Alerts

Poly Implant Prothèse (PIP) update

Background information for consumers about Poly Implant Prothèse (PIP) breast implants

Poly Implant Prothèse (PIP) update

The Therapeutic Goods Administration (TGA) advises that the R3 metal liner component of the R3 acetabular system (used in hip replacements) is being recalled by the Australian sponsor, Smith & Nephew Surgical Pty Ltd.

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

On 21 March 2012, the TGA agreed that the release procedure involving TGA's batch-by-batch review of CSL's ethylene glycol test results need not apply to batches of albumin solution manufactured after 25 January 2012.

PIP breast implants are known to have been used in Australia from September 1999 until April 2010, when non-implanted PIP breast implants were recalled from the market following advice from the French regulator (AFSSAPS) that in making these devices the manufacturer had used unapproved materials which may affect their safety and performance.

PIP breast implants are known to have been used in Australia from September 1999 until April 2010, when non-implanted PIP breast implants were recalled from the market following advice from the French regulator (AFSSAPS) that the manufacturer had used unapproved materials in making these devices which may affect their safety and performance.

Australia's medical devices regulator, the Therapeutic Goods Administration (TGA) again encourages women who have had breast prostheses implanted since 1998 to contact their surgeon to find out the brand of their implant and to attend for a check-up if they know or suspect they have an implant made by the French company Poly Implant Prothese (PIP).

Quarantine of some CSL Biotherapies batches of human albumin product (ALBUMEX) pending further analysis

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As an important part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns.

Human albumin: Clinical advice on ethylene glycol

The Therapeutic Goods Administration (TGA) has taken steps today to quarantine CSL Human Albumin solutions from further use while an assessment is undertaken of the safety of these products.