Artificial Discs and Back Surgery
The FDA recently approved artificial discs and back surgery for use in patients who have degenerative disc disease in the lumbar spine. However, the FDA is now requiring a new study to assess the long-term safety and effectiveness of the artificial discs and back surgery used to insert them, including impact on other discs and on the bony structures of the spine.
The U.S. Food and Drug Administration (FDA) approved an artificial spinal disc for use in treating pain associated with degenerative disc disease (DDD). The device is intended to replace a diseased or damaged intervertebral disc.
The device -- the first of its kind -- is the Charité artificial disc manufactured by DePuy Spine, Inc., of Raynham, Massachusetts. It was approved for use in patients who have degenerative disc disease in at least one level in the lumbar spine (from L4-S1) and who have had no relief from low back pain after at least six months of non-surgical treatment. Currently, patients with degenerative disc disease who get no relief from pain after several weeks of non-invasive therapy may have surgery to implant a variety of devices intended to stabilize the spine, while bone grafts fuse together the two vertebrae surrounding the diseased or damaged disc. The artificial disc provides another alternative for these patients.
The Charité artificial disc is made up of a plastic core sandwiched between two metal endplates. The device helps to restore the natural distance between the two vertebrae, which can allow movement at the level where it is implanted. However, the artificial disc may not allow movement, or the artificial disc may allow too much movement, which can overstress the device. The new system is placed in the spine through a small incision just below the belly button. The diseased or damaged disc is then removed, and the artificial disc is placed in the space.