Larry Kessler, the former U.S. Food and Drug Administration director of the Center for Devices and Radiological Health (CDRH), a section of the FDA that oversees medical devices, is joining the consumer group Public Citizen in asking that the Stryker Wingspan brain stent be withdrawn from the market because of a concern that it may lead to death in users.
The Stryker Wingspan is narrow mesh tube implanted in narrow arteries to the brain to prevent strokes in people who have already suffered one.
This petition, which was filed on December 21st, asked the FDA to revoke Stryker’s 510(k) clearance, which allows medical devices to be quickly released onto the market without clinical studies. The petition also says that clinical trials of this device, used to prevent strokes, actually increases the risk of stroke and death amongst those who use the product. The findings from the trials were published in September in the New England Journal of Medicine.
“The message from the trial could not be clearer. The risks of this intervention substantially outweigh any potential benefit to patients,” Dr. Michael Carome, deputy of Public Citizen’s Health Research Group, stated in the press release. “The device poses an immediate threat of serious harm to patients and should be pulled from the market without further delay.”
If you or a loved one have used the Stryker Wingspan brain stent, you may be entitled to compensation. Please stop by our website for more information, or contact one of our attorneys at 1-800-246-HURT(4878). You may also “Like” our Facebook Page, and follow us on Twitter.