Blood clot filters are supposed to help save lives. They are commonly used on patients who are unable to tolerate blood-thinning medications.
However, NBC News recently conducted an investigation into one U.S. Food and Drug Administration (FDA)-approved device: The Recovery blood clot filter by C.R. Bard, Inc. The news organization found the device to be associated with at least 27 deaths and more than 300 cases involving complications.
One woman, who had the Recovery by Bard filter implanted following a motor vehicle accident, barely escaped with her life, according to NBC. Fortunately, doctors were able to save her in time by finding and removing a sharp piece of the blood clot filter that had broken off and pierced her heart.
Even more shocking is the follow-up report from NBC News, investigating allegations that Bard may have obtained its FDA approval for the Recovery device by forging a specialist’s signature – even after she alerted the company that clinical trials had raised red flags.
Although not all blood clot filters may be dangerous, this particular blood clot filter may be posing a serious risk to the thousands of people who already had the device implanted following an accident or for treatment of a blood clot.
If you or a loved one has experienced complications from a Recovery by Bard blood clot filter, or someone you love is being told they need this device, here is what you need to know:
What Is a Blood Clot Filter?
A blood clot filter is a small, cage-like metal device. It is often implanted as a way to prevent potentially life-threatening blood clots from traveling into a person’s lungs. The device can be implanted permanently to address a long-term risk or temporarily to capture blood clots that may develop following a traumatic accident or surgery. Those with a pulmonary embolus or who have been diagnosed with deep vein thrombosis (DVT) may also require the use of a blood clot filter.
How Do IVC Filters Work?
To get the IVC filter into a person’s inferior vena cava vein (the largest vein in the body), doctors will generally use a catheter that has been placed through a small incision point in the neck or groin area. Once implanted, IVC filters work to capture individual blood clots and prevent these clots from traveling through to the heart and lungs, causing serious complications or death.
What Are the Dangers of Blood Clot Filters?
For patients who run the risk of developing blood clots, or who are recovering from injuries sustained in an accident or following surgery, a properly functioning IVC filter can often mean the difference between life and death.
However, blood clot filters do present risks. According to a FDA safety alert, they can lead to life-threatening problems when the following occurs:
- Device migration – A blood clot filter device may move through the vein and away from where it was originally placed. Migration can cause internal damage and lead to death. Out of the 921 adverse event reports that the FDA received regarding IVC filters between 2005 and 2010, 328 involved device migration.
- Filter perforation – When a filter is perforated or torn, blood clots might be able to make their way through the vena cava vein into the lungs or heart. If this were to happen, it would likely be a life-threatening event. The FDA received 70 reports over a five-year period of time in cases of filter perforation.
- Filter fracture – Filter fracture also poses a substantial risk, as such an event could cause the filter to burst or break thus allowing blood clots to travel to the heart or lungs. In total, the FDA received 56 adverse reports regarding filter fracture.
- Detached device component – If a blood clot filter breaks, it could result in a detached device component making its way along the vein and into the heart or lungs, causing a significant amount of damage along the way. If not discovered or removed in time, a detached device component could be fatal. The FDA received 146 reports regarding device embolization between 2005 and 2010.
FDA Alert and Warning Letters
In recent years, the FDA has issued additional alerts and warning letters to make medical practitioners aware of the potential risks blood clot filters may pose. The general public also needs to be aware of these risks as it is you and your loved ones and friends who may be at risk.
According to the FDA, physicians and clinicians are being advised to remove retrievable IVC filters as soon as a patient is healthy enough to do so and once the benefits of removal outweigh the risks. This way, the potential for serious complications can be dramatically reduced.
Any failure by doctors to follow recommended guidelines, or cease the continued use of dangerous IVC filters could put countless lives at risk. Make sure that you and your loved ones know the risks and discuss these risks with your doctor.
If you or someone you love has already experienced complications or a life-threatening emergency caused by an IVC blood clot filter, it is imperative you seek counsel with a skilled personal injury lawyer right away.
To protect your rights, you need to find out the legal options available to you. Contact the defective medical device attorneys of Salvi, Schostok & Pritchard P.C., today to get information about your case and to learn how we can help you to seek justice and compensation.
Sources / More Information:
- Medical Device to Stop Blood Clots Associated With 27 Fatalities, NBC News
- Did Forged Signature Clear Way for Dangerous Blood-Clot Filter? NBC News
- Inferior Vena Cava Filter Placement and Removal, RadiologyInfo.org
- Removing Retrievable Inferior Vena Cana Filters: Initial Communication, U.S. Food and Drug Administration (FDA)
- Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, FDA
