Publicity on USA products containing illegal human tissues - an update

29 June 2006

In October 2005, the US FDA coordinated a recall of certain therapeutic goods containing material of human origin because some of the human material had been obtained illegally.

At that time, the TGA investigated and found that none of the products subject to the recall had been imported into Australia for use under the Therapeutic Goods Act.

Last week the TGA undertook further investigations of product supplied in Australia via the Special Access Scheme.

The TGA had issued 56 approvals for the product, AlloDerm, under the SAS in the period of time when the suspect materials was in circulation - to 13 medical practitioners to treat 46 patients.

Investigations showed that not all doctors had actioned the approvals and for those who did, none of the batch numbers of the recalled materials matched materials that were imported into Australia. This was confirmed with individual practitioners in Australia by comparing the identification numbers of the batches they had used against those of the suspect batches.

This has been supported by the manufacturers, LifeCell, which has reaffirmed that the batches of concern were not imported into Australia.