Updated Mammogram Guidelines

Hello bOObs Bloggettes:

Sorry it’s been such a long time since I’ve blogged. I’m spending oodles of time editing my second upcoming documentary on alternative cancer therapies. But I wanted to chime in on FDA finally updating its mammogram guidelines and recommendations for women.

The largest change in its regulations were for women with dense breast tissue (DBT). The FDA finally is asking doctors to not only tell all women receiving a mammogram to be told if they’re in the top two categories of DBT (that equates to 50% of us) but, more importantly, why knowing your DBT category matters.

And why it matters is this: Women with higher breast density have a higher probability of having their cancers missed on a mammogram. Why is this? Because on a mammogram, a cancer appears white and so does the DBT.  It’s like “finding a polar bear in a snowstorm,” said one doctor I interviewed.

But while FDA — after 20 years of not updating its antiquated Mammography Quality Standards Act guidelines — is at least telling doctors to tell us that very important factoid, the FDA has still not deemed ultrasound as a primary breast screening tool (mammogram is the only tool that fits this definition). If they did, it would allow Medicare to cover ultrasound straight out and give women in the higher DBT categories the choice to skip the radiographic mammogram and go directly to the non-radiative ultrasound first — the latter thought by many to be a better tool for DBT.

Another irritating fact is that in its press release, the FDA never talks directly about ultrasound, instead referring to it as “further evaluation.” It seems the FDA doesn’t want to plant the potential seed for women to go running to their doctors now hoping to skip the mammogram and instead head straight to the ultrasound — so it refuses to even mention the “U” word for public consumption.

One question I have is: Why did it take the FDA so long to act on this when they solicited public comments four years ago?  It undoubtedly cost many women their lives and/or cut some lives shorter. In addition, FDA is giving mammogram centers another 18 months to implement the changes, therefore more cancers going undetected in DBT and thus incurring more harm. Even in light of the pandemic, the dragging out of this timeline is inexcusable. In addition, a little birdie told me that the only reason the update happened at all was because there was Capitol Hill pressure put on the FDA to get the darn thing done.

Another item that is not discussed in FDA’s announcement is that the calibration of mammography machines is all over the place, many of them delivering much more radiation than FDA’s allowance. This was discussed in one excellent research paper I uncovered. When is that seemingly very large problem going to be addressed?

Interesting to note that the American College of Obstetricians and Gynecologists sent this to the FDA: “Women with [DBT] have a moderately increased risk for breast cancer…” But it’s actually up to six times the risk, a figure women would most likely not deem as “moderate” (I sure as heck don’t).

In addition, neither ACOG or Susan G. Komen mentioned ultrasound in their FDA comments as an alternative to the mammogram. It seems like all the main players are playing out of the same playbook, perhaps?

You’ll be happy to know that I put my two cents in and got 300+ signatures on a document laying out the pros and cons of screening and pointing to thermography and ultrasound as a more prudent choice that should be studied ASAP; I sent that in to the FDA during its open comment period of the new Rulemaking process — now some four years ago.

You can find the FDA press release with links to look up comments (suck as mine) here:

https://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance

bOObs Bottom Line: “We have a long way to go, baby”…

Blog at you soon, thanks for reading and helping to spread the word!  (Please see the “share” links below.)  And we’d love to hear comments from you! (see below as well)

Stay healthy,

Megan

Megan Smith, M.S.
Director, bOObs: The War on Women’s Breasts

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