Nobel Biocare Allowed to Continue Marketing Controversial Implants
BY DAVID KRESSEL, DECEMBER 6, 2006
Nobel Biocare was cleared by Swedish regulators to continue selling the controversial NobelDirect and NobelPerfect implants within Sweden and therefore within the EU. These products are controversial because research has shown using them can cause increased bone resorption at the implant collar, relative to other implant systems.
The Swedish Medical Products Agency concluded its investigation and pointed to flaws in the product instructions and training and subsequent misuse of the product as the root cause of the resorption. Nobel must present its plan for improving written instructions, customer training and sales and marketing materials by January 8, 2007. Until that time, Nobel is permitted to continue selling these products, but may not actively market or promote them.
The removal of this overhang contributed to a 10% increase in Nobel's stock price the day of the announcement. These products contribute 2% of sales, but investors were more worried about the liability and reputational damage Nobel would sustain as a result of a recall. Nobel is out of immediate regulatory danger, but still needs to refute the claims of quick resorption in order to regain the confidence of implantologists worldwide.
