What is an IVC Filter, Why is it Used, Where is it Placed, and What are the Risks?
The Inferior Vena Cava vein is one of the main veins in the body, and deoxygenated blood flows through this vein from the legs and lower extremities back to the heart and lungs where the oxygen is reintroduced to the blood in the right atrium of the heart. When there is a problem with blood clots forming in the bloodstream, there is the possibility of the blood clots moving to the heart and lungs and causing death. An IVC filter is a device that is placed in the Inferior Vena Cava to stop blood clots. Lately, there have been many lawsuits concerning the safety of these devices, and IVC filter lawyers at Cochran, Kroll & Associates, P.C. have been involved with these cases as the understanding of the science catches up with the patients’ claims.
The IVC filter was invented to be an option to treat patients with blood clots. Doctors were often faced with a dilemma when they were unable to administer an anticoagulant to a patient to prevent blood clots because the patient was allergic to the various types of medication, and the IVC filter was introduced to be another way to protect the patient. The use of IVC filters has grown in recent years, and with this increased use the risks to patients have also grown.
What is an IVC Filter?
The IVC filter was invented in 1966, by Doctor Kazi Mobin-Uddin (1930-1999) when he first used it experimentally on animals in the laboratory and later used it experimentally on patients. Up until this time Pulmonary Embolism, the blockage of the arteries in the body, caused many deaths and there was no non-surgical way to prevent the flow of clots to the heart and lungs. The IVC filter designed by Movin-Uddin was an umbrella- shaped apparatus that could be inserted into the Inferior Vena Cava through the large vein in the neck or groin with much less invasive surgery. He became known as the “umbrella man,” and it was said that the IVC device “let through the rain but not the hail.” Through the 1970s the Movin-Uddin filter was the only method to treat Pulmonary Embolism, but during that time other doctors and scientists invented other similar devices, and the Movin-Uddin filter became obsolete.
In Michigan, in 1973, The Greenfield Filter was developed by Dr. Lazar Greenfield, and this improved the efficiency of the procedure for blocking blood clots. This filter is cone-shaped and has extended metal legs that act to adhere to the edges of the vein while forming a basket that catches any blood clots moving through the bloodstream. Since the development of this apparatus, there are now seven different companies making their version of the IVC filter, and each has a unique design. However, the purpose is the same-to be inserted into the Inferior Vena Cava (IVC) to stop blood clots from entering the heart and lungs and possibly causing lung damage, a heart attack, or a stroke.
The number of implants of the IVC filters increased from 2,000 procedures in 1979 to over 167,000 by 2007. By 2012, there were an estimated 259,000 IVC filters used for patients. With such extensive use, there is room to speculate that any risks could lead to numerous medical malpractice lawsuits regarding these implants and there are risks associated with their use. In these cases an IVC Filter lawyer at our law firm should be contacted to ensure complete and professional coverage. The law offices of Cochran, Kroll & Associates, P.C. are up to date on the latest lawsuits brought on behalf of patients who have been injured due to the problems with IVC filters.
Why is the IVC Used and Where is It Placed?
Any condition that slows the movement of blood through the veins is a possible reason to use an IVC filter. Especially if the patient has had Deep Vein Thrombosis or Pulmonary Embolism in the past, the chances of these recurring are greater. Other common medical events may be recent surgery that decreases movement, long periods of travel, injury to the leg, cancer, smoking, or inherited tendency for the formation of blood clots.
The procedure for inserting the IVC filter into the Inferior Vena Cava is usually a simple surgical operation involving a small wound in the large vein in the neck or groin. This operation can be done be numbing only the area of the wound and can be an out-patient visit to the hospital or performed in a hospital bed when necessary. However, sometimes this needs to be a more major operation depending on the patient’s condition.
The IVC filter is placed in the vein in the lower abdomen to be in a position to intercept blood clots moving from the lower part of the body to the heart and lungs. These blood clots are usually formed as a result of Deep Vein Thrombosis (DVT). This condition occurs when the person may be immobile for long periods like in a long plane or automobile ride or lying on an operating table. DVT can also develop from a traumatic injury like a bullet wound or a car accident.
DVT and the formation of blood clots can also be treated with anticoagulants that thin the blood making it more difficult for blood clots to form. However, patients can develop allergies to these medications causing unwanted side-effects during the treatment for the cardiovascular problem. This is why the IVC filter can be a good alternative.
What are the Risks?
There are two types of IVC filters placed in the body to control and prevent the movement of blood clots to the heart and lungs. The most recent development is that of the use of retrievable IVC filters, but the earlier models were permanent.
Complications with the use of IVC filters can occur either at placement, during removal, or if they are left in place for too long a time. Any of these complications can be the result of doctor or the manufacturer’s negligence. Always keep in mind the necessity to contact a medical malpractice attorney at our law firm in case of a related injury.
Whenever the skin is pierced to allow the entrance of a catheter or other apparatus there is the risk of further injury. If the wound site is not cared for properly, there is the risk of infection, and this can happen when the patient is sent home after the procedure.
Usually, during the procedure, the doctor uses a chemical dye to highlight the other organs to make it easier to guide the IVC filter. A patient can have a reaction to this dye, and there can follow irritations to the skin or even minor reactions through erratic breathing.
Inserting a catheter into a vein, although less invasive, is not just a routine medical procedure. When metal and plastic objects are moving through the body there is always a potential for injury. In the case of reaching the part of the abdomen for the correct placement of the IVC filter, one of the main risks in coming from the neck is bypassing the heart and lungs. The foreign tubes being inserted into the vein can sometimes cause pneumothorax or hemothorax. When pneumothorax occurs, air penetrates outside of the lungs and can cause the lungs to collapse. This can happen if the tube or the device being inserted penetrates the lung. Hemothorax occurs when blood enters between the heart and lungs causing complications. Both of these conditions are life-threatening, and great care has to be taken to prevent these from becoming an immediate crisis.
Also, at the site of the incision, blood clots can develop in some patients, and this can lead to further complications if the patient tends to form clots abnormally. Obviously anytime there are blood clots moving through the bloodstream there is the possibility of injury to the heart, damage to the lungs, or a stroke.
Risks When the IVC Filter is in Place
Once the IVC filter has been put in place some things can go wrong. Initially there can be a misplacement of the device, and then the doctor has to reenter the vein to correct the problem or even make the arrangements to retrieve it. Sometimes the filer can end up tilted and not functioning as expected, and this can lead to blood clots slipping by the filter or even blocking the vein so that blood does not flow correctly.
The wire used to guide the catheter, and IVC filter can even become entangled with tissue in the vein and cause a serious risk of penetrating the walls of the vein. This situation can cause the natural tendency of the body to react by forming a clot to protect the wall of the vein and then lead to the formation of a fatal clot that moves towards the heart.
The implantation of an IVC filter is not a cure for the formation of blood clots in the legs and lower body. The only purpose of the filter is to stop blood clots from passing to the heart and lungs. There still remains the risk that blood clots will continue to form and that the IVC filter will itself become clogged stopping the normal flow of blood. That is why it is imperative for doctors using this treatment to be aware of the time the device has been in place and to take steps to remove it once blood thinners can be used or the medical condition changes for the better.
If the IVC filter remains in place for too long there is the chance that the pieces of the device can fracture and break off. When this happens the small pieces can travel through the bloodstream and enter the heart and lungs causing more damage. Doctors have also had cases where the pieces of the IVC filter have penetrated other organs of the body where permanent internal damage has caused life-long treatments.
Risks of Removal
In 2014, the FDA prepared a report on the safety of the use of IVC filters and made some recommendations. They reported that between 2005 and 2014 there were over 900 cases where patients had had problems with the IVC filters when the filters were not removed promptly. The recommendation was that these filters should be removed within 29- 54 days of when they were placed in the patient’s vein.
In addition to the risk of the apparatus breaking while in place, there is also the risk of the device breaking while it is being removed. In addition, the walls of the vein can envelop the metal legs causing the filter to become embedded in the vein. This can lead to more extensive surgery to remove the implant.
Then invention and the further development of the IVC filter for the purpose of blocking the movement of blood clots to the heart and lungs was a much-needed medical break-through for the treatment of Pulmonary Embolism. The use of this device began in 1973 and by 2012 over 267,000 patients were treated with this procedure. Recently, doctors and scientists, and the FDA have recognized some of the drawbacks of this treatment method. As a result, there have been many medical malpractice lawsuits filed as more patients are harmed due to physician errors, and the defects with the device.
At Cochran, Kroll & Associates, P.C. we have been keeping abreast of the developments of the litigations surrounding the uses of the IVC filter. If you have had this procedure done and have noticed some health concerns, contact us immediately for a review of your circumstances. Contact us at Cochranlaw.com or call 1-866-MICH-LAW (1-866-642-4529) for a complimentary case evaluation. Best of all, we never charge a fee unless we resolve your case.