The U.S. Food and Drug Administration proposed new rules Wednesday that will require mammogram centers to tell women more about how dense breast tissue can affect their health and increase their cancer risk.
The proposal aims to identify breast cancer risks earlier, amending regulations under the Mammography Quality Standards Act of 1992.
"The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions," FDA Commissioner Scott Gottlieb said in a statement.
Women with dense breasts will be notified that they are at a higher risk of developing breast cancer and that X-ray results aren't always as accurate for them, because tumors can go undetected behind dense tissue. Some states already require centers to provide this information to patients.
More than half of women over the age of 40 in the U.S. have dense breasts, FDA Principal Deputy Commissioner Amy Abernethy said.
The FDA language will tell women if they should consider more imaging tests or talk to their doctors about their mammogram results.
“Breast cancer is one of the most worrisome health concerns facing women ... As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services," Gottlieb said.
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The American Cancer Society recommends women ages 45 to 54 go for mammograms every year and women 55 and older go at least every two years.
The FDA proposal is open for public comment for 90 days and then will undergo another review before becoming final.
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https://www.usatoday.com/story/news/health/2019/03/28/breast-cancer-screening-fda-mammogram-changes/3296714002/
2019-03-28 13:25:00Z
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