What are IVC Filters?
Inferior vena cava filters (IVC filters) are small, metal devices designed to stop a blood clot from traveling to the lungs. The device resembles a metal cage and is surgically inserted into a patient’s vein. Most patients take blood thinners to stop blood clots, but doctors use IVCs on patients who can’t use blood thinners.
Complications with Retrievable IVC Filters
Retrievable filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device. Serious complications can occur because of the implanted filters, like when a device breaks apart and travels to another area of the body.
In 2010, the U.S. Food and Drug Administration announced a safety alert regarding retrievable IVC filters. The FDA received 921 reports of adverse events from 2005-10. Events involved:
- Device migration
- Filter perforation
- Filter fracture
- Detached device components (called device embolization)
A majority of the adverse events (35 percent) involved device migration. Migration occurs when filters move away from their intended location. The FDA listed embolization as the second most frequently reported complication.
NBC News has also reported on this issue:
January 4, 2016: Confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration.
But instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them.
At least 12 deaths and hundreds of problems are now linked to the G2 series filters, according to Bard and FDA records.
VC Filters Prone to Failure
Studies revealed five retrievable IVC filters prone to failure:
- Bard’s Recovery
- Bard’s G2
- Bard’s G2 Express
- Cook’s Gunther Tulip
- Cook’s Celect
IVC Filter Side Effects
- Perforation of the vena cava, heart, or lungs
- Filter migration
- Chest pain
- Hemorrhagic pericardial effusion (excess fluid around the heart)
- Cardiac tamponade (compression of the heart caused by excess fluid around the heart)
- Lower-limb Deep Vein Thrombosis (DVT)
- Filter embolization
IVC Lawsuits in New Jersey
Patients who suffered complications from Bard and Cook’s IVC filters filed lawsuits against the manufacturers. The plaintiffs allege the filters migrated and broke apart causing organ damage and other complications. Our NJ medical malpractice attorneys can assist you with your claim. Please call our office today at 732-324-7600 for a free case evaluation.