Translation by Cancer Rose, an article published by Judith Garber, a political scientist at the Lown Institute, a nonpartisan think tank for a more just and equitable health care system.

March 18, 2023

LOW-VALUE CARE

New FDA guidance on breast density notifications and the implications of overuse - BY Judith Garber | March 10, 2023

Background

The radiological criterion of "breast density," the predominance of fibroglandular tissue over fatty tissue in the female breast, is now considered to be a risk factor for breast cancer on its own, despite the lack of evidence-based studies.

Breast density is generally high in young, non-menopausal women (but may persist after menopause), in thinner women with low body fat, and in women undergoing menopausal hormone replacement therapy.

A law passed in 2019 by the U.S. Congress required the U.S. Food and Drug Administration (FDA), as part of the regulatory process, to ensure that all mammography reports and summaries provided to patients include information on women's breast density. This authority, which oversees the regulation of mammography facilities and quality standards, has previously required the reporting of breast density in radiologists' reports.

It's done. The FDA recently updated its guidelines to require mammography facilities to inform patients of their breast density.

Why is this an emerging concern for European women populations as well?

Because with the advent of so-called predictive software, the radiological criterion of breast density is being incorporated as a risk factor in its own right in studies such as the European MyPEBS for individualized screening, whereas published studies (see article) show that the increase in breast cancer risk associated with breast density is modest and that for women diagnosed with breast cancer, increased breast density was not associated with an increased risk of poor prognosis cancer or death from breast cancer.

The FDA's decision is supposed, according to Volpara, a company that markets automatic breast density measurement software, to serve as an example "to the rest of the world." (See the very last chapter of this article, "Cancer Rose comments")

The USPSTF (independent task force reviewing U.S. preventive services), already in 2016, raised several points of concern about this legislation requiring women to be notified of their breast density information.
- Significant variability and limited reproducibility in the determination of dense breasts. This variability exists whether one radiologist or different radiologists read it. The exam for a given patient may have different classifications and lead to misunderstandings leading to a reduction in a woman's confidence in screening in general and confusion about her breast cancer risk.
- Uncertainty about steps taken by women notified of significant breast density to reduce their risk of dying from breast cancer. This is the request for additional tests for which no evidence supports the indication. There is no evidence that adding imaging other than mammography for women with dense breasts will reduce cancer mortality; these additions increase false positives, unnecessary biopsies, and overdiagnosis. The recall rate (for false positives) is significantly increased by the addition of ultrasound (by 14%) and by the addition of MRI (from 9 to 23%) with low PPVs[16] and an obvious additional cost. The authors remind us that MRI, often considered harmless, would be susceptible to a (low) excess risk of nephrogenic systemic fibrosis and uncertain risks of gadolinium deposition in the brain when the examinations are repeated.
Tomosynthesis (TS) is mentioned as an additional technique used. Still, the authors point out that longer-term studies are needed to determine whether the routine use of TS in women with dense breasts improves breast cancer outcomes (mortality, decrease in the rate of serious cancers).
- Difficulty communicating information about breast density to patients. Experts consider this communication complex and dependent on the population's literacy level. Study results show poor understanding, confusion, and misinformation among patients when information about breast density is given.

Article of Judith Garber

-Follow link for the complete article-

The US Food and Drug Administration (FDA) recently updated their mammography guidelines to require mammography facilities to notify patients about their breast density. This change, which goes into effect September 2024, is a final version of a rule proposed in 2019 (see our previous coverage on this topic). 

The FDA guidelines contain suggested language for notifications about breast density: 
“Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast
tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”
There are a lot of issues here.....

Comments Cancer Rose

Conflicts of interest of Dense Breast Info members can be seen here in the list by following this link: https://www.rsna.org/-/media/Files/RSNA/Annual%20meeting/2022-AMPPC-Planners-Disclosure

RSNA: Radiological Society of North America, it is a non-profit organization and an international society of radiologists, medical physicists and other medical imaging professionals

Among the "educational supports" we find the Volpara Society. Volpara is a publicly traded New Zealand company (Volpara Solutions Ltd.) that markets software to generate standardized breast density measurements automatically.

Volpara's Investor Statement on 30 Sep 2022 reads:
https://wcsecure.weblink.com.au/pdf/VHT/02601721.pdf

“Volpara is delivering strong growth in line with its upgraded guidance of between NZ$33.5M and NZ$34.5M. We continue our strategy of balancing purpose with profitable growth leveraging focus: our most profitable products, most lucrative markets, and providing the best value for "elephants," or large enterprise accounts. We await the release of the FDA’s breast density legislation, expected between now and early 2023, as per the latest FDA release, which can be found here. “

"Waiting for the Mandate on Breast Density by FDA

- late 2022/early 2023

- Validates the importance of breast density

- Set an example for the rest of the world

- Federal decision = everyone should be informed

- Breast density is considered in risk assessment"

For example, a radiologist extremely well known in the Canadian media, Dr Paula Gordon, who advocates for early breast cancer screening and challenges the CanTaskForce** recommendations for caution, is a shareholder of Volpara company. We can thus read her regular statements in the Canadian press, describing the

Canadian group CanTaskForce as "killers of women":

1- https://theprovince.com/opinion/op-ed/dr-paula-gordon-new-breast-cancer-screening-guidelines-are-going-to-kill-many-women
"Dr Paula Gordon: New breast cancer screening guidelines will kill many women"

2-https://medicinematters.ca/breast-cancer-screening-mammogram-policies-are-based-on-flawed-research-dr-paula-gordon/
"Policies on breast cancer screening mammograms are based on flawed research / Dr Paula Gordon

3-https://globalnews.ca/news/8239335/breast-cancer-screening-canada-report/
"Outdated" breast cancer screening guidelines are failing Canadian women."

** The Canadian Task Force on Preventive Health Care was established by the Public Health Agency of Canada (PHAC) to develop clinical practice guidelines that support primary care providers in delivering preventive health care.