FDA and Bard Study Results

In a recent announcement, the Food and Drug Administration (FDA) reported serious concerns about two types of inferior vena cava (IVC) filters called the Bard Recovery and the Bard G2 vena cava filters. This announcement comes after some interesting results were found from a study completed by Dr. William Nicholson and his fellow researchers at York Hospital located in York, PA. While the results from the study are currently available online, the complete study will be available in print form in November’s issue of the Archives of Internal Medicine. Patients who suffer serous injury after their device migrated or broke are talking to attorneys about IVC filter movement injury compensation.

What are the Bard Recovery and the Bard G2 Vena Cava Filters?

Both the Bard Recovery and the Bard G2 vena cava filters are designed for short term use to reduce the risk of pulmonary embolism. To protect people from blood clots breaking loose from a deep vein their legs and potentially entering their lungs, these IVC filters are implanted in patients for a limited amount of time. For example, the Bard Recovery implant is usually used for around 50 months while the second generation of the implant, the G2 vena cava filter, is used for about 24 months.

The Study’s Results

Dr. Nicholson’s study examined 80 patients who had either of these filters implanted in their body. The study was performed to investigate whether any of the filters had fractured or if broken pieces had migrated to other parts of the patients’ bodies. While the second generation G2 implant was supposed to eliminate the fracture and breakage issues found in the original Bard Recovery implant, both were found to be faulty. In fact, the study revealed that both filters had fractured or migrated in some of the patients involved in the research. The danger with the fracturing, breakage or migration of part of these filters is the threat of serious health complications and potentially sudden death.

The FDA’s Recommendations

After the results from the study were revealed, the FDA has released a statement about the potential risks involved with using these IVC filters. While these devices are designed to help prevent pulmonary embolism in patients who are unresponsive to anti-coagulant medications, the risks may outweigh the benefits. Due to the study’s findings, physicians are now advised to discuss these risks with their patients before the surgery is performed. In addition, physicians may need to be prepared to remove the filters as soon as their patients have a reduced threat of clotting.

Furthermore, the FDA is recommending that doctors thoroughly evaluate each of their patients carefully to consider whether an IVC filter is the best option for their diagnosis. If this implant is required, physicians need to closely monitor their patient’s progress to determine how long the IVC filter should stay in place.

While the FDA is issuing a warning statement about these filters at this time, there is currently not any ban on these products. If you or someone you love has experienced any side effects or injuries caused by defective IVC filters, please contact our law firm to see if you are eligible for compensation.