Inferior Vena Cava Filters
Inferior vena cava filters, or IVC filters, are implanted in a patient's artery to protect the heart and lungs from blood clots. These devices are intended to prevent life-threatening blood clots in individuals who have had surgery or those with blood clotting conditions. However, a number of IVC filter malfunctions have been reported, resulting in internal injuries or failing to stop blood clots from getting to the lungs. Hundreds of patients have filed legal claims against IVC filter manufacturers for causing injury or death.
History of Inferior Vena Cava (IVC) Filters
The first IVC filter for general use was developed in 1967 by Kazi Mobin-Uddin, M.B., B.S. "For the prevention of pulmonary embolism, transvenous interruption of the inferior vena cava by the umbrella filter was performed in 100 patients between July 1968, and June 1970. Filter dislodgement and migration did not occur, and there were no late complications. The recurrent embolism rate was 2 per cent, with a single recurrent fatal embolism."
According to the FDA, "IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012."
However, after doctors began to implement the IVC umbrella filter, there were complications with migration of the filter and the gradual obstruction of the IVC. Improvements included coating the device with heparin, and later developing a percutaneous filter. However, a 1998 medical trial showed no clear benefit of additional IVC filters in patients with deep vein thrombosis (DVT) without contraindications to anticoagulants because of the high thrombosis rate in the filter group.
Therapeutic trials include testing of retrievable temporary filters in contrast to permanent IVC filters, which can be retrieved from the patient. Additionally, improvements in anticoagulant drugs may make doctors less likely to continue the use of IVC filters for many patients.
FDA Approval of IVC Filters
Many IVC filters on the market were approved for use through the U.S. Food and Drug Administration (FDA) 510(k) process. Generally, when a Class I, Class II, or Class III medical device intended for human use does not need a Premarket Approval (PMA), the company must submit a 510(k) premarket submission.
A 510(k) submission made to the FDA must demonstrate that the device is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA. If a new device is substantially equivalent to an existing medical device, the FDA may generally clear the use of the new device without any clinical testing to ensure the device is safe.
On August 9, 2010, the FDA issued a safety communication regarding removing retrievable IVC filters. After numerous reports of adverse events and product problems associated with IVC filters, the FDA recommended physicians and clinicians responsible for ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
The Intended Use of IVC Filters
IVC Filters are generally indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava. Depending on the specific filter, IVC filters are generally used in the following situations:
Pulmonary thromboembolism when anticoagulants are contraindicated;
Failure of anticoagulant therapy in thromboembolic diseases;
Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
IVC Filters Manufacturers
There are a number of IVC filter and IVC filter removal kit manufacturers. These companies often have a number of IVC filter products and kits on the market at any given time. Some of these manufacturers have changed their products, ceased production of certain IVC filters, or taken their IVC filter devices off the market. IVC filter devices include:
Bard Recovery
Bard G2
Bard G2 Express
Cook Celect
Cook Günther Tulip
Johnson & Johnson Cordis
B. Braun Medical Vena Tech
Rex Medical
Rafael SafeFlo
Boston Scientific Greenfield
Adverse Events Involving IVC Filters
The FDA maintains a database of medical device adverse events reports. More than 1,000 adverse events have been reported to the FDA since 2005, resulting in injury, additional surgeries, and death.
Between 2010 and 2005, "the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided."
Complications from Using IVC Filters
There are a number of possible complications that may occur when a patient is fitted with an IVC filter. This could include problems with a permanent IVC filter, temporary IVC filter that is not removed, or during removal of a temporary IVC filter.
Complications include those that occur during initial placement, delayed complications, and during retrieval. During placement, complications include venous access site problems, malposition, and defective filter deployment. During access to the vein, complications include bleeding, arterial puncture, infection, and hematoma. During placement, the filter may be improperly positioned, making the device ineffective, leading to migration, or requiring additional surgery.
After placement, complications include migration, thrombosis, IVC perforation, pulmonary embolism, device fracture, and device infection. A migrating IVC filter can move to the heart or pulmonary outflow tract, requiring possible surgery. IVC filters can also increase the risk of DVT. Filters can perforate the wall of the IVC, resulting in serious bleeding and causing significant morbidity.
Retrieval complications include difficulty extracting IVC filters. Retrievable filters are more easily removed than permanent filters; however, they may still involve difficult retrieval requiring extended procedural time and possible surgery.
FDA Patient Recommendations
In 2010, the FDA released a safety communication regarding removing retrievable IVC filters. After receiving a number of adverse event reports involving device migration, embolizations, perforations of the IVC, and filter fracture, the FDA issued the following recommendations:
"FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed"
In 2014, the FDA released an updated safety communication regarding removing retrievable IVC filters. After the initial safety recommendation and continued adverse event reports involving IVC filters and the difficulty in IVC filter removal, the FDA issued the following recommendations:
"FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
"The FDA encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient's health status."
Academic Review and Clinical Studies
Appropriate Use of Inferior Vena Caval Filters
Ido Weinberg, M.D., M.Sc., F.A.C.C. authored Appropriate Use of Inferior Vena Cava Filters for the American College of Cardiology in October of 2016. According to the conclusion:
"In conclusion, IVCFs are likely being over-utilized. Retrieval rates are low and information regarding appropriate use and surveillance are lacking. Use of these devices should be limited to patients with acute VTE who cannot receive anticoagulation. When IVCFs are inserted for other indications this should be after much thought and coupled with appropriate documentation. Implementation of system wide mechanisms to ensure appropriate IVCF use, surveillance and retrieval is crucial in order to prevent important clinically relevant complications."
Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients Without Pulmonary Embolism
"The FDA developed a quantitative decision analysis using publicly available data available in the medical literature to assess whether there is a time period during which the risk of having an IVC filter in place is expected to outweigh the benefits."
"The decision analysis (Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism) was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013. The mathematical model suggested that if the patient's transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation."
Complications of Inferior Vena Caval Filters
Thuong G. Van Ha, M.D. authored Complications of Inferior Vena Caval Filters, published in Seminars in Interventional Radiology, June 23, 2006. According to the abstract:
"Inferior vena caval filters have been shown to be effective in the prevention of pulmonary embolism, with low morbidity and mortality associated with their implantation. Awareness of potential complications can further decrease the risk of filter placement and lead to early detection and management of complications to improve clinical outcomes. The purpose of this article is to review the procedure-related and delayed complications associated with inferior vena caval filters."
Vena Caval Filters: A Comprehensive Review
Vena Caval Filters: A Comprehensive Review, authored by Michael B. Streiff, published in the July 2000 Blood, provides a review on the use of IVC filters. A portion of the abstract reads, "In view of the absence of randomized comparisons, no filter can be designated as superior in safety or efficacy. Vena caval filters represent a potentially important but poorly evaluated therapeutic modality in the prevention of pulmonary emboli. Randomized trials are necessary to establish the appropriate place for vena caval filters in the treatment of venous thromboembolic disease."
IVC Filters Warnings and Recall Notices
On July 13, 2015, the FDA issued a WARNING LETTER to C.R. Bard, Inc., a manufacturer of a number of IVC filter devices and filter removal kits. The warning letter addressed a number of FDA violations, including:
Adulteration/misbranding in manufacturing Recovery Cone Removal Systems without marketing clearance or approval;
Quality system violations in failing to maintain and establish procedures for receiving, reviewing, and evaluating complaints;
Quality system violations in failing to validate and approve a manufacturing process that cannot be fully verified by subsequent inspection and testing, to ensure the process will continue to meet necessary specifications; and
Failure to submit a report after receiving information suggesting a device has malfunctioned, likely to cause or contribute to serious injury or death.
On September 27, 2013, there was a Class 2 Device Recall issued for the Cordis OPTEASE Vena Cava Filter. According to the recall, "Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. "
On December 2, 2005, there was a Class 1 Device Recall issued for the Greenfield Vena Cava Filter System. According to the recall, "there have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before March 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization."
On August 5, 2005, there was a Class 2 Device Recall issued for the Greenfield Vena Cava Filter. According to the recall, "certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear."
Patient Legal Rights
There are many ways that medical devices and medical products may be considered defective. This could include a design defect where the product is not safe for the intended use, or a failure to warn patients and doctors of the dangers involved with using the medical device.
Patients who are injured by defective medical products may be able to seek damages from the manufacturing company. Damages can include medical costs, income loss, and pain and suffering. Individuals who lose a loved one because of a defect may be able to file a wrongful death claim against the medical device manufacturing company.
Current IVC Filter Cases
More than 100 patients and their families have filed lawsuits against medical device companies involving IVC filter injuries and deaths. Many of these lawsuits are ongoing cases consolidated as class action lawsuits or involving multidistrict litigation. Multidistrict and class action lawsuits are pending in Indiana, Arizona, Florida, Pennsylvania, and California courts.
Claims against the IVC filter device companies include:
Failure to warn patients about product defects
Design defects in IVC filters
Manufacturing defects in producing IVC filters
IVC Filters Defect Lawyers Gilman & Bedigian
If you were injured after an IVC filter surgery or during IVC filter removal, you may have a legal claim for medical bills, lost wages, and other damages. If a loved one died as the result of a defective IVC filter, you should talk to experienced drug defect attorneys about your claim. You should not have to suffer due to the medical device company's negligence.
At Gilman & Bedigian, we will use our experience, knowledge, and dedication to fight for you to receive the compensation you and your family deserve. Our aggressive trial lawyers have helped our clients recover millions of dollars in compensation related to defective medical devices and defective drug injuries. Contact us online or call our law office at (800) 529-6162 for a free consultation.