The inferior vena cava filter is a metal, spider-shaped medical device intended to prevent blood clots from moving from the lower ranges of the body to the heart or lungs. An IVC filter is only recommended in high-risk cases where the patient is at risk of developing a pulmonary embolism, which can be fatal. However, if the IVC filter fractures, metal parts move through the blood, which can cause damage to the heart and lungs, resulting in internal bleeding or even death.
IVC filters have been in use for decades. In 1979, approximately 2,000 IVC filters were in use; in 2007, this figure rose to about 167,000 filters. According to the Journal of the American College of Cardiology, IVC filter use has risen sharply over the past two decades, which has been attributed to the development of retrievable modern filter devices. However, long-term efficacy remains unclear and within the past few years, evidence has come to light which suggests that patients who were given an IVC filter could face a serious risk of complications.
Currently, there is no active IVC filter recall, however, there have been multiple memos issued by the FDA concerning the efficacy of these filters.
2010 FDA Safety Communication Alert: IVC Filters
On August 9, 2010 the FDA issued a safety communication concerning the devices to physicians and clinicians responsible for the ongoing care of patients with IVC filters. This included interventional radiologists, interventional cardiologists, vascular surgeons, emergency room doctors, bariatric surgeons, and primary care physicians.
In the report, the agency stated that it has received 921 “device adverse event reports” involving IVC filters.
- The majority (36%) involved filter migration (328 reports)
- 15% involved detachment of filter components (146 reports)
- 5% involved perforation of the vena cava (70 reports)
- 6% involved filter fracture (56 reports)
The FDA stated that it was concerned that IVC filters, which are intended for short-term placement, are not always removed once a patient’s risk for developing a pulmonary embolism subsides. The FDA instructed all physicians involved in the treatment and follow-up care of IVC filter recipients to consider the risks and benefits of filter removal.
2014 FDA Update to IVC Filter Safety Communication
In May of 2014, the FDA issued an update to its 2010 Initial Communication which focused on removing IVC filters. The agency advised that retrievable filters should be removed between 29 and 54 days after implantation to avoid serious injuries. This was based upon a decision analysis published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.
The analysis involved the development of a mathematical model which assessed when the patient’s transient risk for pulmonary embolism had passed and the risk/benefit profile favored the removal of a filter. The FDA also recommends that patients who have received an IVC filter talk with their physicians immediately to make sure that their filters are still in place and intact, and to explore whether the device should be removed.
PRESERVE and Other Studies
In addition to creating guidelines for IVC filter removal, the 2014 FDA memo discussed the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena cava filter) Study. This is an independent national clinical study seeking to examine the use of IVC filters in the prevention of pulmonary embolism. This study will be composed of 2,500 patients who will undergo IVC filter placement in approximately 50 medical centers in the United States. Patients will undergo mandatory post procedural imaging, including abdominal radiography at 3 months after filter placement and abdominal computed tomography scans at 1 and 2 years after filter placement. Also, they will be required to make follow-up clinic visits at the 3, 6, 12, 18 and 24 months after placement. The study seeks to broaden the knowledge base regarding the long-term effects of IVC filters.
In addition to the PRESERVE study, the FDA noted that other manufacturers are conducting post-market surveillance of IVC filters. About 522 studies were in operation at the time of the 2014 report. The FDA is expecting to be assisted by the data gathered from PRESERVE and the other studies in making a determination as to the proper use and safety profile of IVC filters, and to understand evolving patters of clinical use and ultimately to improve patient care.
IVC Filter Litigation
After the FDA’s safety alert was made public, a growing number of victims have filed IVC lawsuits. The filter most often involved in the IVC filter litigation include: The Bard Recovery filter, the Bard G2 filter, the Bard G2 Express filter, the Cook Gunther Tulip filter, and the cook Celect filter. Other IVC filters causing problems include the Bard Eclipse, the Bard Meridian, and the Bard Denali.
Symptoms that may indicate an IVC filter has malfunctioned include:
- Chest or neck pain
- Internal bleeding
- Heart rhythm problems
- Hypotension (low blood pressure)
- Light headedness
- Shortness of breath
Legal Representation for IVC Filter Malfunctions
Roughly 20,000 blood clot filters are implanted to prevent pulmonary embolisms each year, with the market expected to reach around $300 million by 2022. With those types of profits, one can expect to face a highly skilled defense attorney who is tasked with protecting the financial interests of IVC filter manufacturers.
If your device malfunctions and you wish to pursue a lawsuit, it is critical that you consult with an experienced medical malpractice attorney.
The science behind an IVC filter and the reasons why they may malfunction and cause serious injury is incredibly detailed and complex.
If you or someone you love has received an IVC filter and suffered from serious complications, you may be entitled to compensation for your medical expenses, lost work, and other related expenses. However, it is very important that you work with an attorney who is knowledgeable about these particular devices.
An experienced law firm will know what type of expert witness will be the most critical, how to review detailed and complicated medical records, and will also be aware of the numerous deadlines which are vital to pursuing a successful case.
If you or someone you love has an IVC filter and you’re concerned that you may be experiencing side effects, please contact our law offices today for an initial consultation.