Retrievable Inferior Vena Cava (IVC) Filters are commonly used to prevent blood clots from reaching the lungs. These filters are usually placed for clotting conditions that occur for a short time. When the danger passes, the filters can be removed. Removal is important because the IVC filter legs can weaken and fracture over time, leading to life-threatening injuries. You can consult with your doctor about this.
The FDA Issued Safety Communications About Removing Retrievable IVC Filters
The FDA has issued key communications on Inferior Vena Cava filters in 2010 and 2014, urging physicians to remove retrievable filters as soon as the risk for pulmonary embolism subsides due to reported complications like fracture, migration, and perforation, even leading to death. [ii] These warnings emphasized that extended implantation increases risks due to metal fatigue of the IVC filter legs. The FDA determined that the IVC removal may be appropriate with after 29 to 54 days.
Key FDA Communications & Recommendations:
- 2010 Safety Communication: Noted adverse events (921 reports in 5 years) including device migration, fracture, and thrombosis.
- 2014 Safety Communication Update: Reinforced the 2010 warning, urging clinicians to consider removing filters when no longer needed.
- Mandatory Data Collection: The 2014 communication also required manufacturers to gather more clinical data, leading to studies like the PRESERVE registry.
What Dangers Are Reported in Independent Medical Studies?
The health dangers of IVC filters are a serious matter for healthcare providers to discuss with patients. There are multiple studies showing various risks, and these often increase over time.
These include:
- Filter fracture or migration
- Perforation of the IVC blood vessel wall, which can penetrate into the spine, musles and other organs
- Embolization of device components
- Increased risk of deep venous thrombosis (DVT)
- Tilting of the filter
- Migration to the renal veins
- Penetration and migration that renders the IVC filter unremovable
- Difficulty removing the filter if it becomes embedded in tissue over time
What Many Healthcare Providers Are Doing to Prevent Serious Filter Failure Injuries
- IVC removal when the need has passed.
- Maintain follow‑up care for implanted patients.
- Make patient-by-patient decisions for the risks and benefits of using an IVC filter.
- A patient should be referred to an interventional radiologist for filter removal when the risk of clots has passed.
IVC Filter Injury Legal Claims
If a serious injury has occurred, you can consult with a defective medical device attorney, such as our experienced partner, David B. Rheingold, to see if there is a legal claim.
Time Considerations for Lawsuits
Each state has strict time limits as to when a suit may need to be filed. The time limit to start a suit may start when you were first aware of the filter having a problem, even if you did not know the type of filter and even if the doctor did not recommend removal. These are all things that can be discussed confidentially and without cost with a lawyer experienced in this IVC filter litigation.
Sources
[i] https://evtoday.com/news/fda-updates-safety-communication-on-ivc-filter-retrieval
[ii] https://www.tctmd.com/news/inferior-vena-cava-filter-use-fell-after-fda-warning-remains-high
[iii] https://www.jvsvenous.org/article/S2213-333X(18)30242-7/fulltext