ABSTRACT
Retrievable inferior vena cava (IVC) filters are increasingly implanted prophylactically in patients who may be at transient risk of pulmonary embolism (PE).
In 2009, the Agency detected an increased trend in the number of adverse events (AEs) related to implanted IVC filters, which was considered a possible safety signal. To properly address the total product life cycle of these devices, an internal multidisciplinary working group was developed with representation from all offices involved in the review and surveillance of these devices with the intent to investigate further these findings and decide as to whether or not regulatory actions should be taken to mitigate any potential risks.
Since the majority of these IVC filters are not removed after the risk of PE has diminished and the true risks of developing a device-related complication after successful placement of an IVC filter is unknown, but such risks would be expected to increase with the duration of implantation as with any chronic implant, the Agency developed a quantitative decision analysis model to assess the benefits and risks associated with these devices to elucidate whether implanted filters should be removed once the risk of PE starts to decrease (Morales et al. 2013).
This chapter discusses the benefit–risk assessment that employed a quantitative decision analysis model to address this issue in the absence of well-controlled clinical studies. On the basis of literature review and expert opinion, the model weighs the risks against the benefits of retrievable IVC filter use as a function of the filter’s time in situ so that the optimal time to remove the filters can be easily identified.
The analysis showed that the optimal time to remove the IVC filters from patients without PE and who may be at transient risk of PE is between 1 and 2 months after implantation.
As a result of this analysis, the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) issued two Public Health Notifications, one in 2010 252and another in 2012, recommending removing retrievable IVC filters as soon as protection from PE is no longer needed. Our analysis provided supportive evidence to FDA’s recommendations.
At the end of this chapter, we discussed practical issues and future applications of similar quantitative models.
