Have you or someone you know had an IVC filter implanted some time ago and are curious about whether or not it’s still safe? These devices were initially approved for the long term, but research shows that if it’s been seven months or longer since original implantation, you could face risks upon removal.
Medical Studies Show Dangers of Long-Term IVC Filter Complications
Plenty of studies and adverse event reports filed with the FDA indicate the high risk of IVC filter complications which a patient may only discover after the device has been implanted. However, new research indicates that the longer the period that the patient has had it installed, the greater the risk of severe adverse events and complications.
In one recent study of IVC filter complications, seven months or more inside the patient’s body was associated with the necessity for advanced retrieval tactics. Food and Drug Administration recommendations in the United States state that IVC filters should be removed when the patient no longer needs it.
Research showing that the longer IVC filters are left in the human body the higher the chance of complications, including retrieval. Many patients have come forward with claims of serious pain and migration issues after receiving an IVC filter. These IVC filter complications have led to numerous removal surgeries, each of which presents its own risks of further complications.
Forty percent of retrieval attempts fail for filters implanted for seven months or longer. Additionally, a referral for an advanced retrieval may be required for any patient who has had the device for longer than that seven months.
These devices were originally approved as permanent implant inside the patient’s body; however, in 2010 the FDA issued a safety notice after receiving numerous reports of serious events including lower limb deep vein thrombosis, IVC occlusion, embolization, device migration and filter fracture. At that time, the agency recommended the device be removed from any patient who has the device and was at high risk for IVC filter complications.
A new study published in the Journal of Vascular Surgery, Venous and Lymphatic Disorders in 2013 found that the benefit and risk profile of IVC filters indicated IVC filter complications and supported removal after 29 and before 54 days after it was originally implanted.
A 2017 study published in Circulation: Cardiovascular Interventions, explored more than 750 retrieval procedures completed between 2009-2015. According to the study, typical retrieval techniques failed nearly 20 percent of the patients. With advanced techniques used for failed retrievals, the failure rate dropped to two percent.
However, the risk of standard technique failure for IVC filters implanted for seven months or more was 40.9%. Fifteen minor and three major adverse events were associated with filter retrieval, according to the study.
If you or someone you know has been injured because of IVC filter complications, you need to consult with an attorney immediately. The lawyers at McDonald Worley are here to take your call.