FDA warns against thermography, reinforcing mammo's efficacy
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| Mammogram reveals increased density (arrow) of the right breast. Image source: Indian J Radiol Imaging 2010 May;20(2):98–104. |
Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body. While cleared by the FDA for use as an adjunct, the agency said it should not be used by itself to screen for, or diagnose, breast cancer.
The FDA also sent several warning letters to healthcare providers and a thermography manufacturer who claim that the thermal imaging can take the place of mammography. Websites have been touting thermography as a replacement for mammography and claim that thermography can find breast cancer years before it would be detected by mammography. However, the FDA has 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, MD, 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."
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.
The greatest danger, said Toni Stifano, a consumer safety officer in the FDA’s Center for Devices and Radiological Health, is that patients who substitute thermography for mammography may miss the chance to detect cancer at its earliest stage.
The FDA is advising patients to continue to have regular mammograms according to screening guidelines or as recommended by their healthcare professional.
Patients also are advised to follow their healthcare 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.
This year, the agency has sent warning letters to the following practitioners and manufacturer making misleading claims about thermography: Meditherm; Joseph Mercola, MD and Central Coast Thermography.
The FDA’s position on thermography is shared by breast cancer advocacy groups, including the Susan G. Komen for the Cure and the American Cancer Society.