Occasionally, the medical community will bring us a breakthrough in treatment or drug therapy that years down the road proves to be anything but. Unfortunately, this has turned out to be the case with a blot clot filter called the inferior vena cava (IVC) filter. What was thought to be a giant leap forward in solving a serious problem for many has become nothing short of a nightmare due to the failure rates of this device, leading to the filing of personal injury and product safety lawsuits.
The IVC Filter
First introduced in 1979, the IVC Filter is a small metal device that will stop a blood clot from travelling to the lungs. While many patients are able to take blood thinners for this purpose, some cannot and these metal cage-like devices are surgically inserted into a patient’s vein to prevent a possible embolism. By 2012, IVC Filters had been inserted in approximately 259,000 patients.
IVC Filter Failure
Unfortunately, these devices often failed to perform as intended and were clearly acting as defective products in many respects. The filters would either fall out of place, migrate to other areas of the body, and sometimes even perforate the vein and other organs. There are reports of patients who had their hearts punctured by a migrating IVC filter as well as embolization, the occurrence that these devices were supposed to prevent.
The first safety alert on these devices was issued by the U.S. Food and Drug Administration (FDA) in 2010. At that time, there were 921 reports of adverse events from IVC Filters. A majority of these were due to device migration. By 2014, the FDA was recommending that retrievable devices be removed between 29 and 54 days, yet many have slipped through the cracks. The Journal of American Medical Association (JAMA) found that out of 679 retrievable IVC filters inserted, only 58 were removed. Also, if filters are left in too long, there can be difficulty removing them or adverse events linked to their removal. Studies have revealed the five most failure-prone retrievable IVC filters to be:
- Bard’s Recovery
- Bard’s G2
- Bard’s G2 Express
- Cook’s Gunther Tulip
- Cook’s Celect
It has been found that nearly any of Bard’s devices have a combined 12 percent fracture rate while Cook’s filters will migrate out of place in 40 percent of patients.
IVC Filter Personal Injury Lawsuits
Understandably, patients and families are upset about the harm that these defective products have done. There has been an increase in the number of personal injury lawsuits filed against these companies. It has been determined that some, such as Bard, were aware of the risks and still pushed for approval of their products by the FDA. There are currently more than 100 lawsuits pending against Cook.
Rather than performing as intended, these devices have caused irreparable harm to many, and death to some. If you or a loved one have been harmed by an IVC filter, be sure to seek the assistance of an experienced personal injury attorney.