Great piece by Barry Meier in today’s New York Times outlining the issues that won’t be discussed at a two-day Food and Drug Administration advisory committee meeting on the safety of implanted hips, which have caused numerous injuries and required thousands of patients to undergo repeat replacement operations. He writes:
Neither government, industry nor the medical profession appear eager to address the fundamental issue raised by the episode: Why were these devices implanted in 500,000 people without adequate testing? . . . Under F.D.A. rules, orthopedic implant makers did not have to run clinical trials of the hips before marketing them, nor were they required to follow patients afterward to see how they fared. Doctors embraced the implants without evidence they were better or more durable than existing ones.
The article forgets to mention one salient point. This hearing takes place just one day after Congress passed and sent to the president reauthorization of the FDA’s user fee act. The five-year bill did nothing to redress the well-known problem of inadequate testing for medical devices despite a clear warning from the Institute of Medicine that a complete overhaul of the regulatory process was needed.Did you like this? If so, please bookmark it, RSS feed.