Warning on unproven breast imaging

The Australian Competition and Consumer Commission (ACCC), Cancer Council Australia and the Therapeutic Goods Administration (TGA) are urging Australian women not to rely on unproven commercial breast imaging technologies to detect breast cancer.

The warning comes after Cancer Council Western Australia raised concerns with the ACCC that women may have been misled into believing certain commercial breast imaging technologies are as effective as mammography for early detection of cancer.

The commercial technologies include devices using various processes including electrical impedance, digital infrared thermal imaging, thermal radiometry and computerised/mechanical breast imaging.

The ACCC says it is continuing to assess whether individual businesses offering these services may have engaged in misleading or deceptive conduct under the Competition and Consumer Act.

ACCC chairman Graeme Samuel said that “With the increasing promotion of commercial breast imaging technologies, there is a significant risk that women could be misled into believing these technologies offer an equivalent, or alternative, screening method to mammography.”

“The ACCC understands the only evidence-based screening technology for breast cancer is mammography, as used by the BreastScreen Australia Program. There is a real danger that using unproven commercial breast imaging technologies instead of mammography may delay diagnosis and treatment of cancer.”

Cancer Council Western Australia President, Prof Christobel Saunders, a breast surgeon, said breast cancer mortality rates in Australia had declined in recent years as a result of evidence-based strategies, including mammography screening.

“Mammography is the gold standard for detecting breast cancer early in women without symptoms, particularly those aged 50 to 69,” Saunders said. “The alternative technologies being promoted by commercial interests simply do not compare in the slightest way with the effectiveness of mammography.

“For example, a recently published UK paper showed digital infrared thermal imaging had a very poor cancer detection rate of 25 per cent. The limited evidence on these technologies suggests that they are not at all useful when it comes to detecting breast cancer.”

The TGA is working with the ACCC to ensure that the sponsors of the devices used in commercial technologies only make appropriate claims about their clinical value. The TGA has removed a number of these devices from the Australian Register of Therapeutic Goods because sponsors were unable to substantiate claims made about their value in diagnosing breast cancer.

Information about the commercial technologies can be found in the publications Unproven Breast Imaging – the Facts and Testing for Breast Cancer: Will the real breast screening test please stand up?