Artificial Spinal Disc Nears Approval
Experts Say More Long-Term Safety Information Needed
More Data Requested continued...
About three-quarters of patients who got either a Charité or a BAK implant experienced at least one adverse event including neurological damage, ongoing pain, or disc malfunction. About 12% of Charité patients experienced infection, twice the rate as patients receiving BAK. Company officials say none of the infections was device related.
FDA officials also say that 15% of Charité patients experienced "life-threatening" complications, slightly higher than the 9% rate seen in BAK patients.
That concerns some doctors, who warn that inevitable surgeries to correct failed Charité discs may be complicated and dangerous. It is unclear whether these corrective surgeries can be reliably performed on the back, or whether a malfunctioning disc will have to be removed through an incision that enters the body through the front.
Doctor Training Required
These front-approach surgeries carry high risks, including the danger of damaging blood vessels, says David W. Polly, MD, chief of spine surgery at the University of Minnesota. "What I'm concerned about is this is the first [permanently implantable disc] out of the block," he tells WebMD.
"The challenge is going to be how do you rein in surgeons, how do you do it right," says Polly, who is a paid consultant for Medtronic Inc., a rival medical device company. Medtronic is a WebMD sponsor.
The panel also called on the company to provide training for surgeons who want to implant the artificial disc.
William P. Christianson, DePuy's vice president for clinical and regulatory affairs, assures the FDA that his company would set up training centers to educate surgeons on how to implant the device more safely if the FDA approves it.
"Obviously, physician training is going to be very important for successful launch of this product," he says.