When The Star-Ledger first began examining the world of medical implants, we soon faced a major irony: We were reporting on a flawed regulatory system and, to do it, we were crunching numbers based on data coming out of this flawed system. But we found that troubled data isn't necessarily useless data. It just requires a little more thought. We already knew from documents and interviews that the Food and Drug Administration's regulation of the medical device industry was lax.
The results of our analysis of FDA recall and malfunctioning device data provided numbers that illustrated the scope of the problem in our project, "Foreign Objects: The Risky World of Medical Implants." It showed us what kinds of devices we needed to examine and illustrated what kinds of problems were cropping up with these devices. The idea of looking into the medical device industry, and specifically implantable devices, came out of our Washington bureau.
Reporters Robert Cohen and J. Scott Orr had covered regulatory changes at the FDA for several years and had taken note of some medical device recalls that had made national headlines.