The Medtronic Infuse Bone Graft is a bone growth stimulator used during surgery. “Infuse” is a bone morphogenetic protein, a genetically engineered form of a naturally occurring protein. It is applied in liquid form via sponge; it is meant to grow into bone in order to facilitate re-growth and replace damage. It was originally marketed as an alternative to the traditional procedure of harvesting bone grafts from the hip. The Infuse Bone Graft was approved by the FDA in 2002. But, there’s a catch: it was only approved for a very limited set of surgical procedures. The trouble with the Infuse Bone Graft is when it is used for off-label procedures for which it is not approved. A number of lawsuits have already been filed for botched surgeries that used the Infuse Bone Graft for operations it was not intended for.
Off-label usage of the Infuse Bone Graft has been linked with many serious complications. It has been known to cause difficulty breathing, swallowing or speaking, airway compression, respiratory depression, nerve damage, unwanted bone growth, and even death. Despite the FDA’s warning of the potential dangers of off-label Infuse procedures, usage of this system has not waned. It is alleged that Medtronic actually encouraged doctors to pursue the Infuse Bone Graft for cervical spine surgeries, a purpose for which Infuse has not received approval. Medtronic subsequently received a 3 billion dollar payday as a result of this questionable tactic. The Wall Street Journal also alleges that Medtronic paid a physician to falsify a study that produced positive results from Infuse’s off-label use in the cervical area.
One recent lawsuit involves a woman who still suffers disabling complications after an Infuse spinal surgery in 2006, according to The Courier-Journal. The extensive nerve damage incurred during the procedure has left her barely able to walk or sit up, and simple tasks such as tying shoes and shaving legs are impossible without assistance. It is argued that this surgery was an off-label usage of Infuse carried out without the patient’s consent. This lawsuit is only one of multiple similar suits citing debilitating results of an Infuse Bone Graft. Such extreme side effects should be cause for much stricter enforcement of the Infuse Bone Graft’s usage in only approved procedures. No one should be the victim of a practice that has intentionally hidden the truth from those it affects. Moreover, medical device companies must be held to a higher standard of transparency and legitimate concern for patient outcomes, instead of profit margins.
At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective and deceptive medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.
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