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Das Implantat Nobel Direct von Nobel Biocare soll übermässigen Knochenabbau verursachen
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Die Schwedische Aufsichtsbehörde für medizinische Produkte untersucht ein Dentalimplantat von Nobel Biocare wegen eines angeblich höheren Rückgangs des Kieferknochens als bei anderen Implantaten. Nobel Biocare zufolge verursacht das 2004 auf den Markt gebrachte Implantat Nobel Direct keine solchen Probleme.
Die Behörde, der die Aufsicht der Branche obliegt, sei in Kontakt mit Nobel Biocare wie auch mit der Universität Göteborg, von der die Vorwürfe kamen, so ein Vertreter der Organisation am Donnerstagabend. Die Untersuchungen werden demnach einige Zeit dauern.
Die beiden Professoren Lars Sennerby und Tomas Albrektsson (Biomaterials Department, Universität Göteburg)
warnten nach eigenen Angaben die schwedisch-schweizerische Firma Nobel Biocare, dass Nobel Direct bei vielen Patienten rings um das Implantat eine Auflösung des Kieferknochens verursache, die über das akzeptable Mass hinaus gehe.Das Implantat Nobel Direct wird weltweit verkauft, unter anderem auch in den USA.
Hier der Originaltext (zitiert von DeutscheDental.de)
The Swedish Medical Products Agency is investigating a dental implant made
by Nobel Biocare, the biggest firm in the world in the sector, after two
Swedish professors said it causes more jawbone loss than other implants. The
professors at Gothenburg University told Reuters they had warned the
Swedish-Swiss firm that its dental implant, Nobel Direct, caused the jaw
bone to dissolve around the implant more than was acceptable in many
patients. Jeppe Magnusson, Nobel Biocare`s Head of Research and Development,
said there were no such problems with the implant, which was launched in
2004 and is sold globally, including in the United States.Arne Kardell of the Swedish Medical Products Agency, which oversees the
industry, said on Thursday his organization had been in contact with both
the university and Nobel Biocare and tx_mmforum_posts_textwill investigate what is really
behind these allegations.tx_mmforum_posts_text tx_mmforum_posts_textThis involves scientific assessment of the
facts so it may take some time. These are long-term effects,tx_mmforum_posts_text he said. tx_mmforum_posts_textIt
is always serious when there are allegations about implants not working as
they should, so it must be investigated.tx_mmforum_posts_text Nobel Biocare`s Magnusson told
Reuters his company had itself contacted the agency after a Swedish
television report about the implant. tx_mmforum_posts_textThere is nothing in our studies that
supports their (the professors`) allegations,tx_mmforum_posts_text he said. tx_mmforum_posts_textWe as a company
have to take this very seriously … If there is a problem we have to take
measures, but we have to act on facts,tx_mmforum_posts_text he added. He said Nobel Biocare had
also been in contact with the professors and urged them to provide data. The
professors, Lars Sennerby and Tomas Albrektsson at the Biomaterials
department of the University of Gothenburg, said they have studied X-ray
images of the jaws of hundreds of patients who have the implant and their
findings should be published this summer. tx_mmforum_posts_textWe have looked at more than 300
implants that we are evaluating, and at least a third of them have this
problem. After only one year the effect is very obvious,tx_mmforum_posts_text Albrektsson said.
tx_mmforum_posts_textWe receive more and more material, as more and more dentists discover how
terrible this is,tx_mmforum_posts_text he told Reuters.tx_mmforum_posts_textThese are enormously high figures. Usually this effect appears in only a
few percent of the cases.tx_mmforum_posts_text Albrektsson said that he and Sennerby have twice
before issued warnings on implants from other companies, which were
subsequently withdrawn. Their department had discontinued cooperation with
Nobel Biocare, previously an important source of financing, he added. tx_mmforum_posts_textWe
don`t understand why they don`t see the magnitude of this problem,tx_mmforum_posts_text
Albrektsson said. Magnusson said Nobel Biocare had severed its links with
Albrektsson several years ago and with Sennerby in the spring. Sennerby said
he wrote to the company in May advising it to withdraw the product from the
market and warning of the risk of litigation from patients over the implant.
