IVC Filter Injury
IVC filters (Inferior Vena Cava filters) are designed to be removable devices that are implanted in people to prevent blood clots from traveling to the heart or lungs. IVC filters are an alternative for people who can’t take blood thinners (anticoagulants) to prevent blood clots. The FDA issued a warning in 2010 that Inferior Vena Cava filters that are implanted in patients can move or splinter leading to punctured organs and blood vessels. Then, in 2015 the FDA issued a warning letter to C.R. Bard Inc. a leading manufacturer of IVC filters, for eight violations of federal law regarding its brand of IVC filters.
What are the Warnings Associated with IVC Filters?
The 2010 warning letter from the FDA came after hundreds of reports to the FDA of complications and adverse reports from the use of IVC filters. IVC filters are spider-shaped devices that are implanted in the vena-cava (the largest vein in the body). The function of the IVC filter is to trap blood clots before the clots get to the heart and lungs. The dangers of IVC filters are that the devices can malfunction and migrate or fracture while in use. IVC Filters have been blamed for 27 deaths and at least 300 other non-fatal medical problems.
IVC Filters may cause:
- Punctured heart and lungs
- Punctured blood vessels
- Hemorrhages in the lung
- Necrosis in the lungs
- Pulmonary embolism
IVC Filters Should Be Removed to Prevent Potential Health Risks
The FDA initially warned doctors of potential problems with all brands of IVC filters in 2010. Studies showed that the likelihood of parts fracturing and filter migration increased the longer the filter stayed in the body.
The Western Journal of Emergency Medicine published that 40% of all IVC filters will fracture within 5.5 years of implantation.
The Journal of Vascular and Interventional Radiology studied the Gunther Tulip and Celect IVC filters manufactured by Cook Medical and found that all of these filters perforated the vein wall within 71 days of implantation in 100% of the cases.
As the result of these studies and adverse reports, the FDA recommended that the IVC filters be removed after a clot dissipates, which is typically between 29 and 54 days.
While most IVC filters were designed to be removed, a JAMA (Journal of American Medical Association) study in 2013 followed the charts of 952 patients with retrievable IVC filters and found that doctors only removed 58 of the devices.
Additionally, there are reports that retrieval of IVC devices may not be feasible if the filters have migrated or fractured and perforated arteries or organs. In fact, the FDA cited Bard, Inc. for violations of federal law for not reporting unsuccessful retrieval procedures of its IVC filters.
Bard Inc. is the Subject of FDA Warnings and Product Liability Law Suits
The 2015 FDA letter to Bard, Inc. stated that Bard manufactured an unapproved IVC filter and did not accurately report complications associated with its Recovery IVC filters. Furthermore, lawsuits are emerging that claim that Bard actually knew the risks and concealed data of the dangers that their IVC filters posed as far back as 2003.
At that time, Bard hired an independent doctor, Dr. John Lehman to evaluate the IVC filters that it manufactured. Dr. Lehman found that the Bard Recovery filter models had higher relative risks of death, fracture and migration that all of its competitors. This internal confidential study was not released to the public, and Bard went on to sell more than 34,000 devices. The results of Lehman’s study only came to light when it was accidentally disclosed by Bard attorneys in a product liability lawsuit years later.
IVC Lawsuits in Kentucky
In response to the FDA warnings, a large scale study of 7 inferior vena cava filters made by seven different manufacturers (including Bard) began in early 2015. The Society of Interventional Radiology and the Society for Vascular Surgery are coordinating the five year study.
Clearly there is a need for more information on the safety of the IVC devices; however, Inferior Vena Cava Filters are still being utilized and may potentially cause major health concerns for past, current and future patients. If you feel that you or a loved one has suffered major health complications as the result of an IVC filter, you should contact a Kentucky attorney. Brett Oppenheimer is based in Louisville and will give you a free consultation on your potential claim.
Contact Brett by filling out the contact form on this page or call him at (502) 242-8877.