They are facing a lawsuit from a woman in Texas who is blaming them for off label use and for the injuries she has suffered after her cervical spine surgery!
Mary Selke who is the claimant has saud that she suffered from breathing problems and was unable to swallow due to bone that formed in her neck!
Mark Selke has also got her physician on side who will provide testimony about Medtronic and the promotion of their product.
We would love to hear from any InFuse Bone Graft patients, have you had problems similar to Mary?
There is an estimated half a million people each year that undergo spinal surgery to repair/correct/fuse patients who experience damage to discs or to stablise Scoliosis.
The InFuse Bone Graft is a device to help fuse vertebrae in the lower spine in order to treat degenerative disc disease. It differs from other, similar devices in that it uses genetically engineered protein to help build bone tissue in the fusion process, instead of using a graft of the patient's own bone (an autograft).
According to the Wall Street Journal, Medtronic estimated to have brough in $816 million in the fiscal year, April 2008.
Although Drs are free to use medical devices off-label at their discretion, InFuse Bone Graft is not approved to be used in the neck.
Off-label use of these medical products should be investigated by the U.S. Department of Justice to prevent more people from dying of suffering after their surgery, there was a report in August of 2008, of a lady in California who died after having the InFuse inserted into her neck, the suit claims that Ms Nisbet went into respiratory arrest and a coma, she was kept alive by artificial means.
However, the Hospital of California (where Ms Nisbet had surgery) did not report to Medtronic that the device was the cause of death.
Until this claim can be resolved and some further measures are put into place regarding off-label products, patients need to be aware of the complications that InFuse Bone Graft COULD possibly hold for the patient.
What is Off-Label Use?
In the United States, new drugs and devices cannot be marketed until the Food and Drug Administration finds that they are safe and effective for their intended use. To obtain FDA approval, pharmaceutical and device manufacturers must submit extensive animal, in vitro, and human study data demonstrating safety and effectiveness. Agency staff members—often joined by an external interdisciplinary advisory committee—review the research reports to evaluate the quality of the data and make the essential risk-benefit judgments that determine whether a medical product is safe and effective.
To read more about off-label use and the FDA (Food and Drugs Administration) visit the MedScape website: At Law - The Curious Case of Off-Label Use