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Lawsuits Filed Against Axxent FlexiShield Mini For Tungsten Particles

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At least seven lawsuits have been filed against Axxent FlexiShield Mini manufacturers by woman who discovered that the radiation therapy pads left tungsten particles in their breasts. Mammograms conducted on 16 of the at least 29 affected women showed tungsten particles in their breast.

The manufacturer issued a recall of the tungsten filled, silicone rubber pads made between September 11, 2009 to June 28,2010 after discovering they were defective. The FDA, after approving the device last summer, classified the recall as a Class 1 medical device recall meaning there is a reasonable chance of patients suffering severe injury or death from continued use.

The lawsuits have been filed against the pad manufacturer iCad, formally Xoft, Inc., and Hoag Memorial Hospital Presbyterian in Newport Beach, California where at least 27 of the women involved were treated.

In the lawsuits, the women fear the tungsten particles may be toxic, and fear they will have to have mastectomies. They also claim the particles could be mistaken for cancerous growths. According to the Merriam-Webster dictionary, tungsten is “a gray-white heavy high-melting ductile hard polyvalent metallic element that resembles chromium and molybdenum in many of its properties and is used especially in carbide materials and electrical components (as lamp filaments) and in hardening alloys (as steel).

The lawsuits were filed in California Superior Court in Orange County. ? disclaimer: This article: Lawsuits Filed Against Axxent FlexiShield Mini For Tungsten Particles was posted on Monday, May 9th, 2011 at 7:53 pm at and is filed under Medical Device Lawsuits.

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