--- title: FDA Mammogram Rule Would Notify Women with Dense Breast Tissue description: The FDA's first mammography regulation update in 20 years would require providers to notify women with dense breast tissue. canonical: https://time.com/5560349/fda-mammograms-dense-breast-tissue/ author: Jamie Ducharme article:opinion: false article:content_tier: free article:published_time: 2019-03-28T12:27:35.000Z article:modified_time: 2026-02-23T23:10:03.032Z article:section: Health og:title: The FDA Wants to Change Mammogram Regulations for the First Time in Two Decades og:description: Women with dense breast tissue would have to be notified og:url: https://time.com/5560349/fda-mammograms-dense-breast-tissue/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt761999a018e54375/6989477422fb85000de2803a/mammogram-regulations.jpg?branch=production&width=2400&quality=75&auto=webp&crop=16:9 og:image:width: 1200 og:image:height: 675 og:image:alt: Radiology center og:type: article twitter:card: summary_large_image twitter:title: The FDA Wants to Change Mammogram Regulations for the First Time in Two Decades twitter:description: Women with dense breast tissue would have to be notified twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt761999a018e54375/6989477422fb85000de2803a/mammogram-regulations.jpg?branch=production&width=2400&quality=75&auto=webp&crop=16:9 ---  # The FDA Wants to Change Mammogram Regulations for the First Time in Two Decades ## Video: These 6 Habits May Reduce Your Risk of Breast Cancer [Watch (HLS stream): These 6 Habits May Reduce Your Risk of Breast Cancer](https://cdn.jwplayer.com/manifests/Fr8mHjVO.m3u8) (2:21)  _Published 2018-10-01. Breast cancer is the most prevalent cancer in the U.S., affecting almost 85 of every 100,000 Americans, according to recent data from the World Health Organization’s International Agency for Research on Cancer (IARC)._  by [Jamie Ducharme](/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Mar 28, 2019 12:27 PM CUT  A radiologist looks at the results of mammograms in France. A radiologist looks at the results of mammograms in France.BSIP—UIG via Getty Images  by [Jamie Ducharme](/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Mar 28, 2019 12:27 PM CUT The Food and Drug Administration (FDA) wants to require mammogram providers to tell women if they have a common risk factor for breast cancer. The proposal, released Wednesday, would be the FDA’s first update to mammography regulations in more than 20 years, according to [a statement from the agency](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634509.htm "undefined"). Among other proposed changes, the policy would require mammography providers to inform patients who undergo the [breast cancer screening](http://time.com/4629245/who-needs-a-mammogram-for-breast-cancer-guidelines/ "undefined") test if they have dense breast tissue, which may both [warp the results of a mammogram](http://time.com/3612811/3d-mammograms-cancer/ "undefined") by obscuring signs of cancer, and increase the risk of developing breast cancer in the first place. That information would be delivered in a post-screening summary letter, along with guidance for determining future medical care, the statement says. Providers [in almost 40 states](https://densebreast-info.org/legislation.aspx "undefined") 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. While the FDA called the policy part of an effort to “modernize breast cancer screening and help empower patients,” it is likely to be met with pushback from some doctors. More than half of women over 40 have dense breasts, according to the FDA, and not everyone with this common condition [has the same risk of cancer](http://time.com/3872815/breast-cancer-screening-dense-breasts/ "undefined"), research has shown. The additional information could, in theory, lead to unnecessary testing and anxiety for some women who are not at high risk — a criticism often leveled against mammography in general, which [some experts argue](http://time.com/5050978/mammogram-breast-cancer/ "undefined") can lead to over-diagnosis without preventing many cancer deaths. In its statement, however, the FDA maintained that the proposed regulations “will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” according to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. The plan would also allow the FDA to notify patients if their mammography center did not meet quality standards, tighten equipment and record-keeping requirements for providers and make clearer to providers when a patient has a known cancer diagnosis. The proposal must be open to public comment for 90 days before being finalized. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/"},"headline":"The FDA Wants to Change Mammogram Regulations for the First Time in Two Decades","datePublished":"2019-03-28T12:27:35.000Z","dateModified":"2026-02-23T23:10:03.032Z","description":"Women with dense breast tissue would have to be notified","url":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/","keywords":["Cancer","onetime"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt761999a018e54375/6989477422fb85000de2803a/mammogram-regulations.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Jamie Ducharme","jobTitle":"Ducharme is a contributor to TIME.","url":"https://time.com/author/jamie-ducharme/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt761999a018e54375/6989477422fb85000de2803a/mammogram-regulations.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Radiology center","caption":"Radiology center","creditText":"BSIP—UIG via Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/cancer/","name":"Cancer"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/","name":"The FDA Wants to Change Mammogram Regulations for the First Time in Two Decades"}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"These 6 Habits May Reduce Your Risk of Breast Cancer","description":"Breast cancer is the most prevalent cancer in the U.S., affecting almost 85 of every 100,000 Americans, according to recent data from the World Health Organization’s International Agency for Research on Cancer (IARC).","thumbnailUrl":"https://cdn.jwplayer.com/v2/media/Fr8mHjVO/poster.jpg?width=720","uploadDate":"2018-10-01T18:41:43.000Z","contentUrl":"https://cdn.jwplayer.com/manifests/Fr8mHjVO.m3u8","embedUrl":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/","duration":"PT2M21S","potentialAction":{"@type":"SeekToAction","target":"https://time.com/5560349/fda-mammograms-dense-breast-tissue/?jw_start={seek_to_second_number}","startOffset-input":"required name=seek_to_second_number"}}] ```