IVC Filter Background:
Inferior vena cava (IVC) filters are small, cage-like medical devices that are positioned into a large vein in the abdomen to help prevent blood clot particles from traveling to the heart and lungs. Generally, it’s implanted only in individuals who are unresponsive to, or cannot use, anticoagulation therapy.
There are two types of IVC filters: permanent and temporary. Permanent IVC filters are designed for patients with substantial, ongoing risk for deep venous thrombosis (DVT). The Food and Drug Administration (FDA), however, discovered that IVC filters are more effective if they are removed 29 – 54 days after insertion in most cases. Given this, manufacturers of IVC filters are bringing more temporary devices to market. .
While there are a large number of permanent IVC filter manufacturers, there is a small number of manufacturers producing temporary IVC filters, the two most prominent being Cook (Cook Medical LLC, William Cook Europe ApS, and Cook Incorporated – collectively known as “Cook”) and Bard (C.R. Bard, Inc and Bard Peripheral Vascular, Inc – collectively known as “Bard”).
IVC Filters Manufactured by Cook
Cook produces two types of temporary IVC filters known as the Günther Tulip vena cava filter and the Celect vena cava filter. While these filters are meant to be temporary, the removal of them can occasionally be difficult. In a recent study of patients who underwent placement of the filters, 26% of the filters could not be successfully removed. Removal of filters becomes difficult or too risky when they, for example, migrate, lodge in the wrong place, become embedded into the vein, or change position. Filters that are not removed can be associated with later medical complications.
Last year, a large number of lawsuits alleging that Cook created a defective design, misrepresented their products in marketing, and failed to warn patients / doctors the risks of Cook’s IVC filters were sent to a court in Indiana for discovery and pretrial proceedings.
IVC Filters Manufactured by Bard
Bard produces the G2 vena cava filter, the G2 X vena cava filter, and the Eclipse vena cava filter. These three products create a majority of the injuries resulting from an IVC filter. On August 9, 2010, the FDA issued an advisory to physicians that retrievable filters manufactured by Bard required immediate removal and reissued its advisory on May 6, 2014.
In a consumer alert dated July 13, 2015, the FDA noted that complaints of Bard IVC filters included detached filter limbs that punctured the heart or other organs. Additionally, complaints of the IVC filters produced by Bard included patients who were scheduled to remove an IVC filter and surgery failed to do so.
Other Manufactures and Temporary IVC Filters Include:
- Rex Medical’s Option retrievable vena cava filter
- Cordis OptEase retrievable vena cava filter
- ALN Implants Chirugicaux‘s ALN optional vena cava filter
Getting Legal Help
Despite the brevity of time within the body, retrievable IVC filters can create serious adverse events such as device movement, breaking apart within the inferior vena cava, relocation into or perforating organs, or removal failure.
If you have been harmed by an IVC filter, consulting an attorney who specializes in medical device malfunctions can help ensure that your legal rights are protected.