Hope Slips for Disc Implants

A year ago, Lynette Amodt's back hurt so badly that she sold her Utah home to pay for treatment overseas.

Amodt, a 45-year-old former nurse, had injured her back in 2000 while lifting a dying patient on the job. She and her husband, Carl, a chiropractor, originally sought nonsurgical treatments such as physical therapy and prescription drugs for her condition. They finally decided to try artificial discs, which have a long history in Germany and could become more common here as big medical device makers -- spying a growing market opportunity -- aggressively seek regulatory clearance to sell more of the disc-replacement implants in the U.S.

Dr. Amodt says that his wife got a Johnson & Johnson (JNJ) Charite disc in her lower back and two Medtronic (MDT) discs elsewhere in her spine. But far from curing her condition, he says, the discs have left her feeling much worse than she ever did before.

So he spends a lot of time warning others about a new technology that, not so long ago, he viewed as a miracle cure. He especially worries about the Charite -- the only disc with regulatory approval in the U.S. -- saying he believes that both the manufacturer and the surgeons who use the device overstate its capabilities while downplaying its risks. He and other critics of artificial discs contend that patients are being shortchanged in a rush by device makers to stake a claim to what could end up being a multibillion-dollar market.

"We could find nothing beforehand to clue us in to any of the negative results of this device," he says now. "We were far too late to discover just how bad an option the Charite is. ... And the other [discs] I have seen look even worse and more brutal yet."

Johnson & Johnson says it has been upfront about risks involved with the Charite, that it extensively tested the discs itself and that it found that the vast majority of patients who received the devices were pleased with the results. Indeed, the company has reported that some 88% of Charite recipients who participated in clinical testing of the discs expressed satisfaction with their surgery -- and most of those would be willing to undergo the procedure all over again.

The company originally seemed to enjoy an enviable position as the pioneer of a breakthrough technology that could revolutionize back surgery in the lucrative U.S. market. But just one year after securing permission from the Food and Drug and Administration to sell the Charite disc here, the company finds itself battling a growing crowd of critics and, some fear, threatening the future of artificial discs as a whole. That could mean problems for other companies, such as Medtronic and Stryker (SYK), that are seeking to sell artificial discs of their own.

Already, Medicare has delayed covering Charite discs because it wants more evidence and less controversy about their value. Some big insurers, including Cigna and Blue Cross/Blue Shield of California, have done the same. Industry experts worry about future challenges as well.

After the Centers for Medicare and Medicaid Services launched a full-blown coverage review of the Charite this fall, industry consultant Barb Peterson urged disc supporters to get involved.

"Non-Medicare payers tend to follow CMS decisions," Peterson stressed in an article for HealthPoint Capital, an organization that focuses exclusively on the orthopedics sector. "So, if CMS does issue a non-coverage decision, device companies will have an uphill battle to get all payers to cover and pay for artificial discs. Overturning a national non-coverage decision requires an enormous effort, published data and years to succeed."