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IVC filters, medical devices intended to prevent recurring blood clots in patients with deep vein thrombosis and/or pulmonary embolism are linked to an excessively high failure and complication rate.
According to some estimates, more than 80% of so-called retrievable IVC filters, which were designed to be removed and not as a long term solution will either fail or will become impossible to remove if left in for more than approximately 30-45 days. Now an independent NBC investigation has revealed that one of the most commonly implanted IVC filters made by medical device giant Bard may have been approved as a result of a forged signature and internal documents from the company have revealed that they were aware that it was putting people’s lives at risks, yet continued to sell it until they could get the newer version to the market. Another device maker Cook, had a device, the Cook Celect that had a 43% perforation rate, which is astronomical when compared to the the older “permanent” models.
What is an IVC Filter?
An inferior vena cava (IVC) filter is a type of vascular filter device implanted in the inferior vena cava, or the large vein in the abdomen that carries blood from the lower part of the body to the heart. The filter is designed to trap fragments of blood clots that develop in the veins of the leg or pelvis, a condition called deep vein thrombosis (DVT), thereby preventing the clots from traveling through the vena cava vein to the heart and lungs and causing strokes and other severe complications. Until recently, only permanently implanted IVC filter devices were available for patients at risk for blood clots and pulmonary embolism, but now newer filters, called optionally retrievable filters, can be either left in place permanently or removed from the blood vessel at a later date.
Possible Side Effects of IVC Filters
Although IVC filters were designed to reduce the risk of life-threatening pulmonary embolism complications caused by blood clots traveling through the inferior vena cava and into the lungs, the medical devices may actually put patients at risk for side effects that are equally as devastating, if not more so. The complications allegedly associated with IVC filter devices include the following:
- Device fracture
- Device migration
- Injury to nearby organs
- Perforation of the inferior vena cava
- Inability to retrieve the device
- Build-up of clots in the filter
- Lower-limb deep vein thrombosis
- Build-up of fluid around the heart
Link Between IVC Filters and Serious Complications
In early 2004, IVC filter maker C.R. Bard began receiving complaints of its devices fracturing, and components of the filter traveling to other parts of the body, possibly causing serious injury, a problem that the company had litigation consultant Dr. John Lehmann discreetly compile in a document that afterwards became known as the Lehmann report. The U.S. Food and Drug Administration (FDA) became aware of the alleged risk of IVC filter complications as early as 2005, though it wasn’t until 2010 that the agency finally issued a safety announcement warning that the filters pose a risk of device fracture, device migration and organ perforation, and should be removed as soon as the patient’s blood clot risk subsides.
At the time of the FDA warning, the agency indicated that it had received more than 900 reports of adverse events associated with IVC filters, including 56 instances of filter fracture, 70 instances of filter perforation, 146 instances of filter embolization, and 328 instances of device migration. Product liability lawsuits began cropping up in courts across the country, filed on behalf of consumers who believed they had been harmed by IVC filter side effects, and in December 2012, as part of a lawsuit involving the G2 inferior vena cava filter, C.R. Bard accidentally disclosed the Lehmann report along with 11 other documents during the discovery process. Prior to this, the Lehmann report was only distributed to a small number of Bard employees who needed the document to do their jobs.
Contact our experienced IVC Filter legal team today
More and more former recipients of IVC filters are coming forward with complaints of serious injuries from the implants, and consumers across the country are filing legal claims against the makers of the allegedly defective medical devices, citing poor design and manufacturing as the reasons for their injuries. If you received an IVC filter implant in the past, and you have since suffered complications like device fracture, device migration, or injury to nearby organs, consult an experienced IVC filter attorney like Ford and Associates Nationwide Legal Services as soon as possible to discuss your legal options. With a qualified product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your losses.