Bard IVC Filter lawsuits and Cook IVC Filter lawsuits are revealing that the FDA has done no independent clinical testing of IVC filters. Many patients injured by fractured, migrating, titling on penetrating IVC filters are surprised to learn that the FDA basically rubberstamps approval if new IVC filters.
The pre-market testing and regulatory review that retrievable inferior vena cava (IVC) filters underwent (such as those made by Bard and Cook) before they were marketed in the United States was far less rigorous than what many people assume for an implantable, moderate-to-high risk medical device.
Most IVC Filters Were Cleared Through the FDA’s 510(k) Pathway
Unlike high-risk implantable devices that require full Premarket Approval (PMA) with clinical trial data, most retrievable IVC filters were cleared through the FDA’s 510(k) premarket notification process. [i] Manufacturers must show that their device is “substantially equivalent” to a predicate device already on the market. Under 510k approval, clinical safety or effectiveness data are generally not required.
For many retrievable filters, this means:
- Each new generation was cleared by comparing it to the previous generation as a predicate device.
- No new clinical trials were required to demonstrate safety or effectiveness before marketing.
- Pre-market clinical data may be very limited and not uncover the life-threatening risks of fractured pieces entering the renal veins, internal organs, the heart and the pulmonary artery.
Questions about Cook IVC Approval Process?
A recent medical journal article, Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters , took an in depth look at the approval process for the Cook Celect filter. The article abstract states that “Recently unsealed court documents from litigation related to Celect reveal that the device’s clinical study protocol did not follow U.S. Food and Drug Administration (FDA) guidance for IVC filter testing and that study outcome definitions for IVC perforation had lower sensitivity for detecting adverse events than those recommended by professional societies. Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in the published literature and on the device label, providing patients and clinicians with inaccurate information about the device’s safety.”
An important takeaway from the article is that due to the lack of premarket testing, there needs to be more transparency of post-market usage experience. Any complications, including deaths, need to known by doctors and patients so more informed decisions can be made about IVC fitler use.
The Need for More FDA Oversight?
This is a question that many are asking because the FDA 510k approval process is very weak. Our firm has been filing and settling IVC filter lawsuits for serious injuries from IVC filters that fail. Retrievable filters have been causing serious injuries since 2000. We agree with recent commentary that more oversight and transparency needs to occur.
[ii] https://pubmed.ncbi.nlm.nih.gov/39556835/
