As a Florida defective drug device lawyer, I was concerned by the FDA’s Class 1 recall of of Axxent Flexishield Mini pads. The pad was designed for use in breast cancer patients who received one dose of radiation after undergoing cancer surgery.
The pads were supposed to shield healthy tissue, but instead have left breast and chest muscles peppered with hundreds of particles of tungsten. While the long-term effects of tungsten are unknown, their presence will interfere with mammogram readings that are especially important for women who have had breast cancer and are concerned with recurrence.
The device is made by Hoag. Lawsuits for Axxent pads are being filed by women who have been exposed and have tungsten particles. Some of the affected women are now considering mastectomies to rid themselves of the particles.
Class 1 Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.