Axxent FlexiShield Mini Breast Device. Cleared in June 2009 through the U.S. Food and Drug Administration (FDA) via its abbreviated 510(K) process, the Axxent FlexiShield Mini was recalled in April 2010 in the agency’s most serious recall designation: the Class I.
The Xoft Axxent Flexishield Mini product, model 5300 manufactured by iCad (formerly Xoft), is intended to protect body parts from unwanted radiation during cancer treatment and is placed on the skin or within breast incisions following lumpectomies or mastectomies.
Constructed of silicone rubber and tungsten particulate, the defective device is meant to be cut for individual treatment, but has been found to disburse hundreds of heavy metal particulates into patients’ bodies.
Shedded Tungsten Particles From The Axxent FlexiShield Mini Breast Device Can Be Mistaken For Cancer
The shedded tungsten particles can be mistaken for suspicious calcifications, which look like cancer, during follow up X-rays or scans and which can lead to misdiagnoses and undo stress for patients who have had cancer and are worried about recurrence of the disease. Even worse, the particles can obliterate actual calcifications on scans, hiding potential cancer.
The Axxent Flexishield Mini device is 12.7 cm in diameter by 0.1 cm (1 mm) thick and is meant to shape a therapeutic radiation therapy beam from a low energy source to accommodate different treatment field shapes. The device limits radiation amounts to skin or healthy tissue by shielding areas that do not need radiation therapy. The pad is supposed to be cut to accommodate the radiation therapy beam shape during Intraoperative Radiation Therapy (IORT).
Tungsten’s affect on the body remains unknown, but it is a heavy metal and many heavy metals have been found to be unsafe to human life, such as lead and cadmium.
Lot numbers 800218, 800239, 800240, 800321, 800334, and 800335 are involved on Axxent Flexishields manufactured from September 11, 2009 through June 28, 2010, and which distributed, nationwide, from October 2009 through December 2010.
The 510(K) is a streamlined process in which a manufacturer obtains market approval with very little clinical testing of a device—including no human testing—if a manufacturer can prove the device is “substantially similar” to another product already on the market. This process has been used to approve other medical devices that were ultimately subject to recall.
Class I recalls involve situations in which there is a reasonable probability that use of a medical device will cause serious adverse health consequences or death.
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Axxent Flexishield Mini Device and was infiltrated with tungsten particles or received an inaccurate breast scan reading, our attorneys can help. Call now or fill out our form for a free case review or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).