Axxent FlexiShield Mini Recall Lawsuit Filed Over Tungsten Particles

At least seven Axxent FlexiShield Mini lawsuits have been filed by women who discovered that recently recalled radiation therapy pads have left tungsten particles in their breasts. 

An Axxent FlexiShield Mini recall was issued in February by iCad (formerly Xoft, Inc.) and on April 13, the FDA classified the market withdrawal as a Class 1 medical device recall. The radiation shield, which is meant to protect the skin the skin from overexposure during radiation treatment for breast cancer, has been found to shed particles of tungsten into the breast.

Although the manufacturer has indicated that the tungsten particles are not toxic and that the defective device does not impair bodily functions or cause permanent damage to the body, the Class 1 recall classification means that the FDA believes there is a reasonable probability that consumers may suffer severe injury or death from continued use of the radiation shield.

The lawsuits over the recalled Axxent Flexishield Mini were filed in California Superior Court in Orange County against Xoft, the original manufacturer, and Hoag Memorial Hospital Presbyterian in Newport Beach, California. In the complaints, plaintiffs indicate that they fear the tungsten particles, whcih could be mistaken for cancerous growths, may be toxic and they are considering double mastectomies.

Six lots of the Axxent Flexishield Mini model F5300 were involved in the recall, with lot numbers 800218, 800239, 800240, 800321, 800334, and 800335. The pad is 12.7 cm in diameter and 0.1 cm thick. The affected devices were manufactured from September 11, 2009 through June 28, 2010. They were distributed nationwide from October 2009 through December 2010.

At least 29 women are known to have been affected following use of the radiation treatment pads. Hoag treated 27 of them, and two were treated at the Karmanos-Crittenton Cancer Center in Rochester Hills, Michigan. Follow-up mammograms have been conducted on 16 of the women six months after treatment and all 16 were found to have tungsten particles in their breasts.

The first Axxent FlexiShield lawsuit (pdf) filed was by the first woman at Hoag to undergo treatment with the device after it received approval by the FDA last summer. The unidentified woman is concerned that the tungsten particles are toxic and will require her to have both breasts removed.

The Axxent Flexishield Mini is used during Intraoperative Radiation Therapy (IORT). It is placed over the skin and helps shape the radiation beam so that it only affects targeted areas and protects the rest of the skin from excess radiation exposure. It is a circular silicone rubber pad filled with tungsten particulate.