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The medical field is full of uncertainties, but when it comes to medications and medical devices, physicians and product manufacturers are responsible for disclosing any known risks or complications to the patient. Unfortunately, in the case of IVC filters made by C.R. Bard, Inc. and Cook Group, Inc., patients were unaware of the life-threatening problems associated with their medical device.
Colling Gilbert Wright & Carter represents patients who have suffered complications due to a Bard or Cook medical IVC filter. If you or someone you know has had problems with an implanted IVC filter, please contact our defective medical device lawyers in Orlando today at (855) 880-4741 to schedule your FREE case evaluation.
What is an IVC Filter?
The Inferior Vena Cava (IVC) is the major vein responsible for moving blood from your lower body to your heart. An IVC filter is a wire device that is placed into the IVC vein in patients thought to be at an increased risk for pulmonary embolism. The IVC filter is used to prevent blood clots from reaching the brain, heart or lungs. The filter stops blood clots in the bloodstream, which allows them to degrade over time.
When used on the right patient, an IVC filter can significantly reduce the risk of pulmonary embolism. However, the FDA (Food and Drug Administration) now recommends that the device only be used temporarily in patients who haven’t responded to anticoagulant medication or who aren’t eligible to take anticoagulants due to another medical issue or condition. Additionally, the FDA recommends that patients who already have an IVC filter speak with their doctor to discuss whether the medical device should be removed.
The FDA hasn’t issued a recall for the defective medical product, but they have compiled a guide to help patients and physicians better understand when an IVC filter is necessary and when it poses a greater risk than benefit.
What Are the Potential Complications & Symptoms of a Defective IVC Filter?
The biggest and most serious risk associated with IVC filters is the device’s potential to break apart and send metal pieces through the body, which could lead to organ damage. These medical devices have also been known to migrate away from their targeted area. IVC filter complications can actually lead to a pulmonary embolism as well as stroke, hemorrhage and death.
The most common IVC filter issues are:
- Filter fracturing
- IVC penetration
- IVC filter occlusion
- Filter migration
- Filter embolization
If you have an IVC filter and are experiencing these symptoms, you need to seek medical attention immediately:
- Neck pain
- Chest pain
- Internal bleeding
- Shortness of breath
Defective IVC Filter Lawsuits
There have been many product liability lawsuits filed against the Bard and Cook companies, especially after the FDA issued their decision analysis report. Bard, specifically, neglected to disclose their findings that the filters carried many dangers and forged an employee’s signature to gain FDA approval.
IVC filter lawsuits involve, but are not limited to, these medical devices:
- The Bard G2 Filter
- The Bard G2 Express Filter
- The Bard Recovery Filter
- The Cook Gunther Tulip Filter
- The Cook Celect Filter
- Bard Eclipse
- Bard Meridian
- Bard Denali
When it comes to defective IVC filter lawsuits, the FDA’s guidelines offer a few options for our lawyers to investigate to determine whether you have a valid claim and who is responsible for your injuries.
Medical Negligence & IVC Filter Placement
One of the outlets our lawyers can use to establish if you have a defective medical device claim is by determining whether or not the IVC filter was needed to begin with. The FDA outlines the appropriate use for IVC filters and doesn’t condone any off-label uses.
An IVC filter should only be used in patients who have a risk of pulmonary embolism and are not able to take conventional treatments such as anticoagulant medication. If you have an IVC filter and didn’t exhibit a risk or history of pulmonary embolism, then you may have a medical negligence claim.
According to the FDA, an IVC filter should be placed when:
- The patient has had a “massive pulmonary embolism” and emergency treatment is needed and other treatment methods offer lower benefits.
- Anticoagulant therapy has failed for thromboembolic disease.
- Anticoagulant therapy has failed to treat chronic or recurrent pulmonary embolism.
- Anticoagulant therapy is contraindicated.
IVC Filter Failure & Faulty Manufacturing
The greatest risk for IVC filter patients is device failure. IVC filters are supposed to prevent life-threatening blood clots from reaching vital parts of the body, but these devices have been known to fail, move or break much more often than is normal or acceptable. If the device broke apart or failed to perform the way it was supposed to, then you likely have a defective manufacturing claim.
Failure to Remove IVC Filters
IVC filters should be removed once the risk of pulmonary embolism has decreased. The FDA recommends that this happen between 29 and 54 days after the filter is implanted. Before the defect of the IVC filters was established, physicians typically left them in place, but once the risk has been reduced, your doctor should weigh the consequences of leaving the filter against the risk of removing it.
Filing Your Defective Medical Device Claim
The outcome of your defective medical device claim and subsequent settlement heavily depends on speaking with an experienced attorney as soon as possible. Our lawyers in Orlando will investigate all aspects of your case and will have our medical experts review your records. We have decades of experience in medical malpractice and defective product cases such as the IVC filters. We will fight for you to receive the highest amount of compensation you’re owed for your pain and suffering.
If you or a family member has suffered complications from an IVC filter, please contact Colling Gilbert Wright & Carter in Orlando today at (855) 880-4741 to discuss your defective medical device claim. Our lawyers serve clients throughout Florida and nationwide.