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Ask UsOn February 6, 2006, participants from Medical Products Agency, Nobel Biocare and
clinicians met for a discussion regarding the amount of bone resorption
for the Nobel Direct dental implant.
Nobel Biocare presented data from the multicenter prospective study. The results for the Nobel Direct implant are comparable to conventional implants. The Gothenburg group appreciates the significance of the information presented in the study that encompasses 12 month prospective data. A constructive discussion followed. Based on the data presented at the meeting the Medical Products Agency has found no reason to withdraw the dental implant from the market. Nobel Biocare will continue to carefully monitor the development of the prospective study and has an obligation to act swiftly if compromising data should emanate.
Visiting clinicians presented data from ongoing clinical studies. The data from the Gothenburg group differ significantly from the rest of the multicenter data which they are part of. The Medical Products Agency as well as Nobel Biocare appreciates the significance and importance of the work of the Gothenburg group. The Medical Products Agency therefore urges Nobel Biocare and the Gothenburg group to meet and carefully assess the underlying data in order to explain the differences observed.
Lennart Philipson, Ph.D.
Director Medical Devices
Medical Products Agency
Participants
For the Gothenburg group:
Dr. Mats Hellman
Dr. Lars Jonsson
Professor Lars Sennerby
Professor Tomas Albrektsson
For Nobel Biocare:
Dr. Jeppe Magnusson
Dr. Robert Gottlander
Dr. Lars Enbom
Dr. Torsten Siepenkothen
Professor Daniel van Steenberghe, external consulting expert
For the Medical Products Agency:
Professor Björn Klinge, external consulting expert
Mr. Mats Ohlson, MPA
Mr. Arne Kardell, MPA
Dr. Lennart Philipson, MPA
Source: http://www.mpa.se
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5 Responses to “ Nobel Direct Implant Reviewed ”
As much as I hate to even entertain this topic for discussion, this review would have never taken place if compromising data had not ALREADY emanated. The Nobel Direct implant will not be withdrawn from the market because as long as it’s available, SOMEONE will buy it, and nobel will make money. Does that mean its clinical studies and research documentations are conclusive, absolutely not. Buyer beware.
Where can the text of this meeting be obtained? Are the results of this study going to be published in a peer-reviewed journal?
Curious…Bextra has been removed from the Pfizer Analgesia Line because of three adverse effects in patients…
Apparently the report of failures are not important for Nobel Biocare Company
…oh I see it is because of the money…
in fact it is a new Implant Company…. three years in the market….
What is medical products agency?
Fisrt time to see such a meeting for a discussion.
Other Implant Companies were terribly punished when they came out with the term osteo-compresion i.e Impladent.ltd,but today Nobel appear to be the leader in this field
How many cases in the Gotemburg Study Group. Did they follow the right protocol (from NobelBiocare)?
How many cases with conventional implants had bone loss? My results, with much more cases, are not even comparable with the results from Gotemburg group.
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