FDA Proposes Mammography Rule To Give Women Information About Dense Breasts, A Reason For Increased Cancer Risk
While three dozen states have rules involving breast-density notifications, the new rule would apply nationwide and update regulations for the first time in 20 years.
The New York Times:
Mammogram Centers Must Tell Women If They Have Dense Breasts, F.D.A. Proposes
Centers that provide mammograms to screen for breast cancer will have to tell women whether they have dense breast tissue, which can increase the risk of cancer and mask tumors, the Food and Drug Administration announced in a proposed rule on Wednesday. Dense tissue can hide cancer from X-rays, making mammography less reliable. Women with dense tissue are often advised to have other screening tests in addition to mammograms, such as ultrasound or M.R.I. scans. (Grady, 3/27)
The Associated Press:
US To Require Breast Density Information After Mammograms
More than half of women over age 40 have dense breasts, with less fatty tissue and more connective and glandular tissue. That tissue appears white on X-rays, the same color as growths in the breast, making mammograms harder to read. Dense breast tissue is one of the factors that can increase a woman's chances of developing cancer. Under the FDA's proposal, all women would receive a short summary about their breast density. For those with dense breasts, the letter would note that their tissue "makes it harder to find breast cancer," and could require additional testing. The letter would also recommend that they speak with a doctor about their "individual situation." (3/27)
The Washington Post:
FDA Proposes Mammography Rule To Provide Women With Information About Breast Density
Three dozen states, including California, already have laws involving breast-density notifications but the new FDA language would establish a minimum standard that would apply nationwide. The proposal would modernize the agency’s oversight of mammography services “by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” FDA Commissioner Scott Gottlieb said in a statement. In addition, the changes would allow the FDA to directly notify patients and their healthcare providers if a facility did not meet quality standards and a repeat test might be needed, the agency said. (McGinley, 3/27)
Modern Healthcare:
FDA Proposes First Changes To Mammography Standards In 20 Years
The agency on Wednesday issued its first proposed change in 20 years to regulations governing mammography facilities. Dr. Laurie Margolies, section chief of breast imaging at Mount Sinai Health System in New York, said having a national standard should requires providers to give information that is most relevant toward the care of that individual patient. "What's important for the patient to understand is ... what they may do in addition to mammography to find some cancers that might be masked by the dense breast tissue and therefore might not be found until a later time," Margolies said. (Johnson, 3/27)
