California Soon to Have Breast Density Notification Law

Roxanne Nelson

January 17, 2013

California will soon become the fifth state with a breast density notification law. When it takes effect April 1, California will join Connecticut, New York, Texas, and Virginia, which have already passed similar legislation. In addition, laws are being considered in about a dozen other states, including Florida, Nebraska, North Carolina, Oregon, and Utah. There is also a federal bill pending in the US House of Representatives.

Senate Bill 1538, authored by State Senator Joe Simitian (D-Palo Alto) and signed into law by Governor Jerry Brown, requires that women with dense breast tissue be notified after undergoing screening mammography.

Notification Required by Bill 1538
Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast   cancer.
This   information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician.

However, some experts are concerned whether this type of legislation is ahead of the science.

In 2011, Governor Brown vetoed the bill, which was opposed by a number of professional organizations, including the California Medical Association, the Association of Northern California Oncologists, the American Congress of Obstetricians and Gynecologists (District IX), the California Radiological Society, and the Medical Oncology Association of Southern California.

However, at that time the legislation was supported by a number of healthcare-related groups, including the California Radiological Society, the California Nurses Association, Planned Parenthood Affiliates of California, the California affiliates of the Susan G. Komen Foundation, and the Breast Cancer Fund.

Several months after the initial veto, the California Medical Association joined a large coalition of healthcare groups asking for amendments to the bill. The amended bill, which softened some of the language in the original legislation, was reintroduced and eventually signed into law.

So far, the United States is the only country to pass laws requiring that women be informed about dense breast tissue and be made aware of the limitations of mammography.

Unintended Consequences

Breast density is associated with a higher risk for breast cancer, and mammograms of dense breasts can be difficult to interpret. But having legislation on this topic can have unintended consequences, according to Debra I. Monticciolo, MD, president and chair of the board of directors of the Society of Breast Imaging.

In a previous interview, she pointed out that although many things sound great in theory, that can change once they are put into practice. "New ideas are often accepted enthusiastically because we all want to do better for our patients," said Dr. Monticciolo, who practices in Texas, where a notification law was recently passed. "We want to diagnose more cancers earlier, but we should approach these things with caution or we're going to end up unsatisfied. That is my concern."

"There are many questions around this topic, such as how to consistently and accurately assign breast density in the first place, and yet we have a law," she pointed out. "It may be well intended, but it's premature."

A recent study of a breast imaging practice showed an increase of 3.2 additional cancers per 1000 women screened after the adoption of a breast density notification law in Connecticut in 2009 (Radiology. 2012;265:59-69). However, there was also a very high false-positive rate and a low positive-predictive value for biopsies.

That study exposed many of the weaknesses of current breast ultrasound research and highlighted the prematurity of breast density notification laws, said Carl D'Orsi, MD, from Emory University in Atlanta, Georgia, who coauthored an editorial that accompanied it (Radiology. 2012;265:9-11).

"What happens now is this study becomes a piece of data that people use to justify screening breast ultrasound...[and its] cost effectiveness," he said in an interview with Medscape Medical News when the study was published. "I'm not saying [the data] should never be used; I'm just saying it's a little early to make a law out of it," Dr. D'Orsi explained.

Legislate Medicine?

In an interview with the Los Angeles Times about the new legislation in California, Otis Brawley, MD, chief medical and scientific officer of the American Cancer Society, noted that he is "concerned when people try to legislate the practice of medicine."

Another problem with this type of law is that breast density scores are not yet precise. He points out that "one radiologist's eyes may be very different from another radiologist's eyes."

But perhaps the most pressing issue is that there isn't an evidence-based standard of care. "I am not sure at this juncture what is the right thing to do" with a woman with dense breast tissue, Dr. Brawley said.