The IVC (Interior Vena Cava) filter is intended to prevent blood clots from developing or migrating, however over the last ten years the devices have been associated with a number of serious medical complications. The history of the devices is short though fraught with problems.
In April 2003, C.R. Bard introduced the Recovery IVC filter and was quickly redesigned following several reports of device fractures. The device failures can cause severe medical issues, and may even lead to death.
In 2010, the U.S. Food and Drug Administration published a safety alert that recommended physicians “consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
Due to safety concerns, in 2012, the American College of Chest Physicians recommended that IVC filters should only be used in high risk patients who have contraindications for anticoagulants. Despite these warnings, many lower-risk patients have been implanted with the device.
Joe Lyon is a highly rated Ohio medical device attorney actively involved in product liability litigation nationwide.
In 2010, the FDA reported that over a five year period it had received over 900 adverse event reports related to IVC complications and injuries and released an advisory report.
There have been reports of the IVC filter falling out of place or breaking apart. The metal device, or pieces from it, can then move through the blood, working their way through a vein wall and damaging an internal organ. There are also reports of blood clots occurring at the location where the device was inserted—the same clotting that the device is supposed to prevent.
The most common device complications include:
• Filter migration (to chest, heart, right atrium, or pulmonary artery)
• Embolization (detachment of device components)
• Perforation of the IVC
• Filter fracture
There is a risk of the filters breaking, which may cause metal fragments to move through the blood, potentially causing serious medical issues, including:
• Pulmonary Embolism
• Hemorrhaging or Internal Bleeding
IVC filters are small, cage-like devices that are intended to capture blood clots and prevent them from reaching the lungs, heart or brain. The device catches the clots in the bloodstream and allows them to break down over time.
The filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when other anticoagulant therapy is ineffective. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.
Complications with the IVC device may present themselves with signs and symptoms that include the following:
• Chest pain
• Neck Pain
• Shortness of Breath
The decision to remove an implanted medical device is a serious medical decision and the risks and benefits of such a procedure must be discussed with the treating physician. Lawyers are not qualified to render advice on the appropriate candidacy for surgery, and it is important to know that the Society of Interventional Radiology (SIR) guidelines for removing an IVC Filter:
• No further medical reason for a permanent IVC Filter
• Patient is at a low risk for pulmonary embolus
• No expectation of the patient being at a high risk in the near future
• Life expectancy of more than six months
• Ability to retrieve the IVC Filter
C.R. Bard and Cook are the two manufacturers that control the vast majority of the IVC filter market. The products most often associated with the IVC filter failures include:
• Bard Recovery
• Bard G2
• Bard Eclipse
• Bard G2 Express
• Bard Merdian
• Bard Denali
• Cook Gunther Tulip
• Cook Celect
Plaintiff attorneys have argued in court that the manufacturer C.R. Bard intentionally hid results of its own research which discovered the filters were potentially dangerous. Some cases even allege the company forged an employee’s signature on an FDA application in order to get faster approval.
Records claim that C.R. Bard was concerned about reports of failures for its G2 series filters within four months after the FDA approved the sale of the G2. Instead of recalling the G2 filter, Bard decided to keep them on the market for the next five years, selling more than 160,000 units.
At least 12 deaths are linked to the G2 series filters, according to Bard and FDA records.
There are more IVC Filter lawsuits being filed every month in the U.S. The overall increase in IVC failure cases may be due to the increased sale of these devices. One estimate reports that the IVC filter market may be over $70 million in 2016.
If you or a loved one suffered an injury due to a defective IVC Filter, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.