IVC Filter Removal Specialist Says Devices “Should Have Been Recalled”
Dr. William Kuo, a doctor who specializes in removing damaged inferior vena cava (IVC) filters at the IVC Filter Clinic at Stanford Health Care, has spoken out about the dangers of the controversial medical devices, which have been implicated in hundreds of reports of serious injuries and more than three dozen patient deaths. According to Dr. Kuo, IVC filters, implanted to reduce the risk of blood clots and pulmonary embolism in patients who are unable to take anticoagulant drugs, “absolutely […] should have been recalled.” If you received an IVC filter in the past, and you have since suffered complications like filter migration, filter fracture, or perforation of the vena cava, consult an experienced IVC filter attorney to discuss your legal options.
Potential Side Effects of IVC Filters
IVC filters like C.R. Bard’s Recovery and G2 series of filters are small spider-like devices implanted in the inferior vena cava to trap blood clots that may break free from the lower extremities and travel to the heart or lungs. In most cases, the placement of an IVC filter is meant to be temporary, and the FDA recommends that the devices be removed within one to two months after implantation, to reduce the risk of complications. However, many patients who received retrievable IVC filters in the past have suffered serious complications allegedly caused by the devices, including filter fracture, filter migration, filter embolization, and perforation of the vena cava.
IVC Filters Prone to Fracture, Failure
According to a growing body of research, IVC filters may be prone to fracture and migration, and also tend to be extremely difficult to remove, especially when they have tilted out of position or moved to other parts of the body. In one case of a damaged blood clot filter, 69-year-old Christopher Svedise of San Francisco, California received a Bard G2 IVC filter in 2010, the final year the filter was on the market. In October 2015, Svedise was informed by his doctor that his IVC filter had come loose and migrated from its original position, and was now dangerously close to his heart. Two surgeons refused to remove Svedise’s IVC filter, due to its precarious location, and so Dr. Kuo was called in to help.
Dr. Kuo has developed a special surgical method for removing damaged or defective IVC filters and broken fragments of filters that have fractured and embolized to the heart or lungs. During Svedise’s procedure, two fragments of the filter broke off and floated into the heart muscle, but Dr. Kuo and his team were able to remove them safely. According to Dr. Kuo, he has removed more than a thousand damaged IVC filters since 2006, most of which were manufactured by C.R. Bard. Unfortunately, some filters that have become damaged or migrated out of possible are difficult or impossible to remove, which may expose patients to an even greater risk of injury or death.
Bard May Have Known About IVC Filter Risks
The potential for IVC filters to cause serious and potentially life-threatening complications has been evident for years. In September 2015, an NBC News investigation revealed that executives at C.R. Bard knew about the dangers of the Bard Recovery filter, yet concealed these risks from the public, healthcare professionals and the FDA. And, instead of issuing a recall of its potentially defective Recovery filter, C.R. Bard simply replaced the device with a slightly modified version of the filter, the G2 and G2 Express series of filters. Furthermore, there is evidence that Bard committed criminal fraud in order to obtain approval from the FDA for the new filters.
Pursuing Compensation for IVC Filter Injuries
As Dr. Kuo says, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications. The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted. Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.” If you believe you have been adversely affected by side effects of an IVC filter, you may be entitled to financial compensation for your injuries and medical expenses. Contact a knowledgeable product liability lawyer today for legal help.