Updated IVC Filter FDA Warnings
There have been several IVC filter FDA warnings issued after many patients have experienced complications related to the implanted devices. These warnings are directed at two of the major IVC filter manufacturers, C.R. Bard and Cook Medical, and include Bard’s Recovery, G2, and G2 Express devices, and Cook’s Gunther Tulip and Celect filters. More than 150 lawsuits have already been filed against these manufacturers for the numerous and serious complications these filters can cause. The severe complications and numerous lawsuits prompted the issuance of two U.S food and Drug Administration (FDA) warnings about the IVC filters in less than five years. If you or a loved one has suffered serious complications and injuries following the implantation of an IVC filter, please contact our legal team today to learn more about your legal options.
IVC Filter Complications and Symptoms
IVC filters are implanted in patients who are at a higher risk for developing blood clots and pulmonary embolism. When these filters remain implanted past the point of risk for a pulmonary embolism, the risk of other IVC filter-related complications rises significantly. Primary complications of these devices include fracture, after which pieces of the filter then migrate to other areas of the body, primarily to the heart and lungs. This fracture and migration can result in numerous other serious health complications, including:
- Blood clots, pulmonary embolism, and deep vein thrombosis (DVT)
- Organ perforation and other damage
- Cardiac tamponade
Symptoms of a fractured or migrated IVC filter are similar to that of a heart attack. IVC filter patients may experience chest pain and shortness of breath. It can be difficult to determine the cause of the symptoms, however, these complications are severe and life threatening, typically requiring emergency treatment.
FDA’s First IVC Filter Warning
The FDA issued the first warning regarding IVC filters in August 2010. The statement was issued to warn medical professionals about the potential risks and complications associated with IVC filters. The FDA advised healthcare providers to remove the IVC filters from their patients as soon as the risk of pulmonary embolism has passed to reduce the risk of further complications.
FDA’s Second IVC Filter Warning
The FDA issued their second warning regarding IVC filters in May 2014. The update to the initial warning stated that studies and analyses found that many of the severe complications that are associated with IVC filters are related to the length of time these devices remain implanted in the patient. The FDA also updated their safety statement regarding IVC filters to recommend that the filters should be removed within 29 to 54 days of implantation to minimize risk, or as soon as there is no longer a risk of pulmonary embolism.
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FDA’s Warning to C.R. Bard
In 2015, the FDA issued a specific warning letter directly to Bard regarding the manufacturer’s facilities in New York and Arizona. The warning letter states that Bard misfiled customer complaints, including the report of a patient death; manufactured the Recovery device without the necessary approval; and failed to inform the FDA of serious device malfunctions.
Misfiling of Complaints
A complaint filed in Arizona concerning Bard’s G2 filter was filed by the company as a malfunction when it should have been filed as a death.
Manufacturing Without Approval
Significant changes and modifications were made to the Recovery device, which was then introduced to the U.S. market. These changes should have been submitted to the FDA for approval through a premarket notification as required by 510(k).
Failure to Inform FDA of Risks
Bard failed to inform the FDA within the required 30 days of a complaint that the device malfunctioned and could result in serious injury or death. Unsatisfied with Bard’s response to the FDA’s initial inspection and report, the FDA issued a warning letter, which also suspended any unapproved IVC filters.
Find an Experienced IVC Filter Attorney
The extended implantation of IVC filters often results in serious injuries that require additional medical treatments and surgeries, with ever-increasing medical expenses. If you or a loved one has suffered a severe injury related to an IVC filter, please contact our experienced legal team today to schedule a complimentary consultation to discuss the legal options available to you.