NEJM Study: Early IVC Filter Placement Fails to Reduce Blood Clot Risk
September 12, 2019 – Placement of an IVC filter in patients who have recently been admitted to a hospital for major trauma did not reduce the risk of pulmonary embolism or death, compared with patients who did not have filters implanted after a severe injury, according to a new study published in the New England Journal of Medicine. For the study, a research team led by Kwok M. Ho, PhD, of the University of Western Australia, looked at 240 severely injured patients (median age = 39 years; interquartile range [IQR] = 27-57 years), 122 of whom had retrievable IVC filters implanted and 118 who had no filters.
The researchers found no difference between the IVC-filter group and the no-filter group in the proportion of patients who experienced symptomatic pulmonary embolism or death at 90 days: 13.9% versus 14.4%, respectively (hazard ratio [HR] = 0.99; 95% CI 0.51-1.94; p=0.98). Only 2 patient characteristics were significantly associated with the primary endpoint: higher age (HR=1.3 per 10-year increment) and higher Injury Severity Score (HR=1.5 per 10-point increment; p values not reported), the authors found.
“For an invasive, expensive, and potentially risky preventive measure such as IVC filter, selecting the most appropriate patients is the key to making a treatment strategy the most cost-effective,” Ho said. “Having considered this important issue in the design of our trial, we have confirmed that an IVC filter should be reserved for those who are perceived to have a prolonged contraindication beyond seven days after injury to anticoagulant prophylaxis. A more restrictive approach to using the filters in trauma patients will reduce potential unnecessary complications, health-care cost, and medical litigation.”
What’s the Problem?
The inferior vena cava is the main vessel that returns blood from the lower half of the body to the heart. IVC filters are implanted in people at risk for developing life-threatening pulmonary embolisms who are unable to take anticoagulant drugs. The devices are umbrella-shaped, and have legs that extend to stop blood clots from migrating from the lower body to the heart and / or lungs. IVC filter candidates are typically people with a history of blood clots, trauma victims, at risk for developing deep vein thrombosis (DVT), or who have had a recent surgery.
Unfortunately, IVC filters have recently been found to have the potential to break off and migrate to the heart, lungs, and other vital organs. When this happens, severe, potentially fatal injuries can ensue. The medical literature has reported a significant statistical rate of IVC filter failure, fracture, and migration.
IVC Filter Complications
- IVC Filter Fracture
- Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
Fracture / Embolization Warning Signs
Warning signs that an IVC filter has failed may include:
- Severe pain in the heart or chest
- Pulmonary embolus
- Respiratory compromise
- Perforation of organs, tissues or blood vessels
Patients who believe their IVC filters may have fractured should contact their doctor immediately. A computerized tomography (CT) scan or other test will be used to determine whether the device has failed.
Which IVC Filters are Affected?
Our lawyers are now accepting potential lawsuits on behalf of patients who suffered complications after being implanted with the following brands of inferior vena cava filters:
Bard IVC Filter
Cook IVC Filter
Other IVC Filter Brands
- ALN IVC Filter
- Argon Medical OptionELITE IVC Filter
- B. Braun IVC filters (Tempofilter IVC filter, Tempofilter II IVC filter, VenaTech LGM IVC filter and VenaTech LP IVC filter)
- Cordis OptEase IVC Filter
- Crux Vena Cava Filter
IVC Filter Studies
A research team led by Dr. William Nicholson at York Hospital in Pennsylvania looked at 80 patients who had been implanted with Bard IVC filters between 2004 and 2009. These individuals underwent a fluoroscopy to determine the integrity of the filter and evaluate whether they had broken or if they were still intact. Patients whose devices were fragmented also underwent echocardiography and cardiac computed tomography.
The study’s results indicated that 13 of 80 patients (16%) who received Bard Recovery and Bard G2 filters had at least one fracture. 1st generation Bard Recovery filters had a 25% (7 of 28) fracture rate, with embolizations to the heart occurring in 5 cases. In 2nd generation devices (including the Bard G2 filter), 12% (6 of 52) were also found to have fractured. In 2 cases, the fragment inhibited blood flow, 1 in the vein coming out of the liver and 1 in the lungs. In the other 4 cases, the fragments stayed close to the filter.
“It is essential that patients and their treating physicians be educated about this previously under recognized and potentially life-threatening complication of these devices.” “Armed with this knowledge, educated patients can be alert to the presence of pleuritic chest pain and other symptoms that should prompt immediate evaluation. Such early awareness and evaluation could certainly be life saving. In addition, the propensity for filter fragmentation may be directly related to the duration of implantation. Patients and their physicians should be educated about this fact so that they have the opportunity to consider having the filter removed,” the authors wrote in their report.
IVC Filter Removal
IVC filters can be removed if they were designed to be retrievable, according to the Mayo Clinic. Retrievable IVC filters typically include a hook on the end of the filter which can be grabbed and remove from the body.
Permanent IVC filters, on the other hand, cannot be taken out without significantly more invasive (and dangerous) medical procedures. Removal of filters that were designed to be permanent also increases the risk of complications, such as device fracturing.
Large-Scale Study to Investigate IVC Filter Safety
November 14, 2019 – The first large-scale, multi-specialty research trial to evaluate the safety of inferior vena cava (IVC) filter use in the U.S. is set to begin in spring 2015 with participation from 7 filter manufacturers. The study will address concerns that retrievable IVC filters can migrate or break apart after being implanted, leading to significant health risks for patients.
The study, entitled Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), will be conducted by researchers at the Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS). The two societies formed the IVC Filter Study Group Foundation, a non-profit entity that will sponsor and oversee the study. The goal of the research is to obtain a real-world view of the safety and effectiveness of IVC filters placed in the U.S.
“The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed,” said Peter Lawrence, M.D., foundation vice president.
Manufacturers and devices that will be included in the study are:
- ALN Implants Chirurgicaux (ALN IVC Filters)
- Argon Medical Devices, Inc. (Option Elite Retrievable IVC Filter designed and manufactured by Rex Medical)
- B. Braun Interventional Systems Inc. (VenaTech LP IVC Filter)
- Bard Peripheral Vascular, Inc. (DENALI IVC Filter System)
- Cook Incorporated (Cook Günther Tulip IVC Filter)
- Cordis Corporation (Cordis OptEase Retrievable Vena Cava Filter/ Cordis TrapEase Vena Cava Filter)
- Volcano Corporation (Crux Vena Cava Filter System)
The 5-year study will investigate the safety of IVC filters, and include 2,100 patients at about 60 centers around the country. There will be at least 300 patients included for each participating filter, and patients will be evaluated every 6 months post procedure up to 24 months or filter retrieval.
Greenfield IVC Filter Perforates Patient With All 6 Legs: Study
A study published in the European Heart Journal on June 15, 2015, described a 52-year-old male patient implanted with an abnormally deployed Greenfield IVC filter that had shattered and perforated his inferior vena cava. “Two legs were located in the prevertebral space, one abutted the anterior aortic wall, one leg was deeply invading the right psoas muscle, and two legs arose very close to the duodenum ending up in close proximity to the small bowel loops.” Click here to learn more.
FDA Warning: Filters Intended for Short-Term Use Only
In August 2010, the U.S. Food & Drug Administration (FDA) issued a warning against leaving inferior vena cava filters implanted in patients for extended periods due to their potential to cause cause adverse health complications. FDA warned that IVC filters are for short-term use in patients at risk for pulmonary embolism, and implanting doctors are to remove the devices once the risk subsides. The administration was concerned about doctors not retrieving IVC filters intended for short-term placement, exposing patients to problems caused by fractured implants.
The FDA warning came after the study conducted by Dr. Nicholson noted above found a high prevalence of fracture and fragment embolizations with retrievable inferior vena cava filters. Nicholson’s study was used to challenge the FDA’s medical device approval process. The agency considers IVC filters as Class II devices, or low risk, clearing them without clinical safety or effectiveness data via their controversial 510(k) approval loophole.
How Many People Have Been Injured by IVC Filter Complications?
Since 2005, FDA has been made aware of at least 921 adverse event reports involving IVC filters, which included:
- 328 cases of device migration
- 146 reports of detachment of device component and embolization
- 70 cases of perforation of the inferior vena cava
- 56 IVC filter breaks
NBC News Investigation Reveals ‘Fatal Flaw’ with Bard IVC Filters
A year-long investigation by NBC Nightly News has raised serious questions about why C.R. Bard continued to sell its IVC filters even after it became aware that the devices were failing and causing death and other adverse health complications at rates significantly higher than competing brands. Click on the link below to watch the video:
Studies Evaluate IVC Filter Complications
March 21, 2013 – Two studies and an editorial published this week in JAMA Internal Medicine raised questions about the placement of inferior vena cava (IVC) filters. The research indicates that not only is there a lack of evidence establishing the effectiveness of IVC filters, but that a lack of data has led to great uncertainty as to how to correctly use the implants. IVC filters were approved under the FDA’s controversial 510(k) fast-track clearance process, which allows devices that are ‘substantially equivalent’ to existing products to enter the market without undergoing clinical trials.
In one study, which examined IVC filter use from one hospital to another, researchers identified a large variation in how the devices were implanted based on where the recipient was treated. Another study published in the same issue of JAMA looked at nearly 1,000 patients implanted with IVC filters at the same hospital and found that less than 10% were successfully removed, and nearly 8% of recipients suffered a venous embolism despite the filters.
One study looked at 952 patients implanted with IVC filters at Boston Medical Center, and found that 7.8% of recipients suffered a venous thrombotic event, and nearly a quarter were prescribed anticoagulant medications. Of the 679 vena cava filters that were determined to be retrievable, only 58 (roughly 8.5%) were successfully removed. Efforts to remove the devices failed in 13 recipients, just over 18% of attempts.
“Our research suggests that the use of IVC filters for prophylaxis and treatment of venous thrombotic events, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in sub-optimal outcomes due to high rate of venous thromboembolism,” the study’s authors concluded.
The other study examined the use of inferior vena cava filters in 263 California hospitals, and found that 15% of the 130,643 patients admitted for venous thromboembolism were implanted with the devices. The rate of IVC filter placement varied widely, with some hospitals never using them, and others implanting them in nearly 40% of patients. The researchers concluded that additional studies need to be conducted to determine whether the variations in IVC filter use are based on cultural differences between hospitals, or a lack of evidence about the effectiveness of the devices.
Medical technology giant C.R. Bard is currently facing a large number of lawsuits over its Recovery and G2 IVC filters. The complaints allege that Bard knew – or should have known – about their products’ potential to fracture, but that it failed to warn the public and medical communities about this risk.
IVC Filter Recall
In December 2005, the FDA issued a nationwide Class I Recall for the Boston Scientific Stainless Steel Greenfield Vena Cava Filter. Devices affected by the recall were made before March 10, 2004, and can be identified by the product code M001505010. The filters were recalled due to multiple reports of detachment at the bond between the carrier capsule and the outer sheath of the filter’s delivery system during implantation, putting patients at risk of adverse cardiac outcomes. A total of 8 complaints were received, 2 of which involved severe injuries requiring intervention, and 1 was reported as a death. There were approximately 18,000 Boston Scientific IVC filters affected by the recall.
Bard IVC Filter Litigation
In September 2012, a class action lawsuit filed against C.R. Bard over its Recovery and G2 IVC filters was removed from Florida state court to the federal court system. Attorneys for Bard filed a petition to have the case transferred to the U.S. District Court for the Southern District of Florida, which means that the company believes that the class action will eventually likely include more than 100 plaintiffs, that the total claims could top $5 million, and that members of the plaintiff class will be diverse from at least one defendant.
In addition to the Florida case, a number of other Bard IVC filter lawsuits have been filed in Pennsylvania and California courts, each involving similar allegations that Bard knew – or should have known – about its products’ potential to cause serious side effects, but that it failed to warn about these risks. The claims seek compensation to pay for the medical monitoring patients will require to ensure that the IVC filters have not fractured or embolized in their bodies as long as they remain implanted. To date, approximately 100,000 Bard IVC filters have been implanted in patients around the country.
Health Canada Issues Warning on Blood Clot Filter Complications
July 26, 2016 – Health Canada has issued a product safety warning regarding the health risks associated with IVC filters.
The agency said it has received at least 121 reports of adverse health complications linked to IVC filters since June 6, 2016, according to the warning. Most of these complications were reported in patients whose filters had been left implanted for more than 30 days.
Health Canada identifies the following affected products:
- ALN Vena Cava Filter
Bard Peripheral Vascular
- Denali Vena Cava Filter
- G2 Filter System
- Simon Nitinol Vena Cava Filter
B. Braun Medical
REX Medical, LP
- Option Retrievable Vena Cava Filter System
William Cook, Europe APS and Cook, Inc.
- Cook Celect Platinum Vena Cava Filter
- Cook Celect Vena Cava Filter
- Gianturco-Roehm Birds Nest Vena Cava Filter
- Gunther Tulip Vena Cava MREye Filter Set
Health Canada reminds physicians that vena cava filters are intended for short-term use and that, when possible, they should be removed as soon as the blood clot risk has passed. Hospitals are encouraged to identify all patients who have been implanted a retrievable IVC filter so that a formal strategy for filter removal can be formulated.
Cook IVC Filter Multidistrict Litigation
On October 15, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ruled that all federal lawsuits involving Cook IVC filters will be centralized in the Southern District of Indiana before District Judge Richard L. Young. All of the complaints involve similar allegations that manufacturing defects with Cook vena cava filters make the devices likely to fracture, migrate and puncture internal organs. Click here to learn more.
Do I Have an IVC Filter Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new IVC filter complications cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.