Medical device industry: international investigation exposes lax regulationBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4997 (Published 25 November 2018) Cite this as: BMJ 2018;363:k4997
- Jeanne Lenzer1,
- ICIJ reporters
- 1The BMJ
The results of an international investigation tracking the harms of medical devices that have been tested inadequately or not at all are being released today. The investigation, called the Implant Files, was led by the Pulitzer prize winning International Consortium of Investigative Journalists (ICIJ) and conducted by 252 journalists from 36 countries representing 59 media partners, including The BMJ and UK partners BBC and the Guardian.
The investigation was inspired by a Dutch investigative journalist and broadcaster, Jet Schouten, who led a sting operation by convincing the private companies called notified bodies that are responsible for assessing devices that mesh netting from a bag of mandarin oranges was surgical mesh. Schouten said that the results made her want an investigation into device approval around the world.
Over the course of …