iCAD said it has no evidence of presence of the toxic particles in the device but the FDA stated that those particles may misguide to cancerous calcifications while performing breast x-ray or scans which may conceal cancer or infer cancer even in the absence of cancer, forming the reason for the recall.
The device which releases tungsten particles in breast tissue and chest muscles, aids in directing radiation beam and to guard health tissue, reports examiner.com.
Until now, 29 women are known to be affected while 16 women who had follow up mammograms six months after surgery are detected with tungsten particles.
The regulatory authority asked physicians to stop using these pads and to alert patients that the particles could be present and they should follow the recommendations regarding follow up breast exams.
