State Health Commissioner Cites Concerns at Mammography Facility in Lower Manhattan

Issues Advisory Urging Rescreening to Ensure that Cancers Were Not Missed

Photo of State Health Commissioner Dr. Antonia Novello

State Health Commissioner Dr. Antonia Novello announces a tollfree hotline for patients at risk of missed breast cancer because of substandard mammograms performed by Park Avenue Medical Imaging and Mammography, P.C. at 200 Park Avenue South in New York City.

New York City, November 5, 2003 - New York State Health Commissioner Antonia C. Novello, M.D., M.P.H., Dr.P.H., today urged patients who received their most recent mammogram at Park Avenue Medical Imaging and Mammography, P.C. in lower Manhattan to immediately obtain another mammogram because of concerns about quality deficiencies that leave open the possibility that cancer may have been missed.

To ensure that patients who were screened for breast cancer at the facility receive the information they need, the State Health Department has established a special tollfree number that will operate seven days a week, 24 hours a day. Patients of Park Avenue Medical Imaging and Mammography, P.C. who have questions or concerns are encouraged to call 1-800-808-1987.

"While this is certainly a message we want people to take seriously, it should not be cause for alarm," Dr. Novello said. "It is highly unlikely that the vast majority of the patients involved have an abnormality, but we want them to know that they should be re-screened to make absolutely certain that they are free from cancer. We are urging them to consult with their health care provider and arrange another mammogram without delay."

Commissioner Novello emphasized that this action only pertains to individuals who had their most recent breast cancer screening at Park Avenue Medical Imaging and Mammography, P.C. located at 200 Park Avenue South in Union Square in New York City. Although the exact number of affected individuals is not known, the facility provides mammography for approximately 4,000 patients every year.

The problems were originally uncovered through a quality assurance review undertaken by the New York State Department of Health (DOH) Cancer Services Program of mammography films interpreted by Yefim Vaynshelbaum, M.D., in his capacity as a provider in the Manhattan Breast Health Partnership program. The DOH review found that there was a risk for missed cancer in 74 percent of cases, either because the appropriate diagnostic tests for abnormal mammograms were not ordered, or because the technical quality of the films was poor. Upon completion of the review, DOH placed Park Avenue Medical Imaging and Mammography, P.C. on probation, but the facility could not meet the probationary terms.

The DOH findings prompted additional mammography reviews by the U.S. Food and Drug Administration (FDA), the agency that oversees mammography quality in the nation, and the Centers for Medicare and Medicaid Services (CMS), which conducted a review of mammograms provided to Medicare beneficiaries by the practice. The FDA review was conducted by the American College of Radiologists.

Based on their evaluation of all three mammography reviews, the FDA has determined that the mammograms performed at Park Avenue Medical Imaging and Mammography, P.C. during the review period were so inconsistent with established quality standards as to pose a significant risk to individual or public health.

Commissioner Novello has been in close contact with both the FDA and CMS to ensure that affected patients in New York City are notified of the quality concerns. Patients screened at Park Avenue Medical Imaging and Mammography, P.C. as part of the Manhattan Breast Health Partnership program have already been apprised of the need for another mammogram. Today’s advisory is to provide this important information to all other patients screened at the facility.

Dr. Novello noted that a complete breast screening includes a mammogram along with a clinical breast exam in which a health care provider checks for lumps or other changes in the breasts, and teaches about breast self examination. Therefore, patients who had their most recent clinical breast exam at Park Avenue Medical Imaging and Mammography P.C. also should get another exam. Any patient who has since been screened at another facility need not seek a repeat exam.

"Our Department’s quality assurance activities have been recognized by the Centers for Disease Control and Prevention as a model for other states in the National Breast and Cervical Cancer Early Detection Program," Dr. Novello said. "Nobody should receive a mammogram, only to find out later that it was incomplete or substandard. Today’s advisory is intended to help patients of Park Avenue Medical Imaging and Mammography, P.C. get the information they need to schedule another mammogram and receive accurate results."

An information sheet and letter to physicians is posted on the DOH website at www.health.ny.gov. Patients of Park Avenue Medical Imaging and Mammography, P.C. who have questions should call 1-800-808-1987. Health care providers who require additional information may call the Cancer Services Program at 518/474-1222 during normal business hours.

Editor’s note: The Commissioner’s announcement does not relate to patients seen at another similarly named facility called "Park Avenue Radiologists, P.C." Park Avenue Radiologists, P.C. is located on Park Avenue between 60th and 61st Streets and is in no way affiliated or associated with Park Avenue Medical Imaging and Mammography, P.C.