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Nobel Responds to Dental Implant Critics

Do you think there will be any major repercussions from the recent Nobel Direct dental implant saga, which heated up this past week?

As you may already know, two professors, Tomas Albrektsson and Lars Sennerby, had issued allegations concerning Nobel Biocare's dental implant NobelDirect back in May 2005. This seemed somewhat innocuous. However, last Tuesday,  Par-Olov Ostman, a Swedish dentist, said his clinic would withdraw from Nobel study, which the company is conducting to monitor the Nobel Direct dental implant.

The reason for Ostman´s withdrawal? Ostman's clinic had reported that over 30 percent of the dental implants were accompanied by more than 2 millimeters of bone loss during the first year.  Ostman said six implants had had to be removed due to bone loss. "Nobel keeps telling television and newspapers that there's nothing unusual about this implant, and I cannot agree with that," Ostman told Reuters.

Nobel was quick to fight back against this recent accusation. According to the company, "The information is anecdotic; there are no indications of this material being part of a systematic review and by no means as complete as requested. They contain no scientifically or statistically relevant evidence supporting the allegations." With regards to Ostman´s dental implant findings, Nobel was quick to point out that Ostman has a strong professional relationship with Tomas Albrektsson and Lars Sennerby and more importantly, "the performance of Dr. Oestman's implants is significantly below the average performance of the other participants of the studies." Finally, Nobel reiterated that based on clinical studies the NobelDirect dental implant, " is a safe and reliable product." "Since the Swedish Medical Products Agency is investigating these allegations upon Nobel Biocare's request and since Nobel Biocare fully supports and trusts the Agency's procedures, the Company expects the opinion by the Agency."

Interestingly, the Nobel Direct dental implant accounted for only 2 percent of Nobel´s sales, so the economic impact to Nobel should be limited. However, the key question is whether there will be any impact from this on the marketability of other Nobel dental implant product lines. What are your thoughts?

January 10, 2006 in Dental Implant News, Nobel Biocare | Permalink

Comments

I haven't seen any studies about this or anything other than a press release a while ago. what have been the results of others using this implant? is there anything published or even more news about this?

Posted by: | Jan 10, 2006 2:03:10 PM

I have personally worked with Tomas Albrektsson for 15 years and know his ethical and scientific work to be beyond reproach or question. He is one of the world's top researchers in the field of implant surfaces and osseointegration.

Posted by: | Jan 10, 2006 2:24:26 PM

This absolutely makes me apprehensive about their up and coming product lines.

Posted by: | Jan 10, 2006 2:51:59 PM

I have done several cases, no failures so far, but I have to say than as a periodontics I do not understand the way this fixture may be restored properly by GPs to which it seems is intended for, without leaving a hanger that retains plaque and is difficult to keep cleaned. I have stoped using them for these reason. I have a failure rate less than 0,4% for all implants so I desagree than Dr Oestman's performance is an explanation for his results; I do not know him but I believe this comment from Nobel is very nasty.
I will review my cases and send information about the evolution.

Posted by: Spain | Jan 10, 2006 3:29:43 PM

First they blasted roughened surfaces, then Tiunite was the second coming, Nobel Perfect was marketed with more marketing muscle than anything before with so many promises made, and what? Nobel Direct is now under fire.... And Nobel Guide is not as easy as they say. Meanwhile training GPS to place implants in 2 days. Buyer beware is one person opinion.

Posted by: | Jan 10, 2006 4:05:37 PM

I have been placing implants for over 21 years. I have experienced problems with Sterioss rough TPS coated surface that broke down after 3 to 7 years. They lied to us. They claimed that the TPS was the 1st comming. Then Ti-Unite ...the 2nd comming. Will this surface break down also? They use us as guinea pigs to test their products. Now they are trying to copy the Astra system with the Groovy and again we are the field test. I also think that the company made a big mistake marketing the 2 day surgical course to GPs and now I don't do Nobel any more. They were my #1 company before but not now. I think the dollars blinded them and the direction of the company makes me very uncomfortable.

Posted by: | Jan 10, 2006 4:39:27 PM

I would like to see documentation about the failure of the new Nobel implant. What is so interesting is that some people are adding the added step of adding PRP to the implant before placement. For people doing this, this changes the normal placement and may or maynot add and substract to the success. My reason for bringing this up is that when placing this implant it is very important(I think) to avoid compression necrosis by over torquing the implant...beyond 35 ncm.
If we follow their protocal exactly will we get the results that "they" are getting or as all dentist do....add or subtract step that are important. Another example is tapping the site. Many of us do not tap type 3 bone and should we.
To add to this long post.
Many implant companies are not forth coming...ask about Dentsply Friadent

Posted by: | Jan 10, 2006 4:51:34 PM

My experience with the NobelDirect implant has been less than stellar.I must qualify that I am using this implant only in very narrow spaces like small Max lateral incisors and Mandibular incisors. Contrary to my initial perception,as an experienced implant surgeon, the 3-0 mm. NobelDirect implant is very difficult to place in the mandibular incisor location. This is because often a periapical constriction of the bone is found just below the root apex and a redirection of the body of bone occurs at that location!usually you have one shot at placing this implant. If you don't get primary stability, you might as well forget it and do a conventional bridge since bone grafting in this location is difficult to do. Unfortunately as the previous poster mentionned: Marketing is preceding engeneering too often at the expense of the patient and the dentist! Nobelbiocare should consider reversing their course as it stinks of greed and it is turning off their loyal customer base.It might also open the door for class action lawsuits....The lawyers are salivating already....
My 2 cts.

Posted by: | Jan 10, 2006 5:31:47 PM

Where 10 years ago, before the merge with SteriOss and before the Canepa story, it was difficult to be "allowed" with the Brånemark system.
Now it has become the implant K-mart company where they look afterwoods if the implant succeeds or fails. One can trust people such as Sennerby and Albrektson, they earned their good names in research!
Implantologists all over the world should mis-trust the money greed from this Swiss lady! All the new products they tore out of the ground so quickly, promise more than their performance right now. There was a day that nothing left this Nobel company before well tested. Even P.I. Brånemark took his nameaway from Nobel Biocare since he didnot believe in this agressive marketing strategy. Nowadays there are several good implant-companies performing at least as succesfull, or even better with less circus!

Posted by: | Jan 10, 2006 7:13:27 PM

The one piece Nobel direct implant must take some form of immediate loading because it is exposed. Also, because it is not always easy to obtain ideal angulation in narrow ridge situations, the implant will generally require some form of supracrestal preparation of the metal in order to place a provisional crown. These two factors may be compromising and having an effect for some operators on the percieved sucess of this implant when compared to a traditional two stage approach. I have used this implant on a few cases of congenitally missing laterals with good success. I have not seen the bone loss alluded to during my 2 years of follow-up. As with most situations good case selection and careful technique will go a long way to minimize negative outcomes.

Posted by: Dennis Nimchuk | Jan 10, 2006 9:06:51 PM

When a company has got more than 50% world market shares, I suppose they can say and do as they please and we will beleive it

Posted by: | Jan 10, 2006 10:24:33 PM

I haven't even considered Nobel after Steve Lewis, the developer of the UCLA abutment parted ways with them. He was a big Branemark proponent and is a world renowned speaker.

Posted by: pinpollo | Jan 11, 2006 2:12:15 PM

In my opinion, we are watching the downfall of a great company right before our eyes!
Greed is readily apparent. All you have to do is read Barron's magazine article last year to see the unashamed announcement of greed and proud of it! No mention of quality leader or anything like that.
I find it quite interesting that at the Astra World Congress in April that president of the scientific committee is Albrektsson and other names like Tarnow are on the committee and I heard from the Astra rep even Branemark is involved.
Add this to Carl Misch even using Astra and selling biohorizons, the way NB is treating their reps, it is the cycle of large companies.
We'll see how Astra, Straumann, and 3i and Dentsply (the next biggest market share companies) respond or if some "upstart" like blue sky bio at $95 each starts gaining market share. If you get ignored at $300 an implant, why not get paid attention to at $95 per implant?
fmn

Posted by: fmn | Jan 11, 2006 3:27:44 PM

I ABSOLUTELY agree with the above post, the only mistake is that with bluesky's $95 implant, you wont get paid attention to, because they have No reps or clinical support. All the big names in research and development have gone to Astra, there's a reason for it!!

Posted by: | Jan 11, 2006 8:21:09 PM

What is everybody bitching about Locante published an article describing design that is more specific for immediate function,based on bone compression research and biomechznics,NobelDirect, this implant is not designed for immediate function. Just read Brunskis article (75 pageslong).or better yet take Locantes course on immediate function and it all comes clear.It is a function of Bone architechture,Implant design,surgical approach,opposing occlusion,and provisionalisation. Nobel Direct is not designrd for immediate loading,

Posted by: | Jan 12, 2006 3:14:48 AM

For the last 3 years i have been trying to figure out why our team has been experiencing cover screw exposures in more than 30% of our implant cases, accompanied with a 2-3mm bone loss, even two months after surgery. I have been trying to get answers from the nobel people but with no luck. was it until one cover screw was given for physicochemical analysis, when we finally reached some conclusions because of the diversity of the chemical structure of the cove screw. should be noted that we use four diferrent implant systems and we sometimes experience bone loss only after the reestablishment of the biologic width and limited to the first thread. we stopped using tapered replace implants in the lower arch and we had the same problems with straight nobel implants. i am starting to wonder seriously whether we are paying for a mercedes and we receive a Fiat.

Posted by: DR Nikolaou Eftstathios DDS | Jan 13, 2006 6:49:23 AM

There is no evidence that Nobel direct implants fail, but there is not also evidence that they do work.
Nobel apparently want to be the Microsoft of the computers, but soon they will respond to many problems,because the way they are marketing is clearly uncommon in (another)a dental product .

Posted by: Albert Hall | Jan 14, 2006 7:16:13 AM

I've had a periodontal practice for 30 yrs, have done about 2600 implants, and do about 300 a year , I can't afford to cause problems for my referral base. My system is affordable on both ends, has an elegantly simple design, no screws, employs a locking taper preventing bacterial leakage (no micro gap) between the abutment and implant. If placed properly, there is no routine bone loss to first thread, but great anterior esthetics are routine, it's perfect for tight spaces, or minimal bone height. No need to be concerned about platform switching , this system has already has the platform others are switching to. I'm too old for the Nobel type problems mentioned here. Check out Bicon.com , system works great.

Posted by: Joseph Leary | Jan 14, 2006 8:31:27 AM

The issue here is Nobel Direct System and the relevant comments from Dr. Ostman ( being friend or not from Dr. Albrektsson)...the fact that this appear to be a page to write how succesful we are with one or another System is not also relevant.The fact is that we did accept a Company with no studies and a huge quantity of products.We did allow the Dental Industry to be over our clinical expertise and to me is very dissapointed that great colleagues are playing that game...for money? ....for prestige....Branemark thought also in money and prestige, but being scientific and hard worker.
Today all this is like a Milan Show fashion....
I will not place a Nobel direct to one member of my family nor because of dr. Ostmann appreciation, it is because of the lack of scientific data.I do not belive in the rapid multycenter studies from the company Nobel Biocare AG (Aktien Gesselschaft)

Posted by: Albert Hall | Jan 15, 2006 2:59:36 PM

I totally agree with you Albert, the implant Industry, specially Nobel, has done a lot of damage to the proffession. The lack of evidence, the fact that our patients are the lab pigs of their products, the marketing strategies stating that it is simple, easy , predictable and highly esthetic, and that anyone could do it, has done a lot of harm. They got the money, hence they are running the show, but as long as a few of us are critical and objective, We can still deliver a message to the dental community. I just hope it si not too late. How many failures will be accounted with this nobel direct lie? We will never know, but hey they will always have an explanation....our fault.

Posted by: | Jan 16, 2006 7:03:21 AM

Interesting. All this talk and you would think the industry is going to you know where in a hand basket. Meanwhile, more implants are being placed than ever, and overall industry failures are going down, not up. Maybe we should all pay attention to the "Got Milk" folks and try to elevate the industry so the public has a good perception of dental implants...versus create a stain so all can be fearful? Do you remember which breast implant company was the villain back when breast implants went out of vogue? Yeah, most in the general public just learned that breast implants weren't good, not that some particular company had a problem...and it killed the industry for many years. I place about 250 implants per year, and I just want the field to be recognized for the good it does, and for the patients to keep wanting treatment. We all keep this ridiculous gossip going and I guarantee it will hurt us clinicians, no one else!!!

Posted by: | Jan 17, 2006 11:54:47 AM

I've place 4350 Nobel implants since 15 years and lost 17 up to date. No implant company will ever be responsible for an implant loss. Only clinicians errors or misjudgement will.
I've never placed a NobelDirect implant... because I dont trust the design. Is this design a mistake ? I dont know. Historicaly, Nobel is the only, remember, the only company who cared for long term research. Historically, no company can match the quality records of Nobel. Can any company avoid mistake forever ? Have they lost their touch ? Futur will show.
No company, Astra included, can replace your clinical judgement. If you don't have one, don't place implants !

Posted by: L Chaussé | Jan 17, 2006 3:49:39 PM

I have been placing implants for over 15 years and not all Nobel,however, I believe in immediate function and Tiunite. Nobel Direct 3.0 has been a true product differentiator. Everyone should think about who has an axe to grind and use their own common sense to come to their own conclusions. It is my understanding that the top three Dr's making allogations
were refused contract renewal by Nobel Biocare for various reasons, talk about a Bias!!!
What is that saying...opinions are like assholes, some bigger than others!
Show me some hard evidence, studies and I will listen. Otherwise act like the professional you calim to be!

Posted by: | Jan 17, 2006 5:31:17 PM

I'm a periodontist placing implants for ten years, and one of the things I pride myself in is basing my clinical practice on research - what I read, and what I have learned as a clinician. I think most in the industry stand for the same. Why then do you all use the anecdotal evidence provided by these Drs. to create hysteria over the implant? My Nobel rep has presented me with a multi-center (5 centers) study that thus far shows a greater than 98% success rate for Nobel Direct,one year out. I have also called some colleauges who use it and they report no problem. I agree with the Got Milk guy, we're only shooting ourselves in the foot with this anecdotal poppy-cock. I want a healthy implant industry, cause I've got years of practice ahead of me! Wish we were all so passionate in getting our GP friends to stop prescribing 3-unit bridges and dentures...

Posted by: | Jan 18, 2006 11:57:04 AM

Jack Hahn responds to items posted Jan 10-Jan 17 concerning Nobel Direct and Nobel Biocare as a company. In my thirty-five years of active involvement in implant dentistry and having placed over 35,000 implants, I have come to the realization that implant devices don't cause failure. How we utilize these devices contributes to failure. Nobel Direct is an example. I have placed nearly 200 Nobel Directs beginning in April, 2003 to the present time. Four Nobel Directs failed to integrate. In two cases, the provisional crowns became loose and the patient hyperfunctioned causing early movement of the implant. The other two implants became mobile within the first six weeks due to not having primary stability of 35 mm/cm to 45 mm/cm. My fault, not Nobel's fault. To date, I have not experienced any adverse reactions with Nobel Direct. The soft tissues are pink and stippled with very shallow sulcus depths. Forty implants are presently in my Direct study. Radiographs are taken every six months and there has been absolutely no bone loss. I have offered to show these cases and radiographs to the practitioners who are the Nobel naysayers and they weren't interested. It is like anything in life. A thousand successes, one person knows about it. One failure and a thousand people know about it.
Why am I successful with Nobel Direct implants? I learned not to "push" the system. Achieve primary stability without overtightening. Prepare the abutment portion using new sharp metal cutting burs with copious amounts of water. Construct a well-fitting provisional restoration and use a cement with good adhesive properties (Improv).
I am one of the clinical advisors for Nobel Biocare. In all my years in implant dentistry, I have tried to exercise care in which products I utilized. If I found a problem with a certain product, I abondoned its use and notified the company about my concerns. Many practitioners who have been in implant dentistry for a long time know that I was involved with clinical development of implant devices for Steri-oss. The chief attribute to the company was that it could innovate new products to the market in a relatively short period of time. Under the leadership of Mrs. Canepa, Nobel Biocare has continued this philosophy. As far as clinical studies, no company in the world does more. Nobel presently has over one hundred university based studies. The accusations made in OsseoNews are just that--accusations. If Mrs. Canepa was greedy, she would have sold the company as the stock is over $220. Her philosophy is to develop products that more practitioners can use in their daily practices and that patients will first consider implants instead of three-unit bridges or slipping, uncomfortable dentures.
The last issue that I want to debate is the question of two-day courses for GP's. Implant dentistry is not a specialty, and in my lifetime it probably will never be a specialty. For the past seven years I have been doing hands-on courses for GP's. We teach safe, simple predictable implant placement in areas of adequate height and width of bone. To date, our participants are practicing safe, successful implant dentistry. Even the practitioners who decide not to do implant surgery become more aware of the benefits of implant dentistry to their patients and refer more patients to specialists.
I normally don't comment on the various implant chat lines, but felt I had to respond to this one.

Posted by: Jack Hahn, DDS | Jan 19, 2006 7:44:41 AM