A new study has just been released suggesting that IVC filters may be more dangerous and deadly than previously thought. Most medical complications from the filters occur when the filter fractures and break apart. However, the new study suggests fatal health risks NOT based on the fracturing of the filter. According to the study published by JAMA Open Network, an online medical research repository operated by the Journal of the American Medical Association, there is a previously undiscovered increased risk of dying within 30 days of having an IVC filter implanted; said risk is unrelated to the filter fracturing. See the study here.
IVC filters are small spider-like devices that are implanted to filter out blood clots that might reach a patient’s lungs or heart. The “spider-legs” are meant to “catch” the clots before they can reach the heart or lungs. Many IVC filters are intended to be removed after a certain amount of time; some are intended to be permanent. Both types are implanted when there is a risk of blood clots breaking free from the lower extremities and making their way to the heart and/or lungs. The filters are surgically implanted in the inferior vena cava (IVC) vein — thus the name IVC filter. The IVC is the largest vein in the body; in general, veins bring blood back to the lungs for re-oxygenation.
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IVC filters are generally implanted for those who cannot take blood-thinning medications — in medical terms, those exhibiting a “contraindication to anticoagulation” — and for those with vein thrombosis and/or a pulmonary embolism and/or other conditions associated with venous thromboembolic disease.
Millions of patients have had IVC filters implanted. Statistics show that about 100,000 are implanted every year. But, there are serious problems with some of the filters. Indeed, thousands of patients have had medical complications and thousands of lawsuits have been filed. As noted above, the most common complications are fracturing or the dislodging of the filter. This is the most common claim made in the lawsuits. Fracturing occurs when pieces of the filter–the “spider legs”–break off. These pieces are then carried off by the blood to the heart or other parts of the body. These pieces can become embedded in the walls of the IVC, other veins or in the tissue of the heart muscle. More serious still is when the entire filter becomes dislodged. Again, the filter can become embedded in vein walls or other body tissues.
The new study indicates that filters are more dangerous than previously thought aside from the risks of fracturing and dislodgement. The researchers have called for more research to explain the results.
Georgia IVC Filter Litigation Attorneys — Background on the Study
The study was conducted by a team of medical researchers led by Doctors Tyson E. Turner, Mohammed J. Saeed and Eric Novak from Washington University Medical Center in St. Louis. They reviewed medical records of 126,000 patients who had received IVC filter implants. They found that IVC filter implantation, in general, had benefits and aided in prolonging a patient’s life. As they phrased it, there is “… mortality benefit associated with IVC filter insertion.” This confirms and is consistent with many studies and clinical trials.
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However, their study uncovered an increased mortality rate of IVC filter implantation of 18 percent. The authors conducted their study with the intent to try and remove what is called the “immortal time bias” which is not a research methodology bias limited to IVC filters. This bias is a well-known bias applicable to research with respect to any type of medical intervention. In medical research, the “immortal time bias” is the time interval between a patient being admitted to the hospital and the medical intervention under study — in our case, implantation of an IVC filter. According to the authors, the previous research has failed to account for this potential source of bias. In general, by failing to account for this possible bias, any medical research can erroneously skew the research results in favor of the medical intervention. That is, the bias can falsely confer a mortality prevention advantage to whatever intervention is being studied.
As noted, to date, most of the lawsuits that have been filed concerned filter fracturing and dislodgement. This new study raises a different concern suggesting that the filters are more dangerous than previously thought even if the filter does not fracture or become dislodged.
Georgia IVC Filter Litigation Attorneys — Study Suggests More Research Is Needed
To be clear, the study — entitled “Association of Inferior Vena Cava Filter Placement for Venous Thromboembolic Disease and a Contraindication to Anticoagulation With 30-Day Mortality” — did not make the broad claim that IVC filter implantation causes death within 30 days. Rather, the claim is much more limited — that there is, based on a multivariate analysis, an unaccounted for 18 percent increase in 30-day mortality with respect to IVC filter implantation. The study did not offer an explanation for the correlation but, rather suggested that randomized clinical trials are needed to explain the previously unrecognized risk.
IVC filters have been available and in use since the 1960s. And yet, according to the authors of the study, there remains a lack of complete and variable-controlled research on whether IVC filter use poses health and fatality dangers aside from fracturing.
Georgia IVC Litigation Attorneys: Contact the Roger Ghai Law Offices
For more information, contact the Georgia medical device malpractice attorneys at the Roger Ghai Law Offices Our attorneys can help if you or a loved one has been injured as a result of complication from an IVC filter implantation. As noted, thousands of personal injury and defective medical device cases have been filed here in Georgia and across the country against makers of IVC filters. Some of the cases have already gone to trial and juries have awarded significant compensation to those injuries and their families. Do not wait if you think you have a case. There are strict time deadlines.
The Roger Ghai Law Offices provides legal services for the residents of Cobb County including the communities of Kennesaw, Acworth, Marietta, and the surrounding areas. Click here to schedule your consultation.