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FDA Sets Higher Standards for Mammography

Mammography is the best method for detecting breast cancer in its earliest stages, when the disease is most successfully treated and there are more treatment options. According to the National Cancer Institute, studies have shown that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 74, especially for those over age 50. But studies done to date have not shown a benefit from regular screening mammography in women under age 40, or from baseline screening mammograms (mammograms used for comparison) taken before age 40. 

Mammography Quality Standards Act

As important as mammograms are, they are only worthwhile if the equipment is properly maintained and the personnel properly trained. The primary objective of the Mammography Quality Standards Act (MQSA) is to ensure that mammography is safe and reliable and that breast cancer is detected in its most treatable stages. The FDA has the responsibility for implementing and enforcing MQSA, which requires that all mammography facilities in the United States meet certain stringent quality standards, be accredited by an FDA-approved accreditation body, and be inspected annually.

Limitations of mammography

Despite its usefulness, mammography is not foolproof. The National Cancer Institute (NCI) says that some breast changes, including lumps that can be felt, do not always show up on a mammogram.

In short, occasionally mammograms may miss cancer that is present or may show something that can turn out not to be cancerous. Because the procedure is not as sensitive for the denser breast tissue in younger women, these false readings, according to the NCI, occur more often in women under age 50.

Breast implants can also make it harder to get accurate mammogram readings because silicone implants are not transparent on X-rays and can block a clear view of the tissues behind them, especially if the implant has been placed in front of, rather than beneath, the chest muscles. But the NCI says that experienced technologists and radiologists know how to carefully compress the breasts to improve the view without rupturing the implant. When making an appointment for a mammogram, women with implants should ask if the facility uses special techniques designed to accommodate them. And before the mammogram is taken, they should make sure the technologist is experienced in X-raying patients with breast implants.

How to find a certified mammography facility

The NCI can be reached by calling 800-422-6237 (TTY: 800-332-8615) where you can get a list of the certified mammography facilities in your geographic area. An NCI Information Specialist is available to answer cancer-related questions and to make referrals for free or low-cost mammography exams.

A searchable list of these facilities is also available on the FDA website

While not certified under MQSA, the Veterans Administration facilities operate under a similar program. For information about these facilities, call the VA Mammography Help Line at 888-492-7844.


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