Healthy Skepticism Library item: 18470

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Magazine

Colyer S
TGA clamps down on breast test devices
Australian Doctor Weekly 2010 July 21
http://www.australiandoctor.com.au/articles/56/0C06AF56.asp

Full text:

EXPERTS are welcoming a Therapeutic Goods Administration crackdown on medical devices marketed as an alternative to
mammography, but say greater regulation is needed.

The TGA has been investigating the unauthorised promotion of breast screening equipment and has assessed the evidence
supporting “breast screening functions” claimed for products listed on the Australian Register of Therapeutic Goods.

Chief Medical Officer Professor Jim Bishop said the investigation resulted in the removal of two devices from the
register – a thermographic infra-red scanner and an electrical impedance scanner.

TGA documents showed the devices were initially registered for purposes such as “diagnosing and assessing various
conditions and disease states”.

Professor Bishop said a further two devices were also under investigation.

He said the Federal Government was concerned about techniques such as thermography, compression testing and electrical
impedence, which “may be perceived by women as a valid form of alternative breast screening”.

But he noted the TGA’s power was limited to regulating device manufacturers and sponsors, and did not extend to
companies using the equipment.

Under current regulations, companies can continue to use deregistered devices, provided they were not recalled for
safety reasons, he said.

BreastScreen WA and Cancer Council WA recently published a report identifying seven companies offering alternative
breast screening in Perth that promoted their services as safe, comfortable, able to detect tumours earlier than
mammography, and suitable for women aged under 40.

Professor Christobel Saunders, professor of surgical oncology at the University of WA, said the TGA’s investigation was
a step forward in regulating alternative breast screening devices, but greater legislative controls were needed.

“Being able to remove the title of ‘TGA approved’ is a good step, because the tag immediately makes people think these
devices are not only ‘not dangerous’ but that they offer a benefit,” she said.

“But we also need legislative control over the use of unproven and potentially dangerous tests,” she said, so that
device users – and not just their manufacturers and sponsors – were held accountable.

Professor David Currow, CEO and chief cancer officer of the Cancer Institute NSW, was also concerned, saying there was
no reason for women to turn to alternative providers when mammography through BreastScreen was available.