Just because the results of your mammogram are negative, doesn’t mean you don’t have cancer
“Four months after her mammogram came back “normal,” Susan Quinn-Mullins discovered the lump herself, a smooth, hard mass on her left breast the size of a big marble. An ultrasound revealed a tumour nestled deep in dense breast tissue. It was stage 3 — aggressive, invasive breast cancer that was spreading to the surrounding lymph nodes…”
Breast Density Types
This interesting article not only chronicles the story of people who initially relied on mammography to check the health of their breasts but also serves as an incitement over the undue reliance on this as the sole modality. It also brings in some contra posing views on the debate over dense breast notification laws.
Breast Cancer is the number two killer of women in America, lung cancer is number one at the moment. The issue of dense breast related problems in imaging has been long known but for the most part hidden. It is a sordid tale in some ways. For years women have been told get a mammogram and you will reduce your chances of dying from breast cancer because, with mammography, we can detect the cancer early, smaller than you can palpate, feel with your fingers, the tumor. What has not been discussed is that we can further reduce your chance of dying from breast cancer because, for about half of all women, by adding additional screening techniques we can detect the cancer earlier than it can be seen on the mammogram. What has also not been discussed is that, for about half of all women, their breast biology so compromises the appearance of the mammogram that, without additional screening techniques, the probability of performing unnecessary follow-up diagnostic activities on benign structures is greatly increased.
- Contrary to claims by many in the medical community, mammography is not the only method of early detection which has demonstrated a reduction of mortality from breast cancer. The same studies that many cite to support this position demonstrate that, finding cancers smaller, and before they have spread to the lymph nodes, significantly reduces mortality – regardless of the method used to detect those small early cancers.
- “While mammogram detects 98% of cancers in women with fatty – non dense – breasts, it finds only 48% in women with densest breasts.” (AreYouDense.com) This translates in to at least 100,000 invasive cancers in the US each year which could have been discovered at a meaningful earlier stage than that at which they were actually discovered.
- Even when the cancer is discovered in women with dense breasts, the clinical evidence suggests that it could have been found at about half the size (less than 1cm vs almost 2cm) and, more often, before it spread to the lymph nodes (less than 10% of the time vs 15% to 20% of the time), had an additional screening tool (ultrasound) been added to the mammogram.[i], [ii]
- Women with dense breasts whose cancers are found with mammography alone are 2.5 times more likely to die from that disease than women whose cancers are found with mammography and an additional screening method (30% 20 year mortality for cancers discovered at 15-19mm vs 12% 20 year mortality for cancers discovered at less than 10mm)
- 70% to 80% of cancers occur in women without major known risk factors[iii],[iv],[v] Most breast cancer risk analyses do not consider breast density, despite the fact that density is one of the strongest predictors developing breast cancer (Nancy has this stat).
- In addition to being a major predictor for developing breast cancer, “Breast Density is one of the strongest predictors of the failure of mammography screening to detect cancer” (AreYouDense.com)
- “Approximately 75 percent of women in their 40s have dense breasts. This percentage typically decreases with age – but half of all women aged 40 and older have dense breasts.” (Dense Breast Tissue Should Not Be Ignored, By David C. Weintritt, MD, FACS, Director Breast Care Institute Mount Vernon Hospital, Wednesday, October 24, 2012
- Dr Louise Eriksson and her colleagues from the Karolinska Institutet (Stockholm, Sweden) found that women with denser breasts had nearly double the risk of their cancer recurring, either in the same breast or in the surrounding lymph nodes, than women with less dense breasts. They warn that doctors should take breast density into account when making decisions about treatment and follow-up for these women. … “We found that if you have a PD at diagnosis of 25% or more, you have an almost two-fold increased risk of local recurrence in the breast and surrounding lymph nodes than women with a PD of less than 25%.” (The European CanCer Organisation (ECCO))
- In 2011, approximately 39,520 women were expected to die from breast cancer. Only lung cancer accounts for more cancer deaths in women. Page 6 of this report shows that the incidence rates for breast cancer have continued to increase but death rates have declined.(Breast Cancer Facts & Figures 2011-2012)
- Recent studies indicate that it is not just a family history of breast cancer but perhaps a history of ovarian and prostate cancer may also contribute to increase risk in women. (Susan G. Komen.Org)
Despite study after study indicating there are significant risks to women with dense breast tissue, and the fact that a significant number of women have dense breast tissues – 50% of the population on average – there are those who are seemingly working hard to obscure these facts. Perhaps it is simply they do not want to “panic” women but some people believe there is more afoot than just simple concern for women’s anxiety.
One question needs to be asked, “If this has been known for quite some time, why were women not informed?” Radiologists have known for decades that it was exceedingly difficult, in some cases close to impossible, to detect cancers in women with dense breast tissues. Yet few, if any, radiologists informed women of the significant deterioration in the ability to perform effective early diagnosis for these women. Interesting, because the argument for regular screening mammography has been for women to benefit from early detection. But how beneficial has it been if over 50% of those getting regularly screened were dense, and it was not possible, by relying on mammography alone, to find half of the cancers at an early stage in this population?
Over the past 10 years the movement to force notification to women who have dense breasts has been building. Advocacy groups like, Are Your Dense have been arguing publicly for this need. Yet, something so common sense and simple has taken quite a while for actions to begin to happen. It seemed so simple to approach state legislatures with information about how dense breast tissues are obscuring cancers and increasing the cancer risk and mortality of these women. One would have thought this was an easy decision! Just pass a law to require notification for these women! Simple, right? Evidently not. It has taken over 7 years for 16 states to pass such legislation. Why? In many of these states the law requires notification but ion only a few does it go beyond notification and require alternate screening methods to be disclosed and in even fewer do the states require insurers to pay for the additional screening methods.
Why is this so difficult? Why is it that some organizations have grasped the isolated studies that report breast density has no effect on outcomes when so many other studies point to effectiveness? Why do medical groups, such as those represented by www.breastdensity.info, present information which is factually untrue (“small studies (with screening ultrasound) have shown a modest increase in sensitivity”, when, in fact many, large, studies have shown a dramatic, and statistically significant, increase in sensitivity). Why do so many states listen to those physician groups who argue that the other screening methods do not provide significant value? Why do so many breast centers avoid whole breast ultrasound, the most cost effective secondary method, arguing that it has high false positive rates – it doesn’t, that it adds to the cost – it does by about $110.00, or that it significantly interrupts their workflow and decreases the number of screens that they can do in a day – some systems do this but other systems simply do not. Some cite the high cost of supplementary screening, referring to the use of MRI – a valuable and very capable, and expense diagnostic system – which is clearly not necessary for secondary screening, or the high labor costs associated with ultrasound screening. While MRI devices cost millions to purchase and maintain, effective automated screening ultrasound system reduces labor effort and start as low as $85,000 – for the BreastMapper system from Tractus Corporation, to about $300,000 for other automated screening ultrasound systems (such as the U-Systems be GE).
Governmental Dirty Secrets
While it may be slightly exaggerated to classify these as “dirty secrets,” many states have resisted the call to approve their dense breast notification bills because of legitimate concern over the rise in Medicaid costs due to the increase in early diagnosis and treatment of these breast cancers that otherwise today remains hidden. Logic dictates that earlier detection leads to lower cost of treatment. The cost of providing ultrasound screening to the 15 million women with dense breasts who receive mammograms each year is $1.8 billion, and yields a reduction of just $9,000 in treatment costs for the 200,000 women who are diagnosed with invasive breast cancer each year. This is what much of the literature and reporting indicates. But, for many states, struggling with already tight budgets—further strained due to the extensions under the Affordable Care Act – the costs are seen as significantly problematic. Screening costs are immediate, savings from screening are projected. It is true that the federal government will provide states with subsidies for increases in cost under the expansion rules in the ACA. Yet, this is limited to only the increase in costs associated with those patients that fall into the increased eligibility area, not regular patients that are now signing up due to the increased awareness. Nor is it true for those patients whose costs are increasing due to better diagnosis. California’s governor, Jerry Brown, vetoed his states dense breast bill for three years, only approving it in the last legislative session. As stated, many states have simply enacted a limited law that only requires physicians to provide their patients with a letter stating they have dense breasts – that’s it!
“Dear Ms. Smith, we have the results of your mammogram. It was normal. By the way you have dense breasts!”
The above quote, it a bit of hyperbole but not far from the truth in how many women are being informed of the problem with having dense breasts. First, the report did not tell the woman that she did not have cancer – it reported that her breasts were “normal”. Most patients interpret this to mean that they did not have cancer. They typically do not interpret it to mean that their breasts are “normal” for dense-breasted women and that “normally” the doctor couldn’t find a cancer on that mammogram if their life, much less the life of the patient, depended upon it. I have a lifelong friend, a nurse in Maryland, who after receiving her bi-annual mammogram received a notification that she had dense breasts. No, notice of what this meant to the ability of the mammogram to detect cancer in her breasts, no notice as to what option she may have to get a secondary effective screen for her dense breasts, not even a statement that she should seek a secondary screen! This is what is considered in many of these 16 states as effective notification. I think NOT!
What Should You Do?
First, if your state does not have a dense breast bill and you get a mammogram, ask the radiologist if you have dense breasts. If you do, ask, or perhaps demand is a better word, to have an automated screening ultrasound done! I mean, why not? We are told to demand this drug or that drug form numerous TV commercials that then proceed to tell us of all the dire side effects we can suffer from taking the medication. Why can’t we demand to have an automated screening ultrasound to detect cancer when the potential side effect of the screen is nothing more than 10 to 20 minutes of additional time? Don’t tell me there is the risk of a false positive! There may be! But which do you think is better? A false positive that can then be cleared up by an MRI, or a biopsy, or finding out a few years later that you have a stage 3 or 4 cancer that was undetected due to your dense breasts?
Second, if your state doesn’t have a dense breast notification bill find your local group(s) and get active to demand they address this issue. Check out www.areyoudense.com to find out more. If your state has a law but the law does not require anything more than the kind of notice in the quote above, go raise a little hell! It should at least require some notification of what dense breasts mean in terms of the efficacy of the diagnosis and what options are available to you to get further testing.
Third, after you have achieved these first two objectives, work to get your state insurance commissioner to mandate that automated screening ultrasound – for dense breasted women be approved and reimbursed by insurance companies offering coverage within your state. It is long past time for this issue to get resolved. I have seen a number of people devastated by breast cancer. My mother, mothers in law (more than one), friends, family, and neighbors. While mammography has been a very effective tool over the past so years at reducing deaths from breast cancer, it is now known that it is not as effective as we thought it was, or were led to believe. Let’s change this and get to the next plateau in the reduction of unnecessary death from this horrible disease.
Finally, do not wait for insurance reimbursement to get this, potentially life-saving, procedure. When it pays, insurance reimburses $100 to $150 for whole breast ultrasound. If you are denied coverage find a way to get $150. That is just five cups of coffee per month.
[i] Weigert, et al; “The Connecticut Experiment: The Role of Ultrasound in the Screening of Women With Dense Breasts”, The Breast Journal, Volume 18 Number 6, 2012 517–522
[ii] Bae, et al; “Breast cancer screening with US: Reasons for non-detection”, Radiol (2014) Vol 217:No 2, 369-377
[iii] Colditz GA, Willett WC, Hunter DJ et al (1993) Family history, age, and risk of breast cancer. Prospective data from the Nurses’ Health Study. JAMA 270:338–343
[iv] Gail MH, Brinton LA, Byar DP et al (1989) Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 81:1879– 86
[v] Seidman H, Stellman SD, Mushinski MH (1982) A different perspective on breast cancer risk factors: some implications of the non-attributable risk. CA Cancer J Clin 32:301–313
Figure 1: American Cancer Society Surveillance Research
Figure 2: Stephen W. Duffy, MSc, CStat,* Laszlo Tabar, MD, Bedrich Vitak, MD, and Jand Warwick, PhD, “Tumor Size and Breast Cancer Detection: What Might Be the Effect of a Less Sensitive Screening Tool Than Mammography?”, The Breast Journal, Volume 12 Suppl. 1, 2006 S91–S95