When a surgical patient is at risk for blood clots developing in the veins of the leg or pelvis, extreme care needs to be taken. This is because if a clot (called a deep vein thrombosis, or DVT) breaks up and then travels through the arteries to the heart or lungs, it can cause serious complications and even death. In order to prevent this dire consequence, physicians often proactively place a special filter into the body. These filters are known as IVC filters. It is named for the inferior vena cavity, the large artery that carries blood from the lower body to the heart because that is where it is placed.
IVC Filters and the Dangers
These filters are small metal devices that look similar to cages. Though originally designed to be placed permanently, in recent years they have been modified so that they can be easily retrieved once the danger is past. The devices are particularly valuable for patients who are unable to take blood thinners to prevent clotting and have been implanted in over 260,000 patients in the last 30 years.
Weighing the Benefits & Risks of IVC Filters
Despite the benefits provided by these devices, in recent years it has become apparent that they can cause serious complications. Not least among these are the possibility of causing damage to the veins in which they have been placed and failure to work properly, allowing blood clots to get by and do the harm that the device was designed to prevent. The U.S. Food and Drug Administration has issued a number of safety alerts specifically to call attention to the potential dangers of the retrievable IVC filters. In 2010 the agency indicated that they had received nearly 1,000 reports of problems caused by the devices, including:
- Filter perforation
- Filter migration
- Filter fracture
- Device embolization (parts of the device becoming detached)
Big Concerns from the FDA
One of the biggest concerns that the FDA voiced in 2010 was that though the devices were designed to be removed once the risk of deep vein thrombosis had passed, many were being left in place. In 2014, still concerned about the risk and continued lack of removal of the devices, the FDA issued an updated safety communication in which they provided a specific recommendation that the devices be removed between the 29th and 54th day after implantation.
The FDA recommendation was supported by research published in the Journal of the American Medical Association (JAMA), which cited the specific risks and statistics surrounding IVC filters left in place longer than the recommended period. These included:
- Venous thrombotic events in 7.8 percent of patients
- Pulmonary embolisms in 25 patients
- Inability to remove filters that had been left in too long in 18.3 percent of patients
Some IVC Filter Brands Worse than Others
In addition to these concerns, there have been specific IVC filter brands that have been shown to have a higher likelihood of splintering or fracturing and splinters of the devices making their way to the right ventricles of patients’ hearts, lungs or hepatic veins. In fact, the Western Journal of Emergency Medicine published a report indicating an estimated 40 percent of all retrievable IVC filters fracturing within 5.5 years if left in place.
The specific risks presented by these defective devices are numerous. When the devices fracture or splinter, the pieces travel through the body and can become caught in veins or embedded in organs. Potential risks include:
- Heart attack
- Puncture of internal organs
- Puncture or blockage of arteries and blood vessels
The Damage Caused was Preventable
The damage that has been done by retrievable IVC filters has been tragic, in large part because it was preventable. The devices were designed to do a job and then be removed, but the manufacturers requested that the devices be identified as permanent. The result has been pain, suffering, and even death.
Latest IVC Filter News
- Additional Concerns Raised Over Safety of IVC Filters
- Out-of-State Residents Allowed to Pursue Pennsylvania IVC Filters Lawsuit
- Firefighter Awarded $1.2 Million Over Defective IVC Filter
- New Study Reveals More Serious Problems With IVC Filters
- Judge Upholds Jury Ruling in IVC Filter Lawsuit
- Texas Firefighter Wins $1.2 Million in Case Involving Defective IVC Filter
- New Jersey Man’s Death Blamed on IVC Filter
- Two Studies Highlight the Dangers and Risks of IVC Filter Use
- IVC Filter Defects Lead to Death and Serious Injury
- New Orleans Couple Sues Medical Device Manufacturer over Complications Caused by Allegedly Defective IVC Filter