Gynaecological mesh maker appeals deregistration ruling

Paul Zadow, director  of the TFS Manufacturing Pty Ltd.

Paul Zadow, director of the TFS Manufacturing Pty Ltd.

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FORMER Australian champion basketballer and Newcastle Falcons player Paul Zadow is taking the federal health minister to the Administrative Appeals Tribunal to appeal against the deregistration of his company’s gynaecological mesh products.

Mr Zadow’s South Australian company, TFS Manufacturing, lodged an appeal on March 27 after the Tissue Fixation System mesh product was deregistered by the federal Therapeutic Goods Administration on November 5 – one of the first mesh products in Australia to be deregistered.

The company is appealing to the Administrative Appeals Tribunal after losing an appeal to the Therapeutic Goods Administration against its decision.

Mr Zadow’s company failed to substantiate how its ‘‘tissue fixation system’’ mesh device, developed by

 Dr Peter Petros and used in prolapse surgery in women, complied with relevant standards.

The Therapeutic Goods Administration and the American Food and Drugs Administration deregistered more than 60 mesh products after concluding there was ‘‘little evidence to support the overall effectiveness of these surgical meshes as a class of products’’ following a large number complaints.

In an email on Wednesday, Mr Zadow said the TFS device was deregistered for ‘‘technical reasons’’.

‘‘The TGA has not found or alleged that the TFS device is unsafe,’’ Mr Zadow said.

‘‘TFS Manufacturing is taking all necessary and reasonable steps to have the TFS device re-registered.’’  

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