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Your Healthy Family: FDA issues new regulations on dense breast tissue

Posted at 7:12 AM, Mar 15, 2023
and last updated 2023-03-15 09:12:42-04

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In this Your Healthy Family, we’re talking about the new regulations announced last week by the Food and Drug Administration (FDA) that now require all mammogram providers to notify patients of the density of their breast tissue.

New FDA Mammography Regulations

Dense breast tissue is one factor that can increase the risk of breast cancer because it can make lumps harder to detect - especially early.

According to Dense Breast-Info, a website dedicated to resources about why density matters in breast cancer screening, there has been a decades-long push for better patient education and guidance and life-saving early treatment through early detection of breast cancer. About 50 percent of women in their 40’s have dense breasts, in addition to 40 percent of women in their 50’s and 25 percent of women older than age 60.

The new FDA regulations come as some 38 states already had laws on the books - including Colorado as I learned in October of 2022 when I sat down with Dr. Olga Mengin, a board-certified radiologist and the medical director of breast imaging for UCHealth Memorial in Colorado Springs, who is also fellowship training in breast imaging, to talk about the challenges dense breast tissue presents.

Dr. Mengin told me then, Dr. Mengin says: “There are now 38 states that have created a dense breast notification law of some sort. In Colorado, the law says we have to provide notification to any woman if we discover she has dense breast tissue. If a woman has dense breast tissue, we will need to send her a letter with the notification that you do have dense breast tissue and exactly what that means in layman's terms.”

Explaining dense breast tissue is something Dr. Mengin does with patients regularly. “I'm going to use my hand as an example. Let's say that a woman doesn’t have dense breast tissue, so her tissue is like my fingers and you can see through the gaps between my fingers. Let's say there is a leaf that represents breast cancer; If I put the leaf between my fingers, we can see it. If the leaf is small cancer and we put it behind the palm of our hand, that leaf needs to become bigger before we can see it. That's sort of the analogy that we use between the dense breast tissue and non-dense breast tissue. Dense tissue has what we call a masking effect.”

Dr. Mengin also says dense breast tissue is one of the reasons 3D mammography is becoming more and more common.

“When we see dense breast tissue we want to do something extra. One of the extra things that we do is 3D mammograms. Those make an enormous difference in our ability to diagnose cancer. A 3D mammogram is actually beneficial for all women, not just women with dense breast tissue. All women are recommended to have 3D mammograms so we're able to scroll through that tissue with lots of little images throughout the breast, not just one single image of the breast tissue compressed. It allows us to look through dense tissue and look for breast cancer.”

Nationally, the numbers of women following the current screening recommendations for breast cancer are pretty good. However, Dr. Mengin says in Colorado, we need to be doing better.

“Nationally, approximately 70% of women who are eligible for screening are getting screenings. In Colorado, although we don't have specific numbers, this rate is substantially lower. We have women who don't come every year. We also have women who only come in when they feel a lump, and by the time you can feel cancer, it is much larger on a mammogram. We can find it as small as 3 millimeters on a mammogram; that’s close to an eighth of an inch.”

Knowing you have breast cancer is half the battle, but for some, it's the fear of learning that, and that’s what might keep them away, says Dr. Mengin.

“There's also the stress of, ‘what then? I got through my mammogram. What happens next? What if I get called back?’ We try to tell everyone 1 in 10 women are going to be called back because not all breasts look the same. Everyone has a unique pattern, and sometimes we can't see something as well as we would like. 1 out of 10 women is going to get called back from their mammogram. The majority of those women, once we get extra images and possibly an ultrasound, they're done, they’re OK. Just a small percentage of those women (who get called back) are then going to need a biopsy, but even the biopsies are mostly benign. So only a small percentage of women who need a biopsy will actually be diagnosed with breast cancer.”

Dr. Mengin says there is also the fear that the mammogram will be a painful experience. “If you’re worried that it might hurt, I recommend just trying to relax as much as you can. We have wonderful techs here (at UCHealth) who will guide you through it. They are as gentle as they can be, but they also want to get great images.”

The most important part of raising awareness about breast cancer and getting women to have their annual mammograms all boils down to saving lives, and it’s a topic that Dr. Mengin is passionate about.

“Cancer and the whole point of diagnosing breast cancer is to catch it early because early means are treatable. I like to tell patients in the grand scheme of life, it's like going over a speed bump. Yes, it's not fun to go over a speed bump; You have to slow down - you don't want to jolt everyone, but in the long run, when you look back at that speed bump, that's what it was, just a speed bump. We want women to go on with their life, live a long and healthy life, enjoy their children, their grandchildren, their great-grandchildren, and when you think of it that way, one little mammogram is absolutely worth it.”

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