Telethermographic device is not approved for screening breast cancer

U.S. Food and Drug AdministrationJun 3 2011

The U.S. Food and Drug Administration today warned women not to substitute breast thermography for mammography to screen for breast cancer.

Unlike mammography, in which an X-ray of the breast is taken, thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body. Some health care providers claim thermography is superior to mammography as a screening method for breast cancer because it does not require radiation exposure or breast compression.

However, the FDA is unaware of any valid scientific evidence showing that thermography, when used alone, is effective in screening for breast cancer. To date, the FDA has not approved a thermography device (also referred to as a telethermographic device) for use as a stand-alone to screen or diagnose breast cancer. The FDA has cleared thermography devices for use only as an additional diagnostic tool for breast cancer screening and diagnosis. Therefore, FDA says, thermography devices should not be used as a stand-alone method for breast cancer screening or diagnosis.

"Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages," said Helen Barr, M.D., director of the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health. "Women should not rely solely on thermography for the screening or diagnosis of breast cancer."

The FDA has issued warning letters to some health care providers who have been promoting the inappropriate use of breast thermography. The letters instructed the providers to cease making claims that thermography devices, when used alone, are an effective means of detecting breast cancer. Claims have, for instance, appeared on some providers' websites.

The FDA encourages women to:

• Have regular mammograms according to screening guidelines or as recommended by their health care provider;
• Follow their health care provider's recommendations for additional breast diagnostic procedures, such as various mammographic views, clinical breast exam, breast ultrasound, MRI or biopsy; additional procedures could include thermography;
• Remember that thermography is not a substitute for mammography and should not be used by itself for breast cancer screening or diagnosis.

"While there is plenty of evidence that mammography is effective in breast cancer detection, there is simply no evidence that thermography can take its place," said Barr.