Researchers have reported on a serious potential side effect with temporary inferior vena cava (IVC) filters. The small, cage-like devices are inserted into the vena cava vein, which takes deoxygenated blood from the lower legs back to the heart. It is this vein that can carry dangerous blood clots, potentially causing a pulmonary embolism (PE).
In this particular case, a 31-year-old woman ended up in the emergency room after suffering with severe chest pain for two days. Doctors later discovered it was caused by her defective IVC filter.
Women Ends Up In Emergency Room
According to the case report, the woman was suffering from nausea and severe sweating when she arrived at the emergency room. When doctors examined her, they found a rapid heart beat with elevated blood pressure. According to her medical records, she had been implanted with an IVC filter four years prior to her arrival.
Imaging tests showed that the woman had accumulated fluid around the heart that could be putting pressure on it. She was treated for that, to reduce the fluid and prevent further buildup, but her conditioned worsened, and her blood pressure plummeted.
Doctors performed an emergency procedure to remove the fluid from around the heart, and the patient was stabilized. Doctors were puzzled, however, as to what could have caused the fluid to build up so severely. They examined the heart again, looking for other explanations, and noticed a “faint, barely visible object ‘like a bent wire’” in the pericardium—the sac of fibrous tissues that surround the heart.
Doctors Discover the IVC Filter Caused the Problem
Upon closer examination, doctors determined that the small, bent-wire-like object had come from the patient’s IVC filter. They looked for the filter itself, and found that instead of 12 “legs” or “struts,” like it was supposed to have, it had only eleven. One was missing.
Doctors realized that the missing leg had perforated the vein and other tissues to migrate to the right side of the heart, perforating the wall and leading to the fluid buildup. After more imaging tests to determine the exact position of the misplaced filter leg, they had to perform further surgery to remove it.
The patient recovered quickly after that, and was discharged five days after the operation.
FDA Recommends IVC Filters Be Removed Quickly
The filter at issue in this case was the Bard Recovery IVC filter—a device that is now the subject of at least 22 Bard IVC filter lawsuits. In August 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed cases in the District of Arizona for pre-trial proceedings.
The doctors that reported the case above noted that they had seen other similar cases, and noted that the filter had fractured during excessive physical activity, and in all cases, the filter had been in place for months to years—much longer than the FDA now recommends.
In May 2014, the FDA stated that temporary IVC filters should be removed within 29-54 days after implantation, as long as the patient’s risk of pulmonary embolism had subsided, to protect patients from potentially serious side effects such as those that occurred in this case.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.
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