Health Canada reminds Canadians that thermograms are not a substitute for mammograms for breast cancer screening
- Starting date:
- September 28, 2017
- Posting date:
- September 28, 2017
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Important Safety Information, Medical Devices
- General Public
- Identification number:
OTTAWA - Health Canada is reminding Canadians and women in particular, that thermograms (which use thermal imaging) are not a substitute for mammograms used for routine monitoring and screening for breast cancer. While thermography devices are available in Canada, these devices have not been licensed in Canada to screen for breast cancer. They have been licensed by Health Canada only to measure skin temperature, similar to a thermometer.
Health Canada is not aware of any clinical evidence that thermography devices can be used effectively for the early detection of breast cancer. If women are relying solely on thermography results, there is a potential risk that cancer could go undetected.
Mammography, which is a low-dose x-ray system to see inside the breasts, is the most reliable technique in screening for early-stage breast cancer, and has been proven to be safe and effective. Specialized equipment used in mammography is licensed by Health Canada and is widely available across Canada.
Health Canada is following up with several manufacturers to inform them that it is prohibited to advertise or sell thermography devices (such as cameras and imaging systems) to screen for breast cancer in Canada. Heath Canada will also work with the Canada Border Services Agency to stop any non-compliant devices from entering the Canadian market.
Health Canada has previously communicated about this issue.
What you should do
- Women who have relied on thermograms for breast cancer screening should contact their physician for appropriate follow-up and testing.
- Women concerned about radiation exposure from a mammogram should know that the evidence shows that the benefits outweigh the risks, especially when compared to the danger of breast cancer.
- Patients should continue to have regular mammograms according to screening guidelines or as recommended by their health care professional.
- Patients should follow their health care professional's recommendations for additional diagnostic procedures, such as other mammographic views, clinical breast exam, breast ultrasound, MRI or biopsy.
- Anyone can report incidents or concerns involving a medical device to Health Canada.