Numerous reports of women who have had tungsten particles left in their breasts following radiation therapy have prompted iCad to recall the Axxent FlexiShield Mini radiation therapy pad from the U.S. market. To date, at least seven lawsuits have been filed around the country against the manufacturer, and as many as 30 women are known to have suffered following the use of the defective devices.
Free Axxent FlexiShield Mini Case Evaluation: If you or a loved one has suffered from adverse side effects after undergoing radiation therapy with an Axxent FlexiShield Mini pad, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
April 20, 2011 - The Axxent FlexiShield Mini, a device used during Intraoperative Radiation Therapy (IORT), was named in a recent recall after reports that it had injured nearly 30 breast cancer patients.
In February 2011, iCad recalled six lots of the model F5300 Axxent FlexiShield Mini with lot numbers 800218, 800239, 800240, 800321, 800334, and 800335. The recalled devices were manufactured between September 2009 and June 2010, and distributed nationwide from October 2009 through December 2010.
After reports began to surface about the radiation shield shedding tungsten particles into patients’ breasts, the U.S. Food & Drug Administration (FDA) upgraded the recall to Class 1, which means that there is a reasonable probability that patients may suffer severe injury or death from the device.
The Axxent FlexShield Mini was approved by the FDA in 2009 via the controversial 501(K) process, which 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 501(K) process has been used to approve other medical devices that were ultimately subject to recall, most notably the DePuy Orthapedics ASR hip implant.
Do I have an Axxent FlexiShield Mini Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Axxent FlexiShield Mini lawsuits. We are handling individual litigation nationwide and currently accepting new side effects cases in all 50 states.