Infuse Bone Graft Lawsuits
Infuse Bone Graft linked to Life Threatening Complications
In the past years, Medtronic Infuse Bone Graft has been very useful in treating open fractures and degenerative disc diseases. It is also used in localized alveolar ridge and sinus augmentation, as approved by the US Food and Drug Administration. However, recent reports have linked the Medtonic InfuseBone Graft to causing life-threatening complications to their patients who were given the product outside of what was approved by the FDA.
The Medtronic Infuse Bone Graftcontains a genetically engineered version of protein which is normally produced by the body, also known as the recombinant human Bone Morphogenetic Protein or rhBMP. This product is used by the surgeons to initiate bone growth and re-growth on the specific areas of the spine. This product is limited to use in this specific part of the body only, and should not be used for any other area of the body.Just recently, a certain committee in the U.S. government has conducted investigation regarding the use of the infuse bone graft by the Medtronic surgeons in an off-label setting such as in cervical spine procedures. The patients who have undergone this off-label Medtronic bone graftprocedure experienced several complications like swelling of the airways that led to difficulty of breathing, swallowing and speaking. Some male patients also complained of retrograde ejaculation that might lead to sterility.During the investigation, it was discovered that the surgeons were offered a wide variety of incentives for use of the Medtronic products, regardless of its legality. According to the anti-kickback laws, it is illegal for the manufacturer to promote products in an off-label setting with the help of physician studies if the investigating physician is not truly impartial or independent. Furthermore, companies are not allowed to pay or offer incentives or remuneration or any kind to encourage the physicians to promote their drugs or devices that may be paid by federal healthcare programs like Medicaid or Medicare.Up to this time, investigations regarding the cases of the Medtronic are still ongoing. Unfortunately, patients who used the Infuse Bone Graft are still left wondering if what was used on them was legitimate or from off-label purposes and if they may suffer the same side effects that complained of by other patients.
If you believe a Infuse Bone Graft was done to you, please contact our lawyers immediately to participate in a potential Infuse Bone Graft Lawsuit.