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A risk of death or serious injury exists for people who may form blood clots in their legs or pelvic region, known as deep vein thrombosis (DVT). Some devices intended to reduce or prevent this risk are inferior vena cava (IVC) filters.
Retrievable IVC filters are indicated for temporary or permanent placement inside the IVC. These devices are supposed to catch blood clots traveling from the lower extremities via the IVC. The U.S Food and Drug Administration (FDA) has issued two Safety Communications, however, advising that retrievable IVC filters should be removed as soon as protection from pulmonary embolism (PE) is no longer needed.
The purpose of catching the clots is to keep them out of other organs, especially the heart, lungs or brain, where they can bring about death or do serious damage to organ functioning and overall health.
Some retrievable IVC filters have been found to have problems, especially fracture or migration. This can render them unsafe, causing problems such as:
Some of the retrievable IVC filters in which fractures and other complications have been reported are those manufactured by C.R. Bard, Inc., of Murray Hill, New Jersey, and Cook Medical, Inc., of Bloomington, Indiana.
The Bard retrievable IVC filters of concern are these models:
The Cook retrievable IVC filters of concern are these models:
The FDA has been monitoring the problems with these devices. Reports of retrievable IVC filter injuries have been received by the FDA and Safety Communications have been issued to alert the public regarding optimal removal of the filters.
The Bard Recovery model of retrievable IVC filter received FDA approval in 2003.
The other members of the Bard retrievable IVC filter family received FDA approval in 2008, 2010, 2011 and 2013. The Cook Günther Tulip retrievable IVC filter received FDA approval in 2003, the Celect in 2008.
On Aug. 9, 2010, the FDA issued a Safety Communication to summarize some of the health risks pertaining to retrievable IVC filters and to recommend that implanting doctors should consider removing retrievable IVC filters “as soon as protection from PE is no longer needed.”
On May 6, 2014, the FDA issued an updated Safety Communication about the health risks posed by retrievable IVC filters. This second communication updated the first by providing information about new scientific research and postmarket studies related to these devices.
Specifically, the FDA notified the public of an analysis it had conducted based on medical literature that found that if a patient’s risk for PE had passed, removal of the device was favored between 29 and 54 days after initial implantation in a general risk/benefit profile. The FDA again urged physicians to consider removing retrievable IVC filters as soon as PE protection was no longer needed.
Between 2005 and 2010, the FDA said it received 921 adverse event reports involving IVC filters. Of those, more than one-third involved situations where the device broke free and migrated along the IVC.
In 70 of the reports, the device was determined to have perforated the IVC. Perforation of a blood vessel can be extremely dangerous, sometimes causing death.
Perhaps you or a loved one have or had a Bard or Cook retrievable IVC filter that fractured, migrated, perforated your IVC, or caused some other injury.
If so, your retrievable IVC filter injury may entitle you to compensation. The first step is for you to contact an attorney who can analyze your situation and identify the strengths and weaknesses of your case.
As a nationally recognized personal injury law firm, Weitz & Luxenberg is committed to helping clients win cases. For more than 25 years, we have dedicated ourselves to holding irresponsible practitioners accountable, and we have won $17 billion for our clients.
We would feel privileged to assist you. For a free consultation and more information about your legal options, please call us at (844) 787-8721. If you prefer, you can complete our form, and our client relations representative will contact you shortly.
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