Written by on June 1, 2016 in blogs, Personal Injury

The inferior vena cava (IVC) is a very large vein that moves blood from the lower body to the heart. Patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication, often have IVC filters implanted, especially after major surgeries.

IVC vein filters are small, cage-like devices designed to be implanted to prevent blood clots from moving from the lower body to the lungs or heart. IVC vein filters manufactured by C.R. Bard and Cook Medical may cause serious injuries, including Bard’s Recovery®, G2®, G2® Express (G2®X), Eclipse®, Meridian®, and Denali® Vena Cava Filters.

 According to reports made to the U.S. Food and Drug Administration (FDA), long-term use of retrievable IVC vein filters may cause serious side effects, including:

• Causing Blood Clots (Deep Vein Thrombosis or DVT)
• Difficulty removing the filter
• Movement of the entire filter or filter fragments to the heart or lungs or to another area of the body (Embolization)
• Fracture of the filter
• Causing a hole in the IVC vein
• Tilting of the filter

Side effects may occur in as little as a week or even years after it is inserted.

Risks of Long Term Use

 In 2014, the FDA updated its initial findings and recommended that IVC vein filters be removed between 29 and 54 days after being inserted.1

Another study2 , published in April 2013, found that while most of the IVC vein filters it reviewed were designed for retrieval, only 8.5% were successfully removed. In other words, 91.5% became permanent filters even though recent data show that increasing complications occur when the filters are left in place for longer periods.

NBC News Investigation

In 2015, NBC News reported in a multi-part series about the potential deadly risks of IVC vein filters and how filter manufacturer C.R. Bard allegedly forged a letter to receive FDA clearance for its Recovery blood clot filter – after the FDA previously declined to clear the filter.

In Part I of its investigation into the Recovery blood-clot filter, NBC News revealed that the device, which is implanted in thousands of people, was associated with 27 deaths and hundreds of other non-fatal problems after it received FDA clearance.

In Part II of the report, a former insider at medical giant C.R. Bard raised questions about how the device got that clearance.

And, in Part III, confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration. Instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them. According to C.R. Bard and FDA records, at least 12 deaths and hundreds of problems are now linked to the G2 series filters.

 Watch here:

Part I: http://www.nbcnews.com/nightly-news/video/medical-device-to-prevent-blood-clots-associated-with-27-fatalities-518273603659?cid=eml_onsite

 Part II: http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246?cid=eml_onsite

Part III: http://www.nbcnews.com/health/health-news/why-did-firm-keep-selling-problem-blood-clot-filters-n488166?cid=eml_onsite

FDA Warns C.R. Bard

In July, 2015, the FDA issued a warning letter3 to medical device manufacturer C.R. Bard for eight violations of federal law regarding its IVC vein filters, including but not limited to the Denali Filter,® the Simon Nitinol Filter® and the Recovery Cone Removal Kit.® Some of the violations cited were:

  • Filing of serious injury and death complaints as “malfunctions,” including detached filter arms, broken filter, IVC perforation and aneurysm and filter leg fragment embedment in IVC wall.
  • Failure to fully explain why at least 10 scheduled IVC filter retrieval surgeries resulted in failed attempts at removal.
  • Failure to rule out that the malfunction of one of the firm’s long-term IVC vein filter implants “would not be likely to cause or contribute to a death or serious injury, if it were to recur.”

We Can Help

 If you or a loved one have had an IVC vein filter installed and are concerned about side effects, please contact us for a free consultation.

1     http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm

2    http://archinte.jamanetwork.com/article.aspx?articleID=1669107

3     http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm

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