Bard IVC Filter Class Action Lawsuit
The Bard IVC (inferior vena cava) Filter is used when anticoagulation drugs have little effect in protecting patients who have a venous thromboembolic disease or in prophylactic use for patients with a high risk of pulmonary embolism.
These filters can help prevent blood clots from moving through the body by acting a type of trap for a pre-determined size of blood clot.
The Bard IVC Filter is one of many types and brands on the market today, but it is the Bard type that is of current focus.
IVC filters are inserted into large blood veins sometimes surgically or through the use of a catheter.
FDA Warns Physicians About Concerns Over Serious Health Risks Linked to IVC Filters
The U.S. Food and Drug Administration has become concerned enough about health risks from the use of Inferior Vena Cava (IVC) filters to issue a health warning to consumers and physicians about them.
Among the filters that the FDA has received numerous Adverse Event Reports from patients and physicians are the Bard IVC Filters. Resource4thePeople’s national network of attorneys is investigating claims from victims who may have suffered serious side effects from these devices.
Please contact us as soon as possible for a free consultation about the legal options that you or a loved one may have to seek compensation for medical costs, lost wages, pain and suffering or other expenses caused by these devices.
Here is the warning issued by the FDA about the devices:
Inferior Vena Cava (IVC) Filters
Initial Communication: Risk of Adverse Events with Long Term Use
Audience: Emergency Medicine, Surgery
ISSUE: Since 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 pulmonary embolism (PE) has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.
RECOMMENDATION: 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.
FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
REPORTS OF HIGH FAILURE RATES FOR BARD IVC FILTERS
Significantly high failure rates are being reported for Bard IVC filters, according to allegations that have been filed in Bard IVC lawsuits over the safety of these small, cone-shaped filters that are implanted in patients to block blood clots.
A huge number of incidents in which the "legs" on the filter snap off and drift though the victims' bodies, cause serious health problems that include perforated veins, hearts and lungs, among other serious conditions are being documented.
Some patients may require long-term protection from PE, and implantation of permanent IVC filters is often performed in these cases. Others only require short-term protection, in which case retrievable IVC filters are typically used, as these devices have the option to be removed once the patient's risk of PE subsides.Many of these IVC filters are permanently installed, while a few brands are called retrievable.
- Types of Injuries from a Bard IVC Filter:
- Breaking parts
- Tearing or punctures of internal arteries and or organs
- Pulmonary Embolus
- Pain in the chest area
Both Bard IVC Filters are of the retrievable type, and on average were removed after being in the body for a couple weeks. If they are in place longer some may become overgrown by cells from the IVC wall and there is an increased risk of IVC injury if the filter is dislodged.
There have been reported cases of injuries from the use of both Bard IVC Filter types.
- Bard G2 IVC
- Bard Recovery IVC filter. (no longer being sold)
Because of the possibility of the Bard Recovery IVC filter parts breaking off and moving through the body (at times requiring open heart surgery) there may be a potential class action lawsuit associated with these Bard Recovery IVC filter injuries.
IVC filters fail at alarming rates
The major issue with these small, cone-shaped filters designed to block blood clots is that, according to allegations contained in Bard IVC Filter lawsuits, they have an alarmingly high rate of failure. When that occurs the legs on the filter snap off and wander through the body. This can cause a myriad of problems, including perforated veins, hearts and lungs, among other serious conditions.
If you or someone you know has been hurt or suffered any injuries from the Bard IVC Filters, please contact us for a free case review.