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The Infuse Bone Graft

Manufactured by Medtronic, Inc., this product was originally approved for the use in lumbar spine procedures. However, in recently filed whistleblower and separate individual injury lawsuits, the company has been accused of marketing the product for use in the cervical spine (neck) procedures, which is an "off-label" use and not approved by the FDA.

The Medtronic Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. According to Medtronic's website, the Infuse Bone Graft provides a scaffolding where new bone can grow. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. The U.S. Food & Drug Administration (FDA) has also approved it for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

The FDA has not approved this device for any other procedure. Using it on the neck area, or operating from the back side, is considered off-label. Other procedures with the device put patients at significant risk of injury. The artificial protein contained in Infuse Bone Graft can inflame nearby tissue. If the material isn't inserted properly, or if it leaks, it can cause bone growth in areas outside the surgical site.

Congress is investigating the possible payment to Orthopaedic Surgeons to hide serious side effects of the Medtronic Infuse Bone Graft. In addition, a recently released report stated that during clinial trials, Medtronic was aware of problems with the Infuse Bone Graft device

Despite the dangers, the off-label use of this graft is quite common. In fact, at least three-quarters of the roughly 200 "adverse events" reported to the FDA involve off-label uses of the product. In November 2008, the U.S. Department of Justice began an investigation to determine if Medtronic illegally promoted off-label use of Infuse bone Graft.

 

Jensen & Associates, PLLC

Jensen & Associates, PLLC has successfully represented hundreds of people with claims against drug and device companies, including the company that made the Infuse Bone Graft.  We would be pleased to evaluate your case.

Helping clients nationwide, one client at a time, for over 21 years.

When you are considering what law firm you are going to engage to represent you in your claims against the drug companies, remember, Mr. Jensen actually has obtained recoveries for victims and their families across the country.

Drug companies have no shortage of resources or money. It is important that you hire a firm that has taken a massive drug company to court and prevailed. Keith Jensen has done so repeatedly. Should your case merit we will do all it takes legally and financially to bring your case to trial. We utilize state of the art exhibits, audio and video presenters and we retain highly qualified experts in the field .

While there are other firms that consider cases involving Infuse Bone Grafts, Mr. Jensen has invested the time and resources necessary to understand the complications of infuse bone grafts, what causes them, how devastating they can be to both the victim and the family and how to find the best medical care for you or your loved one.

Mr. Jensen is committed to his clients, and offers not only quality legal services, but also a genuine concern for the welfare and wellbeing of those that seek his counsel.