The United States Food and Drug Administration (FDA) has issued several strong warnings to surgeons related to IVC filter medical devices. These devices are implanted when patients have a condition known as pulmonary embolism. The FDA told surgeons that if their patients’ conditions have subsided, they should remove the IVC filters as soon as possible.
The FDA has warned that these implants are being left in patients too long. In one five-year period, this resulted in nearly 1000 “adverse event reports.” The events included:
- 321 times, the IVC filters detached from the implementation spot and migrated through the body.
- 146 times, the IVC filter traveled to the vessels which provide blood to the lungs or heart.
- 70 times, one of the pieces of the device pierced a blood vessel
- 56 times, the device fractured within the vena cava
IVC filters are implanted in the vena cava when a patient is at risk of blood clots. Normally, these patients would just take blood thinners. But some patients are unable to take the medications for various medical reasons, making the devices the best choice. However, the implants should be removed once the immediate threat is over. Unfortunately, that’s not happening.
IVC Filters ‘Dissolve’ Blood Clots
IVC devices are cage-like filters which block blood clots. They ‘hold’ them until the clots dissolve. This way, clots are unable to travel to the lungs and cause pulmonary embolisms.
The implants are not intended to be permanent. They are a temporary device meant to address an immediate threat. The FDA says they should be used for 29 to 54 days. The devices should be removed after 54 days unless the threat of blood clots remains, because of the potential for IVC devices to migrate.
In their most recent communication, the FDA said that manufactures of the devices are required to participate in two new studies designed to test the safety of the implants. Meanwhile, IVC lawsuits continue to rise.
Two manufacturers, C.R. Bard and Cook Medical, are at the heart of most IVC lawsuits. The devices causing the majority of the problems are:
- The Bard Recovery Filter
- The Bard G2 Express Filter
- The Bard G2 Filter
- The Cook Celect Filter
- The Cook Gunther Tulip Filter
The lawsuits are claiming device defects, failure to warn, negligent misrepresentation, manufacturing defects, and breach of implied warranty.
Did Bard Cover-Up Reports of Problems?
The IVC Filter Lawsuits have turned up a number of irregularities in the approval process for the devices. For instance, Bard hired an independent consultant, Dr. John Lehmann, to review the implants. He issued a report, now known as the Lehmann Report, which showed the implants to be dangerous. Bard allegedly suppressed these findings.
The Goldwater Law Firm
While IVC devices can save people’s lives, they can also cause irreparable harm. If you have been injured by a IVC filter, the Goldwater Law Firm can help. Contact us today for a free and confidential consultation about your case.