FDA proposes changes to mammography standards for first time in more than 20 years

The US Food and Drug Administration announced propose...

Posted: Mar 28, 2019 3:47 AM

The US Food and Drug Administration announced proposed changes to mammography standards Wednesday.

These are the first changes to the regulation of mammography screening in more than 20 years, aimed at improving quality and modernizing breast cancer screening, FDA Commissioner Dr. Scott Gottlieb said.

The key changes include providing patients with information about breast density, in the form of a letter, with screening results.

Mammograms of dense breasts are known to be more difficult to read and interpret. "The dense tissue can obscure signs of breast cancer and lower the sensitivity of the image," according to the FDA. Dense breasts are also known to be a risk factor for breast cancer. More than half of women over age 40 have dense breasts, according to the FDA.

"The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation."

This is one way the proposed changes try to improve communication for patients. Furthering this and to improve communication with providers, the agency has also proposed expanding the categories used to classify mammography findings, currently labeled as "negative," "benign," "probably benign," "suspicious," "highly suggestive of malignancy" or "incomplete: need additional imaging evaluation." The agency would like to add two categories: "known biopsy proven malignancy" and "post-procedure mammograms for marker placement." It also would like to add an assessment category of "incomplete: need prior mammograms for comparison."

This should help screening facilities to "more precisely classify" findings and will help patients and care providers make more informed decisions after receiving mammogram results.

The changes also take into consideration advances "in mammography technology and processes since the current regulations were published." For example, 3D digital screening can provide cross-sectional images of the breast from multiple angles. The result is an "informed image" of the breast tissue, which is preferred for some patients over 2D imaging.

Since 1992, the FDA has been responsible for quality of care at facilities that conduct mammograms including accreditation, certification, inspection and enforcing standards.

The proposed changes move to strengthen the agency's ability to revoke and suspend operations at mammography screening facilities that are violating regulations. This "better positions the agency to enforce and take action," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.

"Mammography is the best tool in determining if a woman has breast cancer," Gottlieb said. Breast cancer is the second most common cancer among American women, after skin cancer, and the second leading cause of cancer deaths after lung cancer. 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.

The American Cancer Society recommends mammograms every year between the ages of 45 and 54 and every other year after that for as long as a woman is in good health and expected to live another 10 years. Women younger than 45 should be given the choice to start annual mammograms, the cancer society says.

There is a 90-day public comment period for the proposed changes, which will be followed by changes based on the comments. Then it will be reviewed before it becomes final.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 313161

Reported Deaths: 3594
CountyCasesDeaths
Multnomah51245642
Washington34995276
Marion32577393
Clackamas26570271
Lane23989246
Jackson20977257
Deschutes16623102
Umatilla12602125
Douglas10712188
Linn1046886
Josephine8659165
Yamhill744999
Klamath643491
Polk623570
Malheur479467
Benton461927
Coos412069
Columbia324237
Jefferson313746
Lincoln276330
Union272737
Wasco239039
Crook212338
Clatsop211725
Tillamook181523
Baker174421
Morrow167921
Curry166817
Hood River163035
Harney78916
Grant7558
Lake6768
Wallowa50811
Gilliam1374
Sherman1283
Wheeler651
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 4644566

Reported Deaths: 68019
CountyCasesDeaths
Los Angeles144512125852
Riverside3579884804
San Diego3495814009
San Bernardino3472035506
Orange3146225354
Sacramento1503072089
Santa Clara1405641841
Fresno1358611888
Kern1358421515
Alameda1162141329
Ventura976901120
San Joaquin973871615
Contra Costa95727924
Stanislaus806991234
Tulare72969896
San Mateo52239607
San Francisco51907605
Monterey49465565
Solano44151312
Santa Barbara43112500
Sonoma39441378
Merced39370535
Placer36487364
Imperial34261755
Kings30124284
San Luis Obispo28300313
Madera21707258
Butte21307230
Shasta20683276
Santa Cruz20151211
Yolo19143239
Marin17106242
El Dorado16004127
Sutter13094153
Napa1226895
Yuba926061
Nevada847685
Humboldt829587
Tehama823784
San Benito709067
Mendocino685575
Lassen637627
Tuolumne615393
Lake603687
Amador492259
Glenn398030
Siskiyou389541
Calaveras342266
Del Norte336034
Colusa290918
Inyo166539
Mono14935
Plumas12406
Mariposa99712
Trinity72010
Modoc6278
Sierra1980
Unassigned1650
Alpine1000
Out of CA00
Medford
Clear
56° wxIcon
Hi: 87° Lo: 46°
Feels Like: 56°
Brookings
Clear
70° wxIcon
Hi: 84° Lo: 56°
Feels Like: 70°
Crater Lake
Clear
56° wxIcon
Hi: 69° Lo: 35°
Feels Like: 56°
Grants Pass
Partly Cloudy
56° wxIcon
Hi: 91° Lo: 46°
Feels Like: 56°
Klamath Falls
Clear
53° wxIcon
Hi: 78° Lo: 41°
Feels Like: 53°
Warmer temperatures with haze returning
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events