Inferior vena cava also known as IVC filters were approved by the US Food and Drug Administration in 1979 and are now available as retrievable or permanent implants – the retrievable type being an option for short-term use.
The FDA received close to 1,000 complaints from 2005 to 2010 about adverse events associated with IVC filter removal complications and the failure of the newer retrievable filters.
There was no report from the FDA about the remaining 34.8% of adverse event reports, but a warning was issued regarding an increased risk of IVC deep venous thrombosis (DVT). In lieu of these reports, the agency set about advising health care providers to remove the retrievable IVC filters once the patient’s condition improved and there was no longer any threat of pulmonary embolism.
The unfortunate part is that a large number of the worst complications occurred when the retrievable filters were removed. Few were caused by the presence of the device in the body or the implantation procedure.
How Do IVC Filters Work?
- 1 How Do IVC Filters Work?
- 2 Types of IVC Filters
- 3 Uses of IVC Filters
- 4 Complications Caused by IVC Filters
- 5 Complications of IVC Filter Placement
- 6 Short-Term Complications from IVC Filter Placement
- 7 Pain Caused by Defective IVC Filters
- 8 History of Safety Concerns about IVC Filters
- 9 Warning Letter
- 10 Complications Claimed in IVC Filter Lawsuits
- 11 FDA Reports and Actions
- 12 Recalls of IVC Filters
- 13 Studies on IVC Filters
- 14 Failure Rates of Filters
- 15 “Significant Decline” Shown in Use of IVC Filters
- 16 Accusations Against Manufacturers of IVC Filters
- 17 Filing an IVC Filter Lawsuit
An inferior vena cava filter is a small, metal device that is designed in such a way so as to prevent a blood clot from making its way to the lungs and resulting in a pulmonary embolism. A pulmonary embolism is a blockage in an artery that transports blood to the lungs from the heart – this blockage can sometimes be fatal.
The cage-like device is surgically implanted into the inferior vena cava, the largest vein in the body. IVC filters are made so they can trap clots, but the flip side is that these sophisticated devices can potentially move in the body and cause IVC filter complications that may have devastating consequences.
Types of IVC Filters
C.R. Bard and Cook Medical are two of the major manufacturers of IVC filters. The most popular IVC filter brands include:
- The Bard G2 filter
- The Bard G2 Express filter
- The Bard Recovery filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
- The Boston Scientific Greenfield filter
As mentioned earlier, there are two types of IVC filters: permanent and retrievable (optional). Although they are intended for short-term use, retrievable filters provide the option for long-term use or removal when a risk for pulmonary embolism is no longer present. On the other hand, permanent IVC filters are designed only for long-term use.
It is important to note that IVC filter lawsuits are only being filed against the manufacturers of retrievable filters.
According to a study from 2014 that was published in the Journal of Vascular Surgery, retrievable IVC filters left in place were linked to significantly higher rates of complications than permanent filters. The authors of the study identified 383 patients with implanted retrievable IVC filters and compared them with patients who had permanent filters. It was found that blood clot-related or thrombotic and device-related were common among patients with retrievable filters.
Uses of IVC Filters
Blood clots that develop in the upper and lower extremities and deep inside the pelvis are referred to as deep vein thrombosis or DVTs.
While they are not typically life-threatening, DVTs can lead to death when they travel to the lungs and produce clots that block the normal flow of blood in the lungs, also known as pulmonary embolisms.
About 300,000 deaths occur each year due to these embolisms. It ranks third among the most common causes of death in hospital patients.
People who had recurrent DVTs while they were on blood-thinning (anticoagulation) medication and/or people who are unable to consume or tolerate these medications due to bleeding or an adverse reaction make good candidates for IVC filters.
Doctors may also recommend these medical devices in patients who undergo surgery because of an elevated risk of blood clots or suffer serious trauma.
Cases in which the use of IVC filters may be recommended include the following:
- Car accidents
- Stabbing or gunshot injuries
- Emergency or voluntary surgeries
- Dialysis treatment
- Cancer diagnosis or treatment
- Spinal cord injury
- Serious falls
- Immobile patients
- Patients who just had a baby
Complications Caused by IVC Filters
IVC filters can in certain cases float away from their surgically-positioned site thus rendering them ineffective. In some cases, the device punctures a vein, resulting in bleeding and other complications.
The filters can break into pieces, which can then travel through the blood and lodge in the heart or other organs. Retrievable filters, in particular, are linked to a number of potential risks, such as failing to stop blood clots from bypassing the device and damaging veins.
Typically, complications caused by IVC filters fall into three categories: procedural, retrieval and delayed.
Procedural IVC filter complications occur when the filter is inserted. These complications include:
- Bruising and/or bleeding in the access site
- Blood vessel puncture
- Malposition and/or incorrect placement of filter
- Deployment of defective filter
Retrieval complications occur when the filter is removed and include the following:
- Perforation of blood vessels
- Large clots in the filter that prevent device removal
- Scars in the vein that prevent device removal
- Difficult retrieval resulting in long surgery times
Delayed complications occur after the IVC filter is implanted in the patient’s body and include the following:
- Migrating to other parts of the heart, vena cava or even other organs
- Breakage or fracture of the filter
- Deep vein thrombosis
- Perforated organs
- Blockage that results in swelling in the legs
- Device infection
- Detachment of device components or embolization
Complications of IVC Filter Placement
To place an IVC filter, a doctor, in most cases, will use a catheter inserted through the skin into a large vein in the thigh or the neck and thread it to the inferior vena cava in the abdomen.
The doctor threads the filter through the catheter into the vein with the help of image guidance, including ultrasound, and x-ray and a contrast agent, or a substance that is introduced into the patient’s body so that the medical professionals are able to see.
This is a procedure that is referred to as percutaneous. It has been reported that the rate of complications from this procedure range from 4% to 11%.
Short-Term Complications from IVC Filter Placement
Other possible complications that can arise from the placement of IVC filters include the guide wire penetrating the vein, kidney dysfunction resulting from the contrast agent, blood clotting at the insertion site, bleeding or infection of the insertion site and a condition called an arteriovenous fistula (AVF), a rare complication that involves an abnormal connection between a vein and an artery. 0.02% of this complication is reported.
Short-term complications related to the procedure can include the following:
- Irregular or abnormal heartbeat
- Reaction to the contrast agent
- Pneumothorax – a collapsed lung resulting from air leaking into the space between the chest wall and the lung
- Air embolization – which is a condition wherein air bubbles block a blood vessel
- Hemothorax – a condition wherein blood pools up in the space between the lung and chest wall
Pain Caused by Defective IVC Filters
When patients experience pain with an IVC filter, it is often related to complications of the filter that may be malfunctioning or defective. Some IVC filter complications that can lead to severe pain include a blocked filter, IVC perforation, or embolization.
IVC filters can also perforate or become embedded in the wall of the IVC. But because there are no nerve endings in blood vessels, it is unlikely that patients will experience any pain that is linked to complications that directly affect the vein and they will consequently not be aware that there is a problem.
However, once the vessel has been pierced all the way through by an IVC filter, or if it breaks apart as it moves through the bloodstream, it can have an effect on other parts of the body causing pain.
The pain that often is caused due to IVC complications can affect the heart, back, abdomen or even the legs.
History of Safety Concerns about IVC Filters
The FDA issued its first safety communication about IVC filters in the year 2010. As mentioned earlier, the agency recommended removing the device once protection from pulmonary embolism was not required anymore.
The safety advisement and recommendation from the agency came after it received and reviewed over 900 reports of adverse events related to the anticoagulation device over a period of 5 years.
Adverse events that were reported included embolization, device migration, filter fractures and perforation of the IVC and organs. In most cases, these events occurred long after the risk for pulmonary embolism in the patient had subsided, yet the IVC filter was not removed from the body.
Updated Safety Communication by the FDA
The FDA issued an updated safety communication in 2014 regarding IVC filter use and removal. There were no new safety concerns in the notice.
Instead, the agency chose to report that after the risk of contracting pulmonary embolism in patients has passed, the IVC filter can be removed. The filter according to the agency’s updated safety communication could be removed between 29 and 54 days after implantation.
The federal agency developed a mathematical model using data that was publicly available from medical literature. This model suggested that the risk of having an IVC filter begins to outweigh its benefits when it is no longer necessary to prevent pulmonary embolisms.
The FDA, concluded that IVC filter complications could be certainly mitigated if doctors promptly removed the anticoagulant device after the risk for pulmonary embolism had abated.
The FDA issued a warning letter to the manufacturer of the Recovery Cone Removal System and several IVC filters, including CR Bard in 2015. The agency noted that the removal system was never given clearance and therefore, there was presumably no method that was approved for the removal of IVC filters manufactured by the company.
The regulatory agency also admonished Bard for failing to follow good manufacturing practices in the processes of manufacturing, packaging and storing its IVC filters, and for failing to establish and maintain appropriate procedures to receive, evaluate and review complaints regarding its anticoagulant devices.
The FDA further noted that CR Bard failed to report information that it received about defects linked with its IVC filters that could possibly lead to injury or death.
Complications Claimed in IVC Filter Lawsuits
People who filed IVC filter lawsuits against manufacturers claim that the devices implanted in their veins moved or broke. These problems can result in serious complications. People can file lawsuits for IVC filter complications such as:
- Blood clots
- Migration of the device
- Fracture of the filter
- Organ perforation
- Organ damage
- Impossible filter removal
It is also important to note that many IVC filter lawyers are accepting cases where no injury or complication has occurred. In other words, if you have an implanted IVC filter, you may be entitled to compensation by filing an IVC filter lawsuit (regardless of injury).
IVC filters are cone-like devices with spindly legs that deploy inside of the inferior vena cava. In some instances, the legs can puncture the veins. Or the filter can perforate or break. If this occurs, the entire filter or parts of it can travel through the body. That can result in damage to the heart, lung or other organs.
FDA Reports and Actions
Between 2005 and 2010, the US Food and Drug Administration (FDA) received 921 reports of adverse events involving IVC filters. Roughly 328 of those reports involved device migration, 70 involved perforation of the device, 146 involved embolizations, and 56 involved fracture of the filter.
Some of the reported events caused patients to experience adverse clinical outcomes. The FDA concluded that the adverse events that were reported could have been caused by a retrievable filter that remained in the patient’s body after the risk for pulmonary embolism had come down.
The agency recommended the removal of retrievable filters within 54 days after they were implanted if the risk has diminished.
The FDA has also required additional information from studies to be collected for IVC filters that are currently marketed in the United States. According to the agency, the studies address unanswered safety questions for permanent as well as retrievable IVC filters.
Manufacturers were given two options for data collection: post-market surveillance or the PRESERVE study. PRESERVE stands for Predicting the Safety and Effectiveness of Inferior Vena Cava Filters.
It is an independent national clinical study that will examine IVC filter use in the prevention of pulmonary embolism. 522 studies will be involved in post-market surveillance.
According to a study in 2016 in Seminars in Interventional Radiology, the FDA said that the data that is collected from the 522 studies and PRESERVE study will help the agency, the manufacturers of the IVC filters and health care professionals make an assessment of the use and safety profile of the filters, understanding evolving patterns in clinical IVC filter use, with the goal of ultimately improving utilization of IVC filters and patient care.
Recalls of IVC Filters
Between 2005 and 2010, manufacturers issued 6 major recalls of IVC filters. The recalls had an effect on over 81,000 units, and the majority was for issues with packaging and labeling.
Since 2015, there have been no major recalls for IVC filters. Thousands of people have reported experiencing complications caused by these medical devices. However, manufacturers have not recalled devices that are known to be most problematic.
An NBC News investigation in 2015 connected Bard Recovery and G2 IVC filters to the death of 39 people. Neither device was recalled by the company. They were replaced with similar models instead.
Cook Medical IVC filters have also come under fire for causing injuries and deaths. Hundreds of reports have been received by the FDA on Gunther Tulip and Cook Celect problems. However, the company never issued recalls for either of these devices.
Studies on IVC Filters
Studies have confirmed that retrievable IVC filters come with problems. The failure rate of the filter was looked at in a 2013 study that was printed in JAMA – Journal of American Medical Association, a group of researchers discovered that only 58 out of 679 retrievable IVC filters were actually removed by doctors.
When the filters, remained in patients longer than medically necessary, 25 patients were reported to have suffered pulmonary embolisms, 18.3% of filter removal attempts failed, and 7.8% of patients had venous thrombotic complications.
Failure Rates of Filters
Introduced in 2003, the Recovery filter was the first-generation product manufactured by C.R. Bard. The Bard G2, a second-generation device, was introduced in 2005 to replace the Recovery. However, before Bard introduced the replacement, the FDA received 300 reports of adverse events that are associated with the device.
One study had results showing that about 25% of the Recovery IVC filters failed, causing the device to break apart or fracture. While the study did not provide a reason, one patient died at home. An NBC News investigation connected the device to at least 27 fatalities.
The Bard G2 had a failure rate of 12% and remained for a shorter period of time in the market than its predecessor.
When the G2 came into the market in 2005, Bard stopped the sale of the Recovery. In 2008, the G2 Express, the G2’s successor, entered the market. One study found that all of the devices manufactured by Bard experienced a combined fracture rate of 12%.
In another study, it was found that both of the filters manufactured by Cook Medical, the Celect and the Gunther Tulip, had histories of perforating the vena cava wall of patients. In most cases, the perforation occurred within 71 days from being implanted, and the filters migrated out of place in 40% of patients.
“Significant Decline” Shown in Use of IVC Filters
A study conducted in 2017 found that IVC filter use experienced a “significant decline” after the safety warning issued by the FDA in 2010.
Researchers at St. Louis’ Washington University School of Medicine examined more than 1 million patient records that covered a period of 10 years. They saw a rise of over 22% in the use of IVC filters between 2005 and 2010. However, there was a dramatic drop in the use of these devices after the FDA advisory, going down by over 25% by 2014.
At their peak in 2010, nearly 130,000 IVC filters were implanted in patients. The number had fallen to about 96,000 by 2014.
Accusations Against Manufacturers of IVC Filters
In IVC filter lawsuits, plaintiffs claim that CR Bard and Cook Medical manufactured devices that were defective, resulting in their injuries.
They also claim that the manufacturers knew or should have known that their products were dangerous. According to the lawsuits, the companies failed to adequately warn health care providers and patients about the dangers associated with IVC filters.
The allegations in IVC filter lawsuits include:
- Defective design and manufacturing of the device
- Misrepresentation in marketing
- Failure to provide warnings about the dangers of the device
Filing an IVC Filter Lawsuit
If you want compensation for an injury caused by an IVC filter, you should file a lawsuit. However, it is important to bear in mind that cases that involve medical devices are complex.
Therefore, you should seek the help of an IVC filter lawyer as they usually have experience in handling complicated lawsuits involving medical devices. IVC filter lawsuits involve complicated medical, legal and engineering issues. With a medical device lawyer, you have a professional with acumen in these areas.
If you have suffered injury due to an IVC filter, you should consult a medical device lawyer who will review your case and determine if you are eligible to sue the manufacturer of the device. Keep in mind that your fight against major companies like CR Bard or Cook will be long and arduous.
Your legal pro will protect your rights and make sure that you are treated fairly throughout the legal process. Because the corporation will have a team of highly trained and experienced lawyers to defend them, it is crucial that you find a legal counselor who will fight just as passionately for you.
If you or a loved one has experienced a serious complication after placement of an IVC filter, you should immediately seek the help of a skilled and judicious medical device lawyer. Your attorney will determine if you should file an individual lawsuit against the manufacturer or join a class action lawsuit depending on the facts of your case.
Once you take the best legal course of action for your case, you can begin the process of suing the manufacturer of the IVC filter and receive compensation for your injury and other damages resulting from the IVC complication.