NobelSmile

Can Nobel Biocare finally smile again? Last week Sweden’s Medical Products Agency (MPA) gave Nobel the green light to continue selling its NobelDirect and NobelPerfect implants. The condition is simply that Nobel Biocare must rewrite instructions for the NobelDirect
and NobelPerfect dental implants to inform customers and dentists of a
possible bone loss problem and how to prevent it, the Swedish Medical
Products Agency said. The company must explain by Jan. 8, 2007
how it plans to rewrite the instructions and cannot market the
product until the new information is available.

Reaction to the MPA rulling was unquestionably positive. “Without a product withdrawal, we believe many of the potential material risks have been avoided,” Michael Jungling, an analyst at Merrill Lynch, said in a report. As a result, it’s unlikely that Nobel Biocare “will face U.S. litigation or that its customer reputation will be tarnished.”

However, it is important to note that a ban of the product is still possible. “We just don’t have enough data to pull the product off the
market at the moment,” Lennart Philipson, the agency’s director
for medical devices, said at a press conference in Uppsala,
Sweden. The shortcomings in the instructions could explain the
increased risk of a breakdown of the jawbone, the agency said.

What are your thoughts on this latest twist in Nobel saga? Has fortune once again smiled upon Nobel?