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For people recovering from physical trauma, accidents, and surgeries, the inferior vena cava filter (IVC filter) is a boon for their medical safety, protecting them from dangerous blood clots. Temporary and permanent vein filters are designed to capture embolisms before they reach the lungs (pulmonary embolism) or the heart.
Unfortunately, the same people these devices are designed to help are suffering serious complications like perforation of the vein, perforation of organs and tissues, migration of the device, and device breakage that can cause small parts of the filter to travel with the blood throughout the body causing damage.
If you or a family member has received an IVC filter, you may be concerned about the safety of these devices and trying to find more information about how they work. This guide aims to give you the most recent relevant information, as well as help you understand the options that may be available to you.
Important Warning Video
What is an IVC Filter?
An IVC Filter is a device used to catch deep vein blood clots as they travel from the lower extremities to the heart and lungs,preventing stroke and other life-threatening events. The device resembles the metal framework of an umbrella and is placed in the inferior vena cava. Though older filters were designed to remain in the body, new devices are removable.
How an IVC Filter Works
The inferior vena cava (IVC) is the human body’s largest vein.Blood travels up the IVC from the lower extremities to the heart and lungs to be re-oxygenated. When someone develops a deep vein thrombosis (clot) in the legs, pelvis, or arms,doctors may implant a filter to catch the clot before it can travel to the heart or lungs and cut off blood supply.
To implant the device, physicians make a small incision in the neck or groin area and slide the filter into the inferior vena cava using a slim, flexible tube called a catheter. The filter is opened and situated so that it can catch any blood clot as it travels up.
Retrievable filters are removed from the body in much the same way they are implanted, except that the catheter has a small hook on the end that connects to a hook on the filter that allows it to be pulled through and out of the vein.
Complications with the IVC filter can occur at nearly anytime between placement and removal. However, these devices have been associated with the following complications and risks –
|IVC Filter Complication||Details|
|Malposition||When the IVC filter is placed, there is a risk ofinfection, bleeding, hematoma, and accidental perforation of thevein, however the most serious risk comes from malposition ofthe device. If it is not positioned correctly, the filter may fail tocatch deep vein blood clots, and the device has a greater chanceof moving to another area in the body.|
|Device fracture||Parts of the IVC filter may break off and travel through the body damaginginternal organs.|
|Migration||The entire device can tilt, move, and travel to other areas of the body, where it maybecome lodged or caused a blockage.|
|Device blockage||The filter may become clogged with the blood clots it catches, preventingblood from traveling from the lower extremities to the heart.|
|Vein perforation||The IVC filter may perforate or poke through the inferior vena cava. It mayalso protrude from the vein, damaging nearby organs.|
|Removal||A physician may not be able to remove the device without a significant risk of injuryto the patient.|
IVC filters were designed to saved lives, however, their use may come with the following known side effects:
- Chest pain
- Lower-limb Deep Vein Thrombosis (DVT)
- Irregular heartbeat
- Obstruction, erosion, or narrowing of the inferior vena cava causing slower blood flow
- Cardiac tamponade (compression of the heart due to excess fluid around the heart)
- Hemorrhagic pericardial effusion (excess fluid around the heart)
- Infection from not properly sterilizing the IVC filter prior to implantation
- Perforation of the heart, lungs, or vena cava
- Fracture and/or filter migration
- Filter embolization
- Health risks associated with removing the IVC filter
In fact, lawsuits have been filed around the country alleging that the benefits of some IVC filters do not outweigh the risks. These complaints also allege that their manufacturer knew of these risks and failed to warn the medical community and their patients about these dangers.
History of Adverse Events
In 2010, the U.S. Food and Drug Administration issued a safety alert about IVC filters and the number of adverse events being reported. At the time, about 921 adverse events had been reported over device migration, perforation, fractures, and embolization of device components. The FDA warned physicians about leaving the filter in the body, and that research suggests filter removal between 29 and 54 days after it is implanted, provided the risk of blood clots has passed.
Other important events include-
|Year||Details of Adverse Events|
|2012||The first IVC Filter injury lawsuits were filed in the U.S.|
|2013||Study finds that of 679 IVC Filters that were implanted, 18% of removal attempts were unsuccessful.|
|2014||FDA recommends IVC Filters be removed within 54 days of implantation.|
A recent 2016 search of adverse events reported to the FDA include at least 1,374 adverse events involving-
- 103 reports of IVC filter-related deaths
- 476 reports of filter malfunction
- 751 reports of device injury
IVC Filters Most Prone to Failure
Research has revealed that five IVC filter types by two manufacturers are more prone to failure than others. The five include-
- Cook Celect filter
- Cook Gunther Tulip filter
- Bard Recovery filter
- Bard G2 filter
- Bard G2 Express filter
A study published in volume 29, Number 3 of Baylor University Medical Center Proceedings suggests that “in vivo motions transmitted from the IVC to the filter” could cause have caused the fracture in the case of a 29-year-old women who had to have a device removed about six years after implantation. Physicians said the surgery was complicated as the filter had fractured and the pieces had to be retrieved. Study authors suggested that the filters could fracture from metal fatigue and damage, as well as overload from acute stress.
Types of IVC Filter Failure Injuries
When these devices fail, you may experience serious or life-threatening events that include:
- Extreme pain
- Dangerous blood clots
- Organ, tissue, and venal perforations and hemorrhage
- Pulmonary embolism
- Heart Failure
IVC filters can fracture, causing the device as a whole or a broken spindle to migrate to other areas of the body where it can puncture or perforate other organs, block blood flow, and cause pulmonary embolism (blood clot in the lung) or even heart failure.
Many of the people who have suffered injuries or experienced other IVC filter complications are turning to the legal system for help. These people allege that these devices are dangerous and that the manufacturer knew of these dangers but chose not to warn physicians of these dangers. In fact, manufacturers left it up to the Food and Drug Administration to determine when these filters should be used and how long they can be left in the body.
If you or a loved one has suffered serious injury from an IVC filter, contact us today. Our attorneys are reviewing cases across the country alleging that devices makers failed to warn about the potential for the filter to break, damage other organs, cause a heart attack or stroke or even death. The chances of these filters migrating or fracturing is high, and we believe the manufacturers knew this. We also believe that device makers hid information and research concerning the dangers of these filters from the FDA in order to receive approval for these devices.
Our firm has spent decades fighting big pharma who puts profits over the safety of the patients who need them most.
If you or someone you love is suffering from IVC filter side effects and complications, call us today. We will fight your rights and be right there, helping you get through this together.