FDA IVC Filter Safety Warnings
The first official use of an IVC filter dates back to 1967, but the devices didn’t gain popularity until many years later. In 2003 and 2004, the FDA approved removable version of the IVC filter, also known as a permanent IVC filter with the option to retrieve.
With this new device, patients had the option to keep the IVC in until their risk of blood clots and pulmonary embolism had subsided. The new permanent IVC filter with the option to retrieve became widely used, and now, an estimated 200,000 IVC filters are implanted each year.
How IVC Filters Work
Unfortunately, these devices can also cause great harm. IVC filters are made out of a kind of metal alloy. The tiny “cages” feature several wires in a spindly shape and are outfitted with a hook so they can be removed.
The filter is intended to significantly lower the risk of blood clots. Unfortunately, there have been many cases where the IVC filter’s metal components deteriorate and break apart. As well as other cases where the filter migrates or the legs puncture the walls of the IVC. When this happens, pieces can dislodge and travel to other parts of the body, puncture veins and organs, or both. The FDA became aware of these problems early on and began issuing warnings to manufacturers.
FDA Study in 2010
In 2010, the FDA released a study originally published in the Archives of Internal Medicine. The study suggested that approximately half of all IVC filter implants were unnecessary. Out of all the patients who received IVC filters to treat acute vein thrombosis, one quarter of them did not actually need the filter. Furthermore, they found that patients with IVC filters had nearly double the in-hospital mortality rate than those without filters. In light of the study results, they pressed for more studies.
FDA Issues Warning Later in 2010
Later in that same year, the FDA announced the results of more than 921 adverse effect reports that had been filed on IVC filters. The report found that of the events:
- 328 were cases of filter migration.
- 146 were of device embolization (detachment of device components).
- 70 were of the device perforating the vena cava wall.
- 56 were reports of fractured filters.
With this information, the FDA urged manufacturers to warn consumers of the risks.
FDA Publishes Results of 8 Year Review in 2011
In 2011, the FDA got to review the 8-year study that had been initiated in 2003. The study examined 952 patients with IVC filters, both permanent and retrievable. Of the 679 patients with retrievable filters, the study found that only 8.5% of them were successfully removed. In 18.4% of cases, a retrieval attempt was made, but was unsuccessful. Furthermore, 25 pulmonary embolisms occurred in patients with the filters.
Warning is Reissued in 2014 With Stricter Timeline
In 2014, the FDA reiterated their statement from 2010, noting that retrievable IVC devices are significantly more likely to perforate, fracture or migrate when left in for long periods of time. This time, they suggested a concrete timeline, stating that the device should be removed within 29-54 days of implantation if the patient’s transient risk of pulmonary embolism has passed.
Numerous Lawsuits Against IVC Filter Manufacturers
Despite multiple reports and warnings from the FDA, manufacturers continued to market, manufacture and sell these devices as optionally removable. Consequently, there are now numerous lawsuits against the manufacturers for releasing defective devices. Martin, Harding & Mazzotti, LLP is an experienced personal injury law firm concentrating in defective device law. Contact us today.