The FDA is investigating biliary stent manufacturers to review “off-label” use of these devices to prop open larger blood vessels.
Since biliary stents are available in much larger sizes than their vascular cousins, doctors commonly use them to prop open large arteries, such as those leading to the legs and kidneys.
According to a story in the Wall Street Journal,
"Our go-to stent for disease in the legs are biliary stents," said Dr. Gary L. Schaer, the director of the cardiac-catheterization laboratory at Rush Hospital in Chicago. A September 2006 article by an FDA scientist also concluded that "virtually all" kidney-artery operations used stents not approved for that purpose.
The Journal story further notes that "some industry sources estimate that as much as 90% of biliary stents are sold to catheterization laboratories and used off-label in arteries. On-label sales of biliary stents amounted to about $38 million last year, according to Millennium Research Group. Those numbers don't include off-label use in arteries."
The problem with off-label use of bilirary stents is that they are not FDA approved for this use, and various serious injuries have been associated with this off-label use. According to the FDA, such injuries include:
- seizure
- coma
- stroke
- device malfunction
If you were implanted with a biliary stent in an artery (i.e., vascular use) , and you have suffered seizure, stroke, coma, other serious medical conditions, you may be entitled to compensation.
Below is a list of biliary stent manufacturers and product names :
- Abbott Laboratories ("Xpert Biliary Self-Expanding Stent System", "WaveMax™ Biliary Stent")
- C.R. Bard, Inc. ("6F BARD® CONFORMEXX™ Biliary Stent," "6F BARD® LUMINEXX® 3 Biliary Stent")
- Boston Scientific Corporation ("Sentinol™ Self-Expanding Nitinol Biliary Stent System," "Express® Biliary LD Stent System")
- Cook Medical ("Fusion Zilver 518 Biliary Stent")
- Cordis Corporation / Johnson & Johnson ("PALMAZ® BLUE™ .014 Transhepatic Biliary Stent," "PRECISE® RX Nitinol Stent Transhepatic Biliary System")
- eV3, Inc. ("PROTÉGÉ® EverFlex Self-Expanding Biliary Stent System," "PROTÉGÉ® GPS™ Self-Expanding Nitinol Stent - Biliary System")
- Edwards Lifesciences ("LifeStent NT Self-Expanding Stent")
- W.L. Gore & Associates, Inc.("VIABIL Biliary Endoprosthesis")
- Guidant Corporation / Abbott ("RX HERCULINK® PLUS Biliary Stent System," "DYNALINK .035 Biliary Self-Expanding Stent System")
- IDEV Technologies, Inc. ("SureSave Stent / SUPERA Stent")
- Medtronic, Inc. ("Racer Over-the-Wire Biliary Stent System," "Assurant Biliary Stent," "Aurora Biliary Stent")
Act now, as delays can harm your case.
On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.)
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