On Wednesday the FDA noted that the recall of the Axxent FlexiShield Mini device that left tungsten particles in the breasts of women is to be classified as one of the most serious types of recalls, meaning there is high probability that use of the device will cause serious health consequences that could include death. This pad, that was used to shield health tissue during the unusual procedure that blasted an entire course of radiation after having a lumpectomy, was flawed. While only inserted into the breast incision tiporarily, it left behind hundreds of particles of tungsten in the breast tissue and chest muscles of countless women.
So little research has been done on the long-term health effects of tungsten, it is truly unknown if it is dangerous or not. However, these particles left behind by the Axxent FlexiShield Mini show up on mammograms, possibly making the difficult to read. This is especially troublesome for women who have suffered from breast cancer in the past and worry about a breast reconstruction. This is because they show up looking like calcium deposits, and calcium deposits can be an indicator of cancer. This fact made the recall a Class I, which is the most serious type of recall according to the Food and Drug Administration. The threat that they could be mistaken for calcifications caused by cancer, or could hide real calcifications interfering greatly with diagnosis is very real and very serious.
At this time, there are 29 women known to have been affected between California and Michigan. Sixteen of these have had mammograms since their surgery and all sixteen have been found to have the particles. Some of these women are so concerned that the tungsten left behind by the Axxent FlexiShield Mini could be harmful that they are considering mastectomies. Several are also suing the manufacturer and one of the hospitals involved according to the attorney representing the women. In terms of the lawsuit, the decision by the government to classify the recall as Class I is just icing on the cake according to the attorney.
The Axxent FlexiShield Mini cleared the FDA approval process in June 2009 but did so under the 510(k) process, which is an abbreviated process for products considered to be the same as products already on the market. It takes less time than the process used for new products, and does not generally require human testing. The shedding of the tungsten particles occurred after the shields were cut to fit the individual patient, though it is not clear why this happened because they were designed for this cutting. The shields were taken off the market in February.