The purpose of this page is to explain the Medtronic Bone Infuse, how it works, and why suits are being filed around the country for injuries from this product.
The Medtronic InFuse Bone Graft is a product that helps patients to create bone in a number of difference situations. The way it works is complicated—it contains recombinant human bone morphogenetic protein (rhBMP-2), and provides a type of “scaffolding” to allow new bone to grow. It is approved for fractures of the tibia, degenerative disc disease, and two types of dental bone grafting procedures. Before this product came along, most patients would have bone harvested from the hip. Three years ago, Medtronic made over $900 million selling this product. In 2013, those sales are falling as the world gets wise to flaws of this products.What injuries can the Medtronic Infuse cause?
Medtronic Infuse injuries include:
- Uncontrolled bone growth
- Nerve damage
- Male sterility/infertility
- Difficulty breathing or swallowing (when used in neck surgeries)
- Loss of bone
- Severe inflammation or swelling
There is a lot of data coming out now about Medtronic Infuse cancer injuries and Medtronic Infuse sterility in men. The cancer risk could be three times as a high as a person who does not use Medtronic Infuse.What did Medtronic do wrong?
Doctors are continuing to discover the problems with Medtronic’s Infuse. The 2011 issue of The Spine Journal was devoted to the Infuse and its high rate of medical complications. Through that report and other patient experiences, we learn that Medtronic rushed this product to the market, and fudged on their data to get it there:
- Medtronic reported ten to 50 times fewer complications than demonstrated by the initial study data
- Many study authors received very high payments from Medtronic
- Infuse can cause problems with the spinal cord and nerves
Stanford University’s Dr. Eugene Carragee stated that:
It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual. Yet harm has been done. And that fact creates a basic moral obligation.
The evidence indicates that Medtronic was probably illegally encouraging doctors to use the Infuse off-label—meaning, for a purpose other than that approved by the FDA. The FDA issue a warning to doctors and to Medtronic in 2008, telling them that off-label use in cervical spine (neck) procedures was a really bad idea.
Medtronic hired Yale to do a study figuring no one could attack Yale, right? Yale released its study in 2013. The results were not good and just confirmed why these suits are being filed in the first place. The Yale study also confirmed what we all knew: Medtronic-sponsored publications analyzed or reported their study results in biased ways to indicate that it was more effective than it really was. So, basically, Medtronic paid Yale $2.5 million to confirm their worst fears. Medtronic's reaction? They continue to defend their product.
This whole thing is such a mess and it is now coming to light. Now, there is a new class action lawsuit that has been filed by Medtronic shareholders coming from this whole mess. That's right. This scandal is so big that stockholders have filed suit alleging they bought Medtronic stock at inflated prices premised on lies about Infuse. Get this: The West Virginia Pipe Trades Health & Welfare Fund is the one that brought this legal action on behalf of all Medtronic stockholders. What does this tell us? The whole system was royally screwed up here. The burden of these mistakes were borne by the group that is often the pawns in these cases: the patients. It is just plain outrageous.
Meanwhile, this company can't get it through its thick head that something very wrong has happened here. In a June 17, 2013 press release, Medtronic said that a recent study shows that Infuse is "a safe and effective treatment option for patients in approved indications for use." This is the same study that found that it is difficult to find "clear indications" for the use of Infuse. The study also said we don't know yet whether it causes cancer and that there is no evidence that Infuse is more effective than natural bone graft in and that there is "some evidence of an association with important harms."
Oh, by the way, this is a Medtronic commissioned study we are talking about. Apparently, when you are not virtually bribing doctors to write good studies, even your own studies do not come out very well.Contact us
If you have used Medtronic Infuse for bone growth and have had any injuries, including additional surgeries, sterility, cancer or swelling, contact our team at 1.800.553.8082, or online. We are investigating Medtronic Infuse lawsuits nationwide.For more information
- More Information on Bone Infuse Claims
- Medtronic’s Infuse Bone Graft fact sheet