Red-flagged medical devices draw lawmakers’ notice

11-09-2011
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“Metal-on-metal” hip implants and “Wingspan” brain stents—two medical devices that have attracted widespread attention for their probable defects—came under even greater scrutiny this month when a contingent of the U.S. House Energy and Commerce Committee (led by Rep. Henry Waxman of California) asked House leaders to hold hearings on the devices’ safety.

The FDA has received more than 5,000 complaints about the hip implants, and has acknowledged that “[t]iny metal particles may wear off” the devices and enter the bloodstream. As for the brain stents, a study published in the New England Journal of Medicine in September revealed that approximately 15 percent of patients who had gotten the devices and were at high risk of a second stroke indeed had a stroke or died within 30 days of the implantation—compared with only about six percent of patients treated without a stent.

Both products obtained clearance from the FDA through irregular procedures.

“Looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices,” the Democratic contingent from the Energy and Commerce Committee wrote in its letter to the Republican House leadership.

If you believe that you have been harmed by metal-on-metal hip implants, Wingspan brain stents or another medical device, contact Hodes Milman Liebeck for a free case evaluation. We’re aggressive personal injury and medical malpractice lawyers based in Orange County, serving all of California. We have the experience to take on the medical industry and have achieved multi-million dollar verdicts for our clients.

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