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April 25, 2011

FDA Recalls iCAD Breast Cancer Device

The US Food and Drug Administration (FDA) has recalled Axxent FlexiShield Mini silicone pads, used to shield internal tissue during interoperative radiation therapy. The FDA discovered that the pads can shed tungsten particles. Manufacturer iCAD has found no evidence that the particles

By cms admin

The US Food and Drug Administration (FDA) has recalled Axxent FlexiShield Mini silicone pads, used to shield internal tissue during interoperative radiation therapy.

The FDA discovered that the pads can shed tungsten particles. Manufacturer iCAD has found no evidence that the particles are toxic, however the FDA stated that they be mistaken for suspicious calcifications during follow-up breast X-rays or scans.

So far 29 women are known to be affected and 16 women who had follow up mammograms six months after surgery detected with tungsten particles.

The FDA informed physicians to stop using the pads and to alert patients that the particles could be present and they should follow the recommendations regarding follow up breast exams.

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