The FDA issued its warning on the dangers against long-term IVC Filter use in 2010. Soon after the alert was issued revealing the dangers of these defective medical devices, a decrease in the use of IVC Filters was recorded. However, this proved to be too little, too late for some patients already implanted with the defective medical device.
Before the safety alert was finally issued by the FDA, IVC Filter placement was rising almost 10% annually according to the National Inpatient Sample (NIS). This means that thousands of patients were implanted with the IVC Filter without being warned of the potential dangers these long-term IVC Filters have on the body. Thousands of patients implanted with the IVC Filter have filed lawsuits claiming several injuries that were caused by the Filter including perforation of the vena cava, migration of the Filter and fracturing of the Filter within the body to name a few.
According to the NIS data, after the FDA issued its warning in 2010, IVC Filter placement rates decreased to an average of approximately 7% annually. However, geographical location seems to play a role in where we are seeing this decrease of placement occur today. After the FDA advisory in 2010, it has been reported that in the United States, the South still places about twice as many Filters as the West. The biggest decline of IVC Filter placement has been recorded in the Northeast since the 2010 FDA alert was issued.
Although the 2010 FDA warning has helped to bring awareness to the dangers of the IVC Filter and led to a decrease in placement in some geographical areas across the United States, those who still have the Filter implanted are subject to the dangers these defective medical devices bring. The injuries associated with the IVC Filter make it increasingly difficult for surgeons to remove these devices. In some cases, the Filters become tilted causing the hook to be embedded into the vena caval wall, making it nearly impossible to remove without increased risk to the patient. If an IVC Filter is unable to be removed, these defective medical devices can cause multiple complications including internal bleeding, cardiac tamponade, vein perforation, organ damage and in some cases death.