AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient
ISSUE: The FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Montana. The FDA worked with the American College of Radiology (ACR) as it performed a routine review of a sample of mammograms performed by Big Sky Diagnostic Imaging, LLC that included images taken between November 20, 2011 and November 20, 2013. Results from that review included poor quality mammograms. The FDA will continue to monitor this issue and keep the public informed as new information becomes available.
This does not mean that the results of the examinations were inaccurate, but it does mean that patients should speak to their health care providers about whether their mammograms need to be repeated.
BACKGROUND: Under federal law (Mammography Quality Standards Act or MQSA), the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet these standards for mammography quality. As of Feb. 6, 2014, the facility is no longer performing mammography. The ACR revoked its accreditation and its MQSA certificate is no longer valid.
RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Big Sky Diagnostic Imaging, LLC any time after Nov. 19, 2011:
- If you have had a mammogram at another MQSA-certified facility since then, you should follow the recommendations from that facility.
- If you have not had a mammogram at another MQSA-certified facility since then, follow these guidelines:
- Talk with your current health care provider as soon as possible about the need for a follow-up exam.
- If your health care provider recommends you have another mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A database 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 service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that will provide free or low-cost mammograms.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/23/2014 - Safety Communication - FDA]