Consumer Tort Network here to review a recent study by Temple University that was published in the July 10th, 2017 issue of JAMA Internal Medicine.
Temple University conducted a nationwide study to identify what impact was made on implant rates, following the FDA’s 2010 safety communication recommending the removal of filters as soon as Pulmonary Embolism (PE) protection is no longer needed.
The professors (led by Riyaz Bashir) used the National Inpatient Sample database to identify all IVC Filter implant patients during January 2005 and December 2014. And here were their findings:
Approximately 1,131,274 patients underwent IVC Filter implant surgery over the 10-year study period. IVC Filter placements saw a 22.2% increase from 2005 to 2010. After the FDA safety communication in 2010, IVC Filters saw a 29% reduction in placement from 2010 to 2014.
For purposes of international comparison, the United States has an IVC Filter implant rate as high as 55 per 100,000 consumers, while the largest European countries have an implant rate of 3 per 100,000 consumers.
Not only did the FDA’s questionable approval process fail the American people, but an earlier safety communications regarding the dangers of IVC Filters could have helped thousands of more consumers.
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