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 Заголовок сообщения: Караул!!??!! Нестерильный Нобель...
СообщениеДобавлено: 08 мар 2011, 23:18 
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Зарегистрирован: 07 фев 2005, 12:48
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Сайт: http://www.dental-revue.ru
Откуда: г. Тверь - Москва
Цитата:
A Las Vegas dentist has filed a FDA Med Watch report regarding the integrity and therefore sterility of Nobel Biocare Replace Implants. To quote from the report: "I have experienced substantial and unexplainable failures with Nobel Biocare`s ("Nobel") Replace(TM) Implants. Of 88 consecutively placed implants,34 required removal due to pain or infection for a failure rate of 38.6% (Attachment #1). I doubt these failures are caused entirely by my case selection or surgical skill because I also recorded the clinical success of 51 consecutively places Implant Direct RePlant(TM) Implants from 2008-2009 with only 2 requiring removal for a failure rate of 3.9% I brought this information to Nobel Biocare`s attention, as shown in my letter of October 27, 2008 (Attachment #3) and submitted failure reports on their forms (Attachment #4). Nobel refused to take back my remaining implant inventory, contending that the problem lay with my surgical skills rather than with their implants. After Nobel`s refusal, I continued to use some of my remaining inventory of Nobel Replace implants while also incorporating Implant Direct`s RePlant implants into my practice. After experiencing a significantly higher failure rate with the Nobel Replace implants compared to Implant Direct`s RePlant implants, I stopped using the Nobel implants altogether. Seven Nobel implants from my inventory were sent to Nelson Labs (Attachment #5) and eight were sent to an ISTA Certified Lab (Attachment #6) for dye immersion tests. As can be seen on these reports, all of the implants tested failed to provide a seal required to assure the maintenance of sterility of the contents."



Итак, у дантиста из Лас-Вегаса вдруг процент потерь имплантатов Нобель вырос до 38,6%... хотя в тоже время он ставил и другие имплантаты и потери были 3,9%...
тогда он взял и отдал 7 упакованных имплантата Нобель в лабораторию - оказалось, что упаковка не выдерживает тест на стерильность...
вся история здесь:
http://www.implantdirect.com/newsletter ... /nobel.htm

http://www.implantdirect.com/us/documen ... rkins2.pdf


:allllkg:

_________________
"Знать - это одно; верить, что знаешь - совсем другое. Знать - это наука, но верить, что знаешь - это невежество". (Гиппократ)


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СообщениеДобавлено: 02 сен 2011, 16:04 
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Зарегистрирован: 02 сен 2011, 14:45
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Откуда: Moscow
мегаржач... это пишет компания, которая делает копии Нобеля... источник, которому, можно безоговорочно доверять :bla:


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СообщениеДобавлено: 03 сен 2011, 18:45 
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Зарегистрирован: 07 фев 2005, 12:48
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Откуда: г. Тверь - Москва
вот такая конкуренция по-американски...
:allllkg:


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СообщениеДобавлено: 23 апр 2013, 09:13 
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Сайт: http://www.dental-revue.ru
Откуда: г. Тверь - Москва
Цитата:
April 17, 2013 -- Nobel Biocare will reportedly pay up to $1.3 million to settle a $450 million lawsuit brought against it three years ago by a California dentist who said the company had misrepresented the safety of its NobelDirect implants.

The lawsuit, which was filed in June 2010 by Jason Yamada, DDS, of Torrance, CA, in the U.S. District Court for the Central District of California, sought compensation for dentists who had to perform surgery on their patients or pay for restorative surgery due to complications from the implants. The complaint alleged that Nobel Biocare had knowledge that the implants were "defectively designed" but marketed them as safe and effective.

The lawsuit was certified as a class action in August 2011, and nearly 3,000 dentists received notices of the lawsuit at that time, according to a story on Law360.com. Those who did not opt out of the case will receive a refund of the actual amounts they paid for the company's failed NobelDirect implants, and in cases in which Nobel's records don't show the actual amount paid, the claimants will receive $450 each. This means the class as a whole could receive as much as $1.3 million.

The court has appointed Audet & Partners, Lopez McHugh, Ochs Law Firm, and Steven Ochs as class counsel, according to Law360.

Nobel Biocare is represented by Eric Kizirian and Roy Brisbois of Lewis Brisbois Bisgaard & Smith. Kizirian was not available for comment as of press time.

_________________
"Знать - это одно; верить, что знаешь - совсем другое. Знать - это наука, но верить, что знаешь - это невежество". (Гиппократ)


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СообщениеДобавлено: 24 апр 2013, 08:37 
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Зарегистрирован: 04 сен 2010, 09:49
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Черный пиар. Только пиарманагер подобран из дешевых. Хитрее надо быть.

_________________
Если вам плюют в спину, значит вы идете впереди. (Конфуций)


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СообщениеДобавлено: 29 янв 2014, 10:16 
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Зарегистрирован: 07 фев 2005, 12:48
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Откуда: г. Тверь - Москва
В Америке разгребают последствия установки Нобель-Директа
http://nobeldirect-litigation.com/

Самое интересное, что появились исследования, где подтверждены его плохие характеристики - но что мешало компании сначала сделать клинические испытания, а потом выпустить новый продукт на рынок.

:allllkg:

Цитата:
ABSTRACT


Introduction: The Nobel Direct® implant (Nobel Biocare AB, Göteborg, Sweden) was developed to minimize marginal bone resorption and to result in “soft tissue integration” for an optimized aesthetic outcome. However, conflicting results have been presented in the literature. The aim of this present study was to evaluate the clinical and microbiologic outcomes of Nobel Direct implants.


Materials and Methods: Ten partially edentulous subjects without evidence of active periodontitis (mean age 55 years) received 12 Nobel Direct implants. Implants were loaded with single crowns after a healing period of 3 to 6 months. Treatment outcomes were assessed at month 24. Routine clinical assessments, intraoral radiographs, and microbiologic samplings were made. Histologic analysis of one failing implant and chemical spectroscopy around three unused implants was performed. Paired Wilcoxon signed-rank test was used for the evaluation of bone loss; otherwise, descriptive analysis was performed.


Results: Implants were functionally loaded after 3 to 6 months. At 2 years, the mean bone loss of remaining implants was 2.0 mm (SD ± 1.1 mm; range: 0.0–3.4 mm). Three out of 12 implants with an early mean bone loss >3 mm were lost. The surviving implants showed increasing bone loss between 6 and 24 months (p = .028). Only 3 out of the 12 implants were considered successful and showed bone loss of <1.7 mm after 2 years. High rates of pathogens, including Aggregatibacter actinomycetemcomitans, Fusobacterium spp., Porphyromonas gingivalis, Pseudomonas aeruginosa, and Tanerella forsythia, were found. Chemical spectroscopy revealed, despite the normal signals from Ti, O, and C, also peaks of P, F, S, N, and Ca. A normal histologic image of osseointegration was observed in the apical part of the retrieved implant.


Conclusion: Radiographic evidence and 25% implant failures are indications of a low success rate. High counts and prevalence of significant pathogens were found at surviving implants. Although extensive bone loss had occurred in the coronal part, the apical portion of the implant showed some bone to implant integration.

http://onlinelibrary.wiley.com/doi/10.1 ... x/abstract


Вложения:
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_________________
"Знать - это одно; верить, что знаешь - совсем другое. Знать - это наука, но верить, что знаешь - это невежество". (Гиппократ)
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СообщениеДобавлено: 05 сен 2014, 09:11 
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Зарегистрирован: 05 сен 2014, 06:55
Сообщений: 6
Вы издеваетесь? Производитель реплик Нобеля решил попиариться ))))


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СообщениеДобавлено: 15 сен 2014, 17:47 
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Зарегистрирован: 07 фев 2005, 12:48
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Сайт: http://www.dental-revue.ru
Откуда: г. Тверь - Москва
Цитата:
April 17, 2013 -- Nobel Biocare will reportedly pay up to $1.3 million to settle a $450 million lawsuit brought against it three years ago by a California dentist who said the company had misrepresented the safety of its NobelDirect implants.

The lawsuit, which was filed in June 2010 by Jason Yamada, DDS, of Torrance, CA, in the U.S. District Court for the Central District of California, sought compensation for dentists who had to perform surgery on their patients or pay for restorative surgery due to complications from the implants. The complaint alleged that Nobel Biocare had knowledge that the implants were "defectively designed" but marketed them as safe and effective.

The lawsuit was certified as a class action in August 2011, and nearly 3,000 dentists received notices of the lawsuit at that time, according to a story on Law360.com. Those who did not opt out of the case will receive a refund of the actual amounts they paid for the company's failed NobelDirect implants, and in cases in which Nobel's records don't show the actual amount paid, the claimants will receive $450 each. This means the class as a whole could receive as much as $1.3 million.

The court has appointed Audet & Partners, Lopez McHugh, Ochs Law Firm, and Steven Ochs as class counsel, according to Law360.

Nobel Biocare is represented by Eric Kizirian and Roy Brisbois of Lewis Brisbois Bisgaard & Smith. Kizirian was not available for comment as of press time.

http://www.drbicuspid.com/index.aspx?sec=nws&sub=thd&pag=dis&itemId=313127

_________________
"Знать - это одно; верить, что знаешь - совсем другое. Знать - это наука, но верить, что знаешь - это невежество". (Гиппократ)


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СообщениеДобавлено: 18 сен 2014, 19:17 
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Откуда: г. Тверь - Москва
Цитата:
Clin Oral Implants Res. 2008 Mar;19(3):219-26. doi: 10.1111/j.1600-0501.2007.01410.x.

Short-term clinical results of Nobel Direct implants: a retrospective multicentre analysis.

Sennerby L1, Rocci A, Becker W, Jonsson L, Johansson LA, Albrektsson T.



Author information



Abstract

PURPOSE:

The present retrospective clinical study was undertaken to evaluate the survival rate and marginal bone conditions around Nobel Direct one-piece implants. The purpose was also to compare the results with when these implants are used for immediate/early loading with implants allowed to heal before loading.

MATERIAL AND METHODS:

Forty-three consecutive patients previously treated with 117 Nobel Direct implants at four different centres were evaluated. The implants had been used in both jaws for treatment after loss of single and multiple teeth. Immediate/early loading (within 2 weeks) with a provisional crown/bridge was applied to 95 implants, while 22 implants healed unloaded for 6 weeks to 6 months before loading. Calculations of marginal bone loss were performed in radiographs taken at placement and after an average of 10.2 months (range 1-18 months) of loading.

RESULTS:

Six (5.1%) of the 117 implants were removed during the follow up. All failed implants belonged to the immediate/early loading group giving a failure rate of 6.3% for this group and 0% for two-stage implants. The failure rate was higher for flapless (7.9%) than for flap surgery (0%). The marginal bone loss was -2.4 mm (SD 1.5) for all implants, while 37.6% showed more than 3 mm of loss during the follow up. Bone loss increased with time of follow up. Implants subjected to immediate/early loading showed more bone loss than two-stage implants: -2.6 mm (SD 1.5) vs. -1.6 mm (SD 1.1). Moreover, 41.3% of immediately loaded and 22.7% of two-stage implants presented with more than 3 mm of bone loss.

CONCLUSIONS:

This short-term retrospective analysis showed a poor clinical outcome of Nobel Direct implants. Extensive marginal bone loss (>3 mm) was found around more than 1/3 of the implants evaluated. Less resorption and no failures were experienced when implants were allowed to heal from 6 weeks to 6 months before occlusal loading. Within the limitations of the present study design, data indicate that immediate loading, the use of this implant for multi-unit constructions and flapless surgery are risk factors for failure of Nobel Direct implants.


http://www.ncbi.nlm.nih.gov/pubmed/18237314

Цитата:




Clin Oral Implants Res. 2007 Aug;18(4):409-18. Epub 2007 May 14.

Direct loading of Nobel Direct and Nobel Perfect one-piece implants: a 1-year prospective clinical and radiographic study.

Ostman PO1, Hellman M, Albrektsson T, Sennerby L.



Author information



Abstract

OBJECTIVES:

The aim of this prospective study was to evaluate the Nobel Direct and Nobel Perfect one-piece implants (OPIs) when used for immediate function.

MATERIAL AND METHODS:

Forty-eight patients were provided with 115 OPIs for loading with a provisional crown or a bridge within 24 h and followed for at least 12 months with clinical and radiographic examinations. A group of 97 patients previously treated under identical conditions by the same team with 380 two-piece implants (TPIs) for immediate loading in the mandible and maxilla served as the reference group.

RESULTS:

Six (5.2%) OPIs failed during the follow-up due to extensive bone loss. Five (1.3%) implants failed in the reference group. After 1 year, the mean marginal bone loss was 2.1 mm (SD 1.3) for OPIs and 0.8 mm (SD 1) for TPIs. 20% of OPIs showed more than 3 mm of bone loss compared with 0.6% for TPIs. When compensating for vertical placement depth, OPIs still showed a lower marginal bone level and thus more exposed threads than TPIs. Depending on the criteria used, the success rate for OPIs was 46.1% or 72.2% compared with 85% or 91.6% for TPIs.

CONCLUSIONS:

The Nobel Direct and Nobel Perfect OPIs show lower success rates and more bone resorption than TPIs after 1 year in function. Factors such as implant design, insertion depth, rough surface towards the mucosa, in situ preparation and immediate loading may have an influence on the clinical outcome.


http://www.ncbi.nlm.nih.gov/pubmed/17501980

_________________
"Знать - это одно; верить, что знаешь - совсем другое. Знать - это наука, но верить, что знаешь - это невежество". (Гиппократ)


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СообщениеДобавлено: 24 фев 2017, 16:53 
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Зарегистрирован: 15 окт 2016, 16:21
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Страшно вообще ходить к врачам.


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СообщениеДобавлено: 15 июн 2017, 14:39 
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Кстати, субъективно, крайнее время много брака у Нобеля. Винты ломаются, абатменты тоже. И периимплантиты частые, еще на этапе ФД. В общем, фигня какая то.

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Если вам плюют в спину, значит вы идете впереди. (Конфуций)


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