Studies Suggest IVC Filters Are Overused and Ineffective

IVC Research
Concern continues to grow in the medical community as numerous studies have emerged to suggest that IVC filters are overused, ineffective, and place unnecessary risks to the health of patients who have been fitted with the devices. The FDA has received 100’s of adverse event reports dealing with complication caused by IVC filters and even sent a warning letter to IVC filter manufacturer C.R. Bard in 2015 in reference to inspections completed at two of the company’s facilities.

As of mid-January 2017, there were nearly 1,400 lawsuits consolidated for pretrial proceedings against Bard and almost another 1,400 lawsuits consolidated against Cook Medical—and the storm appears to be far from over.

The devices emerged as a seemingly safe alternative to prevent pulmonary embolism in cases where patients could not take an anticoagulant (blood thinning medication). However, IVC filters have the potential to dislodge and migrate throughout in the patient’s body, perforating veins and embedding themselves in the heart or lungs. Patients suffer severely, and in some cases, the migration of the device has caused death.

A study published in the January 2017 edition of JAMA Surgery found that the devices did not improve mortality rates in trauma patients, thus suggesting that not all who would receive the filters actually need them. In fact, the unnecessary implantation of the devices often leads to more issues rather than providing any meaningful benefits.

The study was conducted by the trauma center at Boston University School of Medicine and tracked patients who had received an IVC filter between the period of 2003 through 2013. Studying trauma patients provided researchers an opportunity to gauge the effectiveness of IVC filters in a population that was at a high risk of developing blood clots but who could not take blood thinners because of their severe situations.

Researchers compared 451 trauma patients who had received IVC filters to over 1,300 controls who did not have the devices. Astonishingly, the study found that in patients who survived longer than 24 hours, the use of an IVC filter did not improve mortality rates in comparison to those without one. Simply put, the use of IVC filter did not improve survival rates.

Researchers followed up at 6 months and 1-year post-discharge and found no difference between those with and without IVC filters.

Another troubling statistic that was identified during the study was the low retrieval rate of temporary IVC filters in trauma patients. Researchers found that only 8% of patients with IVC filters had them removed.

This is a major concern as medical professionals typically suggest that the IVC filters be removed two to three months after implantation. The FDA has an even shorter window of removal at between 29 to 54 days. Both assume the risk of a blood clot has passed.

Retrieval of the device is essential to the physical well-being of the patient. In May 2014, the FDA issued a Safety Communication that noted the increased chance of IVC filter complications when the devices were left unnecessarily longer that needed.

While the 8% retrieval rate was substantially lower than national numbers, studies show that overall retrieval rates stand at a terrible 30% for all patients (trauma and traditional).

While the devices are designed to improve survival rates from pulmonary embolism, the reality is that low retrieval rates place them at even greater risk of other serious health complications.

Adding to these issues is that trauma patients may not even realize that they have had an IVC filter implanted during surgery and follow-up appointments are hardly practiced or required by law. Furthermore, the doctors who recommend IVC filters may not even be the same who do the implantations, making it much more difficult for patients to understand who is responsible for the removal of the devices.

Dealing with pain and medical complications as a result of an IVC filter? Hotze Runkle PLLC will fight for you.

At Hotze Runkle PLLC, we are committed to helping those who have suffered harm at the hands of negligent and deceitful manufacturers. Your injury and pain deserve justice. Let our legal representatives serve your needs and provide you with the commitment of a team that can get the job done.

If you, or a loved one, has suffered physical, emotional, and financial injury, or even death, as a result of an IVC filter, contact us today at (877) 919-0830.


Why Do IVC Filters Fail?

ivc filters lawsuit lawyers

IVC (inferior vena cava) filters were initially developed as an ideal alternative for individuals who were at risk of deep vein thrombosis (blood clots) but not able to handle anticoagulant medications. Coupled with the risk of anticoagulants increasing the probability of serious internal hemorrhaging, IVC filters were seemingly set to revolutionize the manner in which patients deal with blood clots.

This didn’t happen. Instead, the small metal cage medical devices have exhibited a propensity to fail.

The attorneys at Hotze Runkle PLLC are committed to helping those who have suffered harm at the hands of others.  Your injury and pain deserves justice. Let our legal representatives serve your needs and provide you with the commitment of a team that can get the job done.

IVC Filter Failure

The inferior vena cava is the largest vein in the human body and carries de-oxygenated blood from the lower extremities up to the heart and lungs. Certain patients who have undergone hip or knee surgery may be at risk of pulmonary embolism (blood clot traveling to the lung), which can cause breathing difficulties, chest pain, and even have fatal consequences.

IVC filters are small cone-shaped devices implanted in the inferior vena cava, usually just below the kidney, designed to capture blood clots that are traveling upwards toward the heart and lungs. Ideally, IVC filters work by capturing the blood clots while still allowing blood flow to continue around the area, and over time, natural anticoagulants within the blood should help to break the clot down.

However, what has happened in many cases is that the filters fracture, or fall out of position altogether, causing severe, painful and life-threatening injuries. Failure rates vary by study, but most research done has shown incident rates to be high. For instance, one analysis of 262 patients found that IVC filter struts had pierced the inferior vena cava or other organs in 46% of cases.

Another study conducted at Ohio State found that out of 591 patients, there were 262 cases in which IVC filter perforation had occurred—a little over 44% of patients. Even more troubling, evidence suggests that failure will occur in up to 50% of patients over the course of five years.

If the IVC filter fractures, the small metal shards can perforate other organs, and can even reach the heart. If this occurs, an irregular heartbeat can develop, as fluid such as pus or blood leaking into the tissue lining surround the heart muscle can cause pressure and interfere with the heartbeat.

While the medical devices appear to work effectively within the first few months of implantation, the longer the IVC filter remains in the patient’s body, the greater the chances of failure. Furthermore, the longer it remains in the patient, the more difficult it becomes to surgically remove the device.

Why do IVC filters fail?

Research conducted by Baylor Scott & White Health’s Department of Radiology in Dallas have determined that over time the metal of the IVC filter causes a reaction in the tissue of the arterial walls. Evidently, the filter begins to grow into the arterial lining.

Another major contributing factor that causes many of the side effects found with IVC filter fractures is the flattening of the artery itself as the heart pumps blood. This motion of the artery places stress on the device and causes metal fatigue, eventually causing it to break.

There’s also the issue of the devices becoming hard to remove with the passage of time.

Because the filters can begin  growing into the arterial wall lining, it is highly recommended that the filters be removed with the first year, while there is still a high success rate of removal. This issue, in tandem with the IVC motion, can lead to a complicated retrieval or fracture.

Although the Food and Drug Administration has issued numerous warning about IVC filter failure, the device manufacturers such as C.R. Bard, Cook Medical, and Cordis, have continually failed to inform patients and doctors of the potentially deadly risks.

Let Hotze Runkle PLLC help you fight against the negligent acts of these manufacturers.

There have been thousands of lawsuits filed against the previously mentioned manufacturers. Their concern for profit above your physical well being and safety has to the FDA receiving 1000s of adverse event reports since the IVC filters were first introduced in 2005.

Hotze Runkle PLLC has an experienced team of lawyers who focus on medical device litigation. If you, or a loved one, has suffered a debilitating injury because of an IVC filter, contact us today at (877) 919-0830 for a free consultation.