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Since the introduction of IVC filters in 2005, the FDA has received thousands of adverse reports of filters migrating or breaking off in the human body and causing serious injuries or death. The IVC Filter lawyers at Gomez Trial Attorneys are currently accepting cases involving these filters and they injuries they cause.
IVC Filters are small, cone-shaped devices that are implanted into the human body to prevent blood clots. They are designed to catch an “embolism,” a type of blood clot that has broken loose from one of the deep veins in the leg on its way to the heart and lungs. These filters are typically implanted as an alternative for patients who suffer adverse reactions to blood-thinning medications. Most filters are designed to be permanent implants, but some have the option for retrieval.
Complaints associated with IVC filters are very serious. Reports show that the entire filter or parts of it can break off and move into various parts of the human body. Sometimes the filters or parts of them while migrating actually puncture the human body, such as the patient’s heart or lungs, causing life-threatening injuries or death.
While some IVC filters were initially advertised as being easy to retrieve, this has not been the case. Filters are known to shift or tilt in the body, along with migrating and breaking apart, making removal difficult, expensive, and dangerous. In a 2013 study by the American Medical Association, data showed that the success rate for removal was a dismal 8.5% (58 successes out of 680 attempts). Even worse, some of the reported health complications come from IVC filters actually puncturing the human body during removal.
These are both scary problems, especially when considering the large number of IVC filter patients in America today.
Two of the largest IVC filter manufacturers, C.R. Bard and Cook Medical, are at the center of causing these problems. Both manufacturers create most of the IVC filters that have harmed patients, and there are many claims that they misrepresented the efficacy and safety of their devices.
Lawsuits show that C.R. Bard knew the health risks and occurrence of filter malfunctions less than a year after launch of their devices. One document in particular, an investigative report called the “Lehmann Report,” shows that C.R. Bard knew that the IVC filters were migrating and breaking off in the human body. Yet, despite that report, C.R. Bard did not inform the public or the FDA of those risks, and instead told its employees to keep it a secret. The FDA has since issued warnings on several occasions about these filters and the health problems they pose.
The FDA has also since issued a number of safety warnings about the use of retrievable IVC filters. In 2010, an FDA report detailed over 900 reports of adverse events from retrievable IVC filters, including 70 punctures, 328 device migrations, 56 filter fractures, and 146 embolisms. Based on this data, the FDA concluded that the IVC filters posed risks of filter fracture, device migration, and organ puncture, and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated its findings in 2014, stating that most IVC devices should be removed early, within the 29th to 54th day after implant, as the warnings signs from complications often come too late.
Some manufacturers have responded to these warnings by creating removal systems for their products. Most of them are properly screened and approved. But, in July 2015, the FDA sent a warning letter to C.R. Bard stating that their “Recovery Cone Removal System” was not properly approved for use. As a result, C.R. Bard’s own removal system cannot currently be used to retrieve the company’s own IVC filters. Patients now have to use a different company’s removal filter, which may not be well suited to the design of the device implanted in them.
If you had an IVC filter implant or suffered complications from it, you might have legal options. Please give us a call at (619) 237-3490 and ask to speak to John Gomez, Ahmed Diab, or Kristen Barton. Our IVC Filter attorneys are reviewing potential cases involving these filters and any resulting injuries they cause.
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