Device leaves particles of tungsten in women’s breasts some of the women affected were in Rochester Hills
This medical device called Axxent FlexiShield Mini which is used in the treatment of breast cancer has been recalled and is now distinguished as one of the harshest type of recall involving situations such as a reasonable probability that usage of these products will cause serious negative health effects or even death according to the FDA on Wednesday.
However, there is no current evidence that the particles are toxic according to the manufacture iCAD. The FDA is stating that these particles could be mistaken for cancerous calcification’s during follow up breast x-rays or scans which can mask cancer or suggest cancer when there is no cancer. With that alone the FDA is terming this recall a class 1 action which means that there is a reasonable possibility that the use of these products will cause serious negative health effects and even death.
This device is a pad which is made out of tungsten and silicone rubber that is temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after they have undergone a lumpectomy for cancer. These pads were used to aide in directing radiation beam and to guard health tissue. These pads were faulty leaving the breast tissue and chest muscles infested with hundreds of tungsten particles.
Due to very little research on tungsten and its long term health effects on humans it is not known if this is dangerous. It does appear in mammograms which could cause difficulty in reading them. This makes it very distressing for women who have had breast cancer and worry about recurrences. The particles appear like calcium deposits which can indicate cancer.
So far 29 women are known to be affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and 2 at Karmanos-Crittenton Cancer Center in Rochester Hills, Michigan. Sixteen women have had follow up mammograms six months after surgery and all of them had tungsten particles.
It is natural that some of these women are displaying concern that the tungsten can be harmful and are considering mastectomies to remove these particles from themselves. Seven of these women are suing Hoag hospital along with the manufacture of this device. This comes the attorney who is representing these women, Jeffrey Milman located in Irvine, California.
Mr. Milman has stated regarding the purpose of the lawsuits the decision of the FDA recall classification as being serious had put “icing on the cake”. Please note this device was manufactured by a company called Xoft, it had been purchased by iCAD.
This device was granted approval in June 2009, in an abbreviated process used for devices that are considered equivalent to products already on the market. Known as 510(k) it requires less time than the procedure to grant approval for a new device and it usually does not require testing on human subjects.
The FDA is advising physicians to stop using these pads and to alert patients that the particles could be present and they should follow the recommendations regarding follow up breast exams.
The recall affects model F5300 pads bearing lot numbers 800218, 800239, 800240, 800321, 800334, and 800335. The pads were distributed nationwide from October 2009 through December 2010.
This lawsuit can become very expensive for iCAD than the $1 million in cash and 84.7 million shares of stock that was paid for this device last year.
So far in reports are a request for $14.5 million in damages. The company has stated that based on preliminary analysis they have plans to “vigorously defend the lawsuit”.