The case on my mind today has to do with a lab owner who e-mailed me this week in search of some metal guide tubes for a surgical guide they were making. Now, model based surgical guides have been made for decades and they work for simple surgeries of one or two units, where there is abundant bone and little chance of perforating a nerve or sinus. When I looked at the pictures of these models, I knew this was not the case. I was not just being asked to sell him the tubes, I was also walking him through the process of guide fabrication. Without the benefit of a CT scan/tissue sounding, he was using the diagnostic wax up as the guide for implant positioning. Again, not unusual, but the narrow and deeply resorbed ridge worried me, and I said so.

He replied, “It’s not my responsibility to know what is where. I’m just filling the Rx and showing the doctor the IDEAL position for the implant. It’s up to him to decide if that is possible.”

I’m afraid that was not the impression I was given. In fact, with the doctor requesting metal guide tubes, I believe he was expecting some kind of precision on his osteotomy, not just a suggestion. The prescribing doctor may not even understand how a surgical guide is made, and it was obvious to me that the technician only had a fundamental understanding of the process. Maybe I’m reading between the lines, and I’m all wet on this, but without the benefit of knowing either party, I could only draw conclusions based on assumptions I made at the time.

Let’s be clear about something. There is a big difference between a surgical guide and an acrylic stayplate or nightguard, even though the process for fabrication  combines the techniques of both. We live in a society today where people will usually call their attorney before they call 911 when something goes wrong. When it comes to making a decision like filling a doctor’s prescription, when we don’t have all the information we need, or when we see something being done that is contraindicated, it’s OUR responsibility to decide to go forward or not. To simply state that the responsibility for problems lies downstream with the dentist, is I think, delusional.

Any true understanding of personal or professional responsibility requires that we make decisions based on a sound understanding of the action we are taking. To me that means remaining up to date on technology, not oblivious, not afraid to ask questions or to look too dumb. Sometimes it means passing on a project that I’m not experienced or qualified to participate in. Some friends think that I’ve become an old curmudgeon or even paranoid, or that I’m trying to scare people away from an area of dental technology that holds a lot of opportunity.

You be the judge. A California jury awarded 1.7 million dollars to a patient injured when a dental implant was placed without the aid of CT scanning technology and a computer guided surgery. Read the story here: http://www.pcdl-usa.com/blog/?p=12

As dental laboratories grow in size and assets, the attorneys will see our increasingly deep pockets, we will certainly become targets of litigation, and saying its “not our responsibility” may be a difficult stance to defend. I think it’s wise to take a look at what you are doing, review your insurance coverage and talk to your attorney about liability releases and need for additional coverage if you fabricate surgical guides. The FDA is reviewing their classification status as we speak. Now is as good a time as any.

I don’t want to read YOUR story on the internet.

How do we explain such off the hook fervor for these new crowns?

Maybe we can’t, and that’s exactly what the Black Swan theory is all about. Bestselling author Nassin Taleb continues his study of randomness in his interesting book, The Black Swan, where he examines the influence of highly improbable and unpredictable events that have massive impact.

We humans have a hard time with unpredictable occurrences and we often craft intricate explanations for the unexplainable. How many times have we had an especially prosperous first or second quarter of the year, and surmised that people must have decided to spend their tax returns on dentistry this year, or perhaps they used a new year of dental benefits for the long delayed treatment?

By the same token, how many times have we had a bad quarter and explained it away, saying that people spent too much on holiday shopping, or that the weather had hammered commerce in some region that affected us? Slow summer? It was because of vacations. Busy summer? “Staycations” and spending on self. On and on it goes, as we seek some kind of order to events contrary to our expectations.

While this may give us some kind of emotional satisfaction and help us sleep better with the idea that we do understand what is going on in our little corner of the universe, it really is a useless exercise in the long run, and may only further frustrate you when the same conditions seem to align themselves, but outside events don’t.

Whatever the explanation, BruxZir started off with a humble claim, “more brawn than beauty” and surprised everyone by becoming the labs new prom queen. In an industry where most ads directed to dentists and patients are littered with beautiful people and sparkling smiles, BruxZir said, “look, I’m not pretty, but I’m better looking than a metal occlusal!” I think that by creating low expectations and then over-delivering in the esthetics department, dentists were floored and fell in love with this remarkable little restoration.

This is a rare product in that it has a very high interest from dentists, and they have a very high re-order rate which shows they are exceeding expectations and perceived as a value. The CAD CAM process has created a high degree of precision that has reduced remakes and returns for BruxZir to the level of full cast non-precious metal, which is to say, about equal to the number of bad impressions or uncontrollable redos. Lab errors are virtually zero.

Glidewell’s R&D team has developed a unique zirconia material and processing method, and a special anatomical library for milling that has made this product very difficult to counterfeit or copy, though people are desperately trying to do just that. In what until now has been a flagging economy for most of us, this self proclaimed ugly duckling has been a BEAUTIFUL black swan!

The thing I find frightening is the number of labs who are fabricating model based surgical guides without the benefit of a CT Scan, or any other way of identifying and avoiding anatomical interference from adjacent root tips to the inferior alveolar nerve, or perforating the buccal plate due to angulation problems.

I think labs who are doing this kind of thing, are facing some serious issues when and if these cases go bad. A California Jury recently awarded 1.7 million dollars for a botched implant case where cone beam imaging could have avoided injury. What lessons do you think the insurance industry learned from the painful mistake?

Ask yourself a few questions if you are doing these guides. How will you answer these questions if you are drug into the lawsuit by an overzealous attorney working for the patient (and possibly the dentists’ malpractice company):

• Were you competent to manufacture this guide?

• Even though the doctor asked you to make it, what made you feel qualified to accept the challenge? Were you given all the information you needed and did you ask for more?

• Have you got documentation of your specialized education and experience in this area?

• Does the manufacture of this device require FDA registration?

• Is your lab FDA GMP Compliant?

• Did a competent authority (besides the defendant in the case) review your design?

• Will your product liability insurance cover this product, or are you in violation of the policy?

• Do you need professional liability in addition to your product liability insurance?

The work we are doing is much more sophisticated and technically challenging than the work we were doing just a few short years ago, and the dental technician performing these particular tasks and others like them need a whole new level of skill sets.

It’s important that we do everything in our power to insure we have the proper training and information to accurately manufacturer surgical guides, and that we protect our dentists clients in the same manner. With greater technology, comes greater responsibility. If you think all the responsibility lies with the dentist, please understand that when you started making surgical guides, you crossed over into a whole new world where fitness for use isn’t measured with contact paper and an explorer.

XXXXXXX’s latest project is being well-received by both dentist- and laboratory-clients: full-contour zirconia restorations based on the laboratory’s own technique using XXXXX zirconia and modifying it in its green state using XXXXXXX stains to build color from the inside. Currently, the laboratory has 200 full-contour zirconia restorations in the mouth. “Our clients really like the strength of the full-contour zirconia coupled with the esthetics we can achieve using the stains; laboratories are especially interested in the concept of a one-piece crown because it eliminates fabrication steps and produces a larger profit,” says XXXXXX.

This is exactly why the FDA is interested in what we do, and this is a disturbing trend that should have been squelched in the wake of the ArtGlass failures of the late 1990’s. Since when are we allowed to experiment on our patients? How can we condone and allow labs to mix and match materials, use them outside of the scope of the FDA 510k provisional approval and applaud them for doing so?

Has this lab applied for FDA registration of this adulterated product and are they accurately tracking material performance, failures and lot numbers of the restorative constituents? There are ALREADY products on the market that are designed specifically for this application (BruxZir)! I promise you that when these home-brewed units start to fail, or perform poorly over time, it will taint the materials that were properly engineered for this use, and bring further scrutiny and intrusion upon dental laboratories.

It is one of my biggest wishes that we as an industry quit pretending like we are scientists with a chemistry set and leave the product development to the experts, or at least collaborate with them when it comes to manufacturing medical devices. I am contacting every magazine I read when I see stuff like this. We need to stop this practice before we become so overly regulated that only the big dental manufacturers can be trusted to fill a dentists prescription.

By digging a little deeper, what I’m finding out is that labs are claiming to have something “Just like BruxZir” and then substituting regular isostatically pressed and bound zirconia, which is nothing like BruxZir. I have also been asked to make adjustments to e.max done elsewhere, only to have it ruined in the oven on a regular firing cycle indicating it was just some pressed ceramic material and not lithium disilicate e.max.

Not only is this fraud, but altering a doctors prescription is against the law. Another side effect is that the product failures cannot be accurately reported because there is no proof that the failed product was in fact the material requested. Manufacturers are starting to realize that mislabeled restorations and consumables is a serious epidemic. Just look at the material authentication programs in use today.

If you believe you have received counterfeit products, or to report any other problems with dental products, be aware the FDA has a reporting mechanism in place. They have received up to $100 million dollars this year to enforce these laws, and it’s important you know how to address issues with product failures or substitution. Laboratories not in compliance with FDA GMPs and material disclosure laws take heed.

Here is the process:

Reporting Problems to FDA:

• Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with counterfeit materials, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program2. Healthcare personnel employed by facilities that are subject to FDA’s user facility reporting requirements3 should follow the reporting procedures established by their facilities.

• To help us learn as much as possible about the adverse events associated with counterfeit materials, please include the following information in your reports, if available:

• Manufacturer’s name

• Product name (brand name)

• Date product was manufactured

• Expiration date

• Catalog number

• Lot number

• Size

• Details of the adverse event and medical and/or surgical interventions (if required)

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.

The $32 million dollars earmarked for this will likely be recovered through PENALTIES and possible FEES for dental labs. Especially in these conditions, nobody looks at this as an investment in public safety. This is a “service” and they will get their pound of flesh. How might this affect us? What will trigger an inspection and enforcement action?

Complaints: I suspect this will be the number one cause of a visit from the FDA. Complaints can come from a number of sources. Not surprisingly from disgruntled competitors. Labs who have undertaken the burden of compliance are unlikely to appreciate those who compete unfairly by being scofflaws. Especially those who counterfeit, price gouge or import. Dentist clients may file complaints if they are unhappy with something that happened between them and their lab. Perhaps someone substituted materials, such as using a generic zirconia in place of Lava, or a pressable in place of e.max, or a casting in place of Captek. Manufacturers should rightly complain if they find a lab doing this. Frankly, I think this is way overdue. Disgruntled employees may also be responsible for complaints filed with the FDA. Whistleblowers are protected and encouraged, especially in healthcare.

Improper material disclosure and counterfeiting will be huge, and is an issue for every manufacturer. I’m sure they will applaud this measure.

Product Failures: In the event we experience another wide spread failure of some product, we can expect a great deal of FDA scrutiny. Material recalls and material traceability, or lack of them, can potentially lead to civil liability for both the dentist and the lab. The responsibility for recall identification and notification lies with the dental lab. Manufacturers will be quick to investigate any perceived product problems and documentation will be the only defense. They have a fiduciary duty to protect their brand and eliminate the possibility of counterfeiting, mishandling or the use of gray market materials. Labs caught doing this will most certainly be turned in to the FDA.

New Registrations: Let’s face it, not too many labs have the R&D capability to develop and launch new products, so the likelihood of them filing 510k applications is low, but it does happen, and in some cases it SHOULD happen. The Medical Device Show is going on this week, right here, and the seminar I sat in on last night was all about overhauling the 510k approval process and I’m all for it. More scrutiny is needed, and unqualified people are being very cavalier about making things like apnea devices and surgical guides. Labs who register for repackaging and import/export will most likely get a visit as well, which I also think is completely appropriate.

I think this is perhaps the most important news I’ve heard in a long time. I think our industry needs some of this oversight, mainly because of greed and unscrupulous business people, but also due to the increased complexity of the work that we are doing and sophistication of our processes and materials. I for one am happy about this, and think it bodes well for our future.

Online implant planning, guides and restorations are getting easier to manage every day. iConfident has a very intelligent solution with its online Implant Management System (IMS).  You can upload images, search for and manage components and communicate with others in the implant process. Specialists, lab personnel and general dentists can use it to collaborate on their cases.

Ever get frustrated because you didn’t receive a surgeons report or any implant ID with a case? Ever wonder what height healing cap was used at each site? This is where IMS comes in. I have been using iConfident for some time now. Not just with implant cases but anytime I’d like to share information with more than one team member. My local component of the Seattle Study Club even uses it for case collaboration among members.

Rather than try to explain it all here, my friend Rob Lewis at iConfident has added an online video to to his blog that will show you how it works. Take a look here.

Frankly, in this current economy, I don’t anticipate seeing a lot of exciting new developments. I DO expect to see some very aggressive pricing strategies and more of the inexpensive milling machines being placed in labs for free in order to generate block sales. What the industry does NOT need is another “me-too”, cheap generic zirconia block. Zirconia has become the non-precious metal of all ceramic crowns.

By far, the products generating the most buzz among dentists, are IPS e.Max lithium disilicate and BruxZir Total Zirconia Crowns. Unfortunately, we’ll probably see cheap “generic” versions of these products flooding in from overseas before too long.

In this case, the verdict hinged on the interpretation of informed consent and standard of care, according to Edwin Zinman, D.D.S., ID., in a lecture at the 2009 California Dental Association (CDA) fall meeting.

“Informed consent is meant to be a shield, not a sword,” Dr. Zinman said. “It is all about protecting the best interest of the patient” — and, in the process, protecting the dentist’s best interests as well.

How one applies informed consent in both a clinical and legal setting involves determining whether the standard of care is being met, he noted. In the California case, for example, the implant had been placed so deeply it went into the inferior alveolar nerve canal and also exited out the other side, resulting in permanent pain for the patient (Journal of the History, of Dentistry, Winter 2007, Vol. 55:3, pp. 134-138). The jury concluded that correctly interpreted 3D imaging would have avoided the injury and that the dentist should have used 3D imaging to minimize the risk of over drilling.

“Researchers at the Department of Biomaterials and Biomimetics at New York University College of Dentistry (NYU) recently determined through mechanical mouth-motion simulator testing that IPS e.max CAD lithium disilicate ceramic is the most robust all-ceramic material tested to date. The study results were first presented earlier this year at the 39th Annual Session of the American Academy of Fixed Prosthodontics.”