Medical studies of the past use of IVC Filters and any related side effects and risks have resulted in some basic guidelines for future use of these medical devices. There have been limited studies, and use is highly dependent on individual case conditions. The guidelines for use are different for each patient, but some generalities have been identified.
IVC Filters are a medical device designed to help trap blood clots and keep them from causing severe damage or death when those clots could lodge in organs like the heart and lungs. They are recommended for patients who cannot tolerate regular anticoagulant medicines like Warfarin or Heparin. Excessive bleeding can occur following surgery or trauma, or in other cases. Control of that bleeding is essential for protection of the patient. IVC Filters act like a tiny cage, much like a strainer, that removes clots that pass in the blood flow to major organs from lower extremities.
These devices have been used since 1969, when the Mobin-Uddin system was used to prevent pulmonary embolism. Some studies have been done for about 25 years, but with little concrete agreement among medical professionals other than the IVC Filters should only be used in high-risk patients, with caution. No differences in a 2-year mortality rate were seen between patients who received IVC Filters and those who did not. A general trend showed best success was found in patients who received the IVC Filter and who could also receive anticoagulants. Recent studies indicate that short-term use of retrievable IVC Filters has the best outcome.
Guidelines for Using IVC Filters
The Eastern Association for the Surgery of Trauma (EAST) and The American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) have both issued guidelines for use of IVC Filters. EAST cited a long list of indicators for use in DVT patients. ACCP guidelines are recommendations for IVC Filter placement.
These are general guidelines from the medical community:
- Use of IVC Filters as a routine prophylactic is not recommended for DVT patients who can tolerate anticoagulant medications.
- Use of IVC Filters is recommended for patients suffering from proximal DVT and who are unable to be anticoagulated. Once the bleeding risk is resolved, those patients should be anticoagulated.
- Use of temporary IVC Filters in patients with high risk of PE is possible when the risks of PE or contraindications to anticoagulants are less than two weeks in duration.
EAST recommendations include not using IVC Filters:
- If there is recurrent PE even when a full course of anticoagulant drugs is used
- When there is proximal DVT and the patient cannot utilize full anticoagulation
- When there is proximal DVT and the patient suffers major bleeding despite receiving anticoagulants
- When there is iliofemoral clotting and patient is using anticoagulants
- If there is a large thrombus in the iliac vein or IVC
- When there has been a massive PE and recurrent emboli may result in a fatality
- When the patient is undergoing or recovering from a surgical embolectomy
- Use in very high risk patients who cannot receive anticoagulant medications because it would cause risk of increased bleeding, or if the patient has one of more of these injuries: closed head, incomplete spinal cord injury with para or quadriplegia, complex fractures of pelvis or long-bone fractures
ACCP guidelines include these points:
- Not recommending use of vena cava filter with anticoagulants for patients with DVT
- Recommending placement of IVC Filter in patients who cannot take anticoagulant therapy because it would lead to bleeding
- When patients with acute DVT have had an IVC Filter inserted as an alternative to treatment with anticoagulants, those patients should later receive anticoagulant therapy if the bleeding risk is resolved
IVC Filter Lawsuits
Before the FDA issued warnings against risks associated with use of retrievable IVC Filters, many recipients were harmed. They filed lawsuits against several manufacturers, primarily C. R. Bard and Cook Medical. By 2014, the FDA updated that warning to state that the devices should be removed after a short time, 29 to 54 days following implantation. By 2012, plaintiffs who had suffered harm or the death of a loved one filed lawsuits, including class-actions in California, Pennsylvania, Indiana and, in 2015, in Arizona.
One case, settled by C.R. Bard, was filed by a man whose IVC filter broke, allowing one of the tiny metal legs to move into his heart, where it perforated the organ. He then had to endure open heart surgery and a long recovery from the event. Another case involved a woman who now must take blood thinners for her lifetime. Her G2 filter fractured and a part migrated to her heart. She takes blood thinners because she did not opt for open heart surgery to repair the damage. Two other cases also involved fragmentation and harm to heart and lungs.
A secret document revealed that Bard had received prior complaints about device malfunctions and that they failed to inform the public, keeping this knowledge within the company deliberately. It also was revealed that Bard’s application to the FDA for clearance of the device contained a forged signature.
IVC Filter lawsuits charge the manufacturers with failure to warn the public, negligence in product design, manufacture and misrepresentation. Damage claims include pain and suffering, disability, disfigurement, emotional trauma, loss of normal lifestyle, loss of consortium, lost wages and other problems that harmed those persons.
IVC Filter Attorney
When you are harmed or a loved one dies because a company was negligent, failed to warn users of potential dangers or deliberately hid facts that should have been disclosed to the consumer, there are legal remedies to pursue. You deserve fair compensation for the damage claims, economic and non-economic related to your injuries or the death of a loved one. If you or a loved one experienced harm due to use of an IVC Filter, contact an experienced Personal Injury Attorney who has experience with IVC Filter Lawsuits. This is your best resource to guide you through the legal processes involved in seeking fair compensation through an individual or class-action lawsuit. Start now with a free consultation with our Personal Injury Attorney. Call today and move forward again with legal satisfaction.