Breast implant registry will warn women of faulty devices

EVERY woman who receives a breast implant will have her details recorded on a new national registry so that faulty devices - some of which have ruptured - can be detected early.

As the scandal over defective French-made PIP implants continues, the Australian Society of Plastic Surgeons is preparing to record the information of every breast implant patient, their surgeon and the type of operation conducted.

One of the first registries of its kind in the world, it would act as an early warning system for any future problems with implants. It would be similar to the National Joint Replacement Registry, which has received some government funding and quickly detected problems in Australia with DePuy hip replacements, which have become the subject of global litigation over their high failure rate.

The society, the leading body representing the country's plastic surgeons, wants the federal government to pay the estimated $2 million a year it will cost to run the registry, to keep it independent of implant manufacturers. The society has asked for a meeting with the federal Minister for Health, Tanya Plibersek.

''Such a registry is not only in the best interest of patients in terms of safety and quality assurance, it would also enable rapid comparison of international data should a circumstance, such as the recent PIP incident, occur again,'' the society's president, Rod Cooter, said.

While four European countries have advised women to remove the PIP implants, Australia's Therapeutic Goods Administration (TGA) says there is no need for routine removal.

Under the new registry, which will start collecting data in October, patients will have to specifically request to be excluded.

The NSW Health Care Complaints Commission recommended in October 1999 that a compulsory registry be set up to track recipients of breast implants. In its cosmetic surgery report submitted to the NSW government, it called for the TGA, a federal government agency, to be given legislative powers to manage this registry. But the federal government has not acted on the recommendation.

The registry would replace the existing voluntary system, which costs patients $25 to have their details recorded and is monitored by the society. Just over 44,000 implants are listed on the voluntary registry, but Dr Cooter said about 250,000 implants had been sold in Australia since 1992.

Potts Point plastic surgeon David Caminer said his patients would be happy to have their details recorded on the registry if it meant they would receive early warning of any problems with their implants.

''I don't think anyone would object,'' Dr Caminer, who performs 70 breast implant operations a year, said. ''If some registry gives rise to early notification of potential problems, rather than leaving it to individual surgeons, it can only be a good thing.''

Implant makers refuse to share their sales information, which makes it hard for the Society of Plastic Surgeons to validate the data submitted by patients to the voluntary registry.

The voluntary registry has recorded less than 5 per cent of the 9000 PIP implants sold to Australian women. Dr Cooter said PIP implants cost between 40 and 60 per cent less than other implants, so women who chose them would be unlikely to want to pay extra to be on a registry.

Monash University would manage the registry on behalf of the society. The registry is being trialled in Melbourne and Adelaide and will be launched at the Sydney International Breast Cancer Conference in October.

However, without government funding, the profession warned it would be forced to turn to implant makers to cover the costs.

Data from the registry, stripped of identifying details, may be supplied on request to the federal government. A spokesman for Ms Plibersek did not respond to The Sun-Herald's questions about funding and why the TGA does not have such a system already.

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