Faulty Mammograms at The Breast Institute in West Palm Beach, FL

FDA Declares West Palm Beach Mammography Facility to be “Serious Health Risk”

Floridian women in the West Palm Beach area, please take note: The Breast Institute in West Palm Beach is unauthorized to perform mammography.

The U.S. Food and Drug Administration (FDA) took corrective action against The Breast Institute, located in West Palm Beach, Florida, after declaring that the mammograms performed by the facility are a “serious risk to human health.”

As a corrective action, the FDA required that the facility notify its patients and their healthcare providers of the serious image quality deficiencies of its mammograms via a Patient and Referring Healthcare Provider Notification (PPN).

What The Breast Institute is Telling Patients

To comply with the FDA’s PPN order, The Breast Institute at JFK Medical Center North Campus mailed letters to its patients and their physicians, alerting them to the fact that “there is a serious concern about the quality of the mammography that our facility performed.” The letter notifies recipients that the FDA has required the facility to stop performing mammography as of October 30, 2019.

The letter, signed by Warren L. Reuther, MD, Medical Director of Imaging Services at The Breast Institute, recommends that patients take the following steps:

  1. Talk to their physicians about their mammograms and the possible need for its review or perhaps a repeat procedure
  2. Share the information about the mammogram quality deficiencies with any new health care provider as soon as possible
  3. Call The Breast Institute to request the mammogram and report be provided in the event that the patient’s health care provider recommends a review or repeat mammogram

The Breast Institute further informs patients that the facility will cover the costs for re-evaluation and repeat mammograms.

What Went Wrong

The Mammography Quality Standards Act (MQSA) requires that adverse actions taken against mammography facilities be reported and that the report be presented to the general public, as well as to physicians.

In its annual MQSA inspection in June 2019, the Breast Institute—located at the JFK Medical Center North Campus on N. Congress Ave in West Palm Beach Florida—exhibited quality deficiencies. As a result, the FDA called for an Additional Mammography Review (AMR) of the facility’s mammography. The American College of Radiology (ACR) conducted the AMR and determined that the facility did not measure up to clinical image quality standards. The ACR revoked The Breast Institute’s mammography accreditation in October 2019.

The FDA followed suit by invalidating The Breast Institute’s MQSA certificate. The facility may be reconsidered for MQSA certification once the ACR has reinstated accreditation.

As of March 23, 2020, the facility had yet to apply for such reinstatement.

Locating MQSA-Certified Facilities

The FDA provides a list of MQSA-certified facilities where you can you get your next mammogram. Alternatively, the National Cancer Institute (NCI) can help you find such a facility in your area. Call the NCI at 1-800-422-6237.

SOURCES:

https://www.fda.gov/radiation-emitting-products/reports-mqsa/mammography-facility-adverse-event-and-action-report-march-13-2020-breast-institute-jfk-medical

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mqsa.cfm