Failing to pull brain implant from market, FDA endangers patients
The Food and Drug Administration still has not removed from the market a brain implant that apparently helps prevent strokes—in spite of a study indicating the device is dangerous.
The study published in the New England Journal of Medicine last fall, concluded that patients implanted with the Wingspan Stent System carried a 2.5-times-higher risk of having a stroke or dying within 30 days than those without the implant. The findings alarmed the researchers that they cut off enrollment in the study early.
Also alarmed were members of Congress. A group of them, noting that the Wingspan system and other medical devices later shown to be dangerous had been approved by the FDA through irregular procedures, asked House leaders last fall to hold hearings on the devices’ safety.
Even in the face of these findings and the Feds, the FDA and the Wingspan system’s manufacturer, Stryker, have failed to act. They’ve suggested that the study’s subjects cannot be compared with the patients the system was approved to treat.
Have you been harmed by the Wingspan Stent System or another medical product? 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.