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FDA: Allison Breast Center did not meet the standards for mammography quality

Allison Breast Center
Posted at 1:42 PM, Sep 25, 2020
and last updated 2020-09-25 17:47:06-04

HENRICO COUNTY, Va. -- The U.S. Food and Drug Administration announced Friday the Henrico-based Allison Breast Center can no longer legally perform mammograms based on its failure to participate in an Additional Mammography Review, which would have determined the quality of mammography at the business.

The business has been closed since late May when Virginia suspended the license of its owner, and only radiologist, Dr. Michael Bigg, for allegedly mis-reading 18 patients' mammograms.

As part of the mammography review, the American College of Radiology (ACR) requested clinical images and documentation from the Allison Breast Center, but the center never complied, so the ACR revoked the facility's accreditation.

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"Under the Mammography Quality Standards Act of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet the standards for mammography quality under the Act."

The FDA directed the facility to notify all patients who received mammograms at the Allison Breast Center after June 17, 2018, along with their referring health care providers, about the problems with the mammography quality.

"To date, the facility has not performed the ordered notifications."

CBS6 problem solver investigator Melissa Hipolit asked the FDA if the Allison Breast Center would be penalized for non-compliance with notification, and a spokesperson said "everything we have at this time is in the safety communication."

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