Significantly high failure rates are being reported for Bard IVC filters, according to allegations that have been filed in Bard IVC lawsuits over the safety of these small, cone-shaped filters that are implanted in patients to block blood clots.
A huge number of incidents in which the “legs” on the filter snap off and drift though the victims’ bodies, cause serious health problems that include perforated veins, hearts and lungs, among other serious conditions are being documented.
The U.S. Food and Drug Administration describes IVC filters as small, cage-like devices that are inserted into the inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective. Read more on the Bard IVC Filter recall
Some patients may require long-term protection from PE, and implantation of permanent IVC filters is often performed in these cases. Others only require short-term protection, in which case retrievable IVC filters are typically used, as these devices have the option to be removed once the patient’s risk of PE subsides.
Concerns increasing about IVC safety
The FDA has been increasingly concerned about the safety of these medical devices and now acknowledges receiving more than 900 reports of adverse events with inferior vena cava (IVC) filters. The agency also issued a warning to health care professionals emphasizing that the devices should be removed as soon as it is safely possible.
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for pulmonary embolism [PE] subsides,” according to the FDA’s August 9, 2010 safety report. “Known long-term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis [DVT], filter fracture, filter migration, filter embolization, and IVC perforation.”
These life-threatening side effects are the same as have been alleged in Bard IVC Filter lawsuits that have been filed in state and federal courts across the countries by IVC filter lawsuits on behalf of these victims.
“FDA recommends 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 PE is no longer needed,” states the MedWatch report.
Independent research confirms dangers
In addition to the FDA warning, independent researchers are concluding that there are serious health risks associated with the use of IVC filters. According to the findings of a research study published in the Archives of Internal Medicine the Bard G2 IVC filter fracture rate was occurring in as many as 12 percent of patients. The published findings also warned that that the longer a patient had a filter in his or her body, the more susceptible they were to having a filter fracture and suffering internal damage.
“It is essential that patients and their treating physicians be educated about this previously underrecognized and potentially life-threatening complication of these devices,” according to Dr. William Nicholson and other scientists who compiled the research. “Armed with this knowledge, educated patients can be alert to the presence of pleuritic chest pain and other symptoms that should prompt immediate evaluation. Such early awareness and evaluation could certainly be life-saving. In addition, the propensity for filter fragmentation may be directly related to the duration of implantation. Patients and their physicians should be educated about this fact so that they have the opportunity to consider having the device removed.”