Artificial Lumbar Disc Replacement
The Charite Artificial Disc is available through the Johnson & Johnson-DePuy Company with FDA approval. The device consists of two metal endplates and a polyethylene core. This device is FDA approved for treating low back pain only, and limited to the L3/4, L4/5 or the L5/S1 disc levels. The physicians at the Inland Neurosurgery Institute (INI) have taken the additional training for placement of these artificial lumbar discs at the Johnson & Johnson training center. To date, we have not done a single case for the following issues noted below.
The procedure is done anteriorly (eg, though an incision in the abdomen). The disc causing the back pain removed and the artificial disc inserted. The procedure is generally done by a neurosurgeon or orthopedic surgeon trained in spinal surgery, with an access surgeon (for the abdominal dissection) who is usually a vascular surgeon. The artificial disc has to be perfectly positioned or there are problems with the spinal movement which can translate into a poor outcome with ongoing back pain, etc.
The device may, in some patients work quite well, however there are potentially significant complications with this procedure. If the polyethylene core or either of the metal endplates become dislodged into the abdomen (e.g., spit out) then the major blood vessels directly in front of the spinal column become immediately compressed which can cause poor blood flow into the legs, or prevention of blood returning from the legs though the major vein in the abdomen (the inferior vena cava) which could produce a blood clot into this large vein that could travel into the heart and lungs. This can be a life threatening problem. Surgical revision of this device, under this scenario, can be LIFE THREATENING as well. To remove the device which is now surrounded by scar tissue and to dissect off the very thin walled large vein and the artery can result in massive bleeding and death.
There have been surgeons who have given up the procedure due to this complication. As well, no one knows how long this device will last. If they are not perfectly placed, or if they do not do the job they intended to be done, then a posterior fusion (back of the spine) is performed with pedicle screws (large screws into the vertebral bodies) above and below the implant. Bone is then laid down over the back of the spine to then produce a posterior spinal fusion with the implant being left in position. Many insurance companies will not pay for the device as the insurance companies do not believe in this technology and thus will not authorize the placement of the devices.
Due to the above, we feel that this procedure, with the current technology, is too dangerous of a procedure. Perhaps if there are refinements or further developments with this device, or other devices in the future, we may perform an artificial disc replacement at that time. For additional information on the Internet, read the AANS Lumbar Disc Replacement Site.