What is an IVC Filter?
The U.S. Food and Drug Administration (FDA) approved inferior vena cava (IVC) filters in 1979. At that time, just 2,000 devices had been implanted. By 2007, the number of implanted IVC filters rose to 167,000 and continue to rise.
The human body has large veins known as inferior vena cavas, which carry deoxygenated blood from the legs to the heart. IVC filters are “spider shaped” medical devices that look similar to a small cage. The filters are about one-and-a-half-inches in size, are constructed of metal, and are inserted into the IVC. Once inserted, the filters trap blood clots that may travel to the heart, lungs, and brain.
Typically, an IVC filter is prescribed for patients who are unable to take anticoagulants or for whom these medications are not effective. IVC filters are also prescribed when a patient is diagnosed with a recurrent pulmonary embolism (PE); a blood clot, especially a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); or if a patient suffered a significant accident or injury, including a fall, gunshot wound, stab wound, car accident, or damage to the spinal cord.
Blood clots from the lower body may also occur following knee or hip replacement surgeries and may travel to the heart or lungs, which may lead to a PE. Should a blood clot travel to the lungs the clot may cause serious complications that include difficulty breathing, chest pain, or heart attack.
Generally, IVC filters are meant to remain in the body on a temporary basis and be removed when the threat of blood clots is over. In the past, some IVC filters have been left in patients’ bodies permanently or for extended time periods. This may lead to life-threatening complications.
FDA Issues Warnings for IVC Filters
In 2010, the U.S. Food and Drug Administration (FDA) warned that long-term use of IVC filters should be discontinued over the risk of IVC filter damage. The agency noted that it had received almost 1,000 adverse event reports in the prior five years.
Of those injury reports, over 300 involved IVC filter migration, nearly 150 involved filter component detachment, 70 involved IVC perforation, and 56 involved device fracture. The FDA also pointed out that IVC filters are intended as a temporary measure and warned physicians to consider the risks of these devices when discussing removal of the IVC filters with their patients.
In 2014, the agency updated the 2010 warning and recommended that retrievable IVC filters be removed between 29 and 54 days following implantation. Research reveals that IVC filters’ risks outweigh their benefits when the filter remains in the body for more than two months.
In one of the FDAs two warnings over IVC filter safety and efficacy, the agency indicated that IVC implants may break in a patient’s body and potentially travel through the bloodstream and into vital body areas.
This fracture and movement may also potentially puncture veins and organs and pieces may become lodged in high-risk areas, including the intestines and in other areas of the body in which surgical removal is impossible, according to NBC News.
The Most Common IVC Filter Damage Complications
Federal regulators point out that the most common complications associated with IVC filter damage are:
- Access site thrombosis
- Caval penetration
- Deep vein thrombosis (DVT)
- Filter migration
- IVC filter fracture
- IVC thrombosis
IVC Filters Cleared Without Clinical Trials
Many of the IVC filters on the market today received clearance through the 510(k) route. This method has been tied with increasing controvers
y and is considered by many as a careless method in which to release a medical device to the market. The 510(k) regulatory route enables device manufacturers to receive approval for their devices without undergoing clinical testing as long as the manufacturers are able to provide proof that their products are substantially equivalent to a previously approved medical device product.
IVC Filter Lawsuits
Numerous patients have brought lawsuits against IVC manufacturers such as Boston Scientific, Cook Medical, Cordis Corporation, and C.R. Bard. Allegations include that IVC filters were defectively designed, according to The State Journal. Allegations also include that the devices led to severe pain, bleeding, and the formation of additional blood clots. These injuries seem to be associated with the length of time the IVC filter remained in the patient’s body.
Individuals who have filed lawsuits against companies that manufacture IVC filters allege that they were harmed by the devices. As of January 17, 2017, a total of 1,366 lawsuits were consolidated for pretrial proceedings in a multidistrict litigation (MDL 2641) against C.R. Bard. Another 1,371 lawsuits were consolidated in an MDL (MDL 2570) against Cook Medical.
Study: IVC Filters Not Always Necessary
A study published in the journal JAMA Surgery reviewed the tie between being implanted with an IVC filter and overall death in patients. Researchers reviewed if implantation with an IVC filter in trauma patients impacted their chances of survival.
The study suggests that not all patients who receive IVC filters need them, that implantation may place some patients at unnecessary and increased risk of complications, and that patients who survived more than 24 hours following injury experienced no difference in the likelihood of death regardless of if they were or were not implanted with an IVC filter. In follow-ups conducted six months and one year following discharge, no significant difference between those who had been implanted with an IVC filter and those who were not implanted with the device were evident.
Study authors concluded that use of IVC filters in trauma patients should be reviewed given that although the filter device is meant to be temporary devices are often left in patients’ bodies indefinitely “and there is an increased risk of morbidity in patients with filters that remain in place.”
This means that, while patients implanted with an IVC filter are not at in increased risk of survival, low rates of filter removal may put patients at increased risks of serious, often deadly, health complications.
Filing an IVC Filter
If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations.