Medical Devices

Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication

Date Issued: June 23, 2014

Audience:

  • Patients who had mammograms at Big Sky Diagnostic Imaging, LLC, Butte, Montana any time after Nov. 19, 2011
  • Health care providers who referred patients to Big Sky Diagnostic Imaging, LLC, Butte, Montana for a mammogram performed any time after Nov. 19, 2011

Medical Specialties: Primary care, Family Medicine, Internal Medicine, Obstetrics and Gynecology, Oncology, Radiation Oncology

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

Purpose:
The FDA is alerting patients who had mammograms at Big Sky Diagnostic Imaging, LLC, in Butte, Montana any time after Nov. 19, 2011, about possible problems with the quality of mammograms performed. 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.

Summary of Problem or Scope:
The FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located at the following address:

401 S. Alabama Street, Suite 7
Butte, Mon. 59701

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.

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 The ACR revoked its accreditation and its MQSA certificate is no longer valid.

Recommendations/Actions:
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.

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

This safety communication is in keeping with the 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.

Page Last Updated: 06/23/2014
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