FDA Safety Notification: Mammography Problems at Huntington Radiology in Huntington Park, California

Date Issued: March 10, 2011

Audience:

• Patients who had a mammogram at Huntington Radiology in Huntington Park, California between September 9, 2008 and September 9, 2010.
• Health care providers who have referred patients to Huntington Radiology facility for a mammogram performed between September 9, 2008 and September 9, 2010.

Medical Specialty: Primary Care, Oncology, Radiology, Surgery, Internal Medicine, Obstetrics and Gynecology

Product:
A mammogram is a safe, low-dose X-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages.

Summary of Problem or Scope:
The FDA became aware of problems associated with the quality of mammograms performed at the Huntington Radiology facility, located at the following address:

2679 Zoe Avenue, Huntington Park, California 90255

The FDA worked with the American College of Radiology (ACR) as it performed a review of a sample of mammograms performed by Huntington Radiology that included images taken between September 9, 2008 and September 9, 2010. Results from that review included poor quality mammograms with possibly unreliable results. Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards. This facility did not meet standards for mammography quality under that Act. The facility is not performing mammography as of September 9, 2010 because ACR revoked its accreditation and its MQSA certificate is no longer in effect.

Although Huntington Radiology has sent letters to patients and their referring health care providers, it has been unable to demonstrate to FDA’s satisfaction that all affected patients were successfully notified. The FDA is alerting patients who had mammograms at this facility between September 9, 2008 and September 9, 2010 about possible problems with the quality of mammograms performed. This does not mean that the results of all of the examinations were inaccurate. It does mean that patients might need to have their mammograms re-evaluated and possibly repeated.

Recommendations/Actions:
The FDA recommends the following for patients who had a mammogram at Huntington Radiology facility between September 9, 2008 and September 9, 2010:

• If you have had a mammogram at another facility since then, you should follow the recommendations from the latest mammogram.
• If you have not had a mammogram at another facility since then follow these guidelines:
  • Talk with your current health care provider as soon as possible about a medical follow-up.
  • To request a copy of your mammogram performed by Huntington Radiology, call 323-584-3333. If your health care provider wants you to have another mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A list of MQSA-certified facilities is available online.
  • If your health insurance will not pay for a repeat mammogram, you can call the National Cancer Institute’s (NCI) information number at 1-800-422-6237 for a listing of facilities near you that will provide free or low- cost mammograms.

FDA Activities:
The agency will continue to monitor this problem and keep the public informed as new information becomes available.

This safety alert is in keeping with FDA’s commitment to inform the public about safety issues.

Contact Information:
If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.