In the video above, Gary Falkowitz, an attorney at the national law firm of Parker Waichman LLP discusses cauda equina syndrome (CES) and other risks associated with Medtronic Infuse® bone graft. Medtronic Infuse is a product that uses a genetically engineered protein known as recombinant human Bone Morphogenetic Protein (rhBMP-2) to stimulate bone growth in the spine. The BMP-2 comes as a powder, which is supposed to be mixed with a certain amount of water. Reports suggest, however, that sometimes the wrong amount of water is added, leading to a product that may be too dilute or concentrated; this may lead to serious side effects, such as cauda equina syndrome. Cauda equina syndrome is a serious medical condition caused by the compression of nerves at the end of the spinal cord. Patients with CES may experience symptoms such as:
- Severe pain in the lower back
- Pain, numbness or weakness in one or both legs
- Loss or altered sensations in the legs, buttocks, inner thighs, backs of your legs or feet that gets increasingly worse (saddle anesthesia)
- Bladder or bowel dysfunction, incontinence or trouble with elimination
- Sudden onset of sexual dysfunction
In 2002, the U.S. Food and Drug Administration (FDA) approved Medtronic Infuse for use in the lower spine in a procedure known as anterior lumbar fusion. Later on, it was also approved for two types of dental surgery. Using Infuse in another part of the body, such as the cervical spine, is known as “off-label” use and is associated with serious side effects. However, evidence suggests that Infuse is used off-label for unapproved uses about 90 percent of the time.