Breast Device Recall

Axxent FlexiShield Mini recall elevated to class I.
The New York Times (4/15, A17, Subscription Publication) reports that "the recall of a medical device" known as the Axxent FlexiShield Mini, "that left particles of tungsten in women's breasts has been classified as the most serious type of recall, one involving 'situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,' the Food and Drug Administration said on Wednesday." The device, used during a particular type of radiation treatment, "left the breast tissue and chest muscles riddled with hundreds of tungsten particles." The Times adds, "That the tungsten shows up on mammograms is what made the recall Class I, the most serious type, said Karen Riley, a spokeswoman for the Food and Drug Administration."
Medscape (4/14, Hitt) reported that "internal investigations by the manufacturer showed no evidence that the particles are toxic; therefore, permanent damage to body structures or functions is not expected. The product recall was based on the fact that it was difficult to distinguish tungsten particles from suspicious calcifications in breast tissue on follow up X-rays or scans."