Answers 11/17/1992
T92-54 Sharon Snider
Nov. 17, 1992 (301) 443-3285
FDA URGES WOMEN TO GET HIGH-QUALITY MAMMOGRAPHY
FDA has been receiving inquiries about a study on mammography published
recently in the Canadian Medical Association Journal. The seven-year study
indicated that annual mammography screening did not significantly reduce the
death rate from breast cancer in women 40-49 or women 50-59.
While these data are being reviewed further, FDA will continue to work
closely with the National Cancer Institute (NCI) and the Centers for Disease
Control to encourage women to obtain high-quality mammography.
Mammograms are low-level x-rays of the breast that can pick up tiny
cancers before they can be felt. As women age, the risk of breast cancer
increases. For older women in particular, mammograms continue to be the
most effective way to detect cancer in its earliest, most treatable stages.
High quality mammography can detect 85 to 90 percent of breast cancers
in older women. It can lead to detection of tumors up to two years before
they can be felt. Other studies have shown that deaths due to breast cancer
can be reduced by 30 percent among women age 50 and older through
mammography and regular physical exams.
Since a poor quality mammogram can cost a woman her life, women should
make sure that the facilities they patronize are equipped and staffed to
provide high quality service.
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Page 2, T92-54, Mammograms
FDA recommends that if possible women look for facilities that are both
accredited by the American College of Radiology (ACR) and certified for
mammography by Medicare. This will help ensure that the facility produces
quality mammograms, accurately reads and interprets the x-ray films and
accurately reports results to a woman's doctor or to the woman herself.
Women should consult with their doctors on their individual needs for
mammography. ACR-accredited facilities can be located by calling a local
American Cancer Society chapter or NCI's Cancer Information Service at
1-800-4-Cancer.
Once an accredited facility is located, women should ask if it is also
certified by Medicare for mammography screening. If there are no
credentialed facilities nearby, women should ask their doctors for the
location of another reliable facility.
The ACR voluntary accreditation program was started in 1987 after
studies conducted by the Conference of Radiation Control Program Directors,
with FDA support, showed that mammographic quality needed improvement. As
of Nov. 2, 1992, nearly 5,000 mammography facilities in the United States
had been accredited. Accreditation must be renewed every three years.
The Medicare certification program, established when Congress authorized
Medicare reimbursement for screening mammography, went into effect Jan. 1,
1991. This program ensures that women eligible for Medicare are provided
quality mammography.
Breast cancer now strikes one in eight women in the United States over a
lifetime, and the incidence is on the rise. More than 1.5 million new cases
of breast cancer will be diagnosed this decade.
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Page 3, T92-54, Mammograms
In 1992, Congress passed the Mammography Quality Standards Act, which
provides for inspection and certification of mammography facilities. It
also provides for data collection to evaluate the effectiveness of U.S.
breast cancer screening programs.