FDA issues warning against breast cancer screening by thermogram

The US-FDA has issued a consumer health alert that thermogram breast cancer screening test is no substitute for mammography because of lack of scientific evidence in favor of thermogram.

This alert was issued in wake of reports received from many healthcare centers and patients that many providers are misleading patients into believing that thermogram can be a substitute for mammography.

Helen J. Barr, M.D., director of the Division of Mammography Quality Standards in the FDA’s Center for Devices and Radiological Health said, “Plenty of evidence shows that mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages. You should not rely solely on thermography for the screening or diagnosis of breast cancer.”

Those patients who are screened with thermogram may be falsely assured that they do not have cancer as it has high false negative results. Similarly, patients may receive a false diagnosis of breast cancer when in fact they do not have any lesion.

Thermography was only cleared by FDA as an adjunct tool, to be used with a primary screening method. Some women prefer to get the test done as it is painless and does not expose the patient to radiation.  

FDA also stressed that claims by websites that thermography detects cancers earlier than other screening methods does not have any scientific evidence.

FDA has further taken regulatory action against manufacturers of thermography devices and healthcare providers who are misleading patients to believe that thermography can replace mammography.

FDA has put the alert on consumer update page and it continues to monitor the situation.

FDA consumer alert 

Media Courtesy: FDA