Hope Slips for Disc Implants

Walking Advertisement

In the meantime, big fans of the Charite -- such as Emerson Thompson of North Carolina -- serve as walking advertisements for the discs.

Before his Charite implant earlier this year, Thompson struggled to walk very far at all. An old back injury had caused a painful bulge in his natural disc that, ultimately, made his right calf muscle shrivel and left him unable to climb stairs, let alone enjoy the outdoor activities he so enjoyed. He, like Ms. Amodt, wanted a Charite disc so badly that he felt willing to pay for the surgery on his own.

Thompson fared much better, however. He wound up convincing his insurance carrier to cover the new procedure and now has regained more than an inch of muscle in the leg that hobbled him before. As a civil defense attorney -- who focuses on back injury cases - he feels he did his homework on the disc, recognized the risks involved and would still choose the same route again.

Indeed, he highly recommends the Charite for others and praises Johnson & Johnson for making it available to patients here in the first place.

"My hat is off to Johnson & Johnson for taking the risk and bringing something like this to the very conservative medical community," says Thompson, who offers such endorsements without any compensation from the company. "I think this is going to pay off for everybody down the road."

But the New Jersey-based law firm of Bagolie Friedman, which is currently reviewing cases from disappointed Charite recipients, would classify Thompson as lucky.

"This is a technically demanding operation that very few -- if any -- surgeons are qualified to perform, and the correct sizing and positioning of the device is critical for best functionality and lowest chance of failure," says partner Ricky Bagolie. "The margin of error is so small, and the chance of misplacement so great, that these artificial disc replacements should be recalled to protect the public."

Charles Rosen, founding director of the University of California-Irvine Spine Center, officially asked the FDA to withdraw the discs from the market months ago. He first aired his concerns about the Charite in an article published by TheStreet.com back in early May. He noted that the Charite had been tested against a failed operation, that it still had weak results and that it required life-threatening revisions in the case of failures -- and, ultimately, he questioned why the device had ever won approval in the first place.

Others have since highlighted similar concerns. Meanwhile, Rosen has never backed away from his warnings despite some attacks from those within the close-knit spine community.

Rosen says he even watched, in shock, as he saw his own name flash up on the screen -- as a warning about "airing dirty laundry" on the industry in public -- during this year's meeting of the North American Spine Society. He portrays the convention as "surreal," with participants banned from recording any sessions and literally escorted out if they tried.

He says that scientific debate, normally a hallmark of the gathering, seemed absent when it came to artificial discs this year.

"Medicare had put up this issue of non-coverage, and people were so on edge that they didn't want any negative comments or press to come out of the meeting," Rosen says. "So there was no dissent at all. I felt like I had been transported to Communist Russia or something."