A routine FDA report to Congress revealed that three imaging centers in northern New Jersey were cited by the agency as performing inaccurate mammograms in 2005 and 2006. All the centers were found to have quality problems that might result in the failure to detect cancer. The story was uncovered by The Record in Bergen County. In recent months, more than 1,000 women were told about the potential problems with their screenings at the centers.

The agency has notified affected patients who had mammograms at Hackensack Medical & Molecular Imaging (not to be confused with nearby Hackensack University Medical Center), Englewood Imaging Center (not to be confused with Englewood Hospital and Medical Center), and St. Mary's Hospital in Passaic. Englewood and St. Mary's have addressed the problems and re-opened for mammography. An executive with Hackensack Medical & Molecular Imaging told The Record that the problem at the facility was due to the transition from film to digital mammography in which faulty monitors failed to reveal images as clearly as film. Ironically the center's costly investment in the cutting-edge technology led to the problems, which are being corrected.

Fortunately these types of citations are rare with only 14 of 8,836 mammography centers operating nationwide cited in 2006. However the serious consequences of problems with mammography accuracy are evident. The Record found a patient whose cancer was missed by one of the cited centers and later discovered upon examination at another facility.

Adding to the story are recent closings at local imaging centers under cost pressures including reduced reimbursement. This has resulted in overcrowding for mammography screening at hospital-based imaging centers in the region.

To read The Record's coverage, go to:
http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjcxN2Y3dnFlZUVFeXkzJmZnYmVsN2Y3dnFlZUVFeXk3MTc3MTk1

To read the FDA's CDRH Mammography Facility Adverse Event and Action Report reports, go to:
http://www.fda.gov/CDRH/MAMMOGRAPHY/reports.html

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