In August 2010 the FDA issued a safety warning about the use of IVC Filters, which are commonly used in the treatment of deep-vein thrombosis.
This arose following reports since 2005 to the Food and Drug Administration of issues regarding the use of these filters and was elevated to the status of ‘Safety Alert’ following 921 adverse reports into their use at the time of the 2010 report.
Since that time the issue has been picked up by news media and litigation is on-going against makers of these devices. The original audience for the safety notice was primarily surgical teams and those professionals involved in emergency medicine.
The scope of the issue has however broadened as legal action has been taken and further research work and scientific analysis has been undertaken. In May 2014 the FDA updated its original advice about IVC Filters to widen the alert to all physicians who implant IVC Filters, as well as any professionals who are involved in the ongoing treatment of those who have the devices fitted.
This is indicative of the fact that what had started out as a ‘Safety Warning’ has now morphed over the last few years into something altogether more serious. It now has grown to encompass all of the branches of medicine that use IVC Filters, including trauma care and interventional radiology. So that the original focus of the investigation by the FDA is now much wider, and shows that far more patients may have been affected adversely by these devices then was previously thought.
The work that the FDA has undertaken since their original report in 2010 has been significant. It expands beyond reports from members of the public about concerns and complications from the use of IVC Filters in their treatment. It draws on a wider data-set of current medical studies that exist on the use of IVC Filters and seeks to draw conclusions from an analysis of that data that can be readily acted upon by medical professionals.
This has significance in two particular ways:
First, it is significant for those who have previously been negatively impacted through the use of IVC Filters in their treatment regime. It sets down an analytical framework under which new medical interventions may be advised. It also establishes a likely pattern around which complications may have been experienced. In this regard it is useful as a methodology for doctors to advise treatment structures to mitigate against possible problems. For example, by removing particular IVC Filter brands that have been found to have higher failure rates. Or carrying out checks on those devices to ensure that the problems that some have experienced are not present.
Second, there is also the potential to avoid future issues with new patients. This is especially the case when it comes to treatment suggestions that are indicated by the research that the FDA has investigated.
For future patients who come to be treated for the prevention of blood clots the advice around the use of IVC Filters is now clearer and more defined.
For past patients it seems that the journey to uncover the full extent of the problems that IVC Filters may have caused has only just begun.