FDA: Thermogram No Substitute for Mammogram

Thermography (above) produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body. A mammogram (below) is an X-ray of the breast in which a cancerous mass shows up in white.

Photos courtesy of FDA.

The Food and Drug Administration (FDA) warns that thermography should not be used in place of mammography for breast-cancer screening or diagnosis. The FDA asserts that mammography— an X-ray of the breast—is still the most effective way of detecting breast cancer in its earliest stages.

While cleared by the FDA for use as an additional tool, thermography, which shows the patterns of heat and blood flow on or near the surface of the body, should not be used by itself to screen for breast cancer.

The FDA has sent warning letters to health-care providers, as well as a thermography manufacturer, both of which have claimed that thermal imaging could not only take the place of mammography, but also detect breast cancer years before mammography. The FDA says that there is no evidence to support these claims.

“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.

“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,” Barr added.

Thermography devices have been cleared by the FDA for use as an additional, tool for detecting breast cancer. Toni Stifano, a consumer safety officer in FDA’s Center for Devices and Radiological Health, explains that this means thermography should not be used by itself to screen for or to diagnose breast cancer.

The National Cancer Institute (NCI), part of the National Institutes of Health, estimates that about 1 in 8 women will be diagnosed with breast cancer sometime in her life.

The greatest danger, says Stifano, a breast-cancer survivor herself, is that patients will substitute thermography for mammography, and miss the chance to detect cancer at its earliest stage. The FDA said there has been a steady decline in breast-cancer deaths over the years, and one of the reasons is early detection through mammography.

As for concerns about exposure to radiation from a mammogram, evidence shows that the benefits outweigh risks of harm, especially when compared to the danger of breast cancer.

The FDA is advising patients to continue to have regular mammograms according to screening guidelines, or as recommended by their health- care professional.

Patients are also advised to follow their health-care professional's recommendations for additional diagnostic procedures, such as other mammographic views, clinical-breast exam, breast ultrasound, MRI or biopsy. Additional procedures could include thermography.

The FDA’s position on thermography is shared by prominent organizations active in the fight against breast cancer, and the American Cancer Society.

For additional information Frequently Asked Questions About Digital Mammography.

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