IVC Filter Complications
IVC retrievable filters are used in patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication. Despite these being temporary filters, IVC filters were rarely removed and patients are reporting serious IVC filter complications and injuries including perforation or other damage to organs when the device migrates or fractures. We are helping patients and families – use our contact form for a free case review or call us at 1.800.887.8029.
What is an IVC Filter?
The IVC retrievable filter is a medical device shaped like a small spider-like metallic wire device that is surgically implanted into a large blood vessel known as the inferior vena cava (IVC). This vessel is responsible for taking blood from the lower body back to the heart. The IVC filter is designed to block blood clots from traveling to the heart and lungs, a condition known as venous thromboembolism, and to prevent the blood clots from becoming pulmonary embolisms. Reports estimate that more than 250,000 devices are implanted each year, but only a small percentage of the filters are removed. Starting in 2010, the FDA, with the concern that the device may cause severe complications for patients, recommended that any filters that are retrievable should be removed from patients “as soon as protection from [pulmonary embolism] is no longer needed.” IVC filters are frequently used in hip and knee replacement surgery because those patients are at risk for developing Deep Vein Thombrosis or Pulmonary Embolisms.
Patients implanted with a Cook or Bard retrievable filter have reported serious injury caused by the device. Injuries reported include: fracture of the filter leading to additional surgeries, migration of the device within the inferior vena cava, perforation of the inferior vena cava, and embolization (detachment of device components).
IVC Filter Complications:
- Perforations of Tissue, Vessels, and Organs
- IVC Occlusion
- Lower Limb Deep Vein Thrombosis
- Heart Attack
- Severe and Persistent Pain
- Abdominal Pain
- Crippling Back Pain
- Flushed Face
- Racing Heart
FDA History & IVC Filters
The U.S Food and Drug Administration (FDA) issued several safety warnings regarding the use of retrievable IVC filters.
- August 2010. The FDA reported that it had received more than 900 reports of people suffering adverse events following the implantation of a filter. These events included device embolization, fractures, perforation of organs, and device migration. The agency recommended that doctors remove filters as soon as they were no longer needed.
- May 2014. The FDA updated its 2010 warning to recommend that doctors take out IVC filters within 29-54 days of implantation. It is requiring IVC Filter manufacturers to conduct studies of the device’s safety.
- July 2015. The FDA issued a warning letter to C.R. Bard. In it, the agency stated that the company’s Recovery Cone Removal System had neither been approved nor cleared by the FDA. As a result, there is apparently no approved method to remove that manufacturer’s filters. The letter also informed Bard that it was (1) not following good manufacturing practices in the manufacture, storage, and packaging of IVC filters; (2) did not properly establish and maintain procedures in regard to reviewing and evaluating complaints relating to the G2, G2X, and Eclipse models; and (3) did not report information that reasonably suggested its devices had malfunctioned, and those malfunctions could lead to either a severe injury or death.
IVC Filter Complication News
- Why Did Firm Keep Selling Problem Blood-Clot Filters?, nbcnews.com
- Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?, nbcnews.com
How We Can Help
If you have experienced IVC filter complications, you may want to consider your potential legal claim. For more information, or to talk with our team experienced in injury cases, please call us toll-free at 1.800.887.8029 for a free consultation or fill out an online free case review form below. Zimmerman Reed is experienced in handling medical device cases and we welcome your questions.