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Doctors recommend the inferior vena cava (IVC) filter when anti-coagulants aren’t effective in preventing blood clots from forming. What was introduced as a temporary solution, however, has transformed into a permanent implant resulting in hazardous long-term health complications.
NBC Nightly News shed light on the issue recently with a two-part investigation. The program found IVC filters, particularly the G2 design from C.R. Bard, are associated with 27 fatalities and have a high failure rate that increases with time. Patients implanted with this IVC filter have gone through near-death experiences, as it becomes loose, migrates through the body, and may puncture other organs, including the heart. While other competitors have similar temporary IVC filters on the market, the G2 has an especially high failure rate.
C.R. Bard introduced the G2 as a replacement for its Recovery filter in 2004. However, the company did not declare it a retrievable device until 2008.
IVC filters, in general, get placed inside the inferior vena cava to prevent blood clots from traveling to the lungs. While effective for a couple of months at a time, the device, especially the G2, eventually becomes worn out and begins to fail. When it does, it may fracture, migrate through the body, and lead to life-threatening complications. The vena cava, as a dynamic blood vessel, expands and contracts, which may cause the device to drift toward the heart.
While the first death occurred in 2004, the FDA did not release a warning until 2011. Up to 2010, the organization received 921 adverse reports: 328 concerning migration, 146 about embolization, 70 about perforation, and 56 about fractures. The warning further highlighted a study published in the Annals of Vascular Surgery. The research indicated C.R. Bard filters have a greater migration rate, which may lead to perforation of the vena cava, surrounding tissue, the intestines, spine, vertebrae, and the arteries.
Additional studies supported these initial findings. A 2012 study published in the Journal of Vascular Interventional Radiology found that, after five and a half years, 40 percent of patients may have experienced a filter fracture. The next year, a study in the Journal of the American Medical Association discovered these filters are left in the patient indefinitely.
In 2014, a study introduced at the Midwestern Vascular Surgical Society revealed that 46 percent of all patients experience an organ or tissue perforation issue related to the IVC filter; however, only 1.6 percent of all devices are retrieved, and removal is not always successful, with an 8.5-percent failure rate. The study examined 262 patients, who experienced a penetrated aorta, duodenum, spine, kidney, colon, or two organs.
That same year, the FDA issued another warning, this time stating IVC filters must be removed within one to two months after the risk of pulmonary embolism has passed. C.R. Bard and other manufacturers had not warned doctors about this risk.
When not removed, the IVC filter is associated with multiple health risks:
- Pulmonary embolism
- Severe chest pain
- Respiratory distress
- Tissue and organ perforation
- Vessel perforation
As of August 2015, 117 lawsuits were pending as a Multi-District Litigation (MDL) case. However, prior to that point, a judge awarded a partial summary judgment for C.R. Bard.
Plaintiffs allege the manufacturer introduced the product onto the market with a defective design and misrepresented its usage. Yet, when plaintiffs claimed Bard’s instructions were not sufficient, the judge dismissed the claims, stating they did not provide expert testimony and that this risk is inherent in all IVC filters.
On the other hand, the judge stated Bard failed to establish the device’s safety, as research showed; didn’t fully test it; and hasn’t proven whether the benefits when using it outweigh the risks.
As a result, plaintiffs continue to come forward with claims. If you or a loved one had been implanted with this device, only to find it fracture, bring your case to Trantolo & Trantolo. Our experienced product defect lawyers will examine and redirect your claim.