Mammogram Centers Must Tell Women if They Have Dense Breasts, F.D.A. Proposes

My own cancer was missed an estimated 5-years in a row as it was obscured behind dense tissue. My story was the inspiration for New York's density inform law (kudos to Sen. Flanagan and Assemblywoman Ellen Jaffee) which became first in the nation to inform women if they have dense breasts (prior laws only required women be provided general information about breast density). There are now 37 states with inform laws, but they vary in depth and breadth. This FDA reporting amendment will create a much needed minimum reporting standard for all American women. As many comments here indicate, much education is needed on the topic. To help inform the "I have dense breasts...now what?" questions resulting from density notification, a medically-sourced educational website was launched, please visit www.DenseBreast-info.org.

I have DBT and refuse mammograms because they are so painful. My mom and sister also have DBT and follow the routine protocol knowing they’ll have to go back for another and then probably another biopsy because the industrial medical complex effectively instills fear of cancer and skews the data to make it look like they are saving lives. Every time Kaiser sends me a notice from The Emergency Department (tgat’s right from the Emergency Dept...) that I am years overdue for a mammogram, I respond that if Kaiser cares that much then they should give me a the screening my body deserves such as a sonogram or MRI - and they always respond with another automated reply from the Emergency Dept.

I was told at one point that I had dense breasts. However, I recently discovered that it is not a simple split of non-dense versus dense. There is a grading system: Class A (or 1): Fatty Class B (or 2): Scattered fibroglandular density Class C (or 3): Heterogeneously dense Class D (or 4): Extremely dense It turns out I am a Grade B. My understanding is that the problem is primarily with women who have Grade D breasts.

I was being monitored for a fibroadenoma while living in Europe for a few years. The initial concern led them to order a breast ultrasound, then a mammogram, then an additional breast MRI to be sure it was a fibroadenoma because they said I had dense breast tissue and wanted an additional method of screening just to be certain. They prescribed annual ultrasounds to monitor the size of the fibroadenoma and overall condition of my breasts. When I returned to the U.S. my doctor was unsatisfied with this, and wanted me to get a mammogram as well - of which, at 30 and it being 'diagnostic' procedures (I don't count as being covered for preventative breast screening yet) - I pay for all out of pocket toward my $7500 deductible. She would not follow up with me unless I went for all of the screening. I was quoted a minimum of $2000, plus an unknown charge for the radiologist to interpret the report, plus a follow up with the doctor to discuss next steps, and odds are she would've ordered a needle biopsy just for fun. OH and she told me I needed to get BRCA testing done also. I chose instead to fly to Italy for my annual follow-up at the prominent international research hospital in Milan, where it was cheaper to fly roundtrip from Florida and stay/eat/travel around for a week, then it would be to get all of the screening done here in the U.S. I am fortunate enough to have made this choice, but cannot fathom how this is acceptable in America. Regulations but no insurance coverage?

Densebreast-info.org is a good source for information

Of course women should be notified of this. To have anyone fret over it being “too difficult to understand” is insulting. Our bodies, our business.sc I’ve been told I have dense breasts ever since my first mammogram (I’m 60). I can’t remember how long it’s been since that was specified in the results letter, but I have had the x-Ray techs tell me that. Sometimes images have to be redone because of my dense tissue. So I have always assumed it was an important fact to know, but in no way alarming. Several years ago my primary care doc, who is an internist practicing family medicine, looked at my mammogram results and said, in a dismissive tone, “Dense breasts (smirk). I don’t know why they’re always telling everyone they have dense breasts.” I thought that was so inappropriate!

I have dense breast and breast cancer doesn't run in my family but I've had one biopsy and re-occuring sonograms; 3D mammograms and all is good. My biggest concern is preventive measures to protect our breasts. What can we do to combat this evil disease? I think decreasing your alcohol intake is a start and fresh organic vegetables and herbal supplements etc..., Any thoughts?

I live in Connecticut and have had insurance here and, prior from an employer in New York state. Last night I paid two bills for the services required for a doctor to confirm that I do not have breast cancer. $92 for a mammogram and $658 for an ultrasound. My gynecologist told me that she was also told she has dense breasts, needs an ultrasound to fully determine freedom from breast cancer and cannot find or recommend any form of insurance that covers this. last year, I was charged hundreds of dollars more for my ultrasound than I paid this year and the results are really pretty worthless without it so I fear a clean bill of health is being held hostage by women unable to pay enough. That needs to change.

A woman with dense breasts should not only be informed of such, but also WHY the info matters. If she also takes combined hormone replacement therapy (CHRT), that info AND a well-trained radiologist can make a difference. My annual mammograms had shown no cancer for many years. I was always told that I had dense breasts, but I never knew why this could be critical information. When I was 56, I scheduled my annual mammo 2 months early because I had a break in my work. The radiologist informed me that I had bc. She next asked me if I was on CHRT. I had been taking CHRT--Prempro, followed by the generic for Activella--off and on for menopausal hot flashes and night sweats for about 8 years. She told me to cease taking it immediately, which I did. The mammogram--and the radiologist reading it--caught my bc at stage 1, so I needed surgery and internal beam radiation, but not chemo. Many bc medical experts have concluded that "there is no safe interval for [taking] combined hormone therapy that can be defined given the fact that combined hormones increase breast cancer risk while hindering the ultimate diagnosis (due to radiographic findings). This is particularly true in [women with] dense breasts [who are] placed on [CHRT]." I was fortunate that the radiologist reading my mammo could see my cancer, especially because it was invasive tubulo-lobular, a fairly rare form of cancer that hides well in dense breasts & is closely related to ingestion of CHRT.

Why do mammogram centers fail to question patients about their uncle's siblings having breast cancer.? The BRAC gene can be identified in male members of a family. Three of my grandmother's male siblings had daughters who succumbed top breast cancer in their 40's while only one of her daughters had the disease and she was diagnosed in her late 70's. My great~grandmother succumbed to the disease at age 31.

After my first mammo, I received a scary phone call that I needed "more imaging". This meant I have dense breasts, and needed an ultrasound. This also meant I got to pay for the privilege. To which I said, never again. Way to give the insurance companies a free pass to deny coverage....again.

I had a palpable lump which prompted me to get a mammogram before I turned 40. Even though the lump could be felt, it could not be seen on a mammogram due to dense breast tissue. It was picked up by sonogram (and biopsied) and found to be breast cancer. After an extended treatment period which ended at a double mastectomy partly because I believed that I could not rely on the available diagnostic methods, I had a sonogram of my other breast at a major teaching hospital in Boston. The physician doing the sonogram was not sure if there was anything wrong with my other breast. When I went to the breast center to have a breast sonogram done by a physician who does them all day long, I was told that my other breast was normal. The breast center physician was correct as demonstrated by post-surgical pathology. Mammography is the standard of care as it is available everywhere. If necessary, the films can be sent to a radiologist at a remote location to be read. A sonogram requires a highly skilled physician to be present. One of the reasons that the suggested age for first mammogram was raised to 50 from 40 is the decrease in breast density at menopause. For many women, mammography is not really useful, and they should be told as much so they can understand if they should rely on it, or not.

For years I would get this letter after each mammogram and finally asked my OB/GYN about it. He paused and said he would order a sonogram in addition to my annual mammograms. The first sonogram showed a 8mm tumor that the the mamo did not. Stage 1, Invasive ductal carcinoma, Grade 3 and lobular carcinoma in situ in the other breast. I had bilateral mastectomy, chemo. I was 43. The sonogram (my doctor really for ordering it) saved my life.

Why are we not talking about thermography as an alternative diagnostic?

I guess telling women that they have weird breasts sounds better than telling them that mammograms don’t work on 40 percent of the population, but you need to have a mammogram to find out you’re in that 40 percent. Heaven forbid the medical community admit that mammography, although useful, is not all it’s cracked up to be. And also, knock it off with the “it will cause fear.” How about it will cause legitimate concern about taking time, money, resources, and life disruption to chase down inconsequential findings?

The so called "universal coverage" countries have higher rates of breast cancer than the US, according to the World Cancer Research Fund. https://www.wcrf.org/dietandcancer/cancer-trends/breast-cancer-statistics Rates per 100,000 women: Belgium 113.2 Netherlands 105.9 France 99.1 UK 93.6 Sweden 89.8 US 84.9

The only rational objections to this rule appear to be that: 1) it might unnecessarily scare women into thinking they had cancer when 50% of those with dense breasts are not at risk and 2) the informational reports that are currently being used are often written in language that is too difficult for the average person to understand. I find these objections to be both frivolous and specious. Any Physician should be able and willing to explain these risks and implications to their patients and all medical reports intended for patients should be translated from “medical-speak” into plain language, another regulation the FDA should enact.

My bc was found at 4mm during a routine MRI, which my physician has prescribed due to bc history in family (tested negative to BRC1/BRC2). A 3D mammogram with ultrasound did not catch it. This life saving MRI saved my life and should be the gold standard. Yes it can have false positives, and biopsies are uncomfortable, but I would rather learn early when there are treatment choices. Ladies we must advocate for our own health.

I’m super annoyed now. I had my first mammogram a couple of years ago and the report noted dense breast tissue but didn’t say what that meant or give any indication of elevated risk or necessity of follow up! Luckily I already have another one scheduled and I’ll be sure to ask some questions this time.

I'm one of those dense-breasted women who thought I couldn't possibly get breast cancer--had my mammogram on schedule and was "all clear"-but they'd misread it, and now I'm stage 4. So I hope some technique can be established that really distinguishes dense from lethal. http://www.thecriticalmom.blogspot.com

I found it insulting that 2 reasons arguing against informing women they have dense breasts are that it would frighten women, or be too difficult to them to understand. It sounds like women are being infantilized. Tell women, and explain it in clearer language, with options presented clearly. And make health insurance cover those options.

It astonishing to me that young women are now rarely taught to do self-exams on their breasts. Instead, there is an assumption that now that we have mammograms, there is not the urgency there was in the years before mammograms became prevalent. What women should be taught is not to rely on a mammogram. It is not even clear that the tumors found on mammograms are the ones that are the most aggressive, so all the lives supposedly saved by early detection may have been saved if the tumors had just been found later. Women who are at high risk should be screened, but women should also be taught to trust a self-exam and especially if one has dense tissue, do not assume that a clean mammogram trumps a self-exam.

A good step forward! Young women are especially misdiagnosed too late as they have dense breasts and many doctors assume they don't have cancer anyway. This was the case for me and only a sonogram that I insisted on because I felt something was wrong gave me the correct diagnosis when a mammogram completely missed that I had cancer. I am now cancer free for 19 years.

What a nightmare this policy has been for physicians here in Massachusetts. While MA legislators required radiologists to INFORM patients of their dense breasts, they did NOT require insurance companies to PAY for additional testing, such as breast sonogram or MRI. Really?! I would love it if one of these legislators spent a day in my gynecology office... repeatedly explaining to worried patients that these screening tests would cost them one to two thousand dollars a year out of pocket, and are not covered by their insurance. So, FDA, do more than just frighten women. If you require this wording, then also require insurance coverage to pay for the testing that you are implying is medically necessary.

My state, Minnesota, requires the letter so I'm good except I'm not "good" because depending on my insurance plan, it's either free or it's an out-of-pocket expense of almost $400.00. This makes no sense. If the letter informs me that my risk of having undetected cancer is higher due to dense breast tissue, it seems to me that insurance plans should be required to cover the cost of enhanced imaging, same as they do the traditional 2-D mammogram. They are not. Depending on my insurance plan (which has changed over the past couple of years), it's either covered as a preventive procedure or it's not and when it's not, I have to ask myself if the $400 is worth my peace of mind, or not. Talk about a game of roulette....

As devastating as Dr Capello’s story is, and that of a few commentators, the honest story here is that breast density in and of itself is not a risk factor for breast cancer, in fact, most breast cancers occur after menopause, when density tends to go down or away. On the other hand, aggressive cancers, such as those that present with early metastases, are more common in younger women. It tends to create the idea that cancers were missed in dense breasts. The truth is that those cancers may just be growing and spreading much more aggressively. Part of the problem is that mammography has been over-sold as a screening tool. It is not 100% accurate in either ruling in or out a cancer. Ultrasound can pick up cancer masses that still can’t be felt, but don’t have the amount of calcium deposits that help mammography find smaller tumors. And MRI, while being more sensitive than either, also makes more false diagnoses, because of that increased sensitivity. Looking backwards, if the MRI found a cancer, all’s good (unless the cure kills you, as it did Dr Capello), but as a screening tool, using it to predict the future, many, many more women will have unnecessary biopsies (which because of the way MRIs use magnets, is much more difficult, expensive and uncomfortable than when the suspected mass is seen on ultrasound or mammography). And double, prophylactic mastectomies that don’t affect cure rates.

Tennessee already has this law. Unfortunately, the mammogram centers don’t do the ultrasounds they suggest I need. I haven’t figured out how to get one. Isn’t that part of the centers’ responsibility to me?

This is GOOD news. Each Woman can work with her Physician to determine the best schedule for Mammograms, and any other testing. Also, this is, once again, something that highlights the need for universal coverage. All screenings and treatments must be available and affordable, for everyone. PERIOD. 2020: Vote like your life depends on it. It DOES.

I got this notice and it didn't make me anxious, just angry that someone was giving me one piece of information that seemingly absolved them of any responsibility without telling me what next steps I could/should take. Like telling a car owner that there might be a recall on their vehicle without saying what that means and how they should proceed to find out more or how to get it fixed.

In July of 2013 I had a diagnostic mammogram and was told I had some benign calcifications and to do a repeat in 6 months. In September of that same year I was diagnosed with stage lll breast cancer. The excuse for not seeing it on the mammogram was that I had " dense breasts".

I was always told I had dense breast tissue and that that an ultrasound could be more helpful once this tool was also being used. I subsequently learned I was BRAC1 and MRI screening was added so that I was being tested every six months. My mammogram always stated something like due to the density of the breast tissue cancer can't be excluded additional studies recommend. I never felt reassured by my screening considering I carried a cancer risk over my lifetime of 70%. I ultimately decided for mastectomies. Women need to be well informed about the results of there studies and their treatment options. This is a step in the right direction.

After i read a recent NYT article on Dr. Capello I went for my yearly mammogram but had my doctor also order an Ultrasound of both breast. I knew I have dense breast and get letter from the clinic every year informing me . What good is this notification when the Radiologist herself told me the ultrasound was also not reliable for finding tumors in dense breast . She said if I really wanted to be sure I should have a breast MRI. I have lost at least ten friends or relatives to breast cancer and only one of those was found on a mammogram. My best friend(age35) now deceased from breast cancer was called on her way to surgery and told her mammogram was fine. Insurance companies are not going to pay for these Ultrasounds or MRI's. What women need to be doing is organizing to insist on accurate screening. It is the height of sexism to state this should not be done because women can't "handle" the anxiety. As usual corporate America is making a fortune off these mammograms .The truth is we need to get rid of mammograms centers as the go to screening and insist on the appropriate testing . Follow the money!

In France, a prescription for a mammogram includes an ultrasound exam (performed by a doctor, not a tech) after the x-ray. This was my first mammo, so there was no record of dense breast tissue--it's just what they do, thankfully. I'm so grateful for this healthcare system--it's not perfect, but it's so much better than what I had in the US, plus I'm comforted knowing *everyone* has access to it, not just the employed or wealthy.