need for revision surgery. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
Medsafe publishes periodic summaries of adverse event reports to provide transparency and inform healthcare providers, patients, and regulators about emerging safety signals related to surgical mesh. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
2. Scope of Reported Events
The reports cover surgical mesh devices used specifically for POP and SUI procedures. Adverse events include:
- Pain (chronic or acute)
- Mesh exposure/erosion
- Infection
- Dyspareunia (pain during intercourse)
- Urinary tract complications
- Need for mesh removal or revision surgery
- Other device-related issues
Reports are received through the Centre for Adverse Reactions Monitoring (CARM) and international sources. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
3. Data Summary and Trends
Medsafe has received a number of adverse event reports since monitoring began. Key observations include:
- A significant proportion of reports involve chronic pain and mesh exposure/erosion.
- Many patients required surgical intervention for mesh removal or revision.
- Reports have contributed to safety communications, including recommendations for restricted use and enhanced informed consent.
Detailed numerical summaries and trend analyses are provided in the published reports on the Medsafe website. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
4. Regulatory Actions and Communications
Adverse event data have informed several Medsafe actions, such as:
- Safety updates and alerts to healthcare professionals
- Recommendations for careful patient selection and counselling
- Emphasis on reporting all adverse events to support ongoing monitoring
Medsafe continues to review incoming reports and collaborates with international regulators on mesh safety. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
5. Reporting and Transparency
Healthcare professionals, patients, and manufacturers are encouraged to report adverse events related to surgical mesh to CARM. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
Medsafe publishes de-identified summaries of reports to promote transparency while protecting individual privacy. The reports are updated periodically as new information becomes available. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
6. Additional Resources
The page links to related Medsafe information on surgical mesh safety, including regulatory status, patient information, and international references. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
This ongoing publication of adverse event summaries supports informed decision-making and contributes to post-market safety surveillance of surgical mesh in New Zealand. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/AdverseEventReports.asp
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