On March 21, 2011, an article in The New York Times reported that approximately 30 women who participated in a breast cancer study were infected with metal tungsten in their breast tissue and chest muscles after being treated with the Axxent FlexiShield Mini, a surgical device that was recalled last month. In addition to battling breast cancer, those affected now face the possibilities of additional injuries as a result of the metal ions released by the defective medical device.

Another Example of a Flawed Regulatory Approval Process

Although the fallout from this particular incident including the long-term effects of tungsten exposure, how to rid the body of the metal particles, and treatment options for those affected have yet to emerge, this fiasco is illustrative of an alarming trend – federal regulators are failing to protect public health and safety by consistently allowing defective medical devices on the market. Defective medical devices are slipping through the cracks at a disturbing rate, resulting in widespread injuries to unknowing consumers. Similar to other defective medical devices, the Axxent FlexiShield Mini circumvented the normal approval process on the grounds that it was substantially similar to other products on the market. This process, known as the 510(k) allows manufacturers of medical devices to receive quick approval from the U.S. Food and Drug Administration (“FDA”); the process does not require that the devices be tested on humans before being put on the market.

FDA Oversight of Medical Devices is Lacking

This latest breakdown in the federal regulatory approval process comes at a time when the FDA is already facing intense criticism stemming from the now recalled DePuy ASR metal-on-metal hip implants. At the time of the DePuy ASR recall an estimated 37,000 individuals had already received the defective implants. Like the Axxent FlexiShield Mini, the metal-on-metal DePuy ASR hip implants used the 510(k) process to circumvent the approval process. If these products had been subject to the standard clinical testing and inspection processes normally required for approval, these injuries may have been prevented.

Injured by a Defective Medical Device?

If you or a loved one has been injured by a defective medical device, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our lawyers today for a free and confidential evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our lawyers also provide personal attention to guide you through the complex litigation process.

Published November 17, 2011 by