An inferior vena cava (IVC) filter is a tiny device implanted by doctors to “catch” migrating blood clots that have broken away from an arterial wall. The filters, which are implanted in the inferior vena cava, were designed to prevent life-threatening pulmonary embolisms (PE) – blood clots in the lungs.
Faulty IVC filters have been linked to a number of dangerous conditions including perforation of the inferior vena cava, heart or lungs, filter fracture, filter migration, chest pain, cardiac tamponade (compression of the heart caused by excess fluid), hemorrhagic pericardia effusion (excess fluid around the heart), lower-limb deep vein thrombosis (DVT), or filter embolization. The “spokes” of defective IVC filters have been known to break off inside the patient, and the fragments can cause many of the side-effects listed above.
The device has also been seen to shift or migrate, causing it to be ineffective or cause further damage to internal organs. While retrievable IVC filters were designed and marketed to physicians to be able to be safely removed after their use is no longer required, removal of these devices has shown to be risky for a number of reasons, such as the device becoming embedded or migrating to an abnormal position. Leaving an IVC filter in the body after it had performed its job has led to other serious medical issues.
The most often implanted IVC filters are manufactured by C.R. Bard and Cook Group, Inc. and include:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Celect
- The Cook Gunther Tulip
Other IVC filters manufacturers include: Boston Scientific, ALN Implants Chirurgicaux, Argon Medical Devices, Inc., Rex Medical, B. Braun Interventional Systems Inc., Cordis Corporation and Volcano Corporation.
After receiving a number of complaints about the Bard Recovery filter, C.R. Bard conducted an internal study about the dangers of the IVC filter in 2004. Through this study, C.R. Bard discovered that the struts or legs of the device are prone to break loose and travel to other parts of the body and potentially cause serious injury. Although C.R. Bard knew this information about the dangers of the IVC filter, the company did not inform the FDA or pull the dangerous device from the market.
In 2010, after receiving hundreds of complaints, the FDA released a report analyzing 900 adverse reports regarding IVC filters. These reports included: 70 filter perforations, 328 device migrations; 56 filter fractures; and 146 embolizations, where the components of the device became detached.
One study published in 2012 in Cardiovascular Interventional Radiology found that 100% of Cook Group, Inc. filters perforated the study participant’s venal wall within 71 days of implantation.
In 2013, the Journal of the American Medical Association published a study that looked at the indication, complication and management of IVC filters in 952 patients. Approximately 680 retrievable IVC filters were placed in patients, 608 patients didn’t have the filters removed. Approximately, 58 patients had their filters successfully removed.
Out of the remaining 13 patients where removal of the device was unsuccessful, the study results revealed:
- 8 patients couldn’t have their filters removed because the devices were embedded
- 3 patients couldn’t have their filters removed because the filters projected of the blood vessel
- 2 patients couldn’t have their filters removed because the devices migrated to an abnormal position
- 1 patient had a blood clot located inside the filter
In the 13 unsuccessful removals, 11 patients had their filters for more than 85 days.
The FDA issued a safety bulletin in 2014 stating that the ideal window for device removal was from 29 to 54 days after implantation. That being said, based on the study conducted by the Journal of American Medical Association, removal of the device has proven to be problematic.
Various lawsuits about IVC filters claim negligence, failure to warn, design defects, manufacturing defects, breached of implied warranty and negligent misrepresentation on the part of Bard and subsidiary companies.
In February 2015, C.R. Bard settled the case of Kevin Philips 10 days after trial began. According to his lawsuit, the IVC filter broke inside his body and one of the small metal legs traveled to his heart, perforating it. The tear from the device resulted in Mr. Philips having open heart surgery and an extremely long recovery.
If you or a loved one has suffered an injury from the implantation of an IVC filter to prevent pulmonary embolisms, or have had a IVC filter implanted that is now unable to be removed the defective product attorneys associated with Jacoby & Meyers will review the facts of your case to determine whether you have a valid claim.
Please contact the Jacoby & Meyers defective products attorneys today to schedule your free confidential consultation.