Cook IVC Filter Problems
In 2010, the FDA released a safety communication warning consumers and the medical community about adverse health risks associated with IVC filters. According to the alert, the FDA received 921 adverse event reports involving IVC filters between 2005 and 2010, of which four percent involved fatalities. The other adverse events cited in the FDA communication:
- 328 involved migration of the device or a part of the device to another part of the body.
- 146 involved embolization.
- 70 involved perforation.
- 56 involved filter fracture.
The FDA safety communication noted that patients could be experiencing these problems because the IVC filters they received remained implanted beyond the safe use of the device. In some cases, patients still had IVC filters in place long after the risk for pulmonary embolism (PE) had subsided.
According to the FDA, the 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 alert further advised doctors to remove IVC filters from patients as soon as possible once the risk of PE had passed.
In 2014, the FDA released another communication pertaining to IVC filters, which stated that the agency examined all publicly available data from the medical literature in order to “assess whether there is a time during which the risk of having an IVC filter in place is expected to outweigh the benefits.”
The communication suggested that IVC filters should be removed between 29 and 54 days after they have been implanted. The agency further stated that all IVC manufacturers, including Cook Medical, would be required to collect additional clinical data to address some unanswered questions about the safety of IVC filters.
Reported Cook IVC Filter Complications
- Damage to the heart, lungs or vena cava
- Internal bleeding
- Filter fracture
- Ventricle tachycardia (lower chambers of the heart beat very quickly)
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Nerve Injury
- Cardiac tamponade (compression of the heart caused by fluid collected in the sac surrounding the heart)
Cook Medical IVC Filter Studies
Journal of Vascular and Interventional Radiology (2015)– Researchers compared the Cook Celect IVC Filter with the Rex Medical Option IVC Filter. A total of 99 Celect IVC Filters and 86 Rex Medical Option IVC Filters were implanted in patients who were observed over a 33-month span.
Celect IVC Filters were found to be far more likely to cause perforation (43 percent perforation rate) when compared to the Rex Medical Option IVC Filter.
Journal of Vascular and Interventional Radiology (2009)– Researchers reviewed charts of 115 patients who received a Cook Medical Celect IVC Filter between 2005 and 2007. The study found that doctors had trouble retrieving the filters, because they occasionally became embedded in the vena cava wall.
How to File a Cook IVC Filter Lawsuit
If you or a loved one was implanted with a Cook Gunther Tulip IVC Filter or a Cook Celect IVC Filter, you may be able to recover damages by filing a Cook IVC filter lawsuit. Cook Medical owed a duty of care to patients and physicians to make sure that their IVC filters were safe and effective for use before putting them on the market. According to hundreds of plaintiffs from across the country, Cook Medical failed to warn consumers about the dangerous adverse effects associated with their IVC filters.
The law firm of Baum Hedlund Aristei & Goldman is representing individuals who received a Cook IVC Filter, believing the device to be safe and effective. Our IVC filter attorneys can discuss your legal options with you, and help you to decide the best course of action for you and your family.