The FDA issued several severe warnings about inferior vena cava filters. As a result, manufacturers recalled some IVC filters. Others face major IVC filter lawsuits. Our overview below explains vena cava filter uses, related injuries, and what affected patients can do.
IVC Filters: Intended Use
Thousands of patients receive surgically implanted retrievable IVC filters every year to fight blood clots. IVC filters catch potentially fatal blood clots and dissolve them over time. Doctors prescribe filters for three specific medical problems:
- Pulmonary embolism (PE)
- Recurring stroke risk (such as after a hip surgery)
- Blood thinners don’t work
The Risks of IVC Filters
Unfortunately, the risks are fairly high. The U.S. Food and Drug Administration (FDA) received thousands of adverse event reports. Reported negative side effects include punctured blood vessels, damaged organs, and migration throughout the patient’s body.
In 2010 alone, the FDA received over 900 adverse event reports from patients implanted with IVC filters. Reported injuries include:
- 328 device migrations (meaning the device traveled from the implantation side to another area, potentially damaging organs as well as other blood vessels)
- 146 embolisms (blood clots reached the lungs)
- 70 filter perforations (the device tore holes in patients’ veins)
- 56 filter fractures (the device broke apart in patients’ veins)
Specific IVC filters have been recalled because they do more harm than good, namely the Optease Retrievable Vena Cava Filter. This IVC filter was recalled because the product was designed poorly, and the label did not properly clarify which way the filter should be implanted, causing many to be inserted backwards. This mistake has caused extensive damage for thousands of individuals. The FDA has since encouraged those who have experienced adverse effects following an implanted IVC to report their experiences.
When Injuries Are Most Likely to Occur
Retrievable IVC filters grow more dangerous over time. They recommend in a statement issued to healthcare providers that many complications may be avoided if the filter is removed once the risk of pulmonary embolism has passed—a time frame of 29-54 days. However, due to negligence and faulty IVC filters, these warnings have not been entirely effective.
The FDA also recommends that physicians implanting IVC filters consider device removal concerns for each patient. While the device is potentially life-saving in specific cases, it can also do more harm than good. Physicians should consider the patient’s overall health in determining whether an IVC filter or anticoagulant is best.
How Filters Keep Hurting Patients
The FDA has warned repeatedly about potential IVC filter implantation dangers since 2010. But it was too late for patients already experiencing life-changing side effects.
If you or a loved one has experienced negative side effects regarding IVC filter implantation such as device migration, perforation, fractures, or other complications, you may be eligible for financial compensation. Take our free IVC filter claims review today to find out if you may have a case.