Australia’s TGA Opens Review of All Surgical Mesh Devices

Regulatory NewsRegulatory News
| 21 August 2014 | By Louise Zornoza

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Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for marketing approval. 

The reassessment was prompted by the results of a review of the implants by the TGA’s Urogynecological Devices Working Group that found that, while there may be a benefit in certain patients, there is little evidence to support the overall effectiveness of these devices as a product class.

Where individual mesh devices are found to be non-compliant, the agency will initiate regulatory action, such as the cancellation or suspension of the marketing approval for the device.  

 

TGA Announcement

 

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