Panel raises questions on Nobel Biocare implant

By Sven Nordenstam

STOCKHOLM (Reuters) – An expert panel hired by the Swedish
Medical Products Agency (MPA) to examine Nobel Biocare’s

dental implant NobelDirect has recommended that the firm
stop marketing the product until it has altered the
documentation that goes with it.

The MPA started a probe of the implant after two Swedish
dental professors said NobelDirect caused what they called
unacceptable levels of jaw bone loss.

The company has consistently rejected the professors’
statements about the product, which has been on the market
since 2004, and said the implant represented 2 percent of its
sales.

The panel said in a report, a copy of which was obtained by
Reuters on Wednesday, that NobelDirect should be used with
“great caution” until the firm presents scientific
documentation showing consistently good treatment results for
the implant.

Nobel Biocare shares fell after the news. They closed down
0.6 percent at 289 Swiss francs, after reaching a low of 284
francs earlier in the day, and were the only weaker component
in the Swiss Market Index, which rose 1.9 percent.

“The panel’s recommendation is indeed not good news, but
for a company like Nobel Biocare it is manageable,” said Helvea
analyst Daniel Jelovcan.

“I believe in the end there will be a compromise and that
Nobel Biocare possibly will change the labeling. The worst case
is a complete recall of the product from the market, but that
is long since discounted in the share price.”

The regulatory agency has said the panel’s conclusions
would be important to any decision it makes on the product.

A spokesman for Nobel Biocare in Switzerland said the firm
would wait for a final decision from the MPA.

“We have taken note of it (the report). We must await the
agency’s decision,” the spokesman said.

THREE-WEEK DEADLINE

The independent panel, consisting of three senior dental
scientists, said in its conclusion that the implant could, in
the short time span it had been observed, function
satisfactorily.

But it added: “For certain patients the documented bone
loss is bigger than one would expect. The percentage of
patients showing unexpectedly high bone loss is also greater
than expected, especially considering the advantages which
Nobel Biocare says NobelDirect has.”

The head of the MPA’s medical products division, Lennart
Philipson, told Reuters the report had been sent to Nobel
Biocare and the firm had three weeks to respond.

The MPA could rule in a couple of weeks after that, but he
did not say what he thought the decision would be.

In a separate letter to the agency, a copy of which was
obtained by Reuters later on Wednesday, the experts also
complained that they had only recently learned of a one-year
study that covered 50 NobelDirect implants, even though Nobel
Biocare already had access to the study when they met with the
company in July.

“It is difficult enough to investigate a problem like this
without having to suspect that you have not seen the entire
material,” panel member Per-Olof Glantz told Reuters.

Glantz also said that, according to one of the individuals
in charge of the study, it showed unfavourable results similar
to those of other studies.

Nobel did not return calls seeking comment on the separate
letter, but Swedish news agency TT quoted a Nobel spokesman as
saying he was not aware of it.

The MPA’s Philipson said he had been in touch with Nobel
Biocare’s law firm, which said it would submit the study to the
agency.

The panel’s experts had looked at data on 461 implants
collected by the implant’s critics and data from an undisclosed
number of implants in Nobel Biocare studies, according to their
report.

(Additional reporting by Oliver Hirt in Zurich)