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FDA Encourages Reports of IVC Filter Errors

June 23, 2016 · FLEMING | NOLEN | JEZ, L.L.P.

As more IVC filter lawsuits come to light, we are starting to see even more adverse effects. These are potential problems that may arise after the filter has been implanted in the patient. This device that is supposed to help catch blood clots has been reportedly causing several issues for patients, including migrating devices, perforation, and more. Now, the United States Food and Drug Administration (FDA) has set forth warnings about the use of IVC filters. Their statement included more than 900 adverse events, some that are related to the retrievable device being left in the patient longer than recommended or necessary.

Previous recommendations urged doctors to remove the filter from the patient within 29 to 54 days after it has been implanted. Prolong implantation can lead to serious side effects and health problems associated with the filter. The device can fracture, resulting in blood clots being allowed to move through the vein and towards the lungs and heart. This can result in a pulmonary embolism, stroke, or even death. In some cases, the device is irretrievable, which can cause long-term dangers to the patient.

The FDA provides their MedWatch portal where individuals can report the adverse events. This includes medical professionals and patients alike. There are five main devices currently on the market that have been targeted including the Bard Recovery Filter, the Bard G2 Filter, the Bard G2 Express Filter, the Cook Gunther Tulip Filter, and the Cook Celect Filter. They are designed to be an alternative for patients who are at risk of blood clots, but are unable to take blood thinners or anticoagulant medications. Determining who is liable if you have been harmed by an IVC filter can be difficult, but it usually falls on the manufacturer.

Some studies have been done to determine the rate of IVC filter failures and fractures. Some estimate this to be one in every four filters experience a fracture while other studies have reported up to 31% of IVC filters failing. These shards can puncture the vein or migrate to the lung or heart. It is important for patients and healthcare professionals to report these events to help with potential lawsuits and hold the manufacturer accountable. Not only can an injured patient seek compensation, but filing a lawsuit can help prevent injury to patients in the future due to these defective medical devices.

At Fleming | Nolen | Jez, L.L.P., our IVC filter lawyers have extensive experience handling cases involving defective medical products. We have put together lawsuits for victims of IVC filters and we know how to navigate the legal process. If you or someone you love has suffered a serious injury — or if you lost a loved one — due to an IVC filter failing, fracturing, or perforating, it may be in your best interests to speak with a team who has seen this type of case before and knows how to protect your rights. This is exactly what you’ll find when you have our team on your side.

Our firm has more than 170 years of combined experience and the tenacity necessary to hold IVC filter manufacturers accountable for their failed and defective products. We encourage you to not only report the adverse events to the FDA, but to also contact our firm to learn about your legal rights and options. We aim to help you get the justice you deserve.

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