Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 16, 2026
Approximately 5 minutes
Medsafe Actions on Surgical Mesh Safety in New Zealand
Medsafe Actions on Surgical Mesh Safety in New Zealand
1. Overview of Safety Concerns
Surgical mesh used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has been associated with serious complications including chronic pain, mesh erosion/exposure, infection, dyspareunia, and the need for revision surgery. Medsafe has closely monitored these devices since 2008, responding to both local and international safety signals. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
2. Key Actions Taken by Medsafe
Medsafe has implemented the following major safety measures over time:
2008 – First Safety Alert
Medsafe issued its first safety alert regarding complications associated with transvaginal surgical mesh for POP repair. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
2014 – Updated Advice to Healthcare Professionals
Medsafe updated advice to healthcare professionals, recommending careful patient selection, thorough informed consent discussing risks and benefits, and consideration of alternative treatments. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
2018 – Product Alert and Restricted Use
Following further review of adverse event data and international regulatory actions (notably the 2018 Australian TGA actions), Medsafe issued a product alert restricting the use of transvaginal mesh for POP repair to situations where alternative treatments are not suitable. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
2018–2020 – Enhanced Informed Consent and Training Requirements
Medsafe required healthcare providers to ensure patients receive comprehensive information about risks and benefits before surgery, and encouraged appropriate training for surgeons performing mesh procedures. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
Ongoing Monitoring and International Collaboration
Medsafe continues to monitor adverse event reports, review emerging evidence, and collaborate with international regulators (e.g., TGA Australia, FDA, MHRA) to assess ongoing safety concerns. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
3. Current Status and Recommendations
As of the latest updates, transvaginal mesh for POP repair remains restricted in New Zealand, with use limited to cases where benefits outweigh risks and after appropriate informed consent. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
Healthcare professionals are strongly encouraged to:
- Discuss all treatment options with patients
- Document informed consent thoroughly
- Report all adverse events related to surgical mesh to Medsafe/CARM
Medsafe continues to review the safety profile of surgical mesh and may take further action if new evidence emerges. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
4. Additional Notes
Medsafe's actions reflect a risk-benefit approach, balancing patient safety with access to effective treatments. The page provides links to related safety communications, adverse event reporting, and international references. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
This comprehensive regulatory response demonstrates Medsafe's commitment to protecting public health in relation to surgical mesh use in New Zealand. https://www.medsafe.govt.nz/devices/Surgical%20Mesh/ActionsTakenByMedsafe.asp
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Adverse Event Reports for Surgical Mesh in New Zealand
Medsafe publishes summaries of adverse event reports related to surgical mesh used in pelvic organ prolapse and stress urinary incontinence procedures, highlighting trends in reported complications such as pain, mesh exposure, and infection, with data covering notifications from 2005 onward and ongoing monitoring to inform safety actions.
Approximately 5 minutes
Recall and Field Safety Corrective Actions for Medical Devices in New Zealand
Medsafe oversees voluntary recalls and field safety corrective actions (FSCAs) for medical devices in New Zealand using the Uniform Recall Procedure, requiring sponsors to notify Medsafe, classify recalls by risk level (Class I–III), and implement appropriate corrective measures such as product withdrawal, repair, or user notifications to protect public health.
Approximately 5 minutes
Safety Monitoring of Medical Devices in New Zealand
Medsafe maintains ongoing post-market safety monitoring of medical devices in New Zealand through adverse event reporting to CARM, review of international alerts and recalls, publication of safety communications, and collaboration with sponsors to address emerging risks and ensure continued compliance with essential principles.
Approximately 5 minutes
Adverse Event Reporting for Medical Devices in New Zealand
Medsafe operates a voluntary adverse event reporting system for medical devices through the Centre for Adverse Reactions Monitoring (CARM), encouraging healthcare professionals, patients, and sponsors to report incidents, near misses, and quality issues to support post-market safety monitoring and potential regulatory actions.