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Editor's Note
July 10, 2017

Continued High Rates of IVC Filter Use After US Food and Drug Safety Warning

Author Affiliations
  • 1Department of Medicine, University of California, San Francisco
  • 2Editor, JAMA Internal Medicine
JAMA Intern Med. Published online July 10, 2017. doi:10.1001/jamainternmed.2017.2724

Inferior vena cava (IVC) filters have drawn my attention since I learned about their serious risks from Nicholson and colleagues’ careful study1 of the high fracture rate of (Bard Recovery) IVC filters in 2010. At that time, I commented, “Remarkably, these filters, which are placed inside the IVC, were considered Class II by the FDA—the same risk category of mercury thermometers—and received approval without any clinical data of safety and effectiveness identified in their 510(k) clearances.”2 Publication of the Nicholson study prompted the US Food and Drug Administration (FDA) to review the adverse event database and issue a safety warning in 2010 related to reports of 921 adverse events since 2005 and reminded doctors to remove these retrievable filters. Despite the FDA warning, most retrievable filters are never retrieved3. In addition, evidence suggests that the longer the filter is in place the higher the chance of fracture.1

I learned more about the (lack of) evidence of benefit from IVC filters from the summary of Prasad et al.4 Furthermore, studies show that many IVC filters are placed in persons who are able to take anticoagulants, which is the appropriate first-line treatment for prevention of pulmonary embolism. Indeed, in a chart review of 3 hospitals in Massachusetts only 50% of IVC filters were placed for appropriate indications.5 In addition, the use of IVC filters has expanded to include other groups of patients for whom there is no evidence of benefit, such as prophylactic use prior to bariatric surgery. The report by Reddy et al6 in this issue documents continued unacceptably high rates of IVC filter use after the FDA warning and continued lack of evidence of benefit.

As is true for many treatments that were later shown to be harmful and have been abandoned, such as antiarrhythmic medications for patients following myocardial infarction, or metal-on-metal hips, some argue that it is impossible to do a randomized clinical trial of IVC filters because practice patterns are set.7 As is true for many invasive treatments, IVC filter use is much higher in the United States than any other country. In the absence of evidence of benefit and definite harms, IVC filters get a Less Is More designation. There should be a moratorium on their use unless or until there are data showing efficacy greater than risk.

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Article Information

Corresponding Author: Rita F. Redberg, MD, Department of Medicine, University of California, San Francisco, 505 Parnassus, M1180, San Francisco, CA 94143-0124 (rita.redberg@ucsf.edu).

Conflict of Interest Disclosures: None reported.

References
1.
Nicholson  W, Nicholson  WJ, Tolerico  P,  et al.  Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade.  Arch Intern Med. 2010;170(20):1827-1831.PubMedArticle
2.
Redberg  RF.  Medical devices and the FDA approval process: balancing safety and innovation; comment on “prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade.”  Arch Intern Med. 2010;170(20):1831-1833.PubMed
3.
Sarosiek  S, Crowther  M, Sloan  JM.  Indications, complications, and management of inferior vena cava filters: the experience in 952 patients at an academic hospital with a level I trauma center.  JAMA Intern Med. 2013;173(7):513-517.PubMedArticle
4.
Prasad  V, Rho  J, Cifu  A.  The inferior vena cava filter: how could a medical device be so well accepted without any evidence of efficacy?  JAMA Intern Med. 2013;173(7):493-495.PubMedArticle
5.
Spencer  FA, Bates  SM, Goldberg  RJ,  et al.  A population-based study of inferior vena cava filters in patients with acute venous thromboembolism.  Arch Intern Med. 2010;170(16):1456-1462.PubMedArticle
6.
Reddy  S, Lakhter  V, Zack  CJ,  et al.  Association between contemporary trends in inferior vena cava filter placement and the 2010 US Food and Drug Administration advisory [published online July 10, 2017].  JAMA Intern Med. doi:10.1001/jamainternmed.2017.2719
7.
Jaff  MR, Kaufman  J.  A measured approach to vena cava filter use—respect rather than regret.  JAMA Cardiol. 2017;2(1):5-6.PubMedArticle
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