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December 04, 2013 11:00 PM

More screens from breast density laws may hike false cancer reports

Jaimy Lee
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    Laws in about a dozen states that require radiologists to notify patients if they have dense breast tissue have raised questions about the utilization of new supplemental screening techniques for breast density and how radiologists identify density levels.

    Women with dense breast tissue are more likely to get cancer than those with fatty tissue. There is also a higher risk that their cancers may be missed because denser tissue can mask tumors in a mammogram. About 40 million women in the U.S. undergo mammograms each year. About 40% of women are estimated to have dense breast tissue.

    Thirteen states have passed so-called breast density notification laws, with laws in six of those states set to go into effect in 2014, and more are expected to do so. Rep. Rosa DeLauro (D-Conn.) in October introduced a federal notification law for the second time. Sen. Dianne Feinstein (D-Calif.) is expected to introduce a Senate version.

    Researchers at the Radiological Society of North America's annual meeting this week in Chicago said radiologists can overestimate density. They also said that automated software systems may enhance screening and help explain density to patients but are not commonly used.

    Other radiologists say that a woman's total risk profile, including family history, can outweigh the risk of having high breast tissue density. “It's not the whole picture,” said Dr. Geraldine McGinty, a radiologist based in New York.

    The state laws have made women more aware of the risks associated with dense breast tissue and how radiologists identify density levels. But radiologists say the notification laws may mean that fewer patients will return for supplemental screening due to anxiety over risk or cost concerns. MRI and ultrasound are the most common forms of screening for women with dense breast tissue. However, these can lead to false positives, additional biopsies and other risks, and are generally more costly.

    Connecticut, Illinois and Indiana are the only states to mandate insurance coverage of supplemental screening methods.

    Since a New York state law took effect a year ago, insurers there have been covering adjunct screenings as long as a woman's tissue density has been assessed by a radiologist, said Dr. Stamatia Destounis, an owner of the Elizabeth Wende Breast Care practice in upstate New York. “Our insurers have been paying for ultrasound for patients who do come back,” Destounis said.

    Traditionally, the only way for breast-density levels to be identified is a radiologist's subjective reading of a mammogram. But several medical technology companies are bringing new products to market that they say are expected to aid providers as they assess density, which is separated into four categories.

    Women who have a “3” or “4” using a density scoring system developed by the American College of Radiology are considered to have dense breast tissue.

    Philips Healthcare is expected to receive FDA clearance this year for an application that provides a volume-based breast density measurement. It's expected to cost around $50,000 to install.

    Matakina International and Hologic both sell software that provides an estimate of a patient's density level. Matakina brought its VolparaDensity breast imaging software to market in 2010. It is currently installed in 50 facilities in the U.S. and costs start at $40,000 for implementation.

    The ProMedica Toledo Hospital Breast Care Center in Toledo, Ohio, recently started using the Volpara system and this month has started to share patients' density classification number with them, said Dr. Robin Shermis, the center's medical director. While Ohio has not passed a breast density notification law, a bill is pending. “We want to be ahead of the curve,” Shermis said.

    Follow Jaimy Lee on Twitter: @MHjlee

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