Filter Embolization & Fracture
IVC filters have been around for nearly 40 years, but the dangerous side effects of the optionally removable filters have more recently come to light. Since the first permanent IVC filters with the option to retrieve were approved in 2003 and 2004, thousands of patients have been implanted with these devices. These permanent IVC filters with the option to retrieve were designed to be optionally removable. They’re used in patients who have a temporary risk of blood clots and pulmonary embolisms.
Why do the Retrievable Devices Fail?
The filters, which are comprised of several metal struts and a retrieval hook, are designed to capture blood clots as they travel through the inferior vena cava vein. The device is implanted just below the kidneys, and prevents blood clots from traveling to the patient’s lungs.
Unfortunately, the same features that make these devices retrievable also make them prone to failure. Often times, the delicate struts of the device can fracture and detach, migrating to other parts of the body. The device can tilt. The retrieval hook itself can embed into the walls of the vein, and in some cases, the struts can perforate the IVC and puncture adjacent organs.
The Likelihood of Filter Fracture and Embolization
In 2010, the FDA analyzed 921 reports of adverse effects from IVC filters. The FDA found that device migration and filter embolization were the two most common occurrences. Device migration occurred in 328 patients. IVC filter embolization, detachment of device components, occurred in 146 patients. IVC filter fractures occurred in 56 patients, and 70 patients has a perforation of the IVC.
The study warned of the substantial risks of leaving a permanent IVC filter with the option to retrieve in too long and recommended filter removal once protection from PE was no longer needed.
Additional FDA Warnings and Findings
In 2014, the FDA once again warned manufacturers the devices should be removed from patients as soon as possible. They stated retrievable devices should be taken out between the 29th and 54th day after being inserted if the patient’s transient risk for pulmonary embolism has passed. Two manufacturers in particular seemed to show significant failure rates: C.R. Bard and Cook Medical.
The first generation Bard device, called the Recovery Filter, was found to have a 25% chance of fracturing or breaking apart completely. The Cook Medical devices had histories of puncturing vein walls, most of which were left in the body for an average of 71 days. The manufactures failed to warn consumers and doctors of the risks of leaving the device in for too long.
Early Filter Fracture Reports Were Ignored
Strangely, reports of IVC filter fractures and embolism date back as early as 2004, when the device was first released into the marketplace. According to one report, C.R. Bard started receiving complaints shortly after the device entered the market.
Obviously, this information should have been taken into consideration when continuing to manufacture and sell the device.
Complications from IVC Filter Fractures
IVC filter fracturing and embolization can lead to severe complications. Broken pieces of the device can migrate and become lodged in other areas of the body, even the heart. Fractured pieces can warp and cause puncturing of vein walls and adjacent organs. Severe, uncontrollable bleeding events can occur.
Contact a New York IVC Filter Attorney
Medical device manufacturers have a duty to warn consumers of potential side effects and other risks surrounding the devices they make. When they fail to fulfill this duty, they need to be made accountable for their negligence. Currently, there are numerous lawsuits against the manufacturers of these flawed IVC devices.
Martin, Harding & Mazzotti, LLP works with clients throughout New York, Massachusetts, and Vermont. We are an experienced personal injury law firm with a number of concentrations, including manufacturer negligence in IVC filter cases. You don’t have to be alone in this fight. Contact us today to begin building your case.