News and Events
Dedicated screening ultrasound for dense breasts meets FDA panel's endorsement
"Sometimes the glandular tissue is so dense that radiation doesn't penetrate it. You can't see anything." Robert Smith, American Cancer Society
The U.S. Food and Drug Administration’s (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended unanimous approval of the somo•v® Automated Breast Ultrasound (ABUS) system manufactured by U-Systems.
"We now have the opportunity to integrate 3D automated breast ultrasound screening into clinical practice, which will enable us to find previously undetectable cancers,” said Rachel Brem, M.D., Director of Breast Imaging at The George Washington University Hospital, Washington D.C. “Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. In women with dense breasts, we can’t see over a third of breast cancers, so we need other technologies, other approaches. The potential of 3D ABUS in a screening environment is to find these 30 percent additional cancers that would not have been found with what is now the standard of care."
Robert Smith, senior director of cancer screening at the American Cancer Society remarked on the panel's decision, "Sometimes the glandular tissue is so dense that radiation doesn't penetrate it. You can't see anything."
Are You Dense, Inc. was founded to ensure that women are informed of their dense breast tissue and have access to reliable tools to find cancer at its earliest stage when most treatable thus conferring a better prognosis of survival. The recognition by the FDA panel that mammography does not work equally well for women with dense breasts (misses every other cancer) and that an adjunctive screening devise is effective and safe is a giant step towards preventing later stage cancers.
One major problem! 95% of women do not know their breast density and less than one in 10 learn about their density from their health care providers. Are You Dense Advocacy, Inc. is working with women and state legislators across the country to standardize the communication of breast density in their state. In addition, a national bill has been introduced - HR 3102. It is time that ALL women receive this critical potential life-saving information about their breast health.
Unfortunately, not everyone agrees with our legislative efforts. The American College of Radiology (ACR), Susan G. Komen for the Cure and American Cancer Society (see above quote from Dr. Smith) are "neutral" on these legislative efforts (which equates to not supporting them). The American Medical Association, American College of Gynecologists and Obstetricians (ACOG) are opposing these bills.
And these are the facts:
Breast density predicts the accuracy of a mammogram at any age.
Breast density is a well-established risk factor for breast cancer.
Study after study show that mammography misses every other cancer in dense breasts.
Adding additional tools to mammography increases detection up to 100%.
Isn't it time for medical trade organizations to stop "withholding medical information from women" and join with us to standardize the communication of breast density across the country. These are some of the reasons we hear why this information should not be consistently shared with women: Women will be frightened, there is not enough reimbursement, too many false positives, and women with fatty breasts and at high risk will have unrealistic expectations in their mammogram, and on and on.
Let's give ALL women their medical information so they can have informed educated discussions with their health care providers about their personal screening surveillance.
45,000 women each year read their mammography report (the Happy Gram) as normal YET have an invasive cancer, undiscovered by mammography which will most likely be found by palpation. These cancers will most likely be larger, at a later stage with poorer survival outcomes. We MUST do better.