FDA: Breast thermography not a substitute for mammography
For Immediate Release: June 2,
2011
Media Inquiries:
JeffreyVentura, 301-796-2807, [email protected]
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FDA: Breast thermography not a
substitute for mammography
Telethermographic,
‘infrared’ devices not approved for primary cancer
screening
The U.S. Food and Drug Administration
today warned women not to substitute breast thermography for
mammography to screen for breast cancer.
Unlike mammography, in which an X-ray
of the breast is taken, thermography produces an infrared image
that shows the patterns of heat and blood flow on or near the
surface of the body. Some health care providers claim thermography
is superior to mammography as a screening method for breast cancer
because it does not require radiation exposure or breast
compression.
However, the FDA is unaware of any
valid scientific evidence showing that thermography, when used
alone, is effective in screening for breast cancer. To date, the
FDA has not approved a thermography device (also referred to as a
telethermographic device) for use as a stand-alone to screen or
diagnose breast cancer. The FDA has cleared thermography
devices for use only as an additional diagnostic tool for breast
cancer screening and diagnosis. Therefore, FDA says, thermography
devices should not be used as a stand-alone method for breast
cancer screening or diagnosis.
“Mammography is still the most
effective screening method for detecting breast cancer in its
early, most treatable stages,” said Helen Barr, M.D.,
director of the Division of Mammography Quality and Radiation
Programs in the FDA’s Center for Devices and Radiological
Health. “Women should not rely solely on thermography for the
screening or diagnosis of breast cancer.”
The FDA has issued warning letters to
some health care providers who have been promoting the
inappropriate use of breast thermography. The letters instructed
the providers to cease making claims that thermography devices,
when used alone, are an effective means of detecting breast cancer.
Claims have, for instance, appeared on some providers’
websites.
The FDA encourages women to:
• Have regular mammograms
according to screening guidelines or as recommended by their health
care provider;
• Follow their health care
provider’s recommendations for additional breast diagnostic
procedures, such as various mammographic views, clinical breast
exam, breast ultrasound, MRI or biopsy; additional procedures could
include thermography;
• Remember that thermography is
not a substitute for mammography and should not be used by itself
for breast cancer screening or diagnosis.
“While there is plenty of
evidence that mammography is effective in breast cancer detection,
there is simply no evidence that thermography can take its
place,” said Barr.
For more information:
Link to:
Safety Communication
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Department of Health and Human Services, protects the public health
by assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic radiation,
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