Last week, the FDA designated the Axxent FlexShield Mini as a Class 1 medical device recall, which according to the FDA means that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” In addition to this frightening news, several women have begun filing lawsuits after discovering that the recalled product left tungsten particles in their breasts. As a Fort Lauderdale Products Liability Attorney, I understand the severity of this recall and I am deeply troubled to learn about the plights of the women who have been harmed.
The Axxent FlexShield Mini is a radiation shield, which is supposed to protect one’s skin from overexposure to radiation during treatment for breast cancer, but it was discovered that particles of tungsten were being left behind in the breast. As a matter of reference, the FDA Axxent FlexShield Mini recall report can be found here. As a Fort Lauderdale Personal Injury Lawyer, I can attest that the designation of this recall as Class 1 is part of what makes this such a frightening issue that requires the utmost of attention. Moreover, the women who have been affected are scared because they believe that the tungsten particles that were left behind in their breasts could be toxic. As a result, some of the women are considering double mastectomies in an attempt to rectify the issue.
From a Fort Lauderdale Products Liability Lawyer’s perspective, above anything else I hope that these women can make full recoveries and that they are able to overcome the consequences of this horrifying product failure. If the allegations are true, one can only assume that the personal injury lawsuits against the manufacturer will continue to increase. In sum, this is a very unfortunate example of the serious consequences that can result when a product that we depend on fails to function in the proper manner.