Thermogram is no substitute for mammogram, FDA warns

Thermography shouldn’t be used instead of mammography to screen for or diagnose breast cancer, according to a June 2 press release issued by the United States Food and Drug Administration (FDA). The agency made the announcement in response to claims that thermal imaging can find breast cancer earlier than mammograms.

“Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages,” says Helen Barr, MD, director of the Division of Mammography Quality and Radiation Programs at the FDA’s Center for Devices and Radiological Health. “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.”

The FDA has cleared thermography, which shows the patterns of heat and blood flow on or near the surface of the body by infrared image, as an adjunct tool but not as a standalone method to screen for or diagnose breast cancer. Several warning letters from the agency have been sent to healthcare providers and a manufacturer who claim that thermography is an alternative to mammography.