Under new FDA rules, practitioners will have to tell patients about breast density on mammograms

The US Food and Drug Administration has updated its mammography rules that apply to doctors and medical centers across the country.

Under the new rules, mammography facilities will have to inform patients about the density of their breasts. About half of American women over the age of 40 have so-called dense breasts. The presence of this type of tissue is associated with a higher risk of developing breast cancer and can make diagnosis of the disease more difficult.

So far, similar laws have already been adopted in 38 states, including Colorado and Minnesotathis is the first nationwide regulation.

The new rules will also “strengthen FDA oversight and oversight of facilities and help interpreting physicians better classify and rate mammograms,” the agency – says the press release.

“Today’s action represents the agency’s broader commitment to support innovation in the prevention, detection and treatment of cancer,” said Dr. Hilary Marston, FDA chief medical officer. “Since 1992, the FDA has worked to ensure that patients have access to quality mammograms. The public health impact of the Mammography Quality Standards Act has been significant, including a dramatic reduction in the number of facilities that do not meet quality standards. This means that more women have access to regular and high-quality mammography. We remain committed to advancing efforts to improve women’s health and strengthen the fight against breast cancer.”

What is dense breasts?

Dense breasts or dense breast tissue is a term used to describe the appearance of some breasts on mammograms. Dense breasts have less fat and more tissue, so lumps or other growths may not be visible on images taken with a standard mammogram. On a mammogram, both the formation and the tissue look white.

Dense breasts are very common, according to the word National Cancer Institute, an organization of the National Institute of Health. About half of women over 40 in the United States who have mammograms are found to have dense breasts. The condition is often inherited, but it can also be affected by the use of hormone therapy during menopause and a low body mass index, according to the institute.

Dense breasts cannot be detected by self-examination or clinical examination, but only by mammography.

Having dense breasts is associated with The risk of developing breast cancer is 1.2-4 times higher. However, according to the institute, there is no link between dense breasts and death from breast cancer. According to the FDA, 1 in 8 women will develop breast cancer in their lifetime.

What do the FDA changes mean?

The FDA’s changes are amendments to regulations issued under a 1992 law that gave the FDA oversight of mammography facilities, but only now has the FDA used the law to require facilities to inform women that they have dense breast tissue.

The requirements must be met within the next 18 months, the FDA said in a news release. The amendments include “specific language that explains how breast density can affect the accuracy of mammography,” and recommend that patients with dense breasts talk to their health care providers about their individual situation and risk.

“While nearly all certified mammography facilities continue to meet quality standards, today’s updates, among other things, expand FDA’s ability to communicate directly, when appropriate, with patients and their healthcare providers in cases where a facility does not meet quality standards and does not adequately communicate with “This is intended to ensure that important information that may affect patient care decisions, such as the potential need for further testing or a repeat mammogram, is communicated as much as possible.” in detail”.

The FDA said the changes bring the 1992 law “into the 21st century” and use the best of modern science and mammography to improve breast cancer detection and empower patients.

The changes do not require mammography facilities to use more intensive tools to detect breast cancer. People with dense breasts can use other imaging tests, such as ultrasound or MRI, but the U.S. Prevention Task Force, an independent panel of experts that issues screening guidelines, said this it is not yet clear whether the use of these additional tests is beneficial.

The FDA continues to recommend that people get regular mammograms. The task force advises women ages 50 to 74 get mammograms every year. Younger women may also choose to be screened based on individual risk factors and family history.