FDA warns thermography should not be used in place of mammography to detect, diagnose, or screen for breast cancer
The FDA is aware that health spas, homeopathic clinics, mobile health units, and other healthcare facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis. The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make inaccurate, unsupported, and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.
None of these claims are true or have any valid scientific evidence to support them. In addition, the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening. Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection.
Thermography is a noninvasive tool that uses an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. Thermography devices, also known as digital infrared imaging devices, have been cleared for marketing by the FDA only for use with another screening or diagnostic test like mammography, not for use as a standalone diagnostic tool.
The FDA is alerting women, healthcare providers, and people getting breast cancer screening, that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.
There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.
Mammography (taking X-ray pictures of the breasts) is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection.
The FDA is concerned that people will believe the misleading claims about thermography and not get mammograms to screen for breast cancer. People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages. The agency is taking steps to stop the false advertising of thermography—see the FDA Actions section below for more information.
