Axxent Flexishield Mini Recall
In February 2011, the Food and Drug Administration (FDA) recalled the Axxent FlexiShield Mini device after it was found that the product left particles of tungsten in women’s breasts. A company called Xoft initially made the device; it was subsequently bought by another company called iCad. According to a New York Times article (see here), the Axxent FlexiShield Mini was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles.
The FDA issued a Class I recall (the most serious) because the tungsten was showing up on mammograms and could make them difficult to read – possibly interfering with diagnosis or mistaken for cancerous calcifications.
If you were exposed to the Axxent FlexiShield Mini and had tungsten particles found, please contact us for a free consultation. You may email us or call us toll-free at (800) 351-8588.
To read how this fast-track approved medical device has affected a local Orange County woman, click here.