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FDA Raises Level of Recall of the Axxent FlexiShieldMini: Tungsten Found in Breast Cancer Study

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In March 2011, thousands of women throughout the United States were "Racing for the Cure" for breast cancer in Susan G. Komen Race for the Cure™ fund-raiser walks, runs and other events. At the same time, 29 women who participated in a breast cancer study were in a quandary about how to rid their bodies and breasts of the metal Tungsten due to a faulty medical "device" used in a procedure during the study – "Twenty-nine women are known to have been affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, California, and two at Karmanos-Crittenton Cancer Center in Rochester Hills, Michigan."

Since little scientific research has been performed on the effects of tungsten in the human body, not much is known about how the barrage of tiny metal particles will affect the women who participated in the study in the long term. Denise Grady first reported the "mistake" in a March 21, 2011, article in The New York Times, noting that the device that caused the problem was the AxxentFlexiShieldMini.   the Axxent FlexiShield Mini, is a pad made of tungsten and silicone rubber which 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 cut to fit and used to help direct the radiation beam and shield healthy tissue. Since the pads were flawed, this left the breast tissue and chest muscles riddled with tungsten particles.  

The device recalled in February 2011 by the FDA has now been given the Class I most serious classification of recall. This product was manufactured from Sept. 11, 2009 through June 28, 2010, and distributed nationwide from Oct. 2009 through Dec. 2010.

At that time, it was also noted that the tungsten particles had appeared in the women’s mammograms similarly to the way in which calcium deposits in breast tissues do and this may cast doubt on the accuracy of these women’s mammograms. Calcium deposits in mammograms can also be indicators for cancer of the breast.

The device, originally made by a company called Xoft (now, iCad of Sunnyvale, CA) is apparently responsible: "

In her April 15th follow-up article in The New York Times, Ms. Grady indicates that "Some of the women, concerned that the tungsten could be harmful, are considering having mastectomies to rid themselves of the particles."

As noted in previous blog posts, the U.S. Food and Drug Administration’s (FDA’s) abbreviated approval process of some medical devices may be part of the problem. "The Axxent FlexiShield Mini had been cleared by the FDA in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans."