Roughly half of USA women in their 40s and 50s have dense breast tissue, which increases their risk of breast cancer and makes it harder to detect tumors with mammography. "Supplemental screening tests such as screening whole breast ultrasound, MRI or MBI are not a substitute for mammography because there are still some cancers and precancerous changes that will show on a mammogram better than on other tests". Nuclear medicine equipment service provider since 1975.
Among other proposed changes, the policy would require mammography providers to inform patients who undergo the breast cancer screening test if they have dense breast tissue, which may both warp the results of a mammogram by obscuring signs of cancer, and increase the risk of developing breast cancer in the first place.
The agency on Wednesday issued its first proposed change in 20 years to regulations governing mammography facilities.
The biggest change is the addition of breast density information to letters sent by mammography facilities to women and their referring healthcare providers after the mammogram.
"Mammography is still the gold standard for the detection of breast cancer, even for women with dense breasts, and multiple studies have proven that detection of cancers by mammography reduces the risk of death due to breast cancer for women starting at age 40", Tuite, who wasn't involved in the study, said by email.
The proposal would update regulations issued under the 1992 Mammography Quality Standards Act, which authorized federal oversight of the more than 8,000 mammography facilities in the United States.
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Dense breasts are also known to be a risk factor for breast cancer. "The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed", said Dr. Scott Gottlieb, outgoing FDA commissioner, in a prepared statement March 27. Accordingly, more than 30 states between 2009 and 2018 established their own laws requiring some level of patient notification of breast density. "What's important for the patient to understand is. what they may do in addition to mammography to find some cancers that might be masked by the dense breast tissue and therefore might not be found until a later time", Margolies said.
According to the National Cancer Institute (NCI), approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime. Additionally, mammography can be an important tool in detecting male breast cancers. "This is meant 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".
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To improve the assessment of mammograms, the FDA has proposed to codify 3 additional categories.
There would be stronger record-keeping requirements to improve access to and transfer of patient mammography records. It said that in 2018, more than 260,000 women in the US were diagnosed with breast cancer and more than 40,920 women died of the disease.
Regulators will take public comments for three months before finalizing the proposal, a process that can take months or sometimes years.