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New FDA Warning on Breast Thermography

10/11/2012 | No Comments
Christine Staeger-Hirsch, MD

On June 2, 2011, the Food and Drug Administration (FDA) issued a safety communication warning women and health care providers that thermography is not a safe alternative to mammography [1]. According to the Society for Breast Imaging, (SBI) the warning was issued in response to what the FDA describes as inappropriate claims by thermography facilities and websites promoting thermography as a replacement for mammography. The FDA is not aware of any valid scientific data to show that thermographic devices, when used alone, are an effective tool for any medical condition including the early detection of breast cancer or other breast disease.

 

Thermography is also known as infrared imaging and has been in use for over 50 years. The systems produce images of the breast based on the pattern of temperatures near the skin surface. Thermography was FDA approved in 1982 as an adjunct imaging study. As SBI reports, more recent thermography systems have been approved by the FDA under the 510(k) process, which does not require proof of clinical effectiveness.

 

SBI’s position statement on thermography states, SBI does not currently support the use of thermography/infrared imaging of the breast as either a screening tool in the detection of breast cancer or as an adjunctive diagnostic tool. The American Cancer Society website indicates that no study has ever shown that (thermography) is an effective screening tool for finding breast cancer early. It should not be used as a substitute for maammogram. [2]

 

  1. 1. FDA, FDA Safety Communication:Breast Cancer Screening-Thermography is Not an Alternative to Mammography, 2011
  2. 2. ACS. Newer and experimental breast imaging methods, 2011

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