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Nobel Direct Implant Reviewed

Last Updated: Feb 07, 2006

On 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 BjÃ¶rn Klinge, external consulting expert
Mr. Mats Ohlson, MPA
Mr. Arne Kardell, MPA
Dr. Lennart Philipson, MPA

Source: http://www.mpa.se

6 Comments on Nobel Direct Implant Reviewed

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Anon

2/7/2006

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 The Nobel Direct implant will not be withdrawn from the market because as long as it's available, SOMEONE will buy it, and nobel will make money.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.

Anon

2/8/2006

Where can the text of this meeting be obtained? Are the results of this study going to be published in a peer-reviewed journal?

Albert Hall

2/8/2006

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....

Anon

2/8/2006

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

Anon

2/15/2006

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.

7/27/2008

My daughter is an implant candidate and after seeing this post I went to Medical Products Agency's website in July 2008 and found the following update... "Dental implants NobelDirect and NobelPerfect: restraints rescinded and review concluded Tuesday, February 26, 2008 The Medical Products Agency has now concluded its review of the dental implants NobelDirect and NobelPerfect. The company, Nobel Biocare has improved the instructions for use for the implants and therefore these can be sold again without restraints. The Medical Products Agency (MPA) reviewed the dental implants NobelDirect and NobelPerfect during 2006 and found inadequacies in the instructions for use for the implants. The company behind the implants, Nobel Biocare AB, was requested to take measures to improve the instructions for use and this has been carried out. The MPA has also reviewed the results from the companyâ€™s three-year study of dental implants, as well as the results from an additional three-year study. Data from the studies confirm the picture that the implants unexpectedly are often connected with early degradation of the dentine. This is primarily because of the inadequacies in the instructions for use the MPA has criticized â€“ inadequacies that are now corrected.. At the same time, Nobel Biocareâ€™s register of customer complaints shows that the dental implants do not differ negatively from the other implants in the companyâ€™s product line. The restrictions applied to marketing that the MPA decided on 6 December 2006 can therefore be rescinded and the MPA concludes the review of the dental implants." Still leaves questions on my end. M

nobel direct loss of buccal gingiva prepare the implant in the mouth or make pfm instead nobel buys alpha bio whos next