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 namely the NobelDirect dental implant. The suit by Jason M Yamada, a periodontist, 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. The suit proposed a class action to cover thousands of dentists in the U.S. who have used the NobelDirect implant, adding that Nobel Biocare had knowledge of the defect, but marketed the implant as safe and effective.

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1 Comments:   .. This again shows that a marketing- driven company ..

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The million or so artificial hips and knees implanted each year in the United States are normally not guaranteed. Instead, the costs of replacing implants that fail early because of design or mechanical problems — devices that sell for as much as $15,000 each — are largely paid by Medicare, insurance companies and patients. Implants can fail for many reasons, but if only a small percentage of them fail prematurely because they are substandard, the costs to taxpayers, policyholders and patients can run into the tens of millions of dollars each year, health care experts estimate. Orthopedic producers may sometimes even profit from the failures because they sell the replacements at full price. “Companies have dumped these costs into the health care system,” said Dr. Lawrence D. Dorr, an orthopedic surgeon in Los Angeles who two years ago took the unusual step of drawing attention to one problematic hip device. “They don’t have any skin in the game.”

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Martin Jones, 42-year-old builder, was left blind after an accident at work more than a decade ago. After a remarkable operation in which part of his tooth was implanted in his eye, he can now regain some of his lost sight. The procedure involved taking a minute section of a patient`s tooth, reshaping and chiselling through to grip the man-made lens which was then placed in its core. It is implanted under an eyelid where it become covered in tissue. The process required a living tooth as an implant because doctors suggest there are chances the eye would reject a plastic equivalent. So a canine - which is the best option due to its shape and size - was taken out of Mr Jones` mouth. A patch of skin is then taken from the inside of the cheek and placed in the eye for two months, where it gradually acquires its own blood supply. The tooth segment is finally transplanted into the eye socket. The flap of grafted skin is then partially lifted from the eye and placed over its new sturdy base. Finally, surgeons cut a hole in the grafted cornea to let light through.

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Manhattan Scientifics has announced that its NanoTitanium product has been approved by the FDA. The patented new form of titanium metal originally developed by Russian scientists in concert with scientists at the Los Alamos National Laboratory is expected to significantly improve dental implants. Studies have shown that bone integrates with these new metals up to 20 times faster than with conventional metals. Patients should experience shorter post surgery healing times and a more reliable integration of these new implants into their body. NanoTitanium is highly compatible with bone and is thought to provide stronger, faster bonding with improved strength, biocompatibility, longer life and improved wear and tear. Founded in 2001, Metallicum (recently acquired by Manhattan Scientifics) has developed methods to modify the microstructure of metals by “nanostructuring” them. This procedure simultaneously increases the biocompatibility and strength of virtually any metal. For example, nanostructuring pure titanium (the material that is most commonly used in dental implants) can more than double its strength, making it stronger than most existing titanium alloys. The ability of bone cells to attach to nanostructured pure titanium surfaces at rates greater than 100% higher than with conventional alloys enables the development and marketing of a dental implant that can be fully integrated and useable with half the healing time of existing products.

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Swiss implant manufacturer, Thommen Medical, have developed a new implant packaging system which allows chairside surface conditioning of their implant. The applicator makes effective chairside surface conditioning fast and intuitive. In a matter of seconds, the conditioning agent contained in the applicator hydroxylates the implant surface to achieve the super-hydrophilic INICELL surface. During the chairside conditioning with APLIQUIQ the surface chemistry is slightly modified by hydroxylation. The result of this process is increased surface energy and improved wettability. The superhydrophilic INICELL surface exhibits a water contact angle of less than 5 degrees. A hydrophilic surface, by comparison, is generally considered to have a contact angle of 90 degrees or less. These properties of the INICELL surface promote spontaneous and complete wetting with physiological fluids, particularly blood.

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Austrian Surgeons have designed a system to produce via CAD/CAM individualized Zirconium Dental Implants for use in case of immediate implant placement. In short, after a tooth is extracted it is scanned and a zirconium copy is milled. The milled copy has macro-retentive features which help secure the new implant in the extraction socket. They report a 90% success rate.

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Straumann revealed a new implant material, Roxolid [Rock-Solid], a Titanium- Zirconium alloy that is 50% stronger than pure titanium. Initial animal studies show a significant increase in removal torque values over Straumann`s current SLActive titanium implants. Human trials are underway in Europe and North America. Straumann expects to have the design released for initial markets in 2009.

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1 Comments:   .. It would be interesting to know if the strength co ..

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Southern Implants have released an implant design to address immediate placement in maxillary molars. The very wide (8-9mm) diameter tapered implant is designed to obliterate the molar extraction socket. The placement of this implant involves the use of a shaping tap to taper the osteotomy. Their implant design features both an external hex as well as an internal connection.

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The Baha system utilizes direct bone conduction, which allows the bone to transfer sound to a functioning cochlea – thereby bypassing the middle ear. This unique hearing treatment is the only system of its kind cleared by the Food and Drug Administration (FDA) to treat hearing loss. One reason the Baha system works so well is due to its simple design. The Baha system combines a sound processor with an abutment and a small titanium implant. The implant is placed behind the non-functioning ear. Surgery is minor, and Baha recipients report a wide range of advantages over other hearing devices. The Baha system, which is based on bone conduction, utilizes a titanium implant, which is placed in the skull bone behind the ear. An abutment connects the sound processor with the implant in the bone. This creates direct (percutaneous) bone conduction. In contrast, traditional bone conductors connect indirectly to the bone through unbroken skin (transcutaneous) and work by exerting pressure against the skull. Direct bone conduction, provided by Baha, gives improved access to sound when compared to traditional bone conductors since sound is not weakened when passing through the skin

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BlueSkyBio have released their design of a Nobel Replace Clone. It features an ActivFluor surface treatment for enhanced osseointegration and is compatible with NobelReplace drills, prosthetics and laboratory components. Their design also features increased fracture resistance at over 100Ncm and enhanced apical threads for greater primary stability. Their implants are about 1/3 of the price of Nobel`s Replace and include a cover screw and 3mm healing abutment.

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Three years after patients were given Nobel Direct dental implants, the risk of the implant loosening has increased even more. A follow-up by researchers at the Sahlgrenska Academy shows that eight per cent of the implants are lost. "We have followed up 48 patients who were among the first to get the implant. For each passing year, we have been able to see how the problems related to these implants have grown more and more,” observes Pär-Olov Östman, a dentist who will be presented the study tomorrow at the defense of his dissertation. After one year, about five per cent of the implants had been lost, and 20 per cent of the remaining implants showed bone loss of more than three millimeters. The new report indicates that after three years, eight per cent of the implants had been lost, and 25 per cent of the remaining implants showed bone loss of more than three millimeters. “We believe that the problems related to Nobel Direct result both from the design of the implant and an uneven surface against the soft tissue in combination with the method of treatment recommended by the company,” according to Professor Lars Sennerby.

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JDentalcare have released a one-piece implant designed for immediate function. The aggressive threading features a very deep coil depth designed to provide increased primary stability even in soft bone. Additionally each thread features a series of little steps on the inside of the thread. These steps increase the bone to implant contact area by 15%. The available implant diameters range from 3-5mm and range in length from 10 to 18mm.

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Regeneration technologies have started to manufacture bone screws from bovine metatarsals. These are used in reconstructive surgery such as repairing the torn anterior cruciate ligament that plagues many athletes. The bone is obtained from specially bread cows at the Pranther Ranch. Prather Ranch "allows us the opportunity to satisfy many concerns about sourcing bovine materials because of the way they do their business," said Carrie Hartill, chief scientific officer at Regeneration. "They are the largest closed herd and safeguarded with proper health and animal husbandry." In addition to the special precautions Rickert takes in breeding his cattle, the cow bones need special preparation before they can be used in human surgery. Regeneration and other companies use cleaning techniques (Regeneration`s proprietary version is called BioCleanse) to ensure that no living material remains on the bone. That cuts down on the risk of disease transmission and prevents antigenicity, which happens when the body`s immune system attacks a foreign substance.With clean bones, the work of turning bone into bone screw can begin. "The first thing we do is shape into rough-hewn shapes around the size and specification you might need," Hartill said. "Then you do the fine machining. It`s actually a screw and it has a thread, so we use identical (cutting and milling) equipment to the titanium-screw manufacturers." The selling point for using bovine biological materials is that the body responds to it as it would human tissue, absorbing it into the body. "It eventually remodels into the host bone from six to 12 months" after surgery, Hartill said. "We have instances where surgeons have had to go in to do a repeat surgery and they haven`t been able to find the bovine bone anymore."

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French dental implant manufacturer TBR Group has received the 2007 Frost & Sullivan Technology Innovation Award for their hybrid Zirconia-Titanium dental implant previously profiled on OsseoTech.com.

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JDentalCare has designed and developed JDTorque® ,a torque wrench for surgical and prosthetic use. It is a universal wrench and it can be used as a torque wrench or as a traditional ratchet for every implant system with the appropriate adapter. The high mechanical resistance along with the great elasticity of the plastic material PEEK allows it to measure torque up to 80 Ncm. This material is extremely light compared with metals and can undergo thousands sterilization cycles at temperatures up to 134°C without changing its mechanical characteristic. The torque wrench doesn`t require any mounting or dismounting saving maintenance time.

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Nobel Biocare has released a one-piece implant design `NobelOverdenture` for use in edentulous situations. It features narrow diameter and one piece for ease of handling. It promises to deliver a cost-effective option to secure dentures.

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Straumann has released their new implant - the `bone level` implant. It features the SLActive surface all the way up to the top of the implant. The abutments are anatomically shaped and feature a `platform-switching` concept. It appears that this design is a response to concerns regarding esthetics and recession with implants in the esthetic zone. Straumann reports that `Intermediate data from the first clinical study show excellent esthetic results with regard to both hard and soft tissues indicating a low risk for recession and no esthetic complications.` The BLI implant is available in a limited market release in the US.

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Ziterion of Germany has released a new one-piece implant design `Zit-Implants` that feature exactly the same implant design but are made from either Titanium or Zirconium. The surgical protocol is identical for both implants and allows the surgeon to decide on the material to be used for the implants at the time of implant placement.

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This Swedish company has designed an implant system based on generic implant concepts, but incorporates an efficient packaging system and a web-based reorder/inventory system. Their `White Book` makes for interesting reading.

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Bredent Medical of Germany have designed an implant system which allows the use of either a titanium or a zirconium implant. The surgical instruments are the same in either case. Their zirconium based `White-Sky` implant is made from `brezirkon` and is of the one-piece implant and abutment design. The implants come in 3.5mm, 4mm and 4.5 mm diameters with lengths from 8-12mm.

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The Swedish Medical Products Agency(SMPA) released a demand for Nobel Biocare to improve the instructions for both its NobelDirect and NobelPerfect implants. Previously Nobel Biocare had released a response to the recent marketing ban on their NobelDirect implant following reports that it lost an excessive amount of bone following placement. The SMPA stood by its decision that the firm not be allowed to market the implants until it had carried out the improvement of the instructions. The SMPA stated that the instructional information must be supplemented and further clarified. As an example, the SMPA described Nobel Biocare`s instruction statement: “you don´t have to be a specialist to prepare the site for NobelDirect” as `inappropriate`.

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Zimmer Dental has released a one-piece implant design. It features a straight and angled version with the abutment integrated into the implant. The abutments are asymmetrically contoured and intended for immediate restoration protocols. The implants come in 3mm, 3.7mm and 4.7 mm diameters.

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Nobel Biocare released another implant design called `NobelActive` at their world conference in Las Vegas. This design features a new thread pattern. They claim that: `The one-stage implant features a unique shape and a new thread design with a "self-drilling" capability to facilitate drilling protocols in areas of narrower osteotomy. The product is easy to use and provides high initial stability and good outcomes. NobelActive(tm) has been designed for increased soft tissue volume at the head of the implant, resulting in improved esthetics.`

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Swiss implant manufacturer Nobel Biocare has signed an exclusive agreement with Wyeth Pharmaceutical manufacturer of Bone Morphogenic Protein rhBMP-2. They claim that: `TiUnite(r) will serve as the foundation for the next generation of dental implants with the potential of eliminating the need to graft and use of membranes. Nobel Biocare is currently in clinical testing of an implant designed to create its own bone. This implant will be treated with a bone morphogenetic protein rhBMP-2 (a recombinant version of a naturally occurring human protein).` and furthermore they claim: `it will drastically change the indications for dental implants. Patients that currently do not qualify for implants will now be able to be treated.`.

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Nobel Biocare has released a response to the recent marketing ban in their NobelDirect implant following reports that it lost an excessive amount of bone following placement. The response called the initial report to the Swedish Medical Products Agency (SMPA) on NobelDirect by Dr Albrektsson as `... incomplete and reported in an unscientific way. The analysis of the present manuscript shows that the material still suffers from intransparency and lack of scientific stringency. The process for peer-review may even be questioned.`

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Trinon has designed a series of extremely short, but wide implants designed for use in areas of limited alveolar height. This design is appropriate for severely atrophied, but wide lower and upper jaw architectures. Insertion is via trephine use and are very appropriate for internal sinus lift use. The implants range in size from 4mm to 7mm in height.

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Straumann has been granted a US Patent on its new implant delivery mount. The much needed redesign features `keyless` removal and incorporates an innovative implant indexing system into the mount, anticipating that implant indexing will increasingly be done at the time of implant placement.

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Ceraroot which makes various anatomically shaped single piece zirconium implants has released another `extraction and immediate implant` video on Google video. This one features a maxillary pre-molar.

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Biomet / 3i has released their upgraded surface, Nanotite. Nanotite features their previous Osseotite surface treated with discrete crystalline deposition of Calcium Phosphate (CaP) resulting in a more complex surface topography. They claim that the biologic benefits Of CaP may play a key role in enhanced site response, potentially improving clinical predictability and outcomes. - This surface is named the same as one released by Bicon a few months ago, are they the same?

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The Fraunhofer Institute for Biomedical Engineering IBMT in Germany have developed a dental prosthesis consisting of a drug-filled reservoir, a valve, two sensors and several electronic components. Saliva enters the reservoir via a membrane, dissolves part of the solid drug and flows through a small duct into the mouth cavity, where it is absorbed by the mucous membranes in the patient’s cheeks. The duct is fitted with two sensors that monitor the amount of medicine being released into the body. The patient has to have the agent refilled every few weeks.

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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.

The MPA`s report gives an interesting insight into the basis and timeline of this investigation.

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Sweden`s Medical Products Agency has made a preliminary finding that Nobel Biocare AG`s dental implant Nobel Direct, is too risky to use except with `great care`. The regulator said it will over the next few weeks come to a final view on Nobel Direct and what eventual warnings will be attached to the implant. The agency issued its statement after investigating the results of Nobel Biocare`s own two year study and said this study was not based on a representative sample, and that up to two thirds of the requisite information from the study was not included in the report it received. `Against this background, .... it is our view that implants of the Nobel Direct type should only be used with great care,` the agency said.

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Implant Direct LLC has received a FDA 510(K) Marketing Clearance for their Spectra System. Dr Niznick, inventor of the internal anti-rotational connection, has started his own dental implant design and manufacturing company that employs a web-based order and support model to deliver a versatile line of implants at about 50% of the price of the major manufacturers.

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Sweden`s Medical Product Agency (SMPA) has announced it will delay its final verdict on the safety of Nobel Biocare AB`s dental implant NobelDirect, which is alleged to cause bone-loss, until November. The agency cited a delay in the release of Nobel Biocare`s two-year follow-up study as being responsible. Two Swedish dentists in May 2005 alleged that the product is causing bone-loss, prompting investigations by the heathcare authority.

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BEGO Implant Systems GmbH & Co has designed a customizable healing abutment designed to shape the soft tissue. By customizing the PEEK blank at the chairside the emergence profile can be shaped, elliptical or even triangular, depending on the circumferential shape of the tooth that is to be replaced. It is made of a high-strength and completely biocompatible plastic abutment made of (implantable) polyether-ether-ketone (PEEK). This material is trimmed into the required shape with the handpiece at the chairside and is used in place of a conventional healing abutment to sculpt the peri-implant soft tissue emergence profile.

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Ceraroot have designed five ziconium-based one-stage implants for use in different areas of the mouth. The anatomically designed implants incorporate the abutment into the implant for a very esthetic result. An interesting video is posted on Google Video showing the use of a Ceraroot implant in an immmediate placement procedure.

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3 Comments:   .. its sure look good and i have feeling, this can ma ..

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Merrill Lynch and UBS have released stock research reports regarding Nobel Biocare`s NobelDirect implant design. Several recent studies suggest more than 3mm of bone loss in 14-55% of patients. An expert panel advising the Swedish Medical Products Agency on the safety of the NobelDirect implant has responded to a recent Nobel Biocare rebuttal letter in a critical manner. The Merrill Lynch analyst suggests a NobelDirect withdrawal may be ahead.

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