- Study Suggests IVC Filter Use Offers No Benefit to Trauma Patients
- February 6, 2017 | Author: Peter G. Angelos
- Law Firm: Law Offices of Peter G. Angelos A Professional Corporation - Baltimore Office
- A Journal of the American Medical Association study released in September, 2016, suggests that IVC filters do not provide benefits to trauma patients.
Physicians began using inferior vena cava (IVC) filters as an alternative preventative treatment for patients who could not take blood thinners. The devices are intended to temporarily to block dangerous blood clots-known as pulmonary embolisms-from reaching a patient’s lungs. Throughout the past year, however, various reports have suggested that the filters may pose substantial risks to patients’ health, and can cause fatal complications.
In September, the Journal of the American Medical Association released a study that assessed the benefits of using IVC filters in patients who have suffered severe traumatic injuries. IVC filters are intended to provide temporary filtration of blood through the vein by catching clots before they can reach a patient’s lungs. The research notes that such patients face increased risks of bleeding complications and thrombosis-a condition for which IVC filters are intended. Thus, the use of the device for trauma patients in hospitals has increased. However, data collected through this retrospective study also suggests that IVC filters do not in fact provide additional benefits to trauma patients.
Additionally, when a patient is no longer considered to be “at risk” for pulmonary embolisms, the IVC filter is meant to be removed. Despite this, filters are often left in place for extended periods of time, increasing the risk for device migration, perforation of organs and other potentially fatal complications. Conclusions presented in the September JAMA study correspond with this assertion, indicating that IVC filter removal rates are low and that trauma patients who are implanted with the device have an increased risk of morbidity.
Multiple lawsuits have been filed against IVC manufacturers C.R. Bard and Cook Medical. Patients and their attorneys are alleging that the manufacturers failed to warn them and their physicians of the risks related to the device, and that the device was designed irresponsibly, causing avoidable complications. The lawsuits also claim that the manufacturers were negligent in the representation of the device. These claims stem from information that C.R. Bard received complaints of device fractures and defects a year after the introduction of the Recovery filter. The manufacturer then failed to disclose this information to the public and the FDA, disclosing the reports only to employees with the intention of keeping the information secret.