The U.S. Food and Drug Administration (FDA) is reminding you that mammography (low-dose X-ray imaging of the breast) is still the most effective primary breast cancer screening test. Proper breast cancer screening lets health care providers check for cancer even before there may be signs and symptoms of the disease.
The FDA has received reports from health care providers and patients that some health centers are providing information that can mislead patients into believing thermography, a type of test that shows patterns of heat on or near the surface of the body, is a proven alternative to mammography. But the FDA is not aware of any scientific evidence to support these claims.
Thermography has not been shown to be effective as a standalone test for either breast cancer screening or diagnosis in detecting early stage breast cancer. Mammography is still the most effective primary screening method for detecting breast cancer in its early, most treatable stages.
More About Misleading Thermography Claims and FDA Actions to Protect the Public
The FDA regulates the medical devices used for breast cancer screening.
About 1 in 8 women in the United States will be diagnosed with breast cancer sometime in their lives, reports the National Cancer Institute, which is part of the National Institutes of Health. Men can develop breast cancer, but it happens much less often than in women. Early detection of breast cancer by using mammography reduces the risk of breast cancer death and increases treatment options, according to the American Cancer Society.
One of the greatest dangers from thermography is that those who opt for this method instead of mammography may miss the chance to detect breast cancer at its earliest stage.
Thermography devices have only been cleared by the FDA as an “adjunctive” tool, referring to use alongside a primary screening test like mammography. Patients who undergo a thermography test alone should not be reassured of the findings because the device was not cleared to be used other than with another testing method like mammography. (You can learn more about mammography, including how it works and how to find a certified facility, on the FDA's website.)
Moreover, some websites claim thermography can find breast cancer years before it would be detected through other methods, and they have unproven claims about improved detection of cancer in dense breasts. The FDA is not aware of any evidence that supports these claims.
The FDA has taken regulatory action (including issuing warning letters) against health care providers and thermography device manufacturers who have tried to mislead patients into believing that thermography can take the place of mammography. To protect the public health, the FDA’s regulatory actions can include scheduling a regulatory meeting, sending a warning letter or other correspondence, conducting an establishment inspection, or other actions as appropriate.
The FDA continues to monitor this situation.
Advice for Patients Getting Breast Cancer Screening
Some women have sought out thermography because it is painless and does not require exposure to radiation.
If you are worried about how a mammogram feels, talk to your health care provider about what you can expect. A mammogram can be uncomfortable for the person being screened because it briefly presses on the breast to spread the breast tissue and increase the clarity of the X-ray image. (You can learn more about what to expect during a mammogram on the FDA's website.)
Also talk to your health care provider if you have specific questions about mammography, including questions about when and how frequently you should be screened. As a rule, you should also call your health care provider if you notice any change in either of your breasts such as a lump, thickening of or leakage from the nipple, or changes in how the nipple looks.