Doctors throughout the United States may soon be required to provide women with more information on the results of their mammogram. This week, the Food and Drug Administration announced its intention to update a rule that would require doctors to tell patients if they have dense breast tissue, a complicated risk factor for breast cancer.
Thanks to the Mammography Quality Standards Act of 1992, the FDA has the power to certify, regulate and inspect clinics and hospitals where mammograms are offered annually. As a result, it can also generally define standards for how these services are provided. According to the agency, the proposed rule change would be the first major to go into production for over 20 years.
"As part of our overall commitment to protecting women's health, we are proposing new policies to modernize our supervision of mammography services, capitalizing on a number of important advances in mammography, such as the increased use of 3-D digital screening tools and the need for more uniform reports on breast density, "FDA commissioner Scott Gottlieb said in a statement.
There are different types of dense breasts, but generally the term describes having more fibrous and / or glandular tissue than adipose tissue. About half of women in the United States are considered to have dense breasts, with 10 percent having particularly dense breast tissue.
However, the relationship between breast density and cancer risk is complex. By itself, dense breast tissue is associated with a higher risk of cancer, a risk that increases the denser tissue you have. But dense tissue can also make it harder to read the results of a mammogram, since its white appearance on an X-ray may seem very similar to tumors and other abnormal changes in the breast.
This means that doctors are often less confident that a woman with dense breast tissue is actually at high risk. So these women tend to be advised to get more tests, which may include other imaging techniques like MRI or ultrasound. But while this may seem harmless, it is still unclear whether further tests for these women (particularly those without a family history of breast cancer or other important risk factors) are useful most of the time. In the case of false positives, it could very well be an unnecessary source of stress.
In many states, doctors are already obliged to inform patients in advance about their breast density. But changing FDA rules would set a minimum standard for reporting. This standard would require doctors to also explain the complex nature of breast density to their patients. At present, only a handful of states require insurers to automatically cover any additional tests for this particular risk group.
The FDA plan has not come out of nowhere. In February, an expense account clause that prevented another partial arrest from the government asked the agency to develop these standards for breast density, part of a long-term effort by grassroots activists that is been amplified by senators including Dianne Feinstein (D-California).
Currently, the US Preventive Services Task Force recommends that the average woman get mammograms every two years from 50 to 74, while high-risk women could start at age 40. The American Cancer Society, however, recommends that women receive mammograms annually at the age of 45, moving once every two years from the age of 55 onwards.
. (tagToTranslate) Breast cancer (t) women's health (t) Science (t) Gizmodo