OC Register Covers Jeff Milman’s Lawsuit on FDA Rule
Partner Jeff Milman is representing 13 women all breast cancer survivors forced to have mastectomies after their cancer treatment because of the malfunctioning medical device, Axxent FlexiShield Mini (“Axxent”), which released potentially toxic tungsten particles into their healthy breast tissue. Axxent, designed to shield patient’s bodies from the harmful effects of radiation, was created by Xoft, Inc. to be used during Intraoperative Radiation Therapy (IORT), a process that involves the delivery of a high dose of electron radiation to a cancer site in a single session in order to eliminate the need for a lengthy treatment process. However, the Axxent FlexiShield, which was made of malleable silicone-wrapped tungsten, was later recalled by Xoft and its parent company iCAD in February 2011 after debris from the tungsten shield was found in the breast tissue of 10 women who had been treated with the device; the number of patients afflicted has since risen to 29.
Despite its lack of human testing before heading to market, the Xoft shield was cleared by the FDA under a controversial rule known as 510 (k), which allows new medical devices to obtain approval if they are shown to be “substantially equivalent” to existing devices. Although the Xoft product was made of tungsten rather than lead, like other radiation therapy shields of its kind, it was still approved by the FDA and used on patients like Kelly, who chose to have a double mastectomy due to the high levels of tungsten that remained in her body post-treatment. Long-term exposure to tungsten has been linked to lung disease and cancer. Mr. Milman asserts that requests to iCAD to cover the cost of Kelly’s medical bills have so far been ignored.