IVC filters are small devices implanted in the inferior vena cava to prevent blood clots from traveling to the lungs. They are often used in patients with high risk of pulmonary embolism. Once the danger has passed, removal of the filter becomes crucial. The FDA’s recent findings have warned about extended implications and complications surrounding these devices. Following numerous guidelines changes and added safety concerns, there has been a significant decline in implementation rates.[i]
In the year 2000, IVC filters began to gain popularity due to their effective results They reached their peak by 2010. However, after the FDA published its first safety concerns in 2010 to healthcare providers and patients, the number of implementations started to decline. Over time the number of placements decreased from 132,049 in 2009 to 95,735 in 2014 and the rate continued to drop.[ii]
Risks Identified by the FDA That Have Contributed to the Decrease in Implantation
The health dangers associated with IVC filters are a serious matter for healthcare providers to discuss with patients. Numerous studies have shown various risks, which often increase over time. These include:
Filter Fracture: IVC filters can fracture overtime releasing fragments into the bloodstream and causing damage. This includes perforation of the IVC blood vessel wall, which can penetrate the spine, muscle and other organs. Additionally, there can be difficulties in removing the filter if it becomes embedded in tissue over time.
Migration Risk: There have been reports of IVC filters migrating from their original implantation placement to the renal veins, which can cause serious injuries due to the shift in position. The tilting of filter can prevent it from functioning as intended and migration. There is also an increased risk of deep venous thrombosis (DVT) and penetration can render the IVC filter unremovable.
Long term complication: Patients with long term IVC filters often experience various health issues and may require additional treatment.[iii]
Healthcare Providers Must Try to Prevent Serious Filter Failure Injuries: What Patients Should Consider
- IVC removal when the need has passed.
- Regular monitoring of symptoms and follow ups for patients with implanted IVC filters.
- Staying informed with the new research and recommendation to explore choices in treatment options.
IVC Filter Injuries: Legal Considerations
Primarily medical evaluation, care, and treatment are of utmost importance. If a serious injury has occurred, you can consult with an attorney to see if there is a legal claim. Each state has strict time limits for filing a lawsuit, which may begin when you first become aware of the filter having a problem, even if you did not know the type of filter or if the doctor did not recommend removal. Understanding the liability of manufacturers negligent and gathering documentation such as medical records, consent related evidence and others can help strengthen a case. These matters can be discussed confidentially and at no cost with a lawyer experienced in IVC filter litigation.
[i] https://www.tctmd.com/news/inferior-vena-cava-filter-use-fell-after-fda-warning-remains-high
[ii] https://evtoday.com/news/fda-issues-statement-on-treatment-and-follow-up-regarding-ivc-filter-complications
[iii] https://www.jvsvenous.org/article/S2213-333X(18)30242-7/fulltext
