Axxent FlexiShield Mini Device Recalled After Breast Cancer Patients Left Polluted with Tungsten

The <"">Axxent FlexiShield Mini, a device intended to protect parts of the body from unwanted radiation during cancer treatment, was named in a recall recently, after it injured several breast cancer patients. According to The New York Times, the chest muscles and breast tissue of around 30 patients treated with the Axxent FlexiShield Mini were polluted with hundreds of tiny particles of tungsten, a heavy metal. The tungsten particles could pose significant health risks for these women in the future.

Not surprisingly, the Axxent FlexiShield Mini was approved in 2009 by the U.S. Food & Drug Administration (FDA) via the 510(K) process. As we’ve reported in the past, this process allows a manufacturer to obtain market approval with very little clinical testing of the device – including no human testing – if a manufacturer can prove it is “substantially similar” to another product already on the market. The 510(K) process has been used to approve other medical devices that were ultimately subject to recall, most notably the DePuy Orthopaedics ASR hip implant. In 2010, an internal FDA review – ironically released shortly after the DePuy ASR hip implant recall was issued – found numerous flaws with the 510(k) process, prompting the agency to consider changing it.

According to The New York Times, 27 injuries related to the Axxent FlexiShield Mini occurred at Hoag Memorial Hospital Presbyterian in Newport Beach, California; two others occurred in a study at Karmanos-Crittenton Cancer Center in Rochester Hills, Michigan. The Axxent FlexiShield Mini, a $100 disk made of tungsten and silicone, was temporarily implanted in patients to shield healthy tissue from radiation, the Times said.

According to the Times, manufacturer Xoft Inc., which was bought in December by iCad, intended the shield to be used with its portable radiation device, the Axxent Electronic Brachytherapy System. All of the women implanted with the Axxent FlexiShield Mini were part of a clinical trial to determine whether imaging studies could correctly predict which women would be candidates for the new therapy.

Now it appears that tungsten from the Axxent FlexiShield Mini somehow made its way into the breast tissue and chest muscle of many study participants. According to the Times, the tungsten particles make mammograms difficult to read, an obvious problem for breast cancer patients. Some women fear the tungsten could lead to a cancer recurrence or other problems, and are considering undergoing mastectomies. According to the Times, it’s not known if the tungsten poses any health risks to these women because relatively little research has been done on its long-term effects in the body.

At least one victim of the Axxent FlexiShield Mini has already filed suit against the maker of the device. According to UPI, the woman – a 58-year old psychologist who was treated in Newport Beach – says doctors have advised her to have both breasts removed. The woman’s lawsuit names iCad, Xoft Inc., and Hoag Hospital as defendants.

After investigating the Axxent FlexiShield Mini complications, iCad recalled the device in February. As part of the recall notice, iCad has been telling doctors that impacted patients should have physical exams every six to 12 months. Victims of this defective device will also have to undergo mammography and breast MRIs once a year, along with annual serum and urine tests for tungsten.

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