FDA Warns of Poor Quality Mammograms by Huntington Radiology

Federal regulators are warning physicians and patients about poor quality mammograms from a California radiology lab. 

On March 10, the FDA issued a safety notification that warned of problems with mammograms done at Huntington Radiology in Huntington Park, California.

The FDA said that customers of the lab should be aware of problems with mammograms done at the facility between September 9, 2008 and September 9, 2010, when the company had its American College of Radiology (ACR) accreditation revoked.

The agency first became aware of problems at Huntington Radiology when it worked with the ACR to review samples of mammograms performed by the lab. The FDA requires mammography facilities to meet stringent quality guidelines laid out by the Mammography Quality Standards Act (MQSA) of 1992. The FDA and ACR found that some of the mammograms from Huntington were of poor quality with potentially unreliable results.

Huntington Radiology lost both its ACR accreditation and its MQSA certificate. It is no longer performing mammograms. The facility was instructed to advise all of its former patients about the risk of breast cancer misdiagnosis through the mail. However, the FDA has not been convinced that Huntington has been thorough in making sure all its former patients were notified.

A mammogram is an X-ray of the breast used to detect early signs of breast cancer. It is considered the most effective way to detect breast cancer in its earliest, most treatable stages.

The FDA is advising patients who had a Huntington Radiology mammogram to consider having their mammograms re-evaluated or getting another mammogram at another facility. Patients who have since had mammograms elsewhere should follow the recommendations from that mammogram and not the ones from Huntington Radiology.

For those who have not had another mammogram done, the FDA recommends that they talk with their health care provider about a possible follow-up. Anyone wishing to get a copy of their Huntington Radiology mammogram can call 1-323-584-3333. Patients whose health insurance will not cover another mammogram can call the National Cancer Institute (NCI) at 1-800-422-6237 for a list of facilities that perform free or low-cost mammograms.