Alerts

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

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).

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

Poly Implant Prothèse (PIP) update

TGA has increased the number of samples of PIP breast implants tested for shell integrity

Information on the management of issues related to the recall of PIP silicone gel breast implants

Information on the management of issues related to the recall of PIP silicone gel breast implants

Poly Implant Prothèse (PIP) update

PIP breast implants were available in Australia between 1998 and April 2010. In April 2010 non-implanted PIP breast implants were recalled from the Australian marketplace following reports of increased risk of rupture with PIP breast implants as a result of use by the manufacturer of non-approved silicone gel.

The TGA advises that while PIP breast implants were recalled due to the use of unauthorised silicone, current evidence does not support routine removal in patients without symptoms, and individuals are encouraged to seek medical advice if concerned.

At the time of writing, the TGA has been advised that approximately 9,054 PIP breast implants have been implanted by surgeons between 2002 and 2010. In April 2010 non-implanted PIP breast implants were recalled from the Australian marketplace.

On 26 January 2011, the US Food and Drug Administration (FDA) announced a safety communication to warn about an association between breast implants and anaplastic large cell lymphoma. The risk of a patient developing this type of lymphoma is very low.