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Medtronic Infuse bone graft. If you’ve been watching or reading the news lately, you’re
probably aware of the dangers associated with this product and the recent news about the
alleged cover-ups associated with this manufacturer. My name is Gary Falkowitz and I’m a managing
attorney here at Parker Waichman and I’d like to share some very important information
with you today. July 2002, the FDA (or Food and Drug Administration) provided Medtronic
Inc with permission to promote a product called Medtronic Infuse Bone Graft. This product
is used for spinal surgery. What it consists of is a sponge soaked in a protein that is
then contained in a cage. And it’s usually placed between two vertrbrae to promote bone
growth. Sounds good, right? Not so much. Turns out that not only has the manufacturer been
promoting this product off label – and what does that mean? I’ll explain that to you
in a moment – but recently the news indicates that Medtronic was paying consultants over
$210 million dollars over 15 years. They’ve also edited and changed certain medical journal
articles, downplaying the risks of the product. Now let’s get back to the off label purposes.
Because the FDA only approves the use of products for a certain way, the manufacturer is limited
in how it can promote that product. Well Medtronic decided that these rules didn’t apply to
them. Turns out that 85% of the use of this product was used in an off label fashion.
Now what was it approved for? It was approved for lower lumbar surgery. So lumbar is in
your back. It was also approved for surgery where the entranceway is coming in through
your front (or anteriorly). Turns out it’s been used in the cervical area of your spine
and the thoraxic area of your spine, without a cage, and there are many other ways where
it can be used off label. If this sounds familiar to you and you’ve suffered some of the following
injuries: overgrown bone, atopic bone growth, the need for revision surgery, respiratory
problems, gastrointestional problems, certain types of cancers, nerve injuries, significant
pain; then you may have been affected by this product. 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
Medtronic Infuse every single day. My name is Gary Falkowitz and I thank you for wathcing
this today.