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The devices are most common with trauma patients, bariatric patients and orthopedic surgeries. The annual implantation of these devices has grown from 49,000 in 2004 to over 260,000 by 2012.
Surgeons implant retrievable inferior vena cava filters (IVCs) in the veins of patients who are unable to take anticoagulants (blood thinners) in order to prevent blood clots from moving to the lungs. IVCs catch the clots in the blood stream and, over time, the clots dissipate. They are small, metal devices that resemble a metal cage and are surgically inserted into a patient’s vein. There are two types of IVC filters: permanent and optional/retrievable filters. Retrievable filters provide short-term protection. They’re designed to be removed from a patient’s body when there is no longer a risk for pulmonary embolism (PE). Unfortunately, they are not always able to be retrieved and can cause severe medical complications.
Device migration is one of the severe complications that can arise from an IVC filter implantation. In fact, it was the top complaint reported to the FDA between the years of 2005 and 2010. There are reports of IVC filters migrating from the inferior vena cava to the heart and lungs. The filters also commonly migrate throughout other areas of the body, including the stomach and bowels. Once the filter or fragments of the filter has migrated from its original location, there is a greater risk of the object embedding into veins, arteries, or other organs. If the filter migrates into the lungs or heart, painful and severe effects may present, such as;
  • Chest discomfort and pains
  • Dizziness
  • Feelings of shortness of breath
  • Hypotension
  • Arrhythmias
  • Tachycardia
  • Death
Here are some of the severe complications that have been reported in association with IVC filter placement:
  • Internal bleeding
  • Fracturing of the IVC filter
  • Perforation, puncture or serious damage to the heart
  • Lower limb DVT
  • Permanent damage to the lungs, vena cava, or surrounding organs
  • Ventricular tachycardia
  • Hematoma or nerve injury at the puncture site
  • Chronic pain in the chest, stomach, back, legs, or other places in the body
  • Infection in the body
  • Stroke
  • Death

Please keep in mind that this list does not necessarily include all problems that an injured patient may suffer as a result of a faulty IVC filter. As every BODY is different, not all patients experience the same associated problems.

It is currently recommended that retrievable IVC filters be removed four to six weeks after placement or after the risk of pulmonary embolism (“PE”) has subsided. On August 9, 2010, the FDA released a warning regarding leaving IVC filters in place for longer than recommended. The warning alerted physicians that IVC filters should only be implanted as a short-term “fix” to patients who were at high-risk for pulmonary embolisms. The filters are not meant to be left in the body long-term. If they are left in place longer than recommended, the filter has the potential to attach itself to the vena cava wall. This is known as filter embedment. In these cases, it is generally unsafe to remove the filter, which can cause additional complications to arise.
IVC filter removal can be more difficult than its placement, especially if the filter has migrated from its initial implantation location.

If the filter hasn’t moved, the physician will retrieve the filter in almost the same way that he/she placed the filter. First, the physician will create a small incision in the neck or groin in order to access the vena cava. Then, the physician will insert a contrast dye and take x-ray images to properly visualize the filter, making sure it can be removed safely. Finally, the physician will use a snare to grab the hook, located at the top of the filter, in order to remove it from the body.

When an IVC filter migrates from its original location, removal becomes riskier. In some migration cases, the IVC filter cannot be removed at all, because the filter migrated to a place in the body that was unsafe to operate around, such as the heart or lungs.

After receiving 921 reports of adverse events occurring after receiving the IVC filter implantation since 2005, the FDA issued a warning to doctors in 2010. The FDA put out a formal recommendation that the retrievable filters should be removed once they were no longer necessary. More recently in 2014, the agency recommended that the filters be removed as soon as the patient’s risk of PE was gone.
There has only been one randomized and controlled study evaluating IVC filter safety, which was conducted in 1998. Of the 400 patients who participated in the study, 35% of the participants with filters developed DVT. It was also found that the filter implantation did not improve patient survival.
Anywhere from 9-25% of IVC filters fracture. However, some IVC filter devices hold a higher fracture risks than others. In a study conducted in 2010, it was found that 12% (or 6 out of 52 patients), of Bard G2 filters fractured, compared with 25% of Bard Recovery filters that broke (or 7 out of 28 patients). Arguably little research has been done on IVC filters, and it is expected that with more research conducted, there will be more evidence of fracture occurrence.
IVC filters are supposed to prevent blood clots from traveling to your lungs and other parts of your body. IVC filter implantation is often given to patients who have been diagnosed with deep vein thrombosis, which makes blood clots form in the pelvis and legs of the affected individual. While an IVC filter can assist in stopping the clots from traveling elsewhere in the body, it is not a perfected process or product. Unfortunately, many recipients of the IVC filter have suffered extreme physical harm.
Fenstersheib Law Group, P.A. - Hollywood, FL

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