In a report issued by TheStreet.com on May 13, 2005, questions arose about the possible dangers associated with artificial disc surgery, in particular the Charite Artificial Disc.
The Charité Artificial Disc, approved by the FDA on October 26, 2004, is made of plastic and metal similar to the materials used in hip and knee replacements.
Artificial Disc Surgery Issues
Correct sizing and positioning of the device is critical for best functionality and lowest chance of failure. If these devices fail, the revision surgery may be extremely difficult and fraught with potential dangers of vascular, visceral, or nerve injury.
In addition to the potential complications associated with undergoing surgery and general anesthesia, the complications associated with artificial disc replacement may include: breakage of the metal plate, dislocation of the implant, and infection. Patients may also not improve following the procedure and may require additional surgery.
When should the Charite Artificial Disc not be used? According to the FDA, the Charite Artificial Disc should not be used in patients who have any of the following:
- Active systemic infection or infection localized to the site of implantation
- Osteoporosis
- Osteopenia
- Bony lumbar stenosis
- Allergy or sensitivity to implant materials
- Isolated radicular compression syndromes, especially due to disc herniation
- Pars defect
About Degenerative Disc Disease
Individuals with degenerated discs in the lower (lumbar) spine sometimes suffer from disabling, chronic low back pain. Most patients with degenerative conditions in the spine are treated non-surgically with anti-inflammatory medications, physical therapy and injections. Most of these individuals favorably respond to non-surgical methods of treatment, but a group of individuals will continue to experience pain. As a result, surgical treatment may become necessary.