Thermographic Imaging Systems Not a Replacement for Mammography to Diagnose Breast Cancer

Healthcare personnel, consumers and women taken part in breast screening are informed by the FDA that thermography cannot replace screening mammography and should not be used by itself to diagnose breast cancer.

Background of Thermographic Imaging Systems

Thermographic imaging systems use an infrared camera for the production of thermograms showing the patterns of heat and blood flow on or near the surface of the body.

FDA Alert on Thermographic Imaging Systems

Specific mobile units, facilities  and websites communicate the use of thermography as an alternative, and even superior, to mammography for diagnosing breast cancer.

The early detection of breast cancer, they claim, is feasible with thermography long before mammography. And that, breast compression during mammography can cause or spread cancer when pushing cancer cells to spread to other parts of the body.

Recommendation on Thermographic Imaging Systems

“Woman should have regular mammograms according to screening guidelines or as recommended by a health care provider. Patients should follow a health care provider’s recommendations for additional breast diagnostic procedure which could include thermography, clinical breast exam, breast ultrasound, MRI or biopsy.”

Contacting the FDA to report cases with Thermographic Imaging Systems

In case of detection of adverse events or side effects related to the use of Thermographic Imaging Systems, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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