Thermography is no substitute for mammography when it comes to breast cancer screening, detection or diagnosis, said the FDA.
The agency “is alerting women, health care 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,” said the agency in a just-issued safety communication.
Stating that 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 agency warned that it had received numerous reports that health spas, homeopathic clinics, mobile health units, and other health care facilities are using the technique “inappropriately.”
"Advancing and protecting women's health is a priority for the FDA. As part of these efforts, we will not tolerate individuals or companies who attempt to take advantage of patients by marketing unapproved devices that deceive patients and put them at risk," said FDA Commissioner Dr. Scott Gottlieb, in a statement.
"The FDA is concerned that patients will rely on unapproved claims that thermography may be used as a sole screening device for breast cancer and not get screened with mammography, which is proven to save lives by detecting cancer and prompting patients to seek appropriate treatment,” he added, noting that, “people who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages. We'll continue our efforts to protect patients from those individuals or companies who ignore the FDA's requirements intended to keep patients safe."
The digital infrared imaging devices, which have been FDA-cleared only for use with other screening tools, like mammography, are being touted by some as appropriate on their own for breast cancer screening, which the agency called “false information that can mislead patients into believing that thermography is an alternative or better option than mammography.”
Claims made by some that the technique can spot breast cancer “years before” other methods – or boost dense-breast cancer detection – lack “any valid scientific evidence to support them,” according to the agency's safety warning letter.
It stated that according to the Society for Breast Imaging, mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proved to increase the chance of survival through earlier detection.
As a result, the agency continues to clamp down on what it called “false advertising of thermography” and has issued its latest warning letter to Total Thermal Imaging Inc., in La Mesa, California, this month.
In the past it had already issued such letters to a number of other facilities, including: Thermogram Assessment Services, Nature's Treasures, Meditherm, Dr. Joseph Mercola of Dr. Mercola's Natural Health Center, and Central Coast Thermography.
The letters told the providers to immediately stop making inappropriate claims about thermography devices.
The FDA's warnings to these facilities began back in 2011.
"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," Dr. Helen Barr, former director of the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health, said in a statement issued at that time.
