Ironically, fans of Charite kept pointing to the European experience as proof of the disc's success. They also suggested that data from Europe -- where Charites have been on the market for 17 years -- reduced the need for extended clinical trials in the U.S.
But many who participated in last year's hearing, including the FDA's own expert engineer, expressed concern about the length of the U.S. study. They indicated that many complications would not even surface until well after the study had ended.
"I think that we have already all pretty much agreed that two years is probably not a safe length of time to follow these patients," said Maureen Finnegan, a voting member of the advisory panel with financial ties to the industry. "So I do think that there needs to be a long-term follow-up."
In the end, however, the panel unanimously recommended approval of the devices with some conditions attached. Specifically, the group called for continued monitoring of trial participants and specialized training for surgeons who will be performing the procedures.
During the FDA hearing process, the so-called Spine Arthroplasty Society had already promised to help with the latter.
"Until I read this transcript, I had never heard of this society," Rosen says. "Given that I am a university spine surgeon, one would think I might even be invited to join or participate."
Rosen marvels that such a society -- dedicated to a brand-new procedure in the U.S. market -- already exists in the first place. However, industry critics have long claimed that some professional and consumer advocacy groups are, in fact, little more than fronts for the big health care companies themselves. The SAS Web site, which discloses nothing about the society's funding, almost exclusively promotes the new artificial discs.