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FDA MedWatch Filed on Nobel Biocare`s Replace Implant`s Package Sterility
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."
Dental implant makers lost their shine as a recession-proof investment during the global crisis, which turned fixing smiles into a luxury for consumers who struggled to pay for non-essential work on their mouths. "In spite of their rather functional nature, implants are similar to luxury goods in the sense that they are expensive, discretionary items," Jefferies analyst Stephan Gasteyger said. The dental implant market earned a reputation for being recession-proof by maintaining double-digit growth rates in prior downturns, but the exceptionally tight credit markets during the recent crisis killed growth last year.
Implants have proven to be more cyclical than other parts of the medical technology sector as patients usually have to pay for the often expensive treatments themselves and are rarely reimbursed by insurance policies.
"We are talking about a price category that is similar to a nice Swiss watch," Gasteyger said.
Numerous dental implant company`s have sprung up over the last 3 years that aim to deliver either very similar designs or almost direct copies of established company`s design. These clone implants are often substantially less expense i.e. 1/4 the cost of full service dental implant company`s implants. In addition to mimicking the implant, they have also expanded into compatible prosthetic parts and coverscrews. Especially prominent clone makers Blue Sky Bio (Clone: Straumann, Nobel Biocare and Zimmer) and Dr. Niznick`s Implant Direct (Clone: Straumann, Nobel Biocare, Astra, Zimmer, 3i) are an attractive temptation during less sunny economic times. With some newer designs from the large manufacturers costing close to $500US for the implant and coverscrew, the $100US "out the door" pricing argument of the clone makers is compelling. The Large Manufacturer`s Argument: We invest huge sums in R&D, Service and Support so we want a return on our investment. The Clones` Argument: Marketing+Distribution+Recruitment of Opinion Leaders = 50% the cost of overhead - we dispense with that and pass on the savings to the dentist.
Both are reasonable arguments. One thing is for sure, competition is never a bad thing.
Keystone Dental, funded by private equity firm Warburg Pincus, has settled an unfair competition lawsuit from Noble Biocare for $2million. "The settlement terms provide for Keystone Dental to pay $2 million to Nobel Biocare and that Keystone Dental not hire or solicit any current Nobel Biocare employee through February 1, 2009," the world`s largest maker of dental implants said in a statement. Nobel Biocare filed a lawsuit in late 2007, saying Keystone Dental systematically targeted and hired Nobel Biocare`s sales and marketing employees to gain an unfair competitive advantage. Under the settlement, Keystone Dental is required to destroy confidential and proprietary information on Nobel Biocare in its or its employees` possession, Nobel said.
Implant pioneer Gerald Niznick`s Implants Direct concept of internet-based factory-direct-to-dentist implant sales plans on launching a copy of the Straumann implant design in September. Having already successfully marketed a copy of Nobel Biocare`s implant designs. Read this interview with an European trade journal for interesting details of the strategy.
The FDA has reinspected the BIORA facility and is satisfied with the improvements made. Because the focus of the observations was on the maintenance of quality system documentation and procedures, changes to Straumann® Emdogain, Straumann® PrefGel and Straumann® BoneCeramic were not needed in order to resolve the FDA issues.
Straumann has changed the delivery mechanism of Straumann® PrefGel from a pipette to a syringe, which will help to ensure easier, more effective handling of the root conditioner.
A court in Germany has dismissed a request from Belgian dental implant software maker Materialise for an injunction against a Nobel Biocare software product, NobelGuide. Belgium software maker, Materialise had alleged the updated version of Nobel Biocare`s NobelGuide software infringed one of its patents, a spokesman for Nobel Biocare told Reuters on Wednesday. The Duesseldorf district court decided that the NobelGuide software does not infringe the Belgian company`s patent. The updated version had been introduced as a response to last year`s decision by the same court that found an infringement in the previous software version, Nobel Biocare said.
3M announced that it will acquire Imtec Corp, a leading manufacturer of mini dental implants. “We are looking forward to the reputation, resources and worldwide reach that 3M brings to help us build this business,” said Ron Bulard, DDS and Chairman of the Board, IMTEC Corp. “Its overall strength in oral care with both the 3M ESPE and 3M Unitek divisions makes them a particularly good partner for us.” This acquisition gives 3M ESPE access to two of the fastest growing segments in the dental industry. “Our combined digital products and expertise will enable a digital ‘total restorative’ approach with more options than ever, including IMTEC implants, 3MTM ESPETM LavaTM crowns, and 3M’s advanced digital workflow solutions,” said Jeffrey Lavers, vice president and general manager, 3M ESPE. “Together, we will have an end-to-end implantology solution, making the process easier, faster and better for dentists everywhere.”
Tighter laws are on the cards for dentists wishing to practice implantology in Dubai. A proposed change in policy will require dentists to complete 100 hours of implantology study and to present completed case reports, before being permitted to sit for the oral licensing exam. The move is set to infuriate local product companies, who have previously complained of the United Arab Emirate`s excessive licensing requirements.Industry-led courses are likely to be most affected by the ruling, as most are structured to ensure dentists clock up the 96 hours.
"Most of these courses would not be recognised," said Dr Elhami Nicolas, of Nicolas & Asp College of Postgraduate Dentistry. "It is a positive change. People were not receiving adequate education." The news will be a particular blow for Zimmer Dental whose upcoming course, held through Sharjah University`s College of Dentistry, aimed to fast-track local dentists to license level.
As previously reported, Clearchoice Dental Implant Centers provide one stop implant services: CT-Scan, surgery and restorations. They have sponsored a pseudo-news infomercial in Colorado.
4 Comments: .. The article title had been updated.
Editor ..
Denture cleaners like Polident and Fixodent have caused serious and sometimes fatal reactions in some people. The Food and Drug Administration (FDA) announced Monday that one person died and at least 72 others were sickened as a result of allergic reactions to denture cleaners. In some cases, the reactions were a result of product misuse. The FDA report blamed a bleach called persulfate, an allergen used in most denture cleansers. Persulfates are used in these products as part of the cleaning and bleaching process. The FDA is urging doctors and patients to be aware of the symptoms of an allergic reaction and to only use the cleansers as directed. The person who died and some of those who were sickened misused the cleaners, the FDA said. "Some patients have gargled or swallowed it, resulting in abdominal pain, vomiting, seizure, hypotension and difficulty breathing," it said. Meanwhile, some who reported allergic reactions used the cleaners properly, the FDA said.
Swiss company Nobel Biocare bought Israeli dental implant startup Alpha Bio for $95 million. Alpha Bio Implant was a one-man show: Dr. Ophir Fromovich, CEO, owner and dentist to the stars, not that he`ll say who his clients are. Fromovich founded Alpha Bio Implant in 1988. Alpha Bio created a new type of implant, the first generation of what became called the NobelActive, the implant with the novel thread pattern. The device Web site explains that it does not "cut through bone like conventional implants," it presses through it like a corkscrew. Patients with old-type implants had to wait three to six months for the traumatized jawbone to stabilize before the crown could be "loaded". Also, these old implants could cause bone erosion and lead the gums to recede, which is unsightly. The new one does none of that, says Fromovich. It even suits "soft bone" situations, and causes very little injury to the bone tissue. Also, in most cases, the crown can be loaded on immediately, which is the ultimate victory for the inventors: No need to wait for months to see the patient`s white smile.
Aspiring Mexican dentists are moving to border cities in droves and are luring American patients away from farther flung discount destinations such as Hungary and Thailand. A dental crown in the United States costs upward of $600 per tooth, compared to $190 or less in Mexico. Americans have long crossed the border for cheap medicines, flu vaccines, eye surgery or specialist doctors, but dentists are now in highest demand. "We`ve gone from a handful of patients when we started 2-1/2 years ago to 150 new patients a month," said Joe Andel, an American who owns the Rio Dental clinic in Ciudad Juarez with his Mexican dentist wife, Jessica. Rio Dental, which uses U.S. labs to make its crowns, picks patients up at the airport in El Paso, Texas, across the border and has treated people from as far away as Alaska and Hawaii. "The Internet makes this possible. It allows patients to find us and research us and shows we can do dental work of equal or superior quality to the United States," Andel said.
Internet bloggers swap stories and compare notes about Mexican dentists, but it always comes down to money.
Clear Choice Dental Implant centers provide one stop implant services: CT-Scan, surgery and restorations. They exclusively use one manufacturer`s products and protocols, in this case Nobel Biocare. Two Centers are open so far in Austin TX and Denver CO, with ten more centers planned to open across North America.
The Swedish medical technology company Astra Tech AB is purchasing the US dental company Atlantis Components Inc. for USD 71 million in cash. This business deal is part of Astra Tech’s growth strategy. “The purchase of Atlantis gives us an even stronger product portfolio in the field of dental implants. We strengthen our position in the North American market and can introduce the latest digital CAD/CAM technology in Europe. This also gives us a leading position in the fastest growing segment in the field of implants,” says Astra Tech’s President and CEO, Peter Selley. “Our objective is to be one of the three largest dental implant companies within the next three years,” Peter Selley continues.
Nobel Biocare`s CEO Heliane Canepa has been replaced. Domenico Scala has been named its new chief executive, replacing Heliane Canepa, as of Sept 1, 2007. Nobel Biocare Chairman, Rolf Soiron, explained the decision to replace Canepa by saying: `An international company of this size should not be so greatly identified with a single person as has been the case at Nobel Biocare`. Swiss Sunday paper, SonntagsZeitung, reported Heliane Canepa has come under fire over allegations that the Swedish-Swiss dental implant maker has issued misleading statements regarding the safety of its NobelDirect and NobelPerfect implants.
Canepa said once she leaves the company, she will pursue undertakings of her own.
The continuing FDA ban on importation of Biora`s Emdogain and Bone Substitute has cost parent company Straumann 10 million Swiss francs (8.14 million US$). Straumann chief executive Gilbert Achermann described the loss as `painful`. He furthermore stated that `The US FDA will reinspect our facility in Malmo, but we are not in a position to say when this will happen, If all goes well`, Biora products `could be reintroduced in the US in the first quarter of this year,` Additionally, `According to Achermann, the resumption of the company`s exports to the US depends on the results of an ongoing investigation by US authorities which could last several months.`
Novartis, the Swiss pharmaceutical giant has taken a 10% stake in Swiss dental implant manufacturer Thommen Medical. According to a press release, Novartis`s stake will rise to 20% later in the summer. Andreas Stutz, Thommen Medical CEO says: “Novartis is a strategic partner for us. This opens completely new possibilities in the area of research. The understanding of soft-tissue and bone biology becomes more and more important for the producers of dental implants. Furthermore, we see the interest of Novartis in Thommen Medical as a confirmation of the work we have achieved over the past years.”
Dr. Gerald Niznick of Implant Direct sent a letter to the Editor of IJOMI taking issue with its recent Editorial (JOMI 2006; 21:6) that claimed a direct correlation between innovation and high prices for dental implants. Dr. Niznick`s letter analyzes the published financial statements of Nobel Biocare and Straumann showing their cost of goods at 16% to 20% with marketing expenses in excess of 40% and research costs of only 3.5% - 5% of gross revenues. The editor saw fit not to publish the letter. The Editor acknowledges that Dr. Niznick`s Letter "raised interesting issues" and "describes financial issues that the readership rarely sees." The Editor stated that JOMI "simply cannot afford to use pages for such letters," to which Dr. Niznick points out that the journal contained 34 pages of advertising, many from the same companies who benefit from high implant prices.
A Merril Lynch analyst`s report on the dental implant industry has been released. Issues discussed include: the risk of increasing regulation of implant placement, image guided surgery`s growing importance, Nobel Biocare`s sales strategy and various implant company`s product launches. As always, a very interesting read.
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