One of the most frightening statements a heart doctor can say to a patient is “You have a pulmonary embolism, or lung artery blockage.” A pulmonary embolism (PE) is a severe condition which stops blood from properly flowing to the lungs and can lead to death if not treated extremely quickly. Time is often of the essence when it comes to choosing a treatment plan for this condition. There are a few treatment options available to heart patients suffering from a pulmonary embolism or those with high risk factors.
One of the most potentially dangerous treatment plans is the option of performing surgery to insert an inferior vena cava filter (IVC filter). If you or someone you know has had this surgery performed or is planning on having an IVC filter inserted, make it a priority to contact a Louisville, KY IVC filter lawyer as well as educate yourself on the facts.
What is it and Why is it Potentially Dangerous?
An IVC filter is a small, cage-like medical device that is used to prevent blood clots in the inferior vena cava which is a major vein that carries blood to the lungs from the heart. The filter is inserted during surgery and is designed as a permanent device which will stop a blood clot should it travel to the lungs. IVC filters are only generally recommended after anticoagulation treatment courses and medication are offered for patients with PE and those treatment courses are not successful. They can also be inserted when a patient is at risk of developing a pulmonary embolism.
In theory, the device can prevent heart attacks which may be caused by traveling blood clots. In practice, however, the devices have been proven to cause severe complications in many cases. There are defects in the design of the device which can lead to the device migrating, tilting, detaching, perforating, or fracturing over time, potentially causing the following complications:
- Cardiac tamponade (fluid buildup)
- Deep vein thrombosis
- Pulmonary embolism (in at-risk cases)
- Severe pain
- Shortness of breath
- Respiratory distress
Since 2005, the FDA has received over 900 reports of adverse complications involving IVC filters. These complications tend to have a higher chance of occurring the longer the device is inserted. In particular, they often occur when a patient is no longer at risk for a pulmonary embolism. While originally designed as a permanent medical device, it is now clear that these filters do not hold up well long term.
What Should I Do if I Have an IVC Filter?
The FDA currently recommends that all patients with an IVC filter get the device surgically removed as soon as protection from PE is no longer necessary. The FDA also encourages all physicians who still perform the surgery to properly inform their patients regarding the above risks and that they will need to have the device removed at some point.
Despite these recommendations and warnings, there are hundreds of patients who have received the surgery without proper knowledge about the risks and the fact that IVC filters do not hold up well long term. Many physicians are not even aware of the current risk factors. Post-surgical long term care is also not something many surgeons prioritize when performing operations like IVC filter insertion.
There are hundreds of patients in the United States who have experienced severe medical complications—and death in some cases—due to the defects in these filters. Many of these patients and their families feel that the manufacturers of IVC filters need to be doing more to fix the defects of their products, inform physicians and patients regarding the defects and their associated risk factors, and take the filters off the market if necessary.
Help is Available
Patients and their family members who were and are affected by complications caused by IVC filters are not alone in the above sentiment. Legally, it falls to the responsibility of the device manufacturers to ensure the facts are available to anyone who wishes to have the procedure done. A simple FDA warning is not enough. Patients who have had the surgery performed in the past also need to be informed regarding the importance of device retrieval.
C.R. Bard and Cook Medical are the two manufacturers responsible for most of the filters currently on the market. As of December 2015, there are over 120 pending lawsuits directed toward these companies. If these lawsuits succeed, the manufacturers will be forced to reimburse patients for their suffering as well as ensure that other potential victims are properly informed regarding the facts and their options. Manufacturers need to be held responsible when their devices fail to perform as advertised.
If you or someone you love has an IVC filter or has experienced medical complications due to the device, legal aid is available. It’s not too late to get involved in the pending cases directed toward both filter manufacturers. For more information or a free legal evaluation, don’t hesitate to contact Thomas Law Offices today. Tad Thomas, a Louisville, KY IVC filter lawyer, is currently receiving these types of cases.