FDA Proposes Changes to Mammography Standards to Inform Women About Breast DensityElizabeth Nelson
The U.S. standards for mammography procedures have remained largely unchanged for more than 20 years. But that may soon change, as the FDA has proposed some new rules to modernize and improve the quality of breast cancer screening, as well as ensure that woman are informed about their risk.
One of the main updates to the 1992 Mammography Quality Standards Act will require health care professionals to supply patients with a letter along with their mammogram results that will inform them about their breast density and what it means for their breast cancer risk.
Normal non-dense breast tissue appears black or gray on a mammogram, but dense breast tissue shows up as white, making the image more difficult to read, as it can obscure cancerous tumors, which also appear white on the image.
According to the FDA, “the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image,” and they can also be a risk factor for breast cancer. Because more than half of women over age 40 have dense breasts, which means they have less fatty tissue than “normal” and more connective and glandular tissue instead, it’s important that they be made aware of their risk level and other testing that may be necessary to rule out breast cancer.
The proposal states, “The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.”
More than three dozen U.S. states already require notices of breast density with mammogram screening results, but if finalized, the FDA’s proposal would make this requirement standard across the nation, effectively raising the bar for keeping patients informed and ensuring the use of a standardized summary language.
Another proposed change involves adding potential categories for labeling the results. Currently, the possible ways to categorize mammogram results include, “negative,” “benign,” “probably benign,” “suspicious,” “highly suggestive of malignancy” or “incomplete: need additional imaging evaluation.” The FDA would like to add these to that list: “known biopsy proven malignancy,” “post-procedure mammograms for marker placement,” and “incomplete: need prior mammograms for comparison.”
The new categories will help screening facilities “more precisely classify” women’s mammograms and give patients a better understanding of their results so that they can make good informed decisions moving forward. If a facility fails to comply, the FDA would have the authority to contact patients directly to let them know that their mammogram provider is not meeting quality or disclosure standards.
There have also been many advancements in mammography technology, such as cross-sectional 3-D mammograms, since the 26-year-old guidelines were put in place. The new proposed guidelines take these advancements into account and aim to work with them effectively.
Perhaps most importantly of all, the new guidelines will put the FDA in a position to be able to enforce their regulations more effectively and take action against those who don’t comply. The FDA would have a stronger ability to revoke permissions and suspend operations in facilities where their standards were not being met. They would also be able to penalize facilities that don’t keep adequate records of patient information.
The public will be allowed to submit comments on the proposed changes for the next 90 days, after which time the proposal may be modified based on those comments before becoming final.
The recommendations for frequency of mammograms, as set by the American Cancer Society, will remain the same. The ACS recommends mammograms every year for women between the ages of 45 and 54 and every second year after that for as long as a woman is in good health (i.e. expected to live another 10 years). Women younger than 45 should be given the choice to start annual mammograms.