Dr. William Kuo, the head radiologist at the IVC Filter Clinic at Stanford University, perhaps put it best when he said (in an interview with NBC), “I think that data speaks for itself – [the IVC Filter] was never safe to be implanted…. We can no longer rely on medical device companies to do what’s in the best interest of patients.”
In September of 2015, Sokolove Law blogged about a 2-part NBC special that focused on medical device giant C.R. Bard’s defective Inferior Vena Cava (IVC) Filters. At the time, C.R. Bard’s defective IVC filter, “The Recovery” – a small medical device designed to prevent blood clots from reaching the heart and lungs – was associated with at least 27 deaths in the U.S.
Though the New Jersey-based medical device corporation, worth an estimated $14 Billion, created a second, “more-effective” replacement device that would remedy the first version’s problems, the Recovery’s replacements – the G2 Series, including the G2 Express – were found to be similarly as problematic, and are now associated with at least 12 additional deaths. The G2 data was not available at the time of NBC’s special report, and, unfortunately, the death and injury toll is now only expected to grow, as more than 250,000 new IVC filters are inserted into patients every year.
C.R. Bard IVC Filters Might Be More Deadly Than Other Blood-Clot Filters
In theory, the idea of a blood-clot filter that can be inserted into one’s inferior vena cava – the largest vein in the human body – sounds potentially life-saving, especially for those who have certain genetic disorders or are at high risk for pulmonary embolism (blood clot in the lungs). The IVC filter, a small wire trap, which is shaped like a long-legged spider, is surgically implanted into the vein and used to physically impede blood clots from migrating up towards one’s heart and lungs. While such a filter may sound great in theory, in reality, the IVC filters – especially those manufactured by C.R. Bard – have proven themselves to be unsafe.
Dr. Kuo spoke with NBC’s Stephanie Gosk, saying that he sees more problems with Bard IVC filters in particular than with any other brand – and he’s thus made the decision to stop using the company’s blood-clot filters altogether. Kuo said: "All of the data that we've seen in our own studies, as well as other clinician researchers', is that this device consistently fractures, consistently causes major complications.” Fracturing of the device isn’t the only danger – others include:
- Involuntary device migration
- Inadvertent “tilting” of the device within the inferior vena cava
- Broken device fragments being sent toward one’s heart or lungs
- Piercing of one’s inferior vena cava vein
- Inadvertent “embedding” of the device inside one’s vein, making removal of the device impossible
IVC Filters May Cause Irreparable Damage to Patients
NBC’s year-long investigation into C.R. Bard’s company files turned up evidence that the medical giant knew its device had potentially fatal flaws. NBC’s investigation also unearthed confidential company documents showing that the company was also aware their Recovery filter had higher rates of relative risk of death, filter fracture, and movement than every single one if its competitors.
Instead of issuing a recall on the defective filter, Bard continued to sell the Recovery until they could replace it with the modified version. Still, even when the updated version of the filter – the G2 – was approved for use by the FDA, Bard did not remove the old, defective version of the filter from its product line; instead, they kept selling it.
Worse still, when the G2 was available for use, it, too, caused similar problems, and patient and doctor complaints continued to amount. In spite of these reported issues, which included patient deaths, Bard continued to market and sell the device to doctors for an additional 5 years, until 2010. During that time span, C.R. Bard sold over 160,000 IVC Filters at over an estimated $37,000 per filter.
Facing 39 Deaths & Hundreds of Injuries, Company Still Claims Products Are “Safe”
According to FDA records, 12 deaths have been associated with C.R. Bard’s G2 filter, and hundreds of serious medical problems have also been linked to the device.
Though C.R. Bard has declined interviews with many news agencies, it stated in a letter to NBC that “all medical devices carry some risk” – a blanket statement which is thought to include their own IVC filters. In a separate statement, Bard commented that their filters are “an important clinical option for physicians.” This, in spite of the hundreds of documented problems, the data showing internal knowledge of the high risk for failure, and the collective 39 associated deaths with their Recovery filter and their G2 Series filters.
C.R. Bard’s statement further commented that their company “steadfastly believes in safety and efficacy of these [IVC Filter] devices.”
Such a bold claim, written in a dismissive letter to NBC News, remains to be seen, and in the meantime, until the company lives up to its standards of “safety” and “efficacy,” hundreds of American patients will continue to be harmed by these devices.