FDA

Posts Tagged With ‘FDA’

7049138_mA South Dakota woman has filed a lawsuit against the makers of the IVC filter she’d had implanted to prevent embolism. This decision comes after discovering the filter had become lodged in an internal organ – and considered to be irretrievable.

The IVC filter has been known to cause problems with long term use, so the FDA has recommended that doctors remove the device after their patient is no longer facing threats of pulmonary embolism – usually between 29 and 54 days after the initial implant. For this plaintiff, the IVC filter was never removed. Eventually, the filter dislodged from the spot where it was supposed to stay, migrating around the body before becoming stuck in an internal organ.

Shockingly, there are hundreds of adverse event reports submitted to the FDA. In spite of their concern – not to mention their pain and suffering – IVC filters remain on the market. One small battle has been won, recently, however. The FDA required pharmaceutical companies to include black box warnings that alert both doctors and patients to the potential for danger.

Legal Help

IVC filter lawsuits are being filed across the country.  If you have have an IVC filter and experienced injuries due to the fragmentation and migration of this device, contact our lawyers for a free case evaluation 877-544-5323.

 

If you have an inferior vena cava (IVC) filter implanted, the FDA highly recommends that it be removed as soon as medically possible. The Food and Drug Administration (FDA) issued this warning following nearly a thousand adverse event reports from patients with IVC filters.

IVC Filters Left in Patients Too Long

What many patients – and even doctors – don’t realize is just how dangerous the IVC filters can be when left implanted too long. The filters have been known to migrate within the body, causing potentially life-threatening damage. IVC filter manufacturers failed to warn users about the need to remove the device as soon as the threat of pulmonary embolism passes.

Life-Threatening Complications

Nearly 10 percent of the adverse event reports document the device puncturing a blood vessel or organ. More than a third of the reports show the IVC filter migrating inside the body.

The IVC filter has undoubtedly saved many lives, but without a proper understanding of how the device works, doctors and patients alike are left in the dark about the potential for risk.

IVC Filter Injury Lawsuits. Do You Have A Case?

Have you had complications with your IVC filter?
Were you told your IVC filter could not be removed?
Have you had an IVC filter for an extended period of time?
Was an IVC filter involved in your loved ones death?

The Law Offices of Richard J. Serpe, PC are currently investigating cases related to IVC filter complications. If you would like to setup a free consultation with our office to discuss your situation, contact us at 877-544-5323.

 

A new study shows a link between unretrieved IVC filters and deep vein thrombosis. IVC filters are designed to prevent pulmonary embolism, but many times are not removed after they’ve done their job. This was thought to be harmless, as many of the pharmaceutical companies behind the medical device did not warn physicians of the associated risks.

FDA Says Remove Filters After Danger Has Passed.

IVC Filters Are Being Left in Patients For Far Too Long. 

The FDA recommends that IVC filters be taken out after the danger of pulmonary embolism has passed – usually about one to two months. Unfortunately, however, many patients walk around with these devices for far longer than recommended. When the device isn’t retrieved in a timely manner, the study shows, it can lead to IVC filter thrombosis. If the devices aren’t removed, patients with untreated IVC filter blood clots have a 90 percent chance of suffering post-thrombotic syndrome. This shocking figure likely comes as a surprise to doctors and patients alike.

It’s not easy to diagnose IVC filter thrombosis, which is why advocates urge physicians to remove the filter according to FDA recommendations, rather than wait around for complications to arise.

Numerous Reports of IVC Filter Complications

This is yet another risk associated with IVC filters. In 2010, the FDA reportedly received more than 900 adverse event reports about the device. Since that time, who knows how many more issues have been reported? From migration to tearing and components breaking lose, IVC filters come with risks no patient should be subjected to.

Do You Have A Case?

Have you had complications with your IVC filter?
Were you told your IVC filter could not be removed?
Have you had an IVC filter for an extended period of time?
Was an IVC filter involved in your loved ones death?

The Law Offices of Richard J. Serpe, PC are currently investigating cases related to IVC filter complications. If you would like to setup a free consultation with our office to discuss your situation, contact us at 877-544-5323.

Free, No Obligation Consultation 877-544-5323