FDA issues urgent recall of breast devices that left tungsten in women’s breasts

The FDA has issued an urgent recall of a medical device used during radiation treatment in women undergoing a lumpectomy for breast cancer. The FDA issued a Class I recall which is the most urgent type of recall.

According to the FDA, the Xoft Axxent Flexishield Mini Product, Model 5300, may shed particles of tungsten in the breast when used in treating women.The Axxent is a silicone rubber pad which contains tungsten particulate and it is used to direct radiation treatment while protecting the skin or tissue. The problem is that when the device was used, hundreds of tungsten particles were left in women’s breasts.

Tungsten particles can then obscure future mammograms as the tungsten can appear as calcium deposits. Xoft says that there is no evidence that the tungsten particles are toxic. However, It is not clear whether the presence of tungsten, a metal, in a woman’s breast can cause other health problems in the long-term.

The FDA recommends that customers quit using the devices immediately and return inventory to the company.

Physicians are advised to inform patients in which the device was used that there is a likelihood of Tungsten

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a Seattle product liability law firm and we represent people who have been injured by defective and dangerous products including patients who have been affected by the DePuy Hip recall.

Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten
FDA Recall Notice April 13, 2011
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