FDA: Possible Problems with Mammography Images from California-Based Facility

mammography - FDA: Possible Problems with Mammography Images from California-Based Facility
June 26, 2015

The Food and Drug Administration (FDA) is alerting patients about possible problems with the quality of mammograms that were done at a California-based medical facility.

Coastal Diagnostic Center in Pismo Beach, Calif. had its accreditation revoked by the American College of Radiology in April and some patients may need to have their mammograms reevaluated.

The alert affects women who have had mammograms performed at the center any time on or after Feb. 24, 2013.

The FDA wrote in a statement that this does not mean that the results of the initial mammograms were inaccurate, but patients should consider having their records reevaluated by a facility certified by Mammography Quality Standards Act (MQSA) to determine whether they need a repeat mammogram or additional medical follow-up.

Patients who have had a mammogram at MQSA-certified facility since Feb. 24, 2013 should follow the recommendations from that facility.

Patients who have not should talk with their healthcare provider as soon as possible about the need for a follow-up exam. Repeat mammograms should be done at a MQSA-certified facility to ensure quality and accuracy.

Listings for certified facilities can be found online or by calling the National Cancer Institute at 1-800-422-6237. The National Cancer Institute can also provide listings for facilities that will provide free or low-cost mammograms.

In March the FDA issued a similar warning for patients who had mammograms performed at a Raleigh-based facility.

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