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Check breast implants for rupture, patients told
AUSTRALIAN women with silicone gel breast implants manufactured by French company Poly Implant Prothèse (PIP) have been urged to join a national register and undergo tests for rupture as investigations into a possible cancer link continue.
The implants, which have been used in about 8900 Australian women, were the subject of a product recall last year after the French regulatory agency found them to have an increased chance of rupture.
Recent reports that a French woman with PIP implants had died from anaplastic large cell lymphoma (ALCL), which the US Food and Drug Administration (FDA) warned earlier this year could be associated with breast implants, has sparked a worldwide media storm.
Australian Society of Plastic Surgeons president Associate Professor Rod Cooter urged all patients with PIP implants to see their surgeon and undergo an ultrasound to check for rupture.
However, the Therapeutic Goods Administration (TGA) said the risk of a patient having ALCL was “very low”.
The administration has advised women with breast implants to continue to routinely monitor them and consult their implanting surgeon if they have any concerns, but it does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
“There have been approximately 8900 PIP breast implants used in Australian women,” the administration said.
“The TGA has received 45 reports relating to PIP implants, 39 of which relate to rupture. It should be noted that the cause of rupture may be due to factors other than the device itself.”
ALCL is a rare cancer of the immune system that can occur anywhere in the body and affects an estimated one in 500,000 women per year in the US, while ALCL in the breast is even rarer and affects about three in 100 million women per year.
An FDA review of the scientific literature published from 1997 through to May 2010 identified 34 unique cases of ALCL in women with breast implants, against an estimated 5–10 million women who had received breast implants worldwide.