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Infuse Medtronic – Frequently Asked Questions

What is the Infuse Bone Graft and how does it work?

Infuse Bone Graft is used to promote bone growth and repair spinal discs damaged by degenerative disc disease (DDD) in the lumbar (lower) spine. Spinal fusion is a surgical method used to treat DDD and involves removing the damaged disc and replacing it with bone graft that will fuse – or join – the two adjacent vertebrae together in order to stabilize the spine. Infuse Bone Graft is one type of graft used in spinal fusion surgeries.

The Infuse Bone Graft system consists of two parts: a small, hollow metallic cage (known as the LT-Cage Device), which is then filled with a biologically-engineered protein (known as rhBMP-2) that stimulates bone growth. To apply the graft, the surgeon mixes Infuse powder with sterile water and applies it to collagen sponges. The sponges are inserted into the LT-Cage Device which is then placed between the vertebrae. The LT-Cage acts to stabilize the spine while bone tissue grows between the vertebrae.

Is Infuse Bone Graft FDA-Approved?

Infuse Bone Graft is currently FDA-approved for use in anterior spinal fusion of the lumbar spine, as well as for the repair of open tibial shaft fractures and two minor dental procedures.

Can Infuse Bone Graft be used for non-FDA-approved purposes?

Yes. As with many drugs and devices, off-label use of Infuse Bone Graft is permitted if physicians believe that it will be of benefit to their patients. Examples of off-label use include performing spinal fusion surgeries with Infuse Bone Graft using methods not approved by the FDA, or in areas of the body for which Infuse Bone Graft was not approved, such as the cervical (neck) spine.

What kinds of injuries are associated with the off-label use of Infuse Bone Graft?

While individual cases vary, the majority of patients who had spinal fusion surgery using Infuse Bone Graft in a non-FDA approved method or location have experienced uncontrolled bone growth at the site of the implant or elsewhere in the body, and chronic pain in the arms and legs. Patients who received Infuse Bone Graft for surgical fusion of the cervical spine have experienced life-threatening swelling of the throat and neck that resulted in airway compression, swallowing and breathing difficulties, as well as problems with speech. Deaths have also been reported in association with the use of Infuse Bone Graft for cervical spinal fusion.

Has Infuse Bone Graft been recalled from the market?

No. Neither the FDA nor the manufacturer, Medtronic, have issued a recall of Infuse Bone Graft. The FDA did, however, issue a Public Health Notification to healthcare providers in July of 2008 warning against the use of Infuse Bone Graft in cervical spinal fusions, citing nearly 40 reports of serious injury associated with that specific off-label use. In addition both the U.S. Senate Finance Committee and the U.S. Department of Justice are investigating Medtronic for improperly marketing Infuse Bone Graft for off-label use and failure to report serious adverse events observed during clinical trials of the device.

Is Medtronic responsible for injuries patients have suffered from the off-label use of Infuse Bone Graft?

The answer is not known at this point, but a number of recent complaints filed by patients against Medtronic allege that the company misrepresented the risks and benefits of Infuse Bone Graft and improperly promoted and marketed it for off-label use.

It is important to note that when any drug or device is used in an off-label manner, the physician must inform the patient of the off-label use prior to the surgery, as well as fully explain the potential risks so that the patient can make an informed decision. Many patients who received Infuse Bone Graft for off-label purposes were not informed of the off-label nature, nor were they privy to the potential risks associated with such procedures.

Who is eligible to pursue an Infuse Bone Graft-related medical malpractice and/or personal injury lawsuit?

Anyone who has been negatively impacted by the Infuse Bone Graft – whether it was used as approved or in an off-label manner – may be eligible. State-specific laws vary regarding the time you have to pursue a lawsuit, so do not delay.