iCad Recall for Xoft Axxent Flexishield Mini Deemed Class 1

iCad has recalled the <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Xoft Axxent Flexishield Mini product, Model 5300, which is intended to protect parts of the body from unwanted radiation during cancer treatment. According to the recall notice, the Axxent Flexishield Mini may shed particles of tungsten which can be mistaken for suspicious calcifications during follow up X-rays or scans.

The Axxent Flexishield Mini recall has been deemed a Class I medical device recall. Class I recalls are the U.S. Food & Drug Administration’s (FDA) most serious type of recall and involve situations in which there is a reasonable probability that use of a medical device will cause serious adverse health consequences or death.

The Axxent Flexishield Mini device recall was actually first reported by The New York Times last month, after over two dozen patients temporarily implanted with the Axxent Flexishield Mini were polluted with hundreds of tiny particles of tungsten, a heavy metal. All of the women implanted were part of a clinical trial to determine whether imaging studies could correctly predict which women would be candidates for the new therapy.

iCad maintains that no permanent impairment of bodily functions or permanent damage to body structures is anticipated. But according to the Times article, it’s not known if the tungsten poses any health risks because relatively little research has been done on its long-term effects in the body. What is known is that the tungsten, which shed into the breast tissue and chest muscle of many study participants, make mammograms difficult to read, an obvious problem for breast cancer patients.

The Axxent Flexishield Mini device was manufactured by Xoft Inc., which was bought in December by iCad. It consists of a circular silicone rubber pad containing tungsten particulate. The pad is 12.7 cm in diameter and 0.1 cm (1 mm) thick. It can be cut to accommodate the shape of the radiation therapy beam. The device can either be temporarily implanted in a patient to shield internal tissue during Intraoperative Radiation Therapy (IORT), or it can be placed on the skin.

According to the recall notice issued by iCad, the Axxent FlexiShield Mini recall involves Model 5300, and lot numbers 800218, 800239, 800240, 800321, 800334, and 800335. It was manufactured from Sept. 11, 2009 through June 28, 2010, and distributed nationwide from Oct. 2009 through Dec. 2010.

iCad has been telling doctors that impacted patients should have physical exams every six to 12 months. Victims of this defective device will also have to undergo mammography and breast MRIs once a year, along with annual serum and urine tests for tungsten. The serum and urine tests should continue until the tungsten concentration approaches that of the general population as reported by the Agency for Toxic Substances and Disease Registry (ATSDR).

Not surprisingly, the Axxent FlexiShield Mini was approved in 2009 by the FDA via the 510(K) process. As we’ve reported in the past, this process allows a manufacturer to obtain market approval with very little clinical testing of the device – including no human testing – if a manufacturer can prove it is “substantially similar” to another product already on the market. The 510(K) process has been used to approve other medical devices that were ultimately subject to recall, most notably the <"http://www.yourlawyer.com/topics/overview/DePuy-Hip-Implant-Recall-Johnson-and-Johnson">DePuy Orthopaedics ASR hip implant.

In 2010, an internal FDA review – ironically released shortly after the DePuy ASR hip implant recall was issued – found numerous flaws with the 510(k) process, prompting the agency to consider changing it. Just this past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process.

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