Stryker Wingspan Stent Recall Should Be Issued Due to Risks: Petition

The Stryker Wingspan brain stent should be removed from the market due to serious and potentially life-threatening safety issues, according to a petition filed by Public Citizen, a prominent consumer advocacy group. 

Public Citizen is urging the FDA to pursue a Stryker Wingspan recall, saying that clinical trials have shown that the device, which is supposed to prevent strokes, appears to increase the risk of both strokes and deaths.

The Public Citizen brain stent recall petition comes after the cancellation of clinical trials this summer due to a high rate of strokes and deaths among test subjects implanted with the Wingspan stent.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The Stryker Wingspan is narrow mesh tube implanted in narrowed arteries to the brain to prevent strokes in people who have already suffered one. The stent was approved as a humanitarian use device (HDE), which allowed Boston Scientific, the original designer, to get it approved with only one uncontrolled trial of 45 patients, Public Citizen stated.

In April, the U.S. National Institute of Neurological Disorders and Stroke (NINDS) ordered a halt to further clinical trials of the Wingspan after almost 15% of the patients implanted with the Wingspan suffered strokes or died in the first month. The trial included 451 patients, half of whom were treated with the Wingspan and a drug regimen of Plavix and aspirin, and the other half treated with just drugs alone. Only 6% of those given just the drugs suffered strokes or death.

An independent monitoring board stopped the trials, saying it was unethical to continue. The findings 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 director of Public Citizen’s Health Research Group, stated in the press release. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted today)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted yesterday)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.

Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children
Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children (Posted 4 days ago)

Plaintiffs have submitted a baby food lawsuit Master Complaint that is expected to streamline the filing of lawsuits alleging that toxic heavy metals in Beech-Nut, Gerber, Hain and Nurture products caused ADHD, autism and other developmental disorders.