Infuse bone graft surgery involves the use of a bioengineered liquid protein that helps in bone growth. This prescription chemical creates a scaffold to accommodate the renewed mass of bone, and thus induces the re-growth of damaged bone tissue. Infuse bone graft treatment was approved in 2002 by the U.S. FDA for specific treatments, including degenerative disc disease spinal surgery, open tibial or shin bone fractures, and two dental implant bone grafting procedures.
Any other types of bone graft procedures involving Infuse are considered off-label. Infuse products are sold by Medtronic, Inc., a leading global medical technology company. The company sold nearly one billion dollars’ worth of Infuse products in 2010. However, the FDA has issued warnings since 2008 regarding potential serious side effects of Infuse bone graft treatments, particularly when used for off-label purposes.
Medtronic Infuse Bone Graft treatment over the years has resulted in severe side effects for thousands of patients across the United States. Many victims have been approaching lawyers specializing in infuse litigation cases to assess the possibility of suing Medtronic, Inc., the manufacturer of Infuse.
The issue of Infuse bone graft lawsuits became more pertinent in 2008 when the FDA issued warnings against off-label use of Infuse. FDA evaluated 280 adverse event reports involving Infuse treatment. It was found that in almost three out of four cases, the treatment had been applied for off-label purposes.
In late 2008, the Justice Department launched an investigation against Medtronic for allegedly illegally promoting Infuse bone graft treatment. Criticism against Medtronic’s marketing ethics and claims of the company trying to influence medical trials in favor Infuse have led to a growing number of patients seeking Medtronic Infuse bone graft lawsuits.
Considering the wide range of severe side effects that may have resulted from improper or off-label treatments involving Infuse, the possibility of class action lawsuits against Medtronic has also increased. Formal multi-district litigation or class action lawsuits have not yet been filed against the company. However, it seems to be only a matter of time before some kind of a coordinated legal action becomes initiated on behalf of the victims.
If you or someone known to you has received Infuse bone graft treatment, or even if you are not sure about the kind of bone graft you may have received, you should have your claim legally evaluated as long as you have suffered from serious side effects following the treatment. Even if the effects are not currently serious but are still discomforting and causing you pain or so forth, this should not be ignored, in case this situation gets worse or leads to other complications.
An experienced Infuse bone graft lawyer will offer you a free initial consultation and free evaluation of your claim. You will be under no obligation to hire the lawyer after such a discussion, and they will maintain complete confidentiality and treat your claim with the sensitivity and attention that it deserves.