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Panel raises questions on Nobel Biocare implant

Posted on: Wednesday, 19 July 2006, 13:20 CDT

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)

Source: REUTERS

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