3D Mammogram on the Brink of FDA Approval

Nov. 24, 2010— -- The Food and Drug Administration cleared the next step Monday for a new three-dimensional mammogram device purported by the device maker Hologic to more precisely detect breast lesions and reduce the number of follow-up breast cancer screenings when used in conjuction with conventional digital mammograms.

"This is a major advance that we have been working on for years," said Dr. Daniel Kopans, director of the breast imaging center at Massachusetts General Hospital in Boston, which holds the patent to the device. "It will aid in detecting more cancers earlier, and reduce the false positive callbacks."

The FDA panel that reviewed the device sent Hologic an initial letter accepting the device into its next phase for review. And while experts agreed more precise methods of detecting breast cancer are necessary, many said there's not enough evidence yet to show whether the new device can save lives.

"The real issue here is not which test can find the most cancers, it's about which test can find the right cancers," said Dr. Gilbert Welch, professor of medicine and community and family medicine at Dartmouth Medical School in Hanover, N.H. "Just because you find more and more, more of what you're finding might not be important."

Welsh said he worried earlier detection of benign masses that might not develop into cancer could result in unnecessary treatment in otherwise healthy women.

Long-term randomized trials comparing conventional mammograms to 3D mammograms will be the best way to know whether the new device will actually save lives, Welch said.

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"Mammography, even digital, is far from perfect," said Dr. Emily Conant, professor and chief of the division of breast imaging at Hospital of the University of Pennsylvania.

Conventional mammogram screenings of women over age 40 could result in false diagnoses and a greater challenge in detecting clusters that actually develop into breast cancer, Conant said.

A conventional mammogram overlaps two X-rays taken from different angles of the breast, said Conant, at times making it difficult to detect whether a mass is truly cancerous.