FDA Takes Strong Action to Protect Patients — Breast Institute at JFK Medical Center

Reading mammogram x-ray film critical to patient care

West Palm Beach, Florida

The US Food and Drug Administration (FDA), has recently taken the extraordinary step of requiring The Breast Institute at the JFK Medical Center North, located at 2201 45^th Street in West Palm Beach, Florida, to notify their patients and their medical insurance companies of serious deficiencies in their mammogram imaging.

According to the FDA “Adverse Event and Action Report” dated March 13, 2020, there were serious quality deficiencies detected at two recent evaluations done by the FDA and the American College of Radiology. 

The problems consist of “serious deficiencies with clinical image quality” according to the FDA report.   Serious problems with image quality can lead to a deadly results, including misdiagnosis of breast cancer.  The purpose of getting a mammogram is to determine if a woman has breast cancer at the earliest possible stage, so she can be successfully treated and minimize significant and disfiguring surgery.    But poor image quality defeats that purpose and can, and often does, lead to an erroneous interpretation by the reading radiologist. After all, the evaluation is only as good as the quality of the image on the mammogram.

Breast Institute’s Accreditation to Perform Mammograms  is Revoked

This serious threat to women’s health also lead the US Food and Drug Administration to revoke the mammogram accreditation of The Breast Institute at JFK Medical Center North. That means the Institute’s ability to conduct and read mammograms was revoked until The Breast Institute has complied with all of the FDA’s terms and requirements.

“Serious Risk to Human Health”

The Institute’s mammogram image quality deficiencies means that the mammograms were being so poorly conducted at The Breast Institute that the FDA declared the practice of mammography there to be a “serious risk to human health“.

What that means to the everyday patient is that mammograms taken and read there may have been misread.  A misread mammogram may have disastrous consequences for the patient and her family.   A misread mammogram may well have missed a deadly breast cancer or may have caused a patient to undergo unnecessary and disfiguring surgery. 

FDA Requires “Corrective Action”

The Breast Institute’s Director was required to mail letters to its patients and their physicians which said, in part, “there is a serious concern about the quality of the mammograms that our facility performed “. So far, The Breast Institute has not applied for re-accreditation. The Center released the following statement:

“The Breast Institute at JFK Medical Center North Campus has stopped providing mammography services while we implement a comprehensive plan to improve these services. We are notifying patients who have received scans at our hospital. For patients who had a mammogram during the review period, we are working diligently to have these re-read or re-done, if necessary, at no cost to patients. It’s important to note that this change only affects mammography services; the hospital remains accredited by the Joint Commission, and we’re working closely with the American College of Radiology to improve our mammography services.”

What to do?

If you or someone you know was a patient at The Breast Institute then that person should get another mammogram from an accredited facility as soon as possible.  Time without detection can be a cancer patient’s worst enemy.  Early detection is paramount in the successful treatment of breast cancer.

If you find that you or someone you know has been misdiagnosed, you should consult an attorney and law firm skilled in handling medical malpractice cases. Medical Malpractice is a specialty and you should consult a Board Certified Civil Trial Lawyer who specializes in medical malpractice. 

Greg Barnhart