The FDA has just issued an urgent alert about Allison Breast Center in Richmond that all patients should be aware of.
According to the alert, patients should get their mammograms and medical records from Allison Breast Center and have those mammograms re-reviewed by another breast cancer mammographer immediately.
The alert notes that patients have the right to obtain copies of their mammograms and medical records from Allison Breast Center and provides instructions on how to do so.
Importantly, the FDA’s alert to patients notes that the FDA required Allison Breast Center “to participate in an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the Mammography Quality Standards Act.”
Allison Breast Center, however, has failed to comply with the FDA’s request. As a result, the American College of Radiology has now revoked Allison Breast Center’s accreditation. According to the FDA, the facility does not meet the standards of mammography under the Mammography Quality Standards Act and “may not legally perform mammography at this time.”
On August 27, 2020, the FDA also ordered Allison Breast Center to inform all of its patients “about the problems with the mammography quality at the facility.” According to the FDA, to date, “the facility has not performed the ordered notifications.”
Here is the FDA’s alert, issued on Friday, September 25, 2020: https://www.fda.gov/medical-devices/safety-communications/mammography-problems-allison-breast-center-monument-radiology-richmond-virginia-fda-safety
If you were a patient of Allison Breast Center and need help getting your mammograms and medical records, we can help.