Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication
MedSun: Newsletter #62, July 2011

FDA MedWatch Safety Alert

FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. 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. Women 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.

Additional Information:

FDA MedWatch Safety Alert. Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication. June 2, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun