There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.
Veteran regulatory consultant Michael Drues thinks the problems outlined in the reports echo concerns going all the way back to when the FDA started regulating medical devices in 1976.
They raise similar questions, too. “What do we do to prevent them? How do we prevent more from happening?” Drues said during his newest podcast with Medical Design & Outsourcing.