Transvaginal mesh upgraded to 'high-risk' category

A change in classification means higher evidentiary standards.

Stricter rules for transvaginal mesh products will be introduced by the TGA as part of a wider overhaul of regulation around surgical mesh and implantable medical devices.

Surgery

Minister for Health Greg Hunt has signed off on a new regulatory framework that will require all new surgical mesh devices, including urogynaecological mesh devices, to meet the higher evidentiary standards of a Class III medical device from December 2018.


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