Tip:
Highlight text to annotate it
X
What’s interesting is that doctors are allowed to use their medical judgment and expertise
in deciding to use a product for a purpose that the FDA did not permit. However, manufacturers
of medical devices are not allowed to advocate or pay doctors to use their device for purposes
for which they were not given permission for by the FDA. Recent evidence seems to indicate
that this is exactly what Medtronic was doing with their product Infuse. My name is Gary
Falkowitz and I’m an attorney at Parker Waichman in the mass torts litigation department.
What I just described to you are allegations that have been made regarding the Medtronic
Infuse. Medtronic Infuse is usually used for those individuals suffering from a degenerative
disk disease or DDD, for short. What’s degenerative disk disease? The disease is when the space
between your vertebras shrinks due to the degeneration of the fibrous disk between them,
usually leading to low back stiffness and soreness. Apparently, about 60% of those over
50 have degenerative disks disease. The Infuse consists of two components: a protein and
a carrier component. What it does is genetically engineer bone growth. Unfortunately, reports
indicate that the manufacturers of this device have been up to no good. Surgeons are being
paid significant sums of money for dishonest reports as to the side effects associated
with the use of Infuse, especially when used for non-intended purposes. You see the Infuse
has only been approved for certain areas and certain types of surgeries related to the
lumbar and sacral regions of the spine. Specifically, anterior surgeries (which means surgeries
performed through the front) for areas between the L2 and S1. Use of Infuse for all other
regions of the spine are unapproved, which means that the FDA has not provided approval.
We’ve noticed the following injuries have been linked to those unapproved uses of Infuse:
acute severe swelling of the neck, cancer, nerve injury, difficulty swallowing, difficulty
breathing, retro-grade ***, sterility, and just significant pain. Now ask yourself,
was your surgery performed in the cervical area? And/or was it performed through the
back or posteriorly? Does it sound like your doctor may have used Infuse? If so, here’s
what I want you to do. I want you to pick up the phone and call the number below. I
answer questions about the use of Medtronic Infuse every single day. My name is Gary Falkowitz
and I thank you for watching today.