FDA is looking to revamp current breast cancer screening practices. The agency has made a proposal to amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which Congress passed to ensure quality mammography for early breast cancer detection.
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. FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.
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.
In addition, under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications.
"Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication," Jeff Shuren, MD., J.D., director of FDA's Center for Devices and Radiological Health, said in a release. "While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today's proposed regulations would enhance FDA's ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities' deficiencies. This is intended to help ensure important information that could affect decisions about patient care—such as the potential need for further evaluation or a repeat of a mammogram—is communicated as quickly as possible."
The agency’s proposal comes shortly after it warned several facilities against illegally marketing and distributing unapproved thermography devices as a sole screening device for breast cancer and other diseases.