FDA OKs Artificial Spinal Disc

The Food and Drug Administration granted approval Tuesday for the first artificial spinal disc for use in patients suffering from persistent lower back pain.

The Charite artificial disc is made by DePuy Spine, Inc., of Raynham, Mass. Artificial discs have long been used in Europe.

The disc, a plastic core sandwiched by two metal plates, is intended as an alternative to spinal fusion surgery. The operation eases pain, but can put more pressure on other discs.

More than 200,000 Americans undergo spinal fusion surgery each year. The damaged disc is removed and bones on either side are grafted together.

Government approval followed a study by DePuy Spine that found that two years after surgery, patients with the artificial disc did no worse than patients who had spinal fusion surgery, the FDA said.

The company was more glowing in its own assessment of its product, issuing a statement saying patients who received the artificial disc left the hospital sooner and were more satisfied than patients who had fusion surgery.

The FDA said the disc can be implanted only in patients who have degenerative disc disease and who have had no relief from back pain after at least six months of non-surgical treatment.

Surgeons place the artificial disc in the spine through a small incision just below the belly button. Patients are given general anesthesia.

The bones of the spine have spongy discs between them, tough collagen rings surrounding a fluid-filled cushion, that act as shock absorbers. They keep vertebrae properly separated, cushioned and flexible.

A disc damaged from injury or aging can cause intense pain, especially if nearby nerves are crunched or the disc degenerates enough that bone grinds on bone.

Millions of Americans suffer back pain, often caused by a degenerating disc. Time, painkillers and special exercises help most recover.

The FDA directed DePuy Spine to conduct another study to measure the product's long-term safety and effectiveness, including its impact on other discs.