ACOG reaffirmed its committee opinion (2020) regarding additional testing following detection of dense breasts on mammography in response to a proposed FDA rule of that year (see below). The final FDA rule is expected to be released by the end of 2022. Currently, ACOG states unequivocally that healthcare professionals comply with all laws, evidence is lacking as to clinical utility and improved outcomes with additional screening and testing.
Therefore, currently ACOG
…does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.
The College strongly supports additional research to identify more effective screening methods that will enhance meaningful improvements in cancer outcomes for women with dense breasts and minimize false-positive screening results.
There are multiple states that do have laws requiring breast density notification after mammography, while some states do not necessarily require notification, but do require effort be made to inform and educate. The government, in the funding bill (February 2019) directed the FDA to ensure, at a minimum, language in mammography reports that includes
Effect of breast density in masking the presence of breast cancer on a mammogram
The qualitative assessment of the provider who interpreted the mammogram
A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary
Note: The proposed FDA rule (2019) proposes the following
Require reporting to patients and healthcare providers to include an assessment of breast density, in order to provide them with additional information about their mammography and the potential limitations of their mammogram results so they and their healthcare providers can make informed healthcare decisions
FDA is proposing to amend the mammography reporting requirements in § 900.12(c) to require that the written report of the results of the mammographic examination provided to the healthcare provider and the lay summary of the results provided to the patient also include information concerning patient breast density
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