Axxent FlexiShield Mini Recalled

Although approved in June 2009 through the U.S. Food and Drug Administration’s (FDA) 510(K) process, the <"">Axxent FlexiShield Mini was recalled in April 2010 in the agency’s most serious recall designation: the Class I. Class I recalls involve situations in which there is a reasonable probability that use of a medical device will cause serious adverse health consequences or death.

The Xoft Axxent Flexishield Mini product, model 5300 manufactured by iCad (formerly Xoft), is intended to protect body parts from unwanted radiation during cancer treatment and is placed on the skin or within breast incisions following lumpectomies or mastectomies. Constructed of silicone rubber and tungsten particulate, the defective device is meant to be cut for individual treatment, but has been found to disburse hundreds of heavy metal particulates into patients’ bodies.

The shedded tungsten particles can be mistaken for suspicious calcifications, which look like cancer, during follow up X-rays or scans. This can lead to misdiagnoses and undo stress for patients who have had to suffer through cancer treatments and are understandably very worried about recurrence of the disease. Even worse, the particles can obliterate actual calcifications on scans, hiding potential life-threatening cancer.

The FDA described the Axxent Flexishield Mini device as being 12.7 cm in diameter by 0.1 cm (1 mm) thick and is meant to shape a therapeutic radiation therapy beam from a low energy source. This device enables different treatment field shapes and limits radiation amounts to skin or healthy tissue by shielding areas that do not need radiation therapy. The pad is designed to be cut to accommodate the radiation therapy beam shape during Intraoperative Radiation Therapy (IORT), which is why it is surprising that it is the cutting that seems to release the tungsten particles into the body.

Tungsten’s affect on the body remains unknown, but it is a heavy metal and many heavy metals have been found to be dangerously unsafe to human life. Think: Lead and cadmium, to name just two.

The FDA indicated that lot numbers 800218, 800239, 800240, 800321, 800334, and 800335 are involved and that the Axxent Flexishields were manufactured from September 11, 2009 through June 28, 2010. The defective Flexishields were distributed, nationwide, from October 2009 through December 2010.

The 510(K) is a streamlined process in which a manufacturer obtains market approval with very little clinical testing of a device—including no human testing—if a manufacturer can prove that the device is “substantially similar” to another product already on the market. This process has been used to approve other medical devices that were ultimately subject to recall.

For instance, we just wrote that a new study found that the majority of high risk medical device recalls over the past five years involved products subject to the FDA streamlined 510(K) approval process. The study is posted online on The Archives of Internal Medicine website.

The DePuy ASR hip implant was approved by the FDA via the 510(K) process. In fact, it was shortly after the DePuy hip implant recall was issued that an internal FDA review found numerous flaws with the process. The DePuy recall involves 93,000 devices globally and has forced patients, in growing numbers, to undergo painful, complicated revision surgeries to remove the defective device and be implanted with a new device.

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