FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Australia Withdraws 45 Mesh Devices

Dec. 21, 2017

Australia’s TGA withdrew 45 devices from the market for urogynecological use following an extensive review that found that the risks outweighed the benefits of these products for treating pelvic organ prolapse, the regulatory authority said in a new report.

In August, the TGA re-classified transvaginal mesh devices as “high risk,” bumping them from Class IIb (i.e. medium to high risk) up to Class III (i.e. high risk), requiring manufacturers to seek additional regulatory approval.

Meanwhile, the FDA issued a final order in January reclassifying specialized surgical instrumentation for use with urogynecologic surgical mesh from Class I to Class II with special controls based on new information regarding adverse events.

An FDA-convened panel previously found the devices are associated with various complications, such as damage to blood vessels, nerves, and connective tissue, as well as irritation and infection.

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