Mammography: Early Detection, What Is a Mammogram?

by Food and Drug Administration (FDA)

Janie Pfefferkorn knows all too well the value of having a mammogram. She believes the procedure saved her life.

"I owe a great deal to the American Cancer Society for educating me and other women about the importance of having regular mammograms and doing self-examinations," says the 47-year-old Sikeston, Mo., resident.

Following a routine mammogram in June 1996, Pfefferkorn received a call from her physician saying there was an area of concern in one of her breasts. A follow-up visit and second mammogram the next day both identified an abnormal area. A biopsy taken shortly after revealed that Pfefferkorn was in the early stages of breast cancer.

The Key to Early Detection

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. Mammograms can find 85 to 90 percent of breast cancers in women over 50, and can discover a tumor up to two years before a lump can be felt. In some cases, finding a breast tumor early may mean a woman can choose breast-saving surgery, and she may not need chemotherapy.

Although Pfefferkorn wasn't so fortunate — she was hospitalized for two days in 1996 for a mastectomy and underwent chemotherapy over the next five months — the mother of four daughters feels lucky to be alive.

"Early detection saved my life," she insists. "My girls have the mind-set now to take care of themselves after what we've been through."

The 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) of 1992 is to ensure that mammography is safe and reliable and that breast cancer is detected in its most treatable stages. The Food and Drug Administration 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.

The final regulations for MQSA, which go into effect April 28, 1999, toughen the 1994 interim standards for personnel, equipment, quality assurance and quality control, and requirements for accreditation bodies. For example, physicians who interpret mammograms must now be board certified or have three months of training in mammography, technologists must keep their skills current by doing an average of 200 mammograms every two years, and medical physicists, who survey mammography equipment and facilities, must meet initial and continuing education and experience requirements.

Of significant importance to women is the MQSA regulation that requires mammography facilities to give patients an easy-to-read report on the results of their mammogram. Prior to MQSA, mammography facilities were not required to communicate results directly to patients and, instead, sent results only to the referring physician. Referring physicians will continue to receive the results. Self-referred patients with no designated health-care provider will receive both the simplified report and the one doctors normally receive.

MQSA also clarifies a facility's responsibility to retain and transfer mammograms to a patient's physician or to the patient directly, regardless of whether the transfer is permanent or temporary. This is important because it aids diagnosis by allowing doctors to compare old mammograms with new ones.

In addition, the final regulations:

• better define equipment capabilities needed for high-quality mammography
• require more quality control of mobile mammography units
• set standards for imaging breast tissue in women who have implants
• provide for additional clinical review and patient notification when a facility's images are determined to be substandard and a risk to health
• balance cost with need for mammography to be accessible
• require each facility to have a way for consumers to file complaints or voice concerns about the facility.

To be MQSA-certified, a mammography facility must be accredited by a federally approved private, nonprofit or state accreditation body. FDA has approved the American College of Radiology (ACR) and the states of Arkansas, California and Iowa as accreditation bodies. The agency will announce additional states that become approved.

To be accredited, the facility must apply to an FDA-approved accreditation body, undergo periodic review of its clinical images, have an annual survey by a medical physicist, and meet federally developed quality standards for personnel qualifications, equipment quality assurance programs, and record keeping and reporting. The facility must also undergo an annual inspection conducted by federally trained and certified federal or state personnel. A certificate is required to be displayed at the facility. FDA encourages women getting mammograms to look for this certificate.

What Is a Mammogram?

A mammogram is an x-ray picture of the breast. It uses a dedicated x-ray machine specifically designed for that purpose, as opposed to machines that take x-rays of the bones or other body parts.

Mammograms that look for breast changes in women who have no signs of breast cancer are called "screening" mammograms. The standard screening mammogram includes two views of each breast, one from above and one angled from the side. A trained technologist places the breast on a plastic plate. A second piece of plastic is placed on top and for a few seconds, some pressure is applied to flatten the breast and get a picture. This may be temporarily uncomfortable, but it is necessary to flatten the breast as much as possible because spreading out the tissue makes it easier to spot any abnormal details. The doses of radiation used for mammography are very low and considered safe. The entire mammography procedure lasts about 15 minutes, and the average cost is between $100 and $150. After the procedure, a radiologist reads and interprets the x-ray image of the breast tissue that the mammogram produces.

The M1000 ImageChecker, a computerized device that analyzes the content of mammograms and highlights suspicious areas on the images after the radiologist has done the initial evaluation, is the latest FDA-approved mechanism for improving cancer detection. The device, made by R2 Technology, Inc., Los Altos, Calif., and approved in June 1998, scans the image with a laser beam, then converts it into a digital signal that a computer can process. After the computer marks suspicious areas on a video display of the image, the radiologist can compare the image to the original mammogram to see if any of these areas escaped notice and require further evaluation. The device has been shown to improve radiologists' detection rate from approximately 80 out of 100 cancers to almost 88 out of 100.

If problems are noted, a second "diagnostic" mammogram may be needed. Diagnostic mammograms are also used to assess specific symptoms or unusual breast changes such as a lump, pain, nipple thickening or discharge, or changes in breast size or shape.

About the Author

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