In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:
- Filter fracturing of the device
- Migration of the pieces
- Embolization of fractured device or device components
- Tearing of the inferior vena cava vein.
According to one of the many product liability cases filed against IVC Filter manufacturers:
“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”
The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).
IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.
In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.