(PRWEB) December 02, 2012
Statistics released by the Food and Drug Administration show that the agency has received more than 900 of what are known as Adverse Event Reports about problems with inferior vena cava (IVC) filters.*
These filters – which appear to the layman as tiny, spider-shaped devices – when designed properly can perform a vital medical function. After being inserted into large blood veins they screen blood clots from moving through the blood stream to the heart or lungs and causing strokes and other serious health problems.
However, when the “legs” of these filters break off or snap they can wreak havoc as dangerous as the health problems they are designed to prevent. Tears or punctures of internal organs, pulmonary embolisms and deep vein thrombosis are among the problems cited by the FDA.
Resource4thePeople notes that some victims of these life-threatening conditions have filed lawsuits seeking compensation for the serious health problems they have suffered from these devices and one of the products named in these lawsuits is the Bard IVC Filter.
One such lawsuit was recently filed in California** and includes statistics about thousands of patients who have had the devices implanted in their bodies.
The complaint against Bard claims that the company concealed from patients the dangers of these devices failing. This concealment, according to the allegations, put patients “at significant risk that the filters will fail and/or fracture, which may lead to death, hemorrhage, cardiac/pericardial tamponade, severe and persistent pain and perforation of tissue, vessels and organs.”
Resource4thePeople provides referrals to Bard IVC Filter lawyers who are offering free consultations for patients who have had IVC implants and suffered these problems.
As with most legal cases, there may be legal deadlines for filing such a lawsuit so it is recommended that such victims act as soon as possible to preserve all legal options to obtain compensation for medical expenses, pain and suffering, loss of wages and other expenses.
In its Aug. 9, 2010 MedWatch warning about the increasing number of Adverse Event Reports about IVC filters, the FDA reminded physicians that after these devices are implanted they should be removed as soon as possible in the interest of patient safety.
"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," the agency said in the 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."
The FDA provided additional details about the evolving problems being reported in connection with the filters:
Summary of Problem and Scope:
“IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012 (Smouse and Johar, Endovascular Today, February 2010).
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. 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.”
The FDA described its health warning as an “initial communication in keeping with FDA’s commitment to inform the public about emerging device safety issues.”
Agency officials said they are continuing to review the safety of IVC filters and will issue further information when the analysis of available data is complete.
“As part of developing our final position, FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time,” the FDA said in its release.
“More information about FDA’s decision analysis model including risk/benefit implantation time frame suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.”
A review of one of the Adverse Event Reports sent to the FDA is contained in an Aug. 25, 2011 report*** in which a health care professional reported an incident involving a Bard G2 IVC Filter.
In that report, a Tempe, Arizona, patient required intervention hospitalization for removal of a filter that had been implanted in 2008 after which one of the arms of the device fractured.
** Los Angeles Superior Court Case No. BC4900200