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AustralianTherapeutic Goods Administration (TGA) Australian

TGA Proposes to Reclassify Synthetic Meshes as ‘High Risk’

August 9, 2017

Transvaginal mesh devices and mesh used for hernia repair may soon be classed as "high risk" by the Australian government.

The Therapeutic Goods Administration is proposing that all synthetic meshes be bumped from Class IIb (medium to high risk) up to Class III (high risk), requiring manufacturers to seek additional regulatory approval.

Surgical mesh is used to provide temporary or permanent support for weakened structures and/or muscles in surgery. Other common uses include repair of hernias, pelvic organ prolapse, and stress urinary incontinence.

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