New details on a risky medical device show need for more FDA transparency, researchers say

By Lizzy Lawrence

Nov. 20, 2024

FDA Reporter

Tonya Brand was horrified to find a piece of metal poking out of her inner thigh while relaxing at her house in Georgia in 2011. She had no idea what it could be. 

It was only after extensive imaging that her doctors realized what had happened: A medical device that had been implanted in her two years earlier to catch blood clots had broken and was now migrating to different parts of her body. 

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Brand sued the device maker, Cook Medical, in 2014, dredging up information showing that the device’s clinical trial design may have caused researchers to miss critical safety issues. Neither the Food and Drug Administration nor Cook Medical had made this information available to the public — and a court order prevented anyone involved in the trial from sharing it. 

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   Lizzy Lawrence

   FDA Reporter

   Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter.

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