By | 2018-09-07

A retrievable inferior vena cava filter may be implanted in a person at risk for developing blood clots, which can be serious and life-threatening. This treatment is considered a good option for those that have experienced recurring blood clotting problems in spite of taking blood-thinning medication. It is also prescribed for patients that can’t take anticoagulants due to medical reasons. In August 2010, the United States FDA reported that there has been a marked increase in the use of these medical devices. In 1979, about 2,000 filters were implanted and by 2007 that number had risen to almost 167,000. The inferior vena cava (IVC) carries blood from the lower part of the body back towards the heart. Some individuals are at risk of blood clots, which can start moving towards to the lungs; his condition known as PE (pulmonary embolism). For these patients, temporary IVC filters might be the recommended alternative to blood thinners/anticoagulant medicines. This is especially if the patient can’t take anticoagulants or clots continue forming even after he/she has been put on a blood thinner. FDA safety communication In May 2014, the United States Food Drug Administration issued an official safety communication to doctors that implant IVC filters on the care for patients that have these implants. They advised that once doctors have determined that the patient is no longer at risk for pulmonary embolism, they should consider removing the devices. As per the quantitative decision analysis that the agency conducted, the risk/benefit profile favors removal of the implant29-54 days post the implant surgery. Greenfield filter complications The agency released this communication because they had received a large number of adverse event reports which mention various complications of this filter such as: Migration of the filter Filter fracture Perforation of the implant Embolization (movement of filter fracture fragments/entire filter to the heart/lungs) Difficulty removing the filter The Food Drug Administration determined that the various adverse events described in the reports probably wouldn’t have occurred if the devices had been removed sooner. They ordered filter manufacturers to assimilate some additional data regarding use of Greenfield IVC filters, to get a much clearer picture on the safety profile of these devices. The filter misbranding issue Aside from all these Greenfield filter complication reports that led to the FDA’s directive, the agency also warmed against IVC filter misbranding. In the past the agency has been keeping a close eye on companies manufacturing these devices. C.R. Bard, Inc. had been sent a warning letter for misbranding& adulterating its Model RC-15 -Recovery Cone Removal System, intended for use with its G2X Filter, Recovery G2 Filter and Recovery Filter. Many patients affected by these implants went on to file lawsuits against the manufacturers and distributors of the filters. Today, there are thousands of cases pending in courts across the country with petitioners hoping that they will get justice and the compensation they rightfully deserve. If you have suffered any of the complications mentioned above, you may want to consider getting legal help and file a lawsuit against the manufacturer.