Infuse Bone Graft
The Driscoll Firm, LLC, is investigating potential injury and death claims throughout the United States on behalf of patients who received a Medtronic InFUSE Bone Graft in connection with spine or neck surgery.
The InFUSE medical device is manufactured by Medtronic, Inc., and has been approved by the U.S. Food and Drug Administration (FDA) for use in surgeries to fuse vertebrae in the lower spine and treat degenerative disc disease. It is unique in that it uses genetically engineered protein – instead of a graft of the patient’s own bone – to help build bone tissue in the fusion process.
An estimated 450,000 people have spinal fusion or disc repair surgery each year, primarily to reduce back pain.
Unfortunately, severe complications have been reported from patients who received an InFUSE bone graft, including severe and chronic pain, male sterility, cancer, infection, and bone loss. Additional risks arise when InFUSE grafts are used in surgeries to the upper spine and neck, including cervical fusions. These uses have not been approved by the FDA.
In July 2008, the FDA issued a warning to doctors about life-threatening complications when InFUSE is used for cervical surgeries.
Have you or a loved one had spine or neck surgery involving an InFUSE bone graft and experienced painful side effects such as severe or chronic pain, swelling of the neck or throat, difficulty swallowing, breathing or speaking, or other problems? If so, contact an InFUSE bone graft lawyer at The Driscoll Firm, LLC, at 314-932-3232 to learn about your legal rights and options. The consultation is free and confidential.
Dangerous Side Effects of InFUSE Bone Grafts
InFUSE involves two major components:
- A metallic tapered spinal fusion cage
- A bone graft substitute inside the cage, consisting of a genetically-engineered human protein (rhBMP-2) that is manufactured from bovine [cow] Type I collagen.
The device was approved by the FDA in 2002 to fuse vertebrae in the lower spine. But doctors have commonly used it for neck surgeries as well. Such so-called off-label use by physicians is not illegal – but it is illegal for manufacturers like Medtronic to actively promote off-label use.
In 2008, the U.S. Department of Justice launched a criminal investigation to determine whether Medtronic has actively promoted off-label use.
The FDA warning to doctors came after the agency received nearly 300 reports of adverse effects when InFUSE grafts were used in cervical procedures – including 38 reports of potentially fatal complications. Despite this warning, physicians are continuing to use InFUSE in neck surgeries.
Medtronics has faced a barrage of criticism not only for encouraging off-label use but also for downplaying the serious risk of InFUSE grafts and paying physicians money – up to $12 to $16 million by some estimates – to promote the device. The U.S. Senate Finance Committee has requested records from Medtronic concerning payments and communications with researchers on InFUSE studies.
Contact an InFUSE Bone Graft Litigation Lawyer Today
Patients who have undergone InFUSE bone grafts for spinal fusions have reported severe side effects such as cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. Those who have had InFUSE procedures for neck surgeries have suffered even more serious complications, including death.
If you had surgery using an InFUSE device, contact The Driscoll Firm, LLC You might be entitled to compensation for medical expenses, including hospital bills and future out-patient needs, as well as pain and suffering. Call 314-932-3232 today to speak to an InFUSE bone graft litigation attorney about your case.
The Driscoll Firm, LLC, has represented clients injured by dangerous pharmaceuticals and medical devices for more than a decade. John J. Driscoll solely represents plaintiffs and focuses his practice on complex product liability cases, consumer class actions and personal-injury litigation.
For more information:
- About InFUSE device
- North American Spine Society