Health Care

FDA Says Breast Density Must Be Reported to Women During Mammograms

FDA Says Breast Density Must Be Reported to Women During Mammograms”

Under new guidelines, USA women undergoing mammograms would receive extra information about breast density, which can sometimes make cancer harder to spot.

"We're trying to facilitate a conversation about breast cancer screening between the patient and their healthcare professional", he said. Nuclear medicine equipment service provider since 1975.

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.

The proposal would amend the Mammography Quality Standards Act of 1992 (MQSA), which authorizes agency oversight over mammography facilities, and would "better position FDA to enforce the MQSA regulations and take action when violations are found", according to the agency.

Among other changes, the FDA wants information about breast density in both the mammography lay summary letter given to patients and in the medical report provided to referring physicians. It also can make it harder for health care providers to see malignancies on mammograms.

The issue has become increasingly important amid findings that dense breasts raise a woman's risk of developing breast cancer.

Breast density information is not new to mammography reporting but remains important for patients and clinicians, according to a statement from the American College of Radiology (ACR).

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Visitors walk past a sculpture of a pink ribbon installed to promote the "Pink Ribbon" breast cancer awareness campaign at Cheonggye Stream in central Seoul October 5, 2011.

More than three dozen states already have laws involving breast-density notifications. In turn, this would result in more informed decision-making - especially when it comes to breast cancer diagnoses. Women with dense tissue are often advised to have other screening tests in addition to mammograms, such as ultrasound or M.R.I. scans.

"We believe the proposed rule would help empower patients and healthcare professionals by proposing improvements to the information facilities communicated to them, helping to facilitate the sometimes hard conversations about potential risks for breast cancer", FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement. "We look forward to working with FDA through the details of this process to ensure that any updates to FDA regulations improve patient care and efficiency of care provided". It said that in 2018, more than 260,000 women in the USA were diagnosed with breast cancer and more than 40,920 women died of the disease.

The proposed amendments to MQSA would also help the FDA crack down on mammogram facilities and ensure that they are following quality standards.

The FDA can directly notify patients and their healthcare professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that re-evaluation or repeat of the mammogram at another certified facility may be needed.

The U.S. Office on Women's Health has more about mammography.

The FDA is taking comment on the proposed rule for 90 days after it is published March 28 in the Federal Register.



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