Statement regarding supply of AlloDerm in Australia
22 June 2006
- AlloDerm, a skin graft product that is used mainly in dental and plastic surgical procedures, has been the subject of an international recall. The recall was prompted because the manufacturer was not satisfied with documentation relating to the selection and testing of the donor tissue. Implicated batches were manufactured from early 2004 to September 2005.
- AlloDerm has not been approved for general marketing in Australia.
- AlloDerm has been supplied in Australia on an individual patient basis through the Special Access Scheme (SAS).
- The TGA approved the use of Alloderm under the SAS for only 46 patients.
- The TGA has written to the 13 Medical and Dental Practitioners who may have imported Alloderm and advised them of the concerns regarding this product.
- The TGA has advised State and Territory Health Departments of this issue and will keep them updated with progress of the investigation.
- Patients who have been treated with Alloderm should consult their doctor.
Background
- The Special Access Scheme allows patients in consultation with their practitioners to access product that is not freely marketed in Australia (i.e. not evaluated and approved by the TGA). This mechanism allows patients with serious or life threatening conditions to access treatments that would otherwise be unavailable to them but needed in the opinion of the treating practitioner.
- SAS applications for human and animal tissue products must be accompanied by a copy of the patient's signed consent to the treatment. The consent form is prescribed by the TGA and covers the potential for transmission of infectious disease.
Media contact: Kay McNiece, TGA Media 0412 132 585