Das Implantat Nobel Direct von Nobel Biocare soll übermässigen Knochenabbau verursachen

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) 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 ``will investigate what is really behind these allegations.`` ``This involves scientific assessment of the facts so it may take some time. These are long-term effects,`` he said. ``It is always serious when there are allegations about implants not working as they should, so it must be investigated.`` Nobel Biocare`s Magnusson told Reuters his company had itself contacted the agency after a Swedish television report about the implant. ``There is nothing in our studies that supports their (the professors`) allegations,`` he said. ``We 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,`` 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. ``We 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,`` Albrektsson said. ``We receive more and more material, as more and more dentists discover how terrible this is,`` he told Reuters. ``These are enormously high figures. Usually this effect appears in only a few percent of the cases.`` 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. ``We don`t understand why they don`t see the magnitude of this problem,`` 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.

Letzte Aktualisierung ( Montag, 23. Juni 2008 )