IVC filters are extremely popular medical devices, although there’s little evidence that they have any favorable effect on patient health outcomes. In recent years, major medical organizations, including the Journal of the American Medical Association, have openly questioned whether or not the small net-like implants, designed to catch blood clots in the vein, should be used at all. But beyond their questionable efficacy, IVC filters have been linked to a host of adverse side effects, and patients, health professionals and prominent news organizations are accusing filter manufacturers of concealing damning evidence from the public.
Filters Can Break, Migrate Or Perforate Veins
In 2010, the US Food & Drug Administration made a startling public announcement. The agency had received 921 adverse event reports involving IVC filters – in the span of just five years. Submitted primarily by health care professionals, these reports described a litany of problems, all of which related to device failure.
Filters had “migrated,” or moved out of position, becoming either useless or dangerous. Some devices had broken apart inside the vein, sending shards of metal coursing through a patient’s body. Other implants had perforated the vein in which they were implanted, the inferior vena cava. Many patients landed in the hospital, with portions of a filter’s “struts” (legs) embedded in their vital organs.
Side Effects & Risks
While the task of placing an implant inside a patient’s vein may seem inherently dangerous, few complications have been reported during the implantation procedure. Several patients have described suffering severe infections, likely due to improperly-sterilized filters, but the risk of this side effect appears relatively low. Internal bleeding, though, is not unheard of and a less-than-cautious surgeon can pierce the inferior vena cava accidentally with one of the filter’s sharp components.
If recent lawsuits are any indication, the majority of complications are noticed years after a filter is first implanted. Most patients describe experiencing significant chest pain, and learning of the filter’s failure only after a CT scan or X-ray. IVC filters can:
- fracture, with any number of the device’s metal legs breaking off and flowing to the lungs or heart
- perforate the vein or pierce other internal organs, leading to internal bleeding
- migrate out of position entirely. Physicians have even reported on IVC filters that detached from the inferior vena cava and traveled all the way to the heart, blocking blood vessels.
In some cases, devices have been inappropriately positioned inside the vein, negating any potential benefits they may hold. Tilted at an angle, a “malpositioned” IVC filter stands no chance of capturing a blood clot, and may actually be more likely to migrate.
For a surprising number of patients, surgeons have been unable to remove the shards, and unwilling to cause further damage. It’s quite possible that hundreds of people will be forced to live with metal fragments piercing their hearts and lungs forever. Chronic chest pain, difficulty breathing and even cardiac tamponade, a condition in which bodily fluids build up around the heart, are frequent symptoms of IVC filter failure.
Red flags had appeared far earlier, however, although many patients say they were never alerted to the risks. In 2005, a major study on IVC filter safety found that the devices could actually increase the risk of deep vein thrombosis (DVT), blood clots that develop in the lower limbs. Needless to say, this newly-identified danger appeared perverse to many people, since IVC filters had been designed to prevent the consequences of DVT in the first place.
After Injuries, Patients Raise Troubling Questions
It seemed clear that IVC filters presented significant risks. But who was to blame? Certainly not patients, many of whom had been advised that IVC filters were both safe and effective for treating their clotting conditions. Doctors garnered most of the FDA’s ire; according to the agency, recent generations of IVC filters were designed to be removable, but many doctors were leaving them in too long. But critics also cast doubt on IVC filter manufacturers, companies like C.R. Bard and Cook Medical, who released their devices without providing physicians much instruction on how to use them properly.
Four years after the first warning signs were raised, the FDA again advised doctors to remove IVC filters immediately after a patient’s risk of pulmonary embolism had dissipated. Reiterating the significant number of “adverse events and product problems,” the agency finally suggested a timeline for filter removal: between 29 and 54 days after the device is implanted.
But for many patients, these precautionary guidelines meant nothing. People had already been injured, perhaps thousands, and amid allegations that companies like Bard and Cook had hid safety data, former patients and their loved ones began to file lawsuits.
Lawsuits Say Companies Foresaw Risks, Did Nothing
Today, hundreds of IVC filter lawsuits have been filed. While their circumstances certainly differ, all relate stories of horrific complications and suffering, both physical and emotional.
Elizabeth and James Hughes, residents of Newport, Michigan, say a filter manufactured by Cook Medical broke apart inside Elizabeth’s body, leaving fragments of metal embedded “in her spine and the main artery going to her kidney.” But her surgeons, who only became aware of the problem five years after implanting her filter, were reluctant to remove the pieces. If they tried, Hughes writes in her lawsuit, “she would probably bleed out.” Hughes says she “wanted to have one more child,” but has been warned that attempting another pregnancy “would risk her life.”
Three hundred miles south, in Greensburg, Indiana, Donald and Joy Yates describe a distressingly similar situation. Donald says he was implanted with a C.R. Bard IVC filter at the end of 2008. Instead of capturing a blood clot, however, he says the filter fractured inside his vein, allowing an embolism to pass directly to his lungs. Donald now lives with the broken IVC filter inside his body, perhaps permanently, because his doctors are unwilling to remove the device for fear of further damage. In his own complaint, Yates claims he “will require ongoing medical care to monitor his condition.”
Widows and widowers, after the tragic deaths of their loved ones, have taken the brave step of stepping forward, filing wrongful death lawsuits.
“Built To Fail”?
Far from being an unexpected consequence, plaintiffs say that device failure was literally built into IVC filters from the start. The implant’s components, made from a space-aged military alloy called Nitinol, bear minuscule groove markings, furrows that undermine their structural integrity. It was only a matter of time, patients argue, before the struts fell apart, causing potentially irreparable damage.
But manufacturers, plaintiffs claim, were less than forthcoming with this information. Nor did they publicize the results of numerous damning studies, some of which have found that IVC filters fail in a majority of patients.
Internal corporate documents held by at least one manufacturer, obtained by an NBC News investigation, appear to support these allegations. Shortly after the company’s G2 filter was approved, C.R. Bard’s vice president expressed significant reservations about the device’s safety, noting numerous “problems with […] migration, tilting and perforation.” But rather than recall the implants, NBC reports, “the medical device manufacturer decided to keep them on the market for five years.”
Efficacy In Doubt
IVC filters are far from a recent invention. Similar implants have been used for decades. Theoretically, the filters should be able to prevent death, especially in people living at an increased risk for deep vein thrombosis or pulmonary embolism. But thus far, that theory hasn’t made its way into reality.
While their use has become more and more prevalent, IVC filters have never been shown effective in reducing patient mortality. In fact, research has found that any benefit filters may hold, like preventing a traveling blood clot from reaching the lungs, is negated by an increased risk for deep vein thrombosis. Despite these developments, upwards of 300,000 patients receive new IVC filters every year.
Is IVC Filter Litigation Only Beginning?
As for the IVC filter lawsuits, legal experts believe more are on their way, especially now that litigation against both Cook Medical and C.R. Bard has been “consolidated,” with lawsuits filed in different states all being transferred to central courts for coordinated pre-trial proceedings. That could have a serious effect on the speed at which lawsuits are resolved, attorneys say, as well as the outcomes reached.