Blood Clot Filter Problems Plagued Bard for Years, Confidential Docs Show
Medical device manufacturer C.R. Bard has been in the spotlight lately regarding blood clot filter problems associated with 27 deaths and hundreds of reports of problems from patients implanted with the device.
The devices in question – the Recovery filter and the G2 series filters — are spider-shaped blood clot filters implanted into the body’s largest vein called the inferior vena cava (IVC). They are designed to trap blood clots before they travel to the heart and lungs, where they can cause fatal problems.
The FDA approved IVC filters to treat the following medical conditions:
- Chronic pulmonary embolisms when use of an anticoagulant failed
- Emergency treatment after a massive pulmonary embolism
- Thromboembolic diseases in which anticoagulant therapy failed
- Pulmonary embolism
However, soon after Bard received FDA clearance to put the devices on the market, reports of blood clot filter problems started to climb. These problems included fracture and movement of the device, leading to dozens of deaths.
Patient Reports Detail Blood Clot Filter Problems
Bard is one of 11 manufacturers that make IVC blood clot filters, which are implanted in an estimated 250,000 people in the United States each year.
Their first-generation filter, the Recovery, was introduced in 2002 and the second-generation G2 filter was introduced in 2005.
A confidential study commissioned by Bard and obtained by MSNBC News showed that the Recovery filter had a higher risk for filter fracture, movement and death compared to other filters on the market. Yet Bard did not recall the device.
Instead, Bard replaced it with a similar blood clot filter known as the “G2 series” three years after it put the Recovery filter on the market. Like its predecessor, the G2 series garnered hundreds of reports to the FDA of similar blood clot filter problems.
MSNBC News also obtained a confidential memo written by a Bard vice president in 2005 that shows his concern about hundreds of reports of the G2 filter tilting, migrating and perforating. The memo noted that Bard had another blood clot filter on the market that had virtually no complaints and asked why doctors were not using that one “rather than the G2.”
Data through 2010 shows the G2 series filters had more fractures, migrations and reported blood clot filter problems than any of its competitors – just like the Recovery filter had.
The FDA received more than 900 reports of serious blood clot filter problems associated with these devices between 2005 and 2010, including:
- Filter fracture
- Device migration
- Detached device components
- Filter perforation
Some physicians now believe the filters were never safe to be implanted in the first place.
Although the IVC filters maintain a history of many adverse event reports and concerns shared by physicians, patients now want to know why the company kept the G2 filters on the market for so long when concerns and injuries were indicated much earlier. Blood clot filter problems can cause death if not captured quickly.
IVC Filter Lawsuits
Dozens of medical device injury lawsuits have been filed by victims of IVC filter problems. Plaintiffs accuse device manufacturers, including Bard, of placing dangerous medical devices on the market and failing to warn consumers and physicians about the risks.
If you were injured by an IVC filter or have a loved one who died from IVC filter problems, you may be entitled to compensation. Obtain a free legal review of your claims by filling out the form on this page now. If you have a viable case, you will be contacted by the IVC filter attorneys at Bradley/Grombacher for a free, no-obligation consultation.