Personal injury lawsuits. At least seven women who were implanted with the Axxent Flexishield Mini have filed personal injury lawsuits after the device shed miniscule particles of tungsten, a heavy metal, into their bloodstream. The Axxent Flexishield Mini was the subject of a Class I recall earlier this year because of the issue of tungsten shedding.
The Axxent Flexishield Mini is meant to protect the skin the skin from overexposure during radiation treatment for breast cancer. The device was manufactured by Xoft Inc., which was bought in December by iCad.
It consists of a circular silicone rubber pad containing tungsten particulate. The device can either be temporarily implanted in a patient to shield internal tissue during Intraoperative Radiation Therapy (IORT), or it can be placed on the skin.
The device was recalled in March, after it was discovered that 29 patients in a breast cancer trial who had been temporarily implanted with the Axxent Flexishield Mini were polluted with hundreds of tiny particles of tungsten.
It’s not known if the tungsten poses any health risks because relatively little research has been done on its long-term effects in the body. However, the tungsten can make mammograms difficult to read, because the particles can be mistaken for suspicious calcifications.
The Axxent Flexishield Mini lawsuits claim the tungsten particles are toxic. Some of the plaintiffs are considering undergoing double mastectomies because of their fears.
Axxent Flexishield Mini was recalled
The Axxent Flexishield Mini was recalled in February because of these problems. The U.S. Food & Drug Administration (FDA) later classified the recall as Class I, its most serious recall action. Such recalls involve situations in which there is a reasonable probability that use of a medical device will cause serious adverse health consequences or death.
Despite its contention that the tungsten particles pose no risk, 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.
The serum and urine tests should continue until the tungsten concentration approaches that of the general population as reported by the Agency for Toxic Substances and Disease Registry (ATSDR).
The Axxent FlexiShield Mini was approved in 2009 by the FDA via the 510(K) process. 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.
In 2010, an internal FDA review found numerous flaws with the 510(k) process, prompting the agency to consider changing it. Just this past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process.