For
the first time in 27 years, the FDA has proposed amending mammography
screening regulations. On March 27, 2019, the FDA proposed policy
changes to modernize mammography services. “Among the proposed
amendments to improve communication and medical decision making is the
addition of breast density information to the mammography
lay summary letter provided to patients and to the medical report
provided to their referring health care professionals. Mammograms of
dense breasts—breasts with a higher proportion of fibroglandular tissue
compared to fatty tissue—can be difficult to interpret because the dense
tissue can obscure signs of breast cancer
and lower the sensitivity of the image. Dense breasts have also been
identified as a risk factor for developing breast cancer,” according to
an FDA news release.
The
proposed amendments also seek to enhance information provided to health
care professionals by proposing to codify three additional categories
for the assessments of mammograms, including adding an important
category titled “known biopsy proven malignancy,” which would help
identify for health care professionals those cases where cancer being
mammographically evaluated for therapy are already known and identified.
The proposed amendments would also modernize mammography quality
standards and better position FDA to enforce the MQSA regulations and
take action when violations are found.
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