For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women facing a lifetime of pain and the loss of their sex lives from pelvic mesh products, to necrosis and infections from metal-on-metal hip implants, to deaths and serious “superbug” infections from inadequately sterilized duodenoscopes.
Added media scrutiny, including Netflix’s “The Bleeding Edge” documentary and the International Consortium of Investigative Journalists’ Implant Files, draws worldwide attention and could even lead to tougher device industry regulations in the U.S. and abroad. The FDA, for example, is already considering a reboot of the 510(k) clearance pathway, which critics say allows unsafe and ineffective devices onto the market.
Here are the stories of 10 examples of medical devices that went tragically wrong.
Story by associate editor Danielle Kirsh and managing editor Chris Newmarker. Senior editor Nancy Crotti and executive editor Brad Perriello contributed to this report.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.