You've recently had back surgery and you've just learned that the
doctor used a medical device to implant inside of your back to
help grow the bone. I want to tell you about a specific device
which reportedly might be the cause of some major issues. My
name is Gary Falkowitz and I am an attorney here at Parker
Waichman and in mass torts litigation department. The
Medtronic Infuse is a device that's implanted
inside one's back to combat degenerative disk disease. What
it does is that genetically engineers bone inside of your
back. Whereas in the past doctors may have used bones from
one side of your body to implant in your back to help fight the
degenerative disk disease, this is actually a protein that
genetically engineers new bone in your back. The problem is
doctors are using the Medtronic Infuse off-label. What does
that mean - off-label? The Food and Drug Administration approves
medical devices for a certain purpose and if a doctor or
surgeon uses that medical device for another purpose or another
area in your back, then that's considered off-label. Why is
that an issue? There are some major injuries associated with
the off-label use of the Medtronic Infuse, including
difficulty breathing, difficulty swallowing, revisionary
surgery, cancers.
You probably have questions because you recently
had back surgery and the doctor implanted a device in your back.
I answer questions about surgeries in the back
every single day. My name is
Gary Falkowitz and I thank you for watching this video today.