Category: Medical Devices
FDA Limits Use of Stryker Wingspan Brain Stent
August 9, 2012 -- The U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn that the Wingspan brain stent (a device used to prevent strokes by propping open arteries in the brain) should only be used...
Coloplast Pelvic Mesh Lawsuits Consolidated in MDL
The U.S. Judicial Panel on Multidistrict Litigation has ordered that federal Coloplast pelvic mesh lawsuits must be consolidated into one federal court in the Southern District of West Virginia.
Vaginal Mesh Organ Perforation
One of the most serious vaginal mesh side effects is organ perforation. It can occur while a surgeon is implanting the mesh, or it can occur over time if the mesh erodes into an internal organ.
No Vaginal Mesh Recall from FDA Yet
Vaginal mesh has not been officially recalled by the FDA, although it is possible that there will be a vaginal mesh recall in the future.
$12.7 Million Award In Polar Care Cold-Therapy Lawsuit
August 6, 2012 -- Engler has been awarded $7.5 million in punitive damages and $5.2 million in compensatory damages for skin necrosis, frostbite, and nerve damage caused by a Breg Polar Care cold therapy machine. She was prescribed the device...
Hospital Investigated for Experimental Bone Surgery
August 3, 2012 -- MassDevice is reporting that Pomona Valley Hospital Medical Center is being investigated by the California Health Department after a lawsuit was filed on behalf of a woman who was severely injured when her surgeon used two...
St. Jude Medical Recalls Eon, Eon Mini Implants
August 3, 2012 -- The Minnesota-based medical device company St. Jude Medical has updated a recall on the Eon and Eon Mini pain management system. There is a problem with a weld on some of the batteries, which can cause...
Antiseptic Wipes Recalled for Bacterial Contamination
August 2, 2012 -- Zee antiseptic swabs, Dukal antiseptic wipes, and Dukal BZK swabs are being voluntarily recalled after inspectors from the U.S. Food and Drug Administration (FDA) found some lots were contaminated with the bacteria Burkholderia cepacia. No injuries...