A defective medical device highlights faults in the medtech industry

Dec 25, 2024

In the early 2010s, something horrifying happened to patient Tonya Brand. A piece of metal was sticking out of her thigh.

Doctors soon figured out it was an inferior vena cava (IVC) filter, a device designed to catch blood clots and prevent pulmonary embolism. Brand had the device, made by Cook Medical, implanted two years earlier.

Brand sued Cook Medical in 2014 and, until now, neither Cook nor the FDA has shared any details. And a court order banned anyone involved in the trial from discussing the details—until now.

Illustration by Mary Delaney

The story: A new article in the Annals of Internal Medicine highlights findings that suggest the device’s clinical trial design may have missed critical safety concerns.

One of the authors is Yale cardiologist Harlan Krumholz, who was an expert witness in Brand’s case and thus barred from speaking about the case until successfully lifting his speech restrictions in 2022.
The article argues that patients need a much better understanding of a device’s safety and efficacy before consenting to and undergoing implantation.
The authors take issue with what they see as the FDA’s lack of transparency, which has implications beyond this type of device.

IVC filter woes: Here are some of the key reasons IVC filters specifically can be tricky to manage by both clinicians and regulators.

IVCs are old devices. They were first invented in the 1960s, predating the FDA’s regulation of medical devices, which began in the 1970s.
So, manufacturers have never had to do as stringent clinical review of these devices, submitting new ones through the 510(k) pathway instead, which only requires that manufacturers prove that the new device is substantially equivalent to those in the market.
IVCs also aren’t meant to be permanent, but follow-up doesn’t always happen. In fact, data show that doctors often forget to follow up to remove the device.

However, the authors of the article aren’t just here to ring the alarm on IVC filters. They take issue with what they see as the FDA’s lack of transparency, which has implications beyond this type of device.

Our takeaway: Trust makes or breaks medtech. This is just yet another example of how mistakes and opaque bureaucracy make it harder for patients, clinicians, manufacturers, and regulators to trust one another. And in the end, patients suffer.

Stories like these highlight important safety issues, pressuring manufacturers and regulators to do better.
However, sensational stories of harm, even when very unlikely, understandably frighten patients, eroding trust in care that might truly be lifechanging or even lifesaving in a vast majority of cases.
We need to balance this truly important demand for openness and transparency with the need to build trust.

Moving forward, we’re looking to see how regulatory shifts may or may not make a difference in cases like this one. For instance, the FDA has recently made a change to its high-risk recall policy, ensuring that the public is alerted faster.

We’re heartened by this shift and we hope regulators and developers keep doing better—and that whistleblowers continue to have the courage and right to speak up, for the good of all of our health.