Inferior Vena Cava (IVC) Filters
What Are IVC Filters?
Inferior vena cava filters are small, multipronged nets that are surgically inserted into the inferior vena cava, one of the body’s major veins. The inferior vena cava is responsible for returning blood from the lower body to the heart. IVC filters are designed to catch dangerous blood clots before the clots cause Deep Vein Thrombosis or Pulmonary Emboli.
Who Uses IVC Filters?
IVC Filters are often implanted into patients who are unable to take prescription blood thinners (anticoagulants) or who are recovering from surgery.
What Makes Them Dangerous?
According to multiple medical studies, a surprising number of IVC Filters are defective. Published studies report that as many as 40% of IVC Filters will fail less than five years following implantation.
The types of IVC filter failures include:
- Migration: the filter travels to the pulmonary arteries or within the heart.
- Fracture: a piece of the device breaks off and may migrate.
- Perforation: the device punctures the heart, intestines, ureters, or other internal organ(s).
Who Makes IVC Filters?
The market for IVC Filters is crowded with medical device manufacturers. The two largest are C.R. Bard (manufacturer of the Recovery, G2, G2X, and Eclipse) and Cook Medical (manufacturer of the Tulip and Celect).
What Does The Food & Drug Administration (FDA) Say About IVC Filters?
The FDA has expressed concerns about IVC filters for years. In 2010, the agency sent a warning letter to advising doctors to remove the filter as soon as active blood clots prevention was no longer medically necessary. In 2014, the FDA updated its guidelines; it recommended that doctors remove an IVC Filter within 29-54 days of implantation, after which the potential risks outweigh the benefits.
In 2015, the FDA warned C.R. Bard after discovering multiple violations including marketing devices that had yet to be approved by the FDA and misclassifying data. Shockingly, C.R. Bard had classified a device-related death as a “malfunction” rather than an injury, as required by law.
Were you injured as a result of an IVC filter failure? If so, you may have a claim for damages. Contact Oxner + Permar for a free consultation.