FDA Alert: Thermography Should Not Replace Mammograms for Breast Cancer Screening

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The much-touted thermographic system now being used by many facilities as a stand-alone evaluation tool for screening and diagnosing breast cancer should not be used as a replacement for mammography, the FDA warned in a recent press release. The thermographic system has been called into question by many in the medical community, as there is no scientific evidence that supports the effectiveness of such devices.

What’s the problem?

June 2, 2011 – The U.S. Food & Drug Administration (FDA) today issued a press release warning the public and medical communities that thermography should not be used as a replacement for screening mammography, and should not be used by itself to diagnose breast cancer.

Thermography (also known as digital infrared thermal imaging) is designed to alert a doctor to changes that can indicate early stage breast disease and in the evaluation of unexplained pain. A thermographic device uses a sensitive medical digital camera to take thermal images of the body, and then sends this data to a computer. Humans radiate heat in specific patterns, and these images are identified by the thermographic device and subsequently interpreted by a qualified physician to distinguish between normal and abnormal physiological function of the body.

A growing number of facilities, websites and mobile units around the country have falsely touted thermographic imaging systems as superior to mammographies for screening and diagnosing breast cancer. According to the FDA’s warning:

“The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.”

The FDA recommends that women should continue to have regular mammograms according to normal screening guidelines set by their healthcare professional. Women should follow their physicians recommendations for additional diagnostic procedures which may include:

  • clinical breast exams
  • breast ultrasound
  • magnetic resonance imaging (MRI)
  • biopsy
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