FDA IVC Filter NewsMarch 24, 2016
Almost since it became known that IVC filters designed to fight blood clots could instead cause serious injuries to patients, FDA news of IVC filters has arisen. Indeed, such FDA warnings and reports about IVC filter defects and side effects has been common for several years.
History of IVC Filters and the FDA
First, you may want a brief history of IVC filters related to the FDA, or Food and Drug Administration.
The FDA has made individual approvals or various IVC filters over the years, including some filters which have not become the target of later lawsuits due to defects which were only discovered later. However, some FDA-approved filters have gone on to be linked to injuries and even deaths.
Filters which have become scrutinized for their effectiveness and their history with the FDA include:
- The Cook Celect, made by Cook Medical Inc. of Indiana. The FDA first approved the Cook Celect for permanent use in 2007, and in 2008 the retrievable Cook Celect device received FDA approval.
- Gunther Tulip, made by Cook. It received FDA approval for permanent use in 2000 and for retrievable use in 2003.
- The G2, made by C.R. Bard. The FDA first approved Bard’s G2 IVC filter for permanent use in 2005, and in 2008 the retrievable G2 received FDA approval.
- The Titanium Greenfield, made by Boston Scientific of Massachusetts. This permanent filter was FDA-approved in 1989 and is known as a standard for IVC filters, given its long time on the market.
- The Stainless Steel Over-the-Wire Greenfield, made by Boston Scientific. This permanent IVC filter was approved by the FDA in 1995.
FDA Warnings About IVC Filters
As noted, beyond FDA approval came release of some products which later were found to be defective. Those discoveries have led to FDA warnings and recommendations concerning the use of retrievable IVC filters.
The FDA made its initial safety communication about the risk of retrievable IVC filters not being taken out after a blood clot risk had subsided on Aug. 9, 2010. This FDA warning was titled “Removing Retrievable Inferior Vena Cava Filters: Initial Communication.”
The FDA warning alerted patients that they should not allow IVC filters to remain in their bodies for extended time periods, since the filters could cause life threatening injuries by piercing veins or by eroding.
At this time, the FDA revealed that it had received 921 complaints about IVC filter defects from 2005 to 2010. These involved such defects as filter migration, filter fracture, filter perforation and detachment of device elements. Also, filters which are intended to be retrievable (removable from the body) can become embedded in the vena cava vein and be hard or impossible to retrieve.
When this FDA safety communication was made public, IVC filter lawsuits began being filed against Bard and Cook.
Since 2010, the FDA also has made known that it’s received more than 1,600 adverse event reports connected to IVC filters. Also, FDA records indicate that a dozen fatalities have been associated with the G2 filter made by C.R. Bard, and hundreds of serious medical ailments have been connected to the filter.
Victims Have Rights
Victims of IVC filter defects causing injuries have legal rights. If your family has been affected, notify the Willis Law Firm today to explore your legal options. You may be due substantial economic recovery for your injury losses by means of an IVC filter lawsuit.
Contact us today and get a free case review. Then you can decide if you want to engage an IVC filter lawyer provided by our law firm. For such legal work on your behalf you would pay nothing in up-front legal fees, since we’re only paid if we win your case, and then only from a portion of the settlement you receive.© Willis Law Firm for Drug Attorneys. Replication strictly prohibited without written consent.