Before artificial disc replacement, the standard of care for chronic back pain was spinal fusion surgery. This procedure involves fusing two or more vertebrae together to remove motion in those segments of the spine, allowing for pain reduction or elimination due to the resulting decreased movement. Artificial disc procedures were developed with the goal of pain reduction or elimination, while still allowing motion throughout the spine. Another advantage is the prevention of premature breakdown in adjacent levels of the spine, a potential risk in fusion surgeries.
While these three discs have received complete FDA approval, some insurance companies in the United States continue to deny coverage for the surgery, still classifying it as experimental. Interestingly, data shows that artificial disc replacement patients, when compared to spinal fusion patients, have shorter surgeries, less blood loss, shorter hospital stays and are quicker to return to work following surgery.
The first artificial disc approved for use in the United States is the Charite artificial disc. Invented at Charite University Hospital in Berlin in the mid-1980s by the East German scientist, two-times Olympic champion in women's artistic gymnastics Karin Büttner-Janz and Kurt Schellnack, the disc did not receive FDA approval in the United States until October 2004, following an extensive four-year clinical trial.
The first surgeon to perform a Charite artificial disc surgery in the United States was Scott Blumenthal, M.D., a spine surgeon at Texas Back Institute in Plano, Texas. Blumenthal served as principal investigator for the Charite study and works regularly with all discs on the market, giving him the unique position of performing more artificial disc surgeries than any other surgeon in the United States. Blumenthal is also in the process of developing his own artificial disc, culminating all the knowledge he has gleaned from working with the discs currently on the market.
In addition to total disc replacement, some companies are also working toward developing products and methodologies to replace only the inner portion of the disc. Referred to as disc nucleus replacement, these new techniques would allow for posterior insertion and a potentially shorter surgery with fewer complications.
In addition, there are several class-action lawsuits pending against the Charite Artificial Disc, and reports of complications with the Pro Disc Artificial Disc implant when used in certain surgical situations. A grassroots group of concerned spine surgeons calling itself the Association for Ethics in Spine Surgery has formed to raise awareness and help protect uninformed consumers.