A blockbuster investigation by some print media outlets has spurred a US Senate Finance committee to start beating the bushes once again around the medical devices industry.
There are many questions:
How safe are the products that wind up in your body?
What do the manufacturers know about potential safety issues, but aren’t telling?
Why is it okay for a doctor or surgeon to be paid by a medical device manufacturer? And can you really trust what a doctor [who is paid by the device maker] says about that device?
Do you feel like a guinea pig?
It was revealed yesterday through a series of articles published by the Milwaukee Journal Sentinel and MedPage Today that there is some controversy surrounding Medtronic Infuse, a popular bioagent known as bone morphogenetic protein-2, designed to foster bone growth required for spinal fusions.
Infuse was approved by the US Food and Drug Administration (FDA) in 2002 and doctors love it. It’s easy to work with. And you don’t have to harvest a patient’s own bone from elsewhere, in order to accomplish the surgery. You have to love something that allows a surgery to proceed faster, and more easily.
But here’s the rub—and the reason for the Senate Committee investigation. It seems that a cadre of surgeons around the country were paid by the device manufacturer, Medtronic. Those same surgeons with financial ties to Medtronic were involved both in the clinical trials for Infuse, Read the rest of this entry »