Effective Sept. 10, the FDA required healthcare facilities providing breast imaging services to notify patients of their breast density in mammography reports. Now, some experts are expressing concern over the new mandate, according to an Oct. 12 report from NBC News.
The majority of concerns stem from the lack of guidance over how to proceed once a patient has been identified as having dense breasts, particularly recommendations on additional imaging procedures.
"You cannot counsel an entire population of women with dense breasts with one policy that’s going to be appropriate for everybody," Mark Pearlman, MD, emeritus professor at Ann Arbor-based University of Michigan Medical School, told NBC News.
Nina Vincoff, MD, division chief of breast imaging for New Hyde Park, N.Y.-based Northwell Health, shared similar concerns when she spoke to Becker's about the new rule in September.
"There aren't clear guidelines around the next steps," Dr. Vincoff said. "What might make you choose ultrasound versus MRI? That information isn't spelled out anywhere for people in this letter and doctors might not be aware of some of those distinctions."
Nancy Keating, MD, professor of health care policy at Harvard Medical School, questioned whether the benefits of additional imaging outweighed the potential harms of false-positive diagnoses, according to the NBC News report.
MRI-aided breast cancer screenings have been shown to contribute to false-positive biopsy recommendations while simultaneously preventing cancer deaths, according to a recent study.
Hilary Marston, MD, the FDA’s chief medical officer, highlighted how the notifications can empower patients to have more informed conversations with their physicians.
"We really wanted to make sure that women had the information that they needed in plain language to make good decisions for their own health," Dr. Marston told NBC News.