IVC Filter Attorney –
IVC Filters, used to prevent blood clots from reaching the heart, lungs, or other vital organs, can break off parts and migrate in the body, causing serious complications and even death. If you or a loved one has been injured by an IVC filter, contact an experienced IVC Filter Attorney for a free legal consultation regarding a potential IVC Filter Lawsuit against the medical device’s manufacturer.
The FDA issued a safety warning on August 9, 2010 (“Removing Retrievable Inferior Vena Cava Filters: Initial Communication”), which cautioned against leaving IVC filters in too long. The filters can cause life-threatening complications. The FDA warning informed implanting physicians and clinicians that IVC filters are intended for short-term use only, and only in patients at risk for pulmonary embolisms. Doctors were told to retrieve the IVC filter devices after a patient’s blood clot risk subsided. The FDA’s main concern was that doctors timely retrieve the IVC filters meant only for short-term placement.
This FDA safety warning followed an Archives of Internal Medicine study conducted by Dr. William Nicholson at the York Hospital in Pennsylvania. Dr. Nicholson found an alarmingly high rate of filter fracture and fragment embolizations in the retrievable IVC filters. Dr. Nicholson and others used the report to challenge the FDA and its entire device approval process. The FDA considers IVC filters as Class II devices, or low risk, clearing them without clinical safety or effectiveness data in their 510(k) approval process.
The FDA reported that since 2005, it received 921 adverse event reports involving IVC filters, 328 of which involved device migration, 146 detachments of device components and embolizations, 70 perforation of the IVC, 56 IVC filter breaks.
On May 6, 2014, the FDA released a safety communication titled: “Removing Retrievable Inferior Vena Cava Filters.” this followed the FDA’s August 9, 2010 communication on “Removing Retrievable Inferior Vena Cava Filters.”
On July 13, 2015, IVC filter maker C.R. Bard was hit with an FDA warning letter regarding the company’s failure to properly represent and report adverse events related to its IVC blood clot filters.
IVC Filter Fraud
Veteran regulatory specialist Kay Fuller has intimated that C.R. Bard committed fraud in order to clear the regulatory way for Bard’s Recovery Filter to be unleashed on the public. The FDA had initially turned down Bard’s IVC Filter application for the Recovery filter, then revisited and approved it after what the regulatory specialist implied was fraudulent use of her signature. “That’s not my signature,” Kay Fuller told NBC News after being shown her name signed on the document.
IVC Filter Sales
Approximately 250,000 IVC filters are put into patients each year in the United States. IVC filter makers include C.R. Bard, Boston Scientific, B. Braun, and Cook Medical.
IVC Filter Attorney
Matthews and Associates Law Firm is handling IVC filter cases against C.R. Bard, Cook and other IVC filter manufacturers. Contact Matthews & Associates for a free legal consultation if you would like to consider an IVC Filter Lawsuit. Our IVC filter lawyers do all we can to streamline the medical device litigation process.
IVC Filter Updates
We will keep you up to date on any IVC filter class action lawsuits, additional FDA IVC Filter warnings, and IVC Filter FDA recall announcements.
IVC Filter Injuries, Pulmonary Embolism, Side Effects
A Pulmonary Embolism (PE) is a severe and often fatal condition triggered when a lower extremity thrombus (blood clot) moves to the lungs. Anticoagulant medication is typically the first line treatment for PE, but IVC filters may be implanted if anticoagulation fails. Several severe complications are linked with IVC filters:
• Perforation – penetration of the caval wall by IVC filter legs
• Erosion through the wall of the vena cava
• Embolization of IVC filter device components
• Caval thrombosis
• Pulmonary embolism