FDA sets new rules for dense breasts cancer warning
The US Food & Drug Administration (FDA) has introduced new standards, making it compulsory for mammogram providers to tell women with dense breast tissue, who are higher risk of breast cancer, that their screenings might be difficult to interpret and recommend they consult their doctors about additional tests.
The new regulations must be implemented by providers within 18 months, said the agency.
Supporters of the FDA’s long-expected decision say the new standards will save lives by potentially detecting cancer earlier.
Breast cancer is the most common cancer among women, after skin cancer, and the second leading cause of cancer deaths among women overall, reports The Washington Post.
Thirty-eight US states already require that women be informed if their mammograms reveal dense breasts, but the language varies widely and does not always require providers to recommend that women seek guidance about additional tests. The FDA’s decision sets a minimum standard for about 8 700 facilities across the country, while states can still require even more in-depth language.
Some states currently tell women they have dense breasts, but nothing more, said JoAnn Pushkin, executive director of New York-based DenseBreast-info, a resource website that teached patients and health-care professionals about dense breasts.
“That’s really not enough to raise a red flag in a woman’s brain that they must communicate with a health provider and talk about additional screening,” said Pushkin, whose advocacy helped establish a New York law that since 2013, has required that women with dense breasts be told of their condition and suggests speaking with doctors about more testing.
Dense breasts have relatively less fatty tissue and higher amounts of glandular and fibrous connective tissue. Nearly half of all women 40 and over have the condition. Dense breasts can appear white on a mammogram, but so does cancer, making it difficult for radiologists to detect tumours.
Under the new standards, information about having dense breasts will be included in a “summary letter” mammography providers must give to patients. A fuller report will be sent to the patient’s physician.
The new regulations also tells women that mammograms, while the best screening test for detecting breast cancers, don’t always detect tumours and that other screenings might also be needed.
While there’s no universal consensus on what other tests are the most effective for detecting cancer in women with dense breasts, MRIs and ultrasounds are among the most common.