FDA Updates Mammography Regulations

On March 9, the FDA updated its regulations and required mammography facilities to inform all patients of their breast densities while reinforcing the FDA's errors and implementing facilities to guide medical professionals on mammogram evaluations.

"Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer," says the FDA’s Chief Medical Officer Hilary Marston, M.D., M.P.H.

One crucial update involves notifying patients about their breast density, and dense breasts are often linked with higher risks of a breast cancer diagnosis. Breast density refers to the amount of fibrous and glandular tissue in the breast contrasted with the fatty tissue. There are four categories of breast density:

  • Breasts are made almost entirely of fat, which occurs in about 10% of women
  • Some areas of dense tissue are dispersed through the breast, which occurs in about 40% of women
  • The breasts are generally dense, occurring to around 40% of women.
  • The breasts are severely dense, occurring to approximately 10% of women

Currently, 38 states in the United States require women to have their breast density results in a written form along with a potential breast cancer risk following mammography. Despite the mandate, healthcare providers do not always need to notify patients about their potential risks of getting breast cancer.

Marston continued: "Since 1992, the FDA has worked to ensure patients have access to quality mammography. The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer."

With FDA's change on March 9, all facilities will need to provide patients with information about their breast density and add specified language in the results to easily describe how breast density can affect mammogram results.

Furthermore, the FDA is advising facilities to communicate with their patients regarding breast density and its link with breast cancer, along with the individual consultation.

According to the CDC, approximately one in eight women will be diagnosed with breast cancer in their lifetime. To prevent further damage, it is recommended that people get mammography for early detection and prevention. The new regulation, modified from the Mammography Quality Standards Act of 1992, will necessitate all facilities for execution within 18 months.

The agency concluded: "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 mammogram, is communicated as completely as possible."



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