Bard IVC Filters
Bard Retrievable IVC Filter May Lead To Perforation, Migration, and Pulmonary Embolus
Retrievable IVC Filters, including the C.R. Bard's (unit of Johnson & Johnson) Recovery IVC Filter and C.R. Bard’s G2 IVC Filter System, have reportedly been fracturing and migrating inside of patients, leading to serious injuries, including perforation of the interior vena cava (IVC). A fractured IVC filter can also perforate other organs, including the heart and lungs. When a retrievable IVC filter fractures and migrates, patients can experience severe pain, bleeding, further embolus, and other life-threatening complications.
The defective medical device lawyers at Parker Waichman LLP are investigating potential lawsuit claims stemming from IVC filter injuries. While C.R. Bard’s Recovery IVC Filter and G2 IVC Filter appear to have the highest injury rates, other devices have been associated with similar complications.
IVC filters being investigated by Parker Waichman LLP:
- B Braun Tempofilter IVC filter (retrievable)
- Bard G2x IVC (retrievable, unlimited indwell time)
- Bard G2 (retrievable)
- Cook Günther Tulip (retrievable)
- Cook Celect (retrievable)
- Cordis OptEase IVC filter (retrievable, 23 day indwell time)
- ALN IVC filter (retrievable)
- Rex Medical Option IVC filter (retrievable)
Parker Waichman is offering free lawsuit evaluations to victims of IVC filter injuries, including those caused by C.R. Bard's Recovery IVC Filter and G2 IVC Filter System. If you or a loved one suffered an injury due to the fracturing and
migration of an IVC Filter, it is vital that you contact Parker Waichman LLP today to protect your legal rights.
About Bard's Recovery IVC Filters & G2 IVC
IVC filters are placed in the inferior vena cava of individuals who have deep vein thrombosis in their legs to prevent blood clots that break off from traveling to the heart, lungs and brain. There are two types of filters: permanent and retrievable (meaning the filter is removed once the risk of emboli resolves). While most IVC filters currently on the market are permanent, the retrievable models appear to be associated with the most complications.
Both C.R. Bard's Recovery IVC Filter and G2 IVC Filter System were approved for sale via the U.S. Food & Drug Administration's (FDA) 510(k) protocols. This type of approval allows for clearance of a device without human clinical trials if a device maker can prove it is substantially equivalent to another product already approved for sale and on the market.
C. R. Bard removed the Recovery IVC from the market in 2005, but it is believed that there are still devices implanted in people. The G2, which was the replacement for the Recovery, is still being used.
Retrievable IVC filters have been associated with reports of fracturing and migration. Most often, the fractured portions of the device migrate to the heart and lungs of its victim. However, fragments of IVC filters can also migrate to other organs. Once the metal fragments from a retrievable IVC filter have deposited in the heart, lungs or another organ, grave injury, bleeding, severe pain, further embolus and other complications can occur.
In August 2010, the FDA issued an advisory, after it had received 921 adverse event reports involving IVC Filters. The reports to the agency including:
- Filter Migration (328 reports)
- Embolization (146 reports)
- IVC Peforations (70 reports)
- Filter Fracture (56 reports)
The FDA said in its alert that such complications could be related to a retrievable filter remaining in the body for long periods of time, well after the danger to the patient had subsided. The FDA recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from a blood clot is no longer needed.
Bard IVC Filters Side Effects May Lead
To Pulmonary Embolus Lawsuits
Bard's Recovery IVC Filter and G2 IVC Filter System have been associated with serious injuries and even deaths.
The injuries caused by failure of the Bard Recovery IVC Filter and G2 IVC Filter System have already sparked lawsuits around the country. If you or a loved one has been injured by one of these defective medical devices, our Bard IVC Filter System injury lawyers want to hear from you today.
Bard Recovery IVC Filter and G2 IVC Filter System lawsuits allege that these devices were defective and caused life threatening injuries to the plaintiffs. Such lawsuits seek damages for medical bills, lost wages and pain and suffering.
If you were injured by one of these devices, you may also be eligible for such compensation.
Our Bard IVC Filter System injury lawyers are offering free case evaluations to victims of the Recovery IVC Filter and G2 IVC Filter System. If you or a loved one sustained such an injury, it is vital that you contact one of our Bard IVC Filter System injury lawyers today to protect your legal rights.
Bard Recovery IVC Filter and G2 IVC Filter System Injuries
IVC filters, also known as inferior vena cava filters, are medical devices that are implanted in the inferior vena cava vein in order to filter blood clots that travel from the lower portions of the body to the heart and lungs. These clots are called deep vein thrombosis, or DVT. If they travel to the lungs, they can form a life threatening pulmonary embolism. IVC filters were initially marketed to remain in the body for a finite period of time and therefore marketed as retrievable.
The Recovery IVC Filter and G2 IVC Filter System are manufactured and marketed by C.R. Bard and Bard Peripheral Vascular, Inc. The Recovery IVC Filter was approved by the U.S. Food & Drug Administration (FDA) in 2003. It was marketed as a retrievable device, but safe for permanent placement within the body.
Unfortunately, the Recovery IVC Filter proved troublesome from the start, as several studies published in medical journals pointed to a high failure rate for the device.
According to these studies, the Recovery IVC Filter systems were prone to fracture and migration. Most often, these fractured portions of the device migrate to the heart and lungs of its victim; however, they can migrate to other organs.
Once the metal pieces have deposited in an organ, grave injury, bleeding, severe pain, further embolus and other complications can occur.
One study, published in the Journal of Vascular and Interventional Radiology in November 2008, found the rate of fracturing and migration with the Recover IVC filter concerning. To conduct the study, all patients who received a Bard Recovery filter at a single institution were contacted for consultation and evaluation by noncontrast computed tomography. Fourteen of 16 patients with Bard Recovery filters were evaluated. Final images demonstrated filter arm perforations in all 14 patients, and there were a total of four fractures with migration in 21% of patients.
The Recovery IVC Filter was ultimately pulled from the market in 2005. It was replaced by the G2 IVC Filter system, which was modified to reduce filter fracture and migration. Unfortunately, studies have shown that the G2 IVC Filter system is also prone to fracturing and migration.
Once the Recovery IVC Filter or G2 IVC Filter system is found to have failed, patients must undergo surgery to remove the device, as well as the broken pieces. However, in some cases, it may be too dangerous to remove the fractured components due to the risk of further injury and/or death.
Warning Signs and Complications of IVC Filter Failure
Warning signs that a Recovery IVC Filter or G2 IVC Filter System has failed include chest pain and shortness of breath. In most cases, victims end up in the emergency room. A CT scan or other test will be used to determine if the IVC filter system has failed.
The failure of the Recovery IVC Filter or G2 IVC Filter System can lead to serious and life-threatening complications.
- Constant severe pain in the heart, chest or elsewhere
- Pulmonary embolus
- Respiratory compromise
- Perforation of tissue, vessels and organs
- Constant anxiety or worry over the fact that metal shards are in the organs
| Legal Help for Victims of Bard IVC Filter System Injuries
Our Bard IVC Filter System injury lawyers know how awful complications from a fractured Recovery IVC Filter or G2 IVC Filter System can be. We will do everything legally possible to make sure the victims of these defective devices are fully compensated for their injuries.
If you or a loved one were injured as a result of a defective Recovery IVC Filter or G2 IVC Filter System, you have valuable legal rights. Please fill out our online form, or call1-800-YOURLAWYER (1-800-968-7529)to discuss your case with a qualified Bard IVC Filter System injury lawyer.