Hemorrhagic Pericardial Effusion and IVC Filters
IVC filters have now been found to cause a multitude of adverse effects. These devices, which were originally intended to treat patients who were at risk for blood clots and pulmonary embolisms, have a high rate of failure.
In the early 2000s, when the permanent IVC filters with the option to retrieve were first released, thousands of patients had them implanted. Now, many of them are coming forward after suffering devastating side effects.
Retrievable IVC Filters Hit the Marketplace
The permanent IVC filters with the option to retrieve were first released to the market via FDA 510(K) clearance. For 501(K) clearance, a device manufacturer must demonstrate a device is substantially equivalent to a predicate device (one that has been cleared by the FDA or marketed before 1916). The FDA does not “approve” 510(K) submissions, it “clears” them.
Problems with Retrievable IVC Devices
Although the devices appear similar to their permanent counterparts, the optionally retrievable versions of a different design can be made from different materials and are fitted with a hook, which surgeons use as a snare when removing the device. However, when the devices are left in place for an extended period of time, which happens frequently as they are permanent with the option to retrieve, the hook of the device can embed in the walls of the IVC, the struts can perforate the IVC, the cells of the IVC can overgrow the device and make it difficult or impossible to remove.
Furthermore, the filters themselves are prone to breakage and migration. When this occurs, pieces of the filter or the entire filter can be misplaced to other locations in the body. Unfortunately, many of these unintended locations are vital veins and organs. When the misplaced filter becomes lodged in one of these locations, the complications can be severe and deadly.
Complications from IVC Filter Failure
Several models of these permanent IVC filters with the option to retrieve have particularly high rates of failure. Failures include fracturing of the filter, detachment of the filter, perforation of vein walls, and filter migration. These issues can further compound one another: a piece of the filter may break off, migrate, and puncture multiple areas. In other words, multiple complications can and do happen.
Example of Additional Complications: Pulmonary Effusion
One particularly interesting case is the case of a 68-year-old woman who suffered pulmonary effusion (excess liquid around the heart) because of a broken IVC filter. The woman visited the hospital complaining of chest pain and shortness of breath. An initial CT scan showed that she had excess fluid around her lungs, for which she was treated with oral steroids. Preliminary tests suggested that the IVC filter she had received 16 months before the incident seemed to have no complications.
However, upon conducting an abdominal and chest CT scan, doctors found that a fragment of the IVC filter had broken off and lodged itself in the right ventricle of her heart. The first attempt to remove the filter using its snare was aborted because cells had overgrown the hook.
The doctors had to use a combination of several additional snares and Glidewire to remove the filter. The broken fragment that was lodged in her right ventricle had to be removed through open heart surgery. Thankfully, the woman recovered.
Multiple Lawsuits Against IVC Filter Manufacturers
Pericardial effusion is just one of the myriad complications that can result from a dislodged or broken IVC filter. Unfortunately, complications like this are not limited to only one patient. In fact, there are currently many lawsuits against the manufacturers of IVC filters. Reports have found that although the FDA released several warnings about the dangers of retrievable IVC devices, manufactures failed to address these notices appropriately.
Personal Injury Attorneys Concentrating in Handling IVC Filter Cases
Martin, Harding & Mazzotti, LLP has extensive experience in personal injury law, defective device litigation, and IVC filter cases. The manufacturers who ignored the warnings given about their devices must be held liable for their negligence. Join the other victims who have come forward against these companies, and contact us today.