FDA Proposes Reclassifying Surgical Mesh as 'High-Risk Device'

The U.S. Food and Drug Administration has issued a proposed rule to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a Class III "high-risk device." The mesh is currently classified as a Class II device, labeled as moderate-risk.

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.

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