Lobbying the FDA to Mandate Breast Density Notification
In November I traveled to DC to issue a statement to the FDA advisory committee regarding breast density. Several radiologists, breast cancer patients and advocates, representatives from the American College of Radiology, as well as Karen Handel from the Susan G. Komen foundation were on hand to render opinions regarding a new rule being considered by the FDA, which would mandate the inclusion of breast density information in the official mammogram report that goes to the referring doctor, and that the radiology facility providing a mammogram would directly inform the woman of her breast density when she receives her mammogram results in the letter known as the “lay summary.”
Here is an excerpt from my statement to the FDA:
Testimony at the 2011 FDA National Mammogram Quality Assurance Advisory Committee Meeting
“When I give a woman with dense breasts a normal mammogram report, I am only 50 percent certain that there’s no cancer in her breast. This is ineffective screening by any definition. And by not routinely informing women with dense breasts that their mammogram is limited and that they have a choice to pursue second-level screening with breast ultrasound, MRI, or another test, we are poorly serving many of our patients.
Women who are diligent and come to me yearly for their mammograms expect to be effectively screened for cancer. They trust me to do that for them. We do not provide effective screening if breast density is ignored.
The FDA does not accept blurred films or images with dust or small artifacts on them. Why do we accept the huge limitations of breast density?” - Dr. Stacey Vitiello
The entire transcript from the meeting can be viewed here: http://tinyurl.com/7kuc3zm
End result: The consensus of the NMQAAC was that all mammography reports and lay summaries should include a woman’s breast density. Yippee! However, considering how slowly the wheels turn at the FDA, these changes may not be seen in real practice for many years. In the meantime, we’ll continue to support legislative efforts in statehouses across the country, as well as at the federal level, to make breast density notification a reality for all women in the near future.
Learn more about breast density and what it means to you here.