FDA proposes rule to notify women with dense breasts of higher cancer risk and imprecise mammograms

The Food and Drug Administration is proposing a new rule for breast cancer screenings that would require doctors to give women more information about the risks associated with dense breasts, the agency said in a statement Wednesday.

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                                                                                                        The agency wants doctors to ensure patients understand how dense breasts, which don't have a lot of fatty tissue, can skew the accuracy of mammograms and present a higher risk of developing breast cancer later in life.  Approximately 12.4 percent of all women are diagnosed with breast cancer at some point in their life, the FDA said, citing data from the National Cancer Institute.

                                                                                                                                                                "Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy," FDA Principal Deputy Commissioner Amy Abernethy said in a statement.

                                                                                                                                    Mammograms are considered the best way to detect breast cancer. However, they're not as reliable in dense breasts, characterized as those with not as much fat and more fibrous or glandular tissue, according to the American Cancer Society. Dense breast tissue makes it harder for doctors to see cancer, meaning the tests can be less accurate.

                                                                                                                                                                "Mammograms of dense breasts ... can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image," the FDA said. "Dense breasts have also been identified as a risk factor for developing breast cancer."

                                                                                                                                                                The FDA is proposing specific language to explain how density may skew the results and to encourage women to talk to their doctor about how this relates to cancer risk and their individual situation. The agency also wants to tighten its regulation of mammography facilities, including with the ability to notify patients that testing did not meet the FDA's quality standards. The rule will be open for public comments for the next 90 days. 
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