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 MQSA ensures that mammography is safe and
reliable and that breast cancer is detected in its most treatable stages.

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.

Mammography is the best method for detecting
breast cancer in its earliest stages.

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.

Mammography can find 85 to 90 percent of breast cancer in women over 50
and can discover a tumor up to two years before a lump can be felt.

Although a mammography device like the one above failed to detect Meg Long's breast cancer, she continues to visit Norman Radiology Services, Inc., for her annual screening. Long, who is now cancer-free, works with the American Cancer Society to help other women battle breast cancer.

Ensuring High-Quality Mammography

FDA first turned its focus on mammography following a 1974 Pennsylvania report. A state inspector had found that some mammography techniques used in different facilities had resulted in a few extremely high doses of radiation.

"That was the first time there had ever been any real attention paid to mammography--how it was being conducted and what was happening," says Richard Gross, recently retired from FDA's Center for Devices and Radiological Health.

In an effort to reduce the exposures, two voluntary programs were developed between 1975 and 1985 that involved industry working to improve the equipment. Mammography techniques began to change and radiation doses began to decrease.

"But we were concerned that much of the pressure to reduce the dose might have the effect of compromising image quality," Gross says. One program conducted, for example, showed that some images were found to be so bad that it would have been very difficult to detect anything. And these were issues over which FDA, at the time, had no regulatory authority and which had to be corrected within the facility. The American College of Radiology agreed to try to help correct the problem and in 1987 established its voluntary mammography accrediting program. FDA regulated the equipment, and ACR policed the facilities.

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. Meg Long's tumor was one of them.

When the 56-year-old Norman, Okla., resident found a lump in one of her breasts in the middle of the night in 1988, a mammogram only hours later failed to detect any signs of the mass. NCI says if a woman's tumor at the particular time she has a mammogram is the same density as the surrounding breast tissue, it may not show up on the x-ray. Fortunately for Long, the tumor appeared on an ultrasound taken immediately following the mammogram.

In short, occasionally mammograms may miss cancer that is present or may indicate 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 NCI, occur more often in women under age 50.

Breast implants can also impede 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 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.

Occasionally mammography may miss cancer that is present
or may indicate something that is not cancerous.

NCI agrees that women in their 40s who are at average risk for breast cancer should have a screening mammogram every one to two years. In addition, the institute says women who are at increased risk due to a genetic history of breast cancer, or who have had breast cancer, may need to get mammograms at an earlier age and more frequently.

For example, women who carry either of two genetic mutations called BRCA1 and BRCA2 were advised in 1997 guidelines by the National Genome Research Institute to begin getting annual mammograms between the ages of 25 and 35. These women, ACS advises, should seek medical advice about when to begin having mammograms and how often to be screened.

According to NCI, many women claim they have--or don't have--mammograms based on whether or not their doctors routinely recommend them. NCI advises that if your doctor fails to remind you about routine mammograms, it is important for you to take charge of your own health care and remember to raise the issue.

"Cutting life short because I did not take charge of my health would have been such a waste," says Pfefferkorn. "The advances in treatment and early detection are there until we find a cure."

Carol Lewis is a staff writer for FDA Consumer. Judith Willis, a member of FDA's public affairs staff, contributed to this article.

When Should a Woman Get a Mammogram?

Breast cancer strikes about 180,000 American women yearly and kills about 44,000, according to both the American Cancer Society (ACS) and NCI. Next to skin cancer, breast cancer is the most frequently diagnosed cancer in women in the United States. It is second only to lung cancer in cancer-related deaths. Although the risk of developing the disease increases as a woman gets older, it can occur in young women and even in a small number of men.

While there has never been a disagreement on the health benefits of annual screening mammograms for women age 50 to 69 according to ACS, there has been a split among health-care organizations about when and how often women in other age groups should get a mammogram. Current guidelines from ACS recommend women age 40 to 49 have a routine screening mammogram every one to two years, with the first one beginning at age 40.