Life Threatening Injuries Linked to IVC Filters
Patients who are at risk of developing blood clots and cannot take blood thinners may have a medical device implanted to capture blood clots that break loose in the legs and would move toward the heart and lungs. Doctors implant the small, cage-like device just below the kidneys in a major vein called the inferior vena cava that carries blood from the legs to the heart.
The IVC filters were originally designed as permanent implants. However, in the last decade, several manufacturers of medical devices have developed optionally retrievable IVC filters. These retrievable IVC filters have been promoted to physicians to use in trauma and bariatric patients to prevent pulmonary embolism. Although such patients only had a temporary need for such prevention a majority of the retrievable IVC filters have been left in place, even after the need for them was no longer present because they were marketed as permanent filters with the added removable option.
The U.S. Food and Drug Administration (FDA) said it is concerned that retrievable IVC filters used to address a short-term risk of a pulmonary embolism are not removed from the patients once the risk passes. The risk of complications may be expected to increase with the length of implantation, suggesting that the medical devices have a defective design and expose patients to an unreasonable risk of injury.
The medical device lawyers at Hardison & Cochran are investigating cases of injury and side effects among patients who have implanted retrievable IVC filters. Anyone injured by an IVC filter may have a right to seek compensation. Let a product liability lawyer at Hardison & Cochran review the specifics of your surgery and explain your legal options for pursuing an IVC filter lawsuit.
FDA Receives Thousands of Adverse Event Reports Involving Retrievable IVC Filters
The FDA has received thousands of reports of problems linked to the IVC filters including reports that these filters perforate, migrate, tilt, and fracture. Fractured pieces can migrate to the heart or lungs or perforate tissue, with serious and severe consequences.
A 2012 study in the medical journal Cardiovascular Interventional Radiology found that nearly 100 percent of the Cook Celect and Gunther Tulip IVC filters caused punctures in patients’ venal cava vein within 71 days after being implanted. The study said that 40 percent of the filters shifted out of position.
Some complications may be linked to the length of time that the filters remain in a patient’s body, the FDA said. The FDA said some adverse side effects may be prevented if the filter is removed as soon as the risk of a blood clot has subsided. In a 2014 safety alert to doctors, the FDA recommends that doctors who are treating patients who have retrievable IVC filters consider removing the filter as soon as the patient is beyond the risk. The medical device manufacturers may not have adequately warned doctors of the need to remove the IVC filters.
A 2013 article published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders said a risk-benefit analysis starts to favor removal of the retrievable IVC filters 29 to 54 days of implantation for patients with a temporary risk of pulmonary embolism. An increase in retrieval of the filters might help reduce the number of long-term complications, the study said.
The FDA is requiring medical devices that produce the retrievable IVC filters to collect post-marketing data to assess the safety and effectiveness of the devices. Some companies are taking part in an independent national PRESERVE study examining the use of IVC filters.
Contact Medical Device Injury Attorneys at Hardison & Cochran
If you or a loved one has had a retrievable IVC filter implanted, you should talk with your physician about whether it is appropriate to remove the device. You should discuss your legal options for seeking compensation for adverse effects and consequences caused by an IVC filter with a personal injury lawyer at Hardison & Cochran.
You can reach our medical device attorney by calling (800) 434-8399 or by filling out an online contact form.