What is an IVC Filter?
An Inferior Vena Cava filter (IVC filter) is a tiny medical device that is implanted into the large vein which returns blood from the body to the heart. This vein is also known as the Vena Cava. The IVC filter is intended to “catch” any blood clots that may break away from arteries or veins before they travel through the heart to the lungs and become a deadly pulmonary embolism. The IVC filter is used in patients who are at risk of pulmonary embolism due to deep vein thrombosis (DVT) or other clotting disorder.
Normally, patients who have DVT or another clotting disorder are given anticoagulant medication, but some patients cannot take anticoagulants and were implanted with IVC devices to catch blood clots that may form. Devices currently in use were designed to be temporary and are designated “retrievable” IVC devices which should be removed after danger of a blood clot complication has passed.
Though IVC devices were designed as retrievable devices, intended to be temporary and removed after a short period of time, many were left in place. The device has been shown to cause multiple complications while in place and removal has proven to be difficult, potentially exposing the patient to additional harm.
C.R. Bard is facing hundreds of lawsuits by plaintiffs who claim that its Recovery IVC filter and G2-IVC filter caused medical injury. This is not Bard’s first experience with lawsuits as they have faced thousands of legal claims regarding harm caused by transvaginal mesh and other medical devices.
Bard Recovery IVC Filter and G2 IVC Filter
Bard, formerly called C.R. Bard, is a New Jersey-based medical device manufacturer with an estimated annual revenue of about $3 billion. Bard manufacturers a number of medical devices including urological, surgical, and gynecological products and is one of the largest manufacturers of IVC filters. Two of Bard’s most popular products include the Recovery and G2 IVC filters.
About IVC Filters
The Inferior Vena Cava is the largest vein in the human body. It is the pathway that “used” blood travels from the body to the right side of the heart where it is pumped to the lungs to be re-oxygenated. From the lungs it returns to the left side of the heart where it is pumped again to provide oxygen and nutrients to body tissues.
People with certain medical conditions such as deep vein thrombosis (DVT) and other clotting disorders may develop blood clots which can break off and travel to the lungs. A blood clot that travels to the lungs is known as a pulmonary embolism and may result in near-immediate death.
Most patients with DVT and related clotting disorders will be given anticoagulant medication but not all patients may tolerate this medicine. IVC filters were designed to be implanted into the Inferior Vena Cava in these patients, to catch any blood clots which may have formed and are loose in the blood.
The IVC filter is a very small “basket” or “cage” made of metal which catches any blood clot and retains it until the body’s natural systems break it down. The first IVC filters were “permanent” devices and were intended to be left in place. When devices such as the Recovery IVC filter were approved, they were initially approved for permanent placement and later approved as “retrievable”, intended for removal after the danger of DVT or clot has passed.
Unfortunately, though currently marketed IVC filters are intended to be removed, retrieval may be difficult, and many are left in place. The devices may shift in place, perforate venous tissue, break apart or detach from the original placement.
Recovery and G2 IVC Filter Side Effects and Adverse Events
The Bard Recovery filter and Bard G2 filter have been named as two retrievable IVC filters that are prone to failure. The Recovery filter was the first-generation filter, introduced in 2003. The second generation or G2 was introduced in 2005, intended to replace the Recovery device.
Between 2005 and 2010, the FDA received 921 reports of serious adverse events involving IVC filters including reports of:
- Device migration or movement to another area
- Detached device components which travel to other organs (called device embolization)
- Filter perforation
- Filter fracture
Device migration was the most common adverse event and was responsible for 36 percent of adverse event reports with device embolization as the second most frequent. The FDA issued an advisory in 2010 stating that complications could be caused by retrievable filters which remained in place for too long. The FDA recommended that implants be removed as soon as the danger of blood clot had passed.
Bard IVC Filter Complication Study
A 2010 study published in Journal for the American Medical Association (JAMA) Internal Medicine showed that about one-fourth of Bard G2 filters failed with device fracture or breakages. The study reported the death of one patient though the cause of death was not specified.
A 2012 research study published in the CardioVascular Interventional Radiology journal indicated retrievable IVC filters manufactured by other companies also failed. Two devices, the Gunther Tulip and Cook Select were shown to have a high rate of Vena Cava wall puncture within 71 days of placement and showed a 40 percent migration rate.
Even though the retrievable IVC filter devices should be removed after risk of pulmonary embolism has passed, a 2013 study showed that less than 9 percent of devices were actually removed.
The same study identified other issues including:
- 18.3 percent failure rate in device removal attempts
- 7.8 percent venous thrombosis event, 25 percent of which were pulmonary embolism, the exact medical condition the devices were intended to prevent.
Because of these complications, in May 2014, the FDA advised that retrievable IVC filters should be removed within 29 to 54 days after implantation.
Because of the risk of device migration, fracture, and detachment, IVC filters may also cause serious side effects including:
- Perforation of blood vessels, tissues, and other organs
- Internal bleeding or hemorrhage
- Severe pain
- Additional blood clots
- Pulmonary embolism
- Cardiac Tamponade
FDA IVC Filter Warnings
Many of the IVC filters on the market were approved via the FDA’s shortcut approval process known as 501(k). This allows medical products similar to those already on the market to be approved for sale without the usual tests required for new products.
In response to the numerous reports, the FDA issued an advisory warning in 2010 to doctors. The warning alerted doctors to the fact these retrievable devices should be removed and if left in place too long, would cause serious complications.
Medical studies confirmed the danger and showed a high failure rate for Bard’s Recovery and G2 filters. Data showed complications that included:
- Venous wall puncture
- Venous thrombosis
- Pulmonary embolism
- Device removal failure
According to one of the studies, only nine percent of the retrievable devices had been removed – leaving 91 percent of IVC filter recipients at risk.
In 2014, the FDA issued an updated warning about IVC filter. The warning called for doctors to remove retrievable IVC devices within 29 to 54 days of implantation.
Patients who are left with devices beyond the encouraged removal date are at risk for:
- Severe pain
- Blood clots
- Hemorrhaging due to perforation
- Pulmonary embolism
- Heart failure
IVC Filter Lawsuits
Medical device manufacturer, Bard is facing several hundred lawsuits regarding injury caused by the Recovery and G2 IVC filter devices. Plaintiffs allege that the company knew the devices were prone to fracture and migration but failed to warn the public and the medical community. Bard has tried unsuccessfully to have several of the lawsuits dismissed.
Injuries cited in IVC Filter lawsuits include blood clots, pulmonary embolism, heart failure, hemorrhage and death that occurred after receiving a Bard Recovery of B2 IVC filter.
As a result of the problems with IVC filters many users have filed lawsuits against Bard. The first case to go to trial settled in 2015 after just 10 days of litigation. The plaintiff in the case was forced to undergo open heart surgery following device embolism that perforated his heart.
Additional lawsuits included claims of:
- Device fracture and migration to the renal vein
- Device embolism in the heart
- Devices migration to the pulmonary artery
- Device migration that triggered cardiac tamponade
- Vena cava puncture from device migration
According to information listed in the complaints, Bard began receiving complaints in 2014 and knew there were issues with the IVC filters but chose not to disclose the reports to the FDA or the medical community.
As a result of Bard’s negligence and their experience with a faulty medical device, IVC filter recipients may be eligible for compensation and should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.