THREE times as many Australian women have had PIP breast implants rupture than first thought, the medicines watchdog has said, warning the number of those affected by the faulty device will rise.
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The Therapeutic Goods Administration initially received 37 unconfirmed reports that implants made by the French company Poly Implant Prothese (PIP) had leaked. It has now revised the figure to 102 confirmed cases and 14 unconfirmed.
But the Public Health Association of Australia predicted the rupture rate would rise dramatically. Its chief executive, Michael Moore, said given the standard breast implant rupture rate was one in 10 over 10 years, the estimated number of women affected by leaking PIP implants would climb to more than 1200.
''We can confidently say there will be more,'' Mr Moore said yesterday.
The TGA has told surgeons supplied with PIP implants to contact each patient for a check-up. It also expected the number of patients reporting their breast implants to have ruptured to increase.
"At this stage there is insufficient evidence of a problem with the Australian supplied implants to warrant routine removal of the implants that have not ruptured," a TGA spokeswoman, Kay McNiece, said yesterday.
The federal Minister for Health, Tanya Plibersek, was yesterday unwilling to upgrade her advice. When contacted by The Sun-Herald, a spokesman for Ms Plibersek said: ''The minister continues to receive regular updates from the Chief Medical Officer and the TGA who are constantly evaluating information from around the world.''
He also advised women who have concerns to contact the Breast Implant Information Line. There have been more than 2000 calls to the line, set up in response to the issue.
The TGA recalled PIP implants in April 2010 after French authorities found they had abnormally high rupture rates. PIP was shut down after concerns it was using industrial silicone, not medical-grade silicone, for implants. The TGA estimates 12,300 PIP implants were sold in Australia between 1998 and 2010.
Ms McNiece said health authorities were working with experts locally and overseas "to obtain more comprehensive information that will help further inform the risk assessment of this situation."
The TGA's updated figures for ruptured PIP implants are more in line with those collated by the Medical Error Action Group.
Three weeks ago the group had received more than 100 reports of ruptured implants. The PIP scandal has exposed the inadequacy of the data the TGA holds on breast implant recipients.
The Sun-Herald recently revealed that the Australian Society of Plastic Surgeons is preparing to record the details of every breast implant patient, their surgeon and the type of operation on a national register of breast implants, which will act as an early warning system in the event of faulty devices.
The Society of Plastic Surgeons wants the federal government to fund the estimated $2 million it will cost to run the register every year.
A spokesman for the parliamentary secretary for Health and Ageing, Catherine King, revealed yesterday that the ''establishment of medical registers for certain medical devices is under consideration".
with Sarah Whyte