FDA Warnings on IVC Filter Implants
IVC Filters have been used for many years, their development was designed to help decrease the risks of blood clots to the heart and lungs from the lower part of your body. Bard launched their Recovery IVC Filter in 2003 but quickly discontinued and replaced by the Bard G2 IVC Filter in 2005. As complaints and injuries continued to come into the FDA, the investigation into the IVC Filter began to intensify. It finally reached it’s boiling point when the FDA issued a safety alert in 2010, urging doctors and patients to investigate the removal of these temporary filters. The majority of the problems occur when the removable device is not removed in a timely fashion. These "retrievable" IVC Filters were designed for the short term and were to be removed once the blood clot risks subsided. Unfortunately, only a small amount of these devices have been removed which caused the FDA in 2014 announced that these devices should be removed within 29-54 days of implantation.
What is an IVC Filter?
IVC Filters are implanted into the inferior vena cava (IVC) vein. The purpose of the IVC is to transfer blood back from the lower half of the body back to the heart and lungs. The device is an small octopus-like device that expands when it is implanted. These implants occur in the abdomen region and are meant to help individuals that have a temporary increased risk of blood clots originating from the lower half of the body. Blood clots that occur in the heart and lungs can cause Pulmonary Embolisms (PE). There are permanent IVC Filters and Retrievable IVC Filters. The retrievable devices are the ones having the most issues because the filters are being left in longer than it was intended. Here are the manufacturers having complications with their devices:
- Bard Recovery Filter
- Bard G2 Filter & G2 Express Filter
- Cook Gunther Tulip Filter & Celect Filter
- Cordis Optease Filter (Johnson & Johnson)
- Crux Vena Cana Filter
Retrievable IVC Filter Complications
Most of these complications were very preventable as the device manufacturers were warned by the FDA about the issues with these temporary devices being left in too long. All of the below complications can have minor, serious or even fatal side effects. It is important to contact your doctor immediately if you or a loved one has an retrievable IVC Filter implant. You owe it to your health and family to educate yourself about the risks associated with your implant and what happens when it is left in past its intended time. Here are the current complications being caused by IVC Filter implants:
- IVC Filter Migration
- IVC Filter Fractures
- Filter Perforation
- IVC Filter Tilting
- Immovable IVC Filters
Side Effects of the IVC Filters
The tragedy with this device that was meant to help people, is that it has numerous painful and even permanent side effects. That is why it is crucial to contact your doctor as soon as possible to limit any potential complications with your implant. These side effects include:
- Severe Pain
- Pulmonary Embolisms
- Perforation of Organs
- Heart Attacks
Hopefully, you found this information and contact your physician as soon as possible. After speaking with your doctor, make your next call to an attorney so they can review your case and make sure your rights are being protected. The personalized service and close attention to detail our defective medical devices lawyers at Reed & Terry, L.L.P. provide, can get you the results you deserve and need. You must act now and call us 24/7 at 281-201-0988 or toll free at 1-877-543-3523 to schedule a free initial consultation or contact us online.
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