The FDA held a device classification panel meeting to discuss the mesh’s suitability as a Class III device. The panel recommended reclassifying the device as Class III because “general controls and special controls together would not be sufficient to provide reasonable assurance of the device,” according to the proposed rule.
If reclassified, manufacturers would be required to submit a premarket approval application to the FDA to evaluate safety and effectiveness.
The FDA is proposing the rule following a review of literature regarding adverse events associated with these devices.
“Based on its review, FDA believes that the rate and severity of mesh-specific adverse events following vaginal POP repair with mesh calls into question the safety of these devices,” reads the proposed rule. “Additionally, the available scientific literature does not provide evidence that surgical mesh used for vaginal POP repair offers a clear improvement in effectiveness when compared to traditional repair.”
The FDA is accepting comments on the proposed rule for 90 days.
More Articles on Device Safety:
FDA Requires Epidural Corticosteroid Label Changes to Warn of Potential Neurological Adverse Events
Many Approved Pediatric Devices Not Tested on Pediatric Patients
GS1 Healthcare US Releases UDI Implementation Guide
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.