Wednesday, 26 June, 2019

FDA proposes changes to mammography regulations

FDA changes mammogram policies to provide women with breast density information Women Must Get Breast Density Information Along With Mammograms: FDA
Anna Jefferson | 29 March, 2019, 22:12

Prior research has shown that breast density surpasses all other known risk factors for developing breast cancer, including having a personal history of benign lesions or a family history of the disease.

Another proposed rule meant to provide more information to health care providers would add three additional categories for the assessments of mammograms, including one called "known biopsy proven malignancy", which would alert health care providers about cases where cancer being evaluated by mammogram for treatment is already known and identified.

The FDA is proposing language that would outline how breast density can influence the accuracy of mammography and recommend that patients with dense breasts talk to their healthcare provider about their breast cancer risk.

Doctors say tumors are more hard to detect in mammogram images of dense tissue. Providers in nearly 40 states are required to give patients some information about breast density - though not necessarily about their own personal risk - but the FDA's rule would codify such policies at a national level. Women with dense tissue are often advised to have other screening tests in addition to mammograms, such as ultrasound or M.R.I. scans.

The proposed changes would add information about breast density to the letter given patients and reports sent to referring medical professionals.

The "much needed" proposed changes would give the FDA appropriate oversight of breast imaging and mammography practices, including recent technologic advances such as digital breast tomosynthesis mammography, said Stamatia Destounis, MD, of Elizabeth Wende Breast Care in Rochester, New York.

Mammograms of dense breasts are known to be more hard to read and interpret.

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Dense breasts are hardly an anomaly; at least half of women have a high ratio of of fibroglandular tissue to fatty tissue.

According to the National Cancer Institute, more than 260,000 women in the United States were diagnosed with breast cancer in 2018, and more than 40,920 women died from breast cancer that year. "We look forward to working with FDA through the details of this process to ensure that any updates to FDA regulations improve patient care and efficiency of care provided".

The Food and Drug Administration's proposed rules would standardize the information given to millions of women following scans to detect breast cancer. The agency also proposed to include a recommendation that patients with high breast density have a conversation with their provider to learn more about how breast density correlates with cancer risk.

The FDA can directly notify patients and their healthcare professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that re-evaluation or repeat of the mammogram at another certified facility may be needed.

FDA issued a proposed rule Wednesday aimed at improving "robust oversight" of mammography facilities. They also suggest requiring only digital accessory components that are specifically FDA-approved or cleared for mammography be used and strengthening record-keeping requirements.

The FDA has shared the proposed amendments online for public comment for 90 days post-publication.

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