This is the First Amended Complaint, which was filed on October 21, 2010: 
Swiss dental implant maker Nobel Biocare has been sued by a California dentist seeking class-action status on behalf of dentists whose patients have suffered complications such as bone loss from one of its products.
A company spokesman said on Monday the NobelDirect dental implant was safe and that Nobel Biocare would fight the lawsuit, which was filed on June 30 in the U.S. District court in Los Angeles.
The suit by Jason M Yamada seeks compensation for dentists who have had to perform surgery on their patients, or pay for restorative surgery, after complications from the implants, which it said were defectively designed.
“Because of Nobel’s practices, plaintiff and the class members now face a flood of complaints from injured dental patients who have needed, and will need, immediate intervention to remove the defective implants,” the lawyers Lopez McHugh and Audet & Partners wrote in the 26-page complaint.
Read more: http://uk.reuters.com/article/idUKTRE6641BV20100705
A dentist from California is suing Nobel Biocare, a Swiss company that manufactures dental implants.
Jason Yamada is acting on behalf of a number of dentists and their patients; in a 26 page file, Yamada’s lawyers listed the complaints of a number of dentists and patients and stated that Nobel Biocare had manufactured faulty and defective dental implants, which had caused patients to suffer negative side-effects and complications. As a result of complications caused by Nobel Biocare’s dental implants, patients were also forced to pay for restorative dental care, according to Mr Yamada. The suit also states that Nobel Biocare was aware of the defects, but was marketing their product as a safe and effective restorative device.
Nobel Biocare had previously arranged for Dr. Jason M. Yamada to speak at an educational conference in Houston on August 7, 2010, and to give two lectures in Boston on October 21, and 22, 2010.
Nobel Biocare has now unilaterally canceled those lectures. Please see the counsel letter to Nobel Biocare in regards to this matter.
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 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 Directs and Nobel Perfects 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.
Direct loading of Nobel Direct and Nobel Perfect one-piece implants: a 1-year prospective clinical and radiographic study. Read more: http://nobeldirect-litigation.com/wp-content/uploads/2010/07/DirectLoadingPaper.pdf
The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user qualifications and skills required so that a dentist can use the implants safely. Nobel Biocare may not actively market the dental implants until the information activities are carried out.
Read more: http://www.osseotech.com/?page=14
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.
Two-Year Outcome with Nobel Direct® Implants: A Retrospective Radiographic and Microbiologic Study in 10 Patients. Read more: http://www3.interscience.wiley.com/journal/121402770/abstract
BACKGROUND: A recently introduced implant, the NobelDirect (Nobel Biocare AB, Göteborg, Sweden), has previously been documented with substantial bone resorption in a large number of operated cases. PURPOSE: The aim of this study was to evaluate the failure rate of NobelDirect implants in a retrospective multicenter survey. MATERIALS AND METHODS: A total of 550 NobelDirect implants consecutively placed in over 269 patients at 18 centers were evaluated with regard to failure rate after an average follow-up of about 1 year. RESULTS: The overall failure percentage was 10.9% (59 failures). The 58 implants not loaded directly showed only one failure (1.7%) versus 58 failures (11.8%) of those implants that were loaded directly. A chemical x-ray photoelectron spectroscopy analysis of an implant from the original batch showed up to 3.5% silicon at parts of the implants. A retrieval analysis of one implant removed at 2 years after placement demonstrated bone resorption down to the level of the fifth thread. CONCLUSIONS: It is concluded that the NobelDirect implant, if placed with a punch procedure, ground down in situ, and loaded directly, shows an unusually high failure rate at 1 year.
Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers. Read more: http://www.ncbi.nlm.nih.gov/pubmed/17535329
The Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products. Their task is to ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner.
Here is an excerpt from a letter that the MPA sent to Nobel Biocare on 12/6/2006.
As shown, the percentage shares with marginal bone resorption >3 mm throughout are double-digits for NobelDirect and NobelPerfect, that compared with 1% for Brånemark System inT-091. CSR in T-106, fulfils the high demands, while the 92.8% in Sennerby’s report should be seen to lie at the lower limit for the expected. Recently, Nobel Biocare supplemented T-106 A+0B with results from the 2-year follow-up. This includes 62 implants whereof none from Clinic 4. The share of implants with marginal bone resorption >3 mm now amounts to 8% and CSR to 98%, which must be considered to point to that bone resorption in this group at least did not progress during the second year. However, the MPA’s position is that this 2-year data in spite of everything does not eliminate the view that NobelDirect and NobelPerfect in these treatment series are associated with early appearance of raised marginal bone resorption unexpectedly often.
Read more: http://nobeldirect-litigation.com/wp-content/uploads/2010/07/061206-Nobel-Biocare-Beslut-EN.pdf
If you are a dentist, and you have implanted any NobelDirect device, and you have had to subsequently remove the device, or have had other problems with the device, you are urged to immediately contact class counsel to protect your rights. You may call us toll-free at 877.775.6337 to speak to an attorney, or you may fill out the simple form on the right side of this page.
Nobel Biocare is a company operating in dental implantology and aesthetic dental solutions. The headquarters are located in Kloten near Zurich, Switzerland. The company was founded as Nobelpharma in 1981 and renamed Nobel Biocare in 1996.
The firm concentrates on the development, production and marketing of dental implants, crowns and bridges as well as veneers and laminates as dental prostheses. Nobel Biocare has four production centers in Sweden and the USA and its own sales organizations in 33 countries.
[From Wiki]
The NobelDirect implant was launched in 2004. It was claimed by Nobel to be simple to use by nonspecialist dentists and to result in essentially no incidence of “bone re-absorption.” The implant is recommended by Nobel Biocare for placement without the need for a surgical flap, followed by immediate “loading” of the implant.
However, according to allegations in a recently filed lawsuit, the long, narrow, non-linear tapered design of the implant leads to an excessively high about of marginal bone loss surrounding the implant. This allegedly occurs as a result of the defective design of the implant, and is not a result of dentist-specific causes.
In fact, one study concluded that after approximately one year, over 10 percent of NobelDirect implants placed had already completely failed (i.e., they had to be entirely removed from the patient’s jaw.)
Another allegation in the complaint is that Nobel Biocare “knowingly and intentionally” marketed these devices to general dentists, knowing that the allegedly defective devices would soon have to be removed.
According to the filed lawsuit, this has caused innumerable problems for dentists who purchased and implanted these implants for their patients. These dentists now face a flood of complaints from injured patients. As a result of this allegedly defective design and marketing on the part of Nobel Biocare / NobelDirect, both the dentists and their patients have been harmed by these devices.
If you are a dentist, and you have implanted any NobelDirect device, and you have had to subsequently remove the device, or have had other problems with the device, you are urged to immediately contact class counsel to protect your rights. You may call us toll-free at 877.775.6337 to speak to an attorney, or you may fill out the simple form on the right side of this page.
