Infuse Bone Graft, manufactured by Medtronic, is commonly used in spinal fusion surgeries to promote bone growth. The device is made up of two parts. The first is rhBMP-2, which is a protein that is found in everyone's body. The second is the carrier for the deliver- a sponge manufactured from bovine (cow) Type 1 collagen. The synthetic protein (rhBMP-2) generates bone growth at the site of implantation and is used in place of the traditional process in which bone is harvested from other parts of the body.

The Infuse Bone Graft was approved by the FDA in 2002 for use in lumbar (lower back) spinal repair surgeries to promote bone growth, including Degenerative Disc Disease (DDD). In spinal operations, it is only approved for anterior surgical approaches, that is, from the front of the patient. However, it is widely used for off-label purposes for other surgical techniques.

Risks associated with off-label uses are supposed to be exposed before the procedure is done. However, a history of Medtronic-sponsored studies have largely downplayed the risks associated with off-label uses of Infuse, according to other experts in the field.

The associated risks, according to The Spine Journal, include: inflammatory reactions, adverse back and leg pain events, radiculitis, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement.

If you believe Medtronic's Infuse Bone Graft has caused your injuries or those of a loved one, please contact us by filling out our online contact form, or call our office for a free consultation. We have been handling dangerous drug and device cases for over 27 years. GoldenbergLaw has the resources and expertise to help you pursue your case.

Sources and additional information:

http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf

http://www.nytimes.com/2011/06/29/business/29spine.html?pagewanted=all

http://www.medtronic.com/health-consumers/lumbar-degenerative-disc-disease/surgery/questions-and-answers/