February 26, 2019
Thermography should not be used as an alternative to mammography for breast cancer screening or diagnosis, warns the US Food and Drug Administration (FDA) in a safety communication issued February 25.
Thermography devices, also known as digital infrared imaging devices, have an infrared camera that produces images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body, the agency explained.
It noted that these devices have been cleared for marketing by the FDA only for use with another screening or diagnostic test, such as mammography, not for use as a stand-alone diagnostic tool.
However, that is how thermography is being marketed by some providers — as an alternative to mammography — with sometimes disastrous consequences.
A report that was aired February 13 on the American television show Good Morning America highlighted the case of two women in California who had breast cancer that was missed by thermography. One of the patients subsequently died of the disease after believing a thermography result that showed she was disease free.
The FDA said that it is aware that health spas, homeopathic clinics, mobile health units, and other healthcare facilities are using thermography inappropriately as a stand-alone tool for breast cancer screening or diagnosis.
The agency 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," the FDA emphasized.
The agency pointed out that the Society for Breast Imaging says that there is a lack of evidence that thermography has any effective role in breast cancer screening.
Steps to Stop False Advertising
The agency is taking steps to stop false advertising regarding thermography. It issued a warning letter on February 22 to Total Thermal Imaging, Inc, in La Mesa, California, for marketing and promoting thermography devices for uses that have not received marketing clearance or approval. Similar letters have been issued in the past to other thermography clinics and natural health centers.
The warning letters tell providers to immediately stop making inappropriate claims about thermography devices.
"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," the FDA said.
Mammography Is Only Effective Tool
"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," the agency stated.
"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," it added.
The agency recommends that women regularly undergo mammography according to screening guidelines or on the advice of their healthcare provider and that they follow their provider's advice on additional steps to diagnose breast cancer, such as undergoing a clinical breast exam, other breast imaging (eg, breast ultrasound or MRI), or breast tissue biopsy.