FDA Safety Communication Targets Mammogram Quality at Palm Beach Broward Medical Imaging Center
The FDA Safety Communication, released on January 3, 2018, is directed toward female patients who received mammograms at the Palm Beach Broward Medical Imaging Center on or after April 2, 2016, as well as local health care providers who referred patients to the imaging center.
As the FDA states, patients are being alerted to potential problems with mammogram quality. While underlying issues do not mean mammogram results were inaccurate, patients and health care providers are being advised to have their mammograms re-evaluated at a facility certified by the Mammography Quality Standards Act (MQSA) and whether a new mammogram or medical follow-up is necessary.
According to the FDA, regulators became aware of mammogram quality issues following a yearly MQSA inspection in February of 2017. During the inspection, it was discovered that quality control tests recommended by the manufacturer were not performed after April 1, 2016. As a result, FDA officials notified the Palm Beach Broward Medical Imaging Center that it would be required to undergo an Additional Mammography Review (AMR) in order to determine if the quality of imaging tests were impacted by the facility’s failure to comply with accepted standards.
Following the Additional Mammography Review, the American College of Radiology revoked the facility’s accreditation on November 9, 2017. Per the FDA, the revocation resulted from the facility’s failure to meet baseline quality standards required to operate legally in the U.S.
If you or someone you love had a mammogram at the Palm Beach Broward Medical Imaging Center on or after April 2, 2016, the FDA recommends the following actions:
- Follow the recommendations of different MQSA certified facility if a more recent mammogram was taken.
- Speak with your health care provider as soon as possible regarding a follow-up, potential re-evaluation of the mammogram, and possible repeat mammogram or further evaluation.
- Take any recommended repeat mammogram at a MQSA certified facility.
Our legal team at Clark, Fountain, La Vista, Littky-Rubin & Whitman will continue to follow FDA safety communications regarding this facility and issues involving the quality of mammograms. As a law firm with a nationwide reputation in cases involving medical malpractice, we also make ourselves available to any patients who suffered harm as a result of the Palm Beach Broward Medical Imaging Center’s failures, including any potential cases of misdiagnosis or failed diagnosis of breast cancer. To learn more about your rights, contact us for a free case evaluation.