Dental Insider Blog

Observation and Commentary On the Dental Industry

Lead Contamination in Off Shore Dental Lab Restorations

Posted by dentalinsider on February 29, 2008

This story seems to be all over the place the last few days, this could become as big as the handpiece sterilization story that appeared on 20/20 in 1992. What is with the Chinese and lead, toys, dental restorations…what else?

Recently, NADL was contacted by a dental patient in Ohio who has documentation of lead contamination in her dental restoration. The affected patient, a senior citizen, received a three-unit dental bridge from a dentist in Ohio. After having an adverse reaction to her dental work, and having it removed, the dentist disclosed that the prescription was sent to an offshore dental laboratory and disclosed to the patient that the restoration was made in China. The patient then had the restoration sent to a chemical laboratory for analysis. The documentation of the dental material analysis of this patient’s restoration showed unsafe levels of lead in the porcelain on the restoration.
This case has attracted the attention of an Ohio television reporter who was already working on a story about offshore dental laboratory work. As part of the reporter’s investigative research for the story, the TV station ordered a series of crowns from several offshore dental laboratories. One of those restorations contained 210 parts per million of lead in the materials. The U.S. Congress, in response to the toy recalls in 2007, lowered the acceptable levels of lead in toys to 90 parts per million.

The testing of these restorations for the reporter’s investigation was conducted by a chemical research laboratory in Ohio and, at the suggestion of NADL, at the Boston University School of Dental Medicine. In addition to the documentation of lead, the chemical analysis revealed the restoration contains traces of radioactive isotopes.

The reporter contacted NADL and interviewed co-executive director, Bennett Napier, CAE, for this story. Others interviewed include the attorney for the patient in Ohio; a lead expert; a spokesperson from the Ohio Dental Board, a Columbus dentist and laboratory owners from central Ohio. The TV report contains position statements or quotes from the American Dental Association and the U.S. Food and Drug Administration.

WBNS 10 TV in Columbus, Ohio, will broadcast this story Wednesday. You can view the full investigative report Wednesday evening at the station’s Web site www.10tv.com. The owners of the regional television station also own the Columbus Dispatch, the local daily newspaper. An article about the story will be run in that paper’s Thursday, February 28th edition.

It is likely that with the significance of this story it may be picked up by other media outlets in large metropolitan areas by the end of this week and possibly may be picked by national news media outlets as well.

NADL’s Position:

NADL has worked with the U.S. Food and Drug Administration to promote patient safety and ensure laboratories have a voice in any regulation of the industry. NADL is on record supporting regulations that assure patients their restorations are safe for use, regardless of where they are manufactured. NADL’s position has been presented consistently to the American Dental Association since 2003.

The National Association of Dental Laboratories believes that every dental patient has a reasonable expectation that the dental restoration placed in his or her mouth is safe, regardless of where it is manufactured. Therefore, in an attempt to provide the necessary documentation for disclosure as well as to document competency, the NADL strongly supports the following:
The necessity of at least one Certified Dental Technician (CDT) in each dental laboratory.
The necessity that all dental laboratories register with either the U.S. Food and Drug Administration or an appropriate state governmental agency.
The written documentation of all materials included in a final restoration and the point of origin (country and laboratory) where the restoration was manufactured.
The necessity that each of these items be documented in the patient’s record.

Additional Information:

NADL informed the American Dental Association’s executive leadership so they could tell their members about this pending story and possible outcomes including the public’s response.

The ADA will be sending out an alert to its members this week sharing guidance about what questions to ask dental laboratories relative to outsourcing activity and statements of assurance on material content of dental restorations. NADL member’s laboratories should be prepared for such requests.

Additionally, it is expected that state dental societies will be discussing possible regulatory options to address this issue at the state level in state dental practice acts. State dental societies may be contacting your state’s dental laboratory association about possible collaborative efforts or to seek additional information. NADL members are encouraged to share NADL’s model bill for state regulation with state dental societies or inquiring dental clients that may request a template for state regulation. Members of the laboratory industry may download this document from NADL’s Web page at www.nadl.org.

Dental laboratories should be prepared for increased calls from your dental clients and possibly local media outlets during the next few weeks as this news story circulates the country. NADL will be providing up-to-date guidance documents to our members on the member section of our Web site www.nadl.org to assist you when answering questions. We are committed to keeping our members well informed and prepared.

There is a good discussion of this with more information over at www.dentalsalespro.com

DI

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21 Responses to “Lead Contamination in Off Shore Dental Lab Restorations”

  1. LabGirl said

    I am a lab owner in the USA and I can tell you, the dentists are not all innocent in this. I have met so many dentists who are paying $39 for crowns, and don’t want to pay me a reasonable price for a crown because these offshore labs offer them so inexpensively. My business is suffering, and so will the patients. 80% of dentists “price shop” dental prosthetics. They know when crowns are being shipped to China & Mexico. One client I had told me that “they fit, but they look like s**t” and started sending me only the front teeth because he told me the patients don’t know how to tell if it is ugly, and “probably won’t notice the back teeth not looking right anyway”. These dentists know what is going on…they know if they are paying such cheap prices for these crowns, that there must be something inferior about them…just as consumers, we know something is not right when there is an item we are thinking about buying that should cost way more…and we think to ourselves…hhmmmmmnnnnn, whats wrong here? These are doctors, they went to medical school…they have brains…when the average price of a crown in the USA is $135-$175, and there are crowns for sale in China for $39…something HAS to click in their brains! Yes! It does, they are making more profit from the patient! I am not saying every dentist is this way…there are some incredible dentists out there…but I have also met some snakes…and some of the things that come out of their mouths simply amaze me. It’s about time this happened..I am sorry for the patient who got lead poisoning, but am relieved that maybe dentists will start thinking twice, and start keeping some lab work in the USA so small labs like mine can make a living. I am a single woman lab, and fabricate all of my work in my lab in the USA by myself. I am very Anti-Outsourcing. To the patients out there…start asking questions! Where is my crown made? Who made it? Can I see a list of the materials in my crown? Can I have the labs phone number so I can call and verify that my crown is made in the USA? All of this information should be provided to you! Good luck all!

  2. AssociateQ said

    Did everyone see the ADA’s response? What a joke.

    http://ada.org/public/media/releases/0802_release05.asp

    They need to come out and say they will not stand for it, but of course greed gets in the way.

    This story is already under the rug and as long as the dentist can keep the patient in the dark, they will.

    In the end it will be everyone’s downfall, but hey why worry about the future.

    Greed.

    Q

  3. […] in Dental Restorations The Dental Insider is reporting on a story about an investigation of lead found in dental laboratory restorations. An […]

  4. AssociateQ said

    NADL fired off an e-mail today. You can all find the full details at:

    http://www.nadl.org/jdtunbound/

    Long story short. The NADL is still, I repeat is still, protecting these off shore labs. Makes you wonder why? Maybe because they are funded by the labs that are doing this outsourcing? Then they say “We want a CDT is every lab”. You know what, and I think most CDT’s would agree with me, THE DESIGNATION CDT IS A JOKE.

    IT MAKES ME SICK. Why is it that the NADL and NBC are basically one organization? That would be like putting the ADA in charge of Dentists. But no, that is handled by a state board.

    The NADL sits by while people get sick and jobs are lost.

    How about XRAY? Does anyone think they want to go on the record about offshore labs? I am sure they don’t, considering they own a lab in China.

    If I had the time and energy I would say so much more. But I am tired and it seems very few want to listen. Plus LabGirl was right on in her post.

    The fact is that we Americans do not want to face the facts. There are bad people among us. There are people who consider their checkbook before another’s safety. We need look no further than the welfare line.

    I love this country and I am damned proud to be an American. Yet still I am ashamed that the actions of a few greedy, lazy, assholes can tarnish the reputation of many.

    This behavior is unacceptable and will lead to the demise of this industry as we know it.

    Q

  5. The Boss said

    The NADL has a neutral position on off shore work, as they should. There are quite a few big labs and small labs who are members and work as distributors. If they indeed wish to represent the whole, they can’t really take sides the way a labor union would. That is the big difference between a labor union and a trade organization.

    We don’t have to like it, but it’s a fact.

  6. joyce said

    It is the Dental Patient’s Right to Know where their dental crown was made
    and exactly what materials The Dentist has made a permanent part of the Patient’s Mouth.
    In light of recent revelations, Crowns of foreign origin must be considered to be sources of chronic lead poisoning either with or without a Certificate of Alloy Content.
    The only certain way to quell the fears is by recalling each patient whose mouth harbors such a crown, and definitively ruling out the possibility of Lead Contamination.
    Last week (Feb. 27, 2008) our local Ohio newspaper, The Springfield News-Sun, reported that on lead-contaminated dental crowns that some Ohio dentists have imported from China.
    Earlier this month Chinese contaminated Heparin was reported by the New York Times to have caused the deaths of four US patients.
    Last summer, The Times identified China as the source of toothpaste and cold syrup containing antifreeze that killed patients in Panama and other countries in Latin America.
    The New York Times also gave full coverage to the use of lead contaminated paint by Chinese toy manufacturers.
    Chinese environmental standards are much looser and have not seen lead-contamination as a hazard.
    Unfortunately, in search of reduced costs, products made under these dangerous loose standards are being imported under the noses of the US regulatory agencies like the (FDA, EPA).
    Some dentists have outsourced their dental lab work to China, using DHL, FedEx, or UPS to ship round-trip to China in as little as four or five days.
    It could be very injurious to your health to have a lead-containing-crown in your mouth.
    “I guess that tells me I need to be a little bit more concerned about other potential sources of lead,” said Dr. Marcel Casavant, who runs central Ohio’s lead program and poison control center. “I never would have guessed somebody would have put lead into a piece or a part installed into a human being.”
    Casavant said adults can live with lead poisoning for years and not know it.
    “The symptoms are what we call non-specific – a little ache or a pain – abnormal bowel function,” Casavant said.
    Even high blood pressure and kidney trouble could be symptoms, according to Casavant.
    In addition to the physical damage to the body’s organ systems, there are a number of subtle neurological symptoms that are also associated with lead poisoning:
    Behavioral symptoms in adults
    • Irritability
    • Unexplained changes in mood or personality
    • Changes in sleep patterns
    • Inability to concentrate
    • Memory loss
    Neurological symptoms (caused by effects of lead on the nervous system)
    • Poor coordination
    • Weakness in hands and feet
    • Headaches
    • Seizures
    • Paralysis
    • Coma
    (as listed in WebMD)
    Because the symptoms of lead poisoning are painless, until irreparable damage has occurred, it is important that all sources be identified and removed from the patient’s environment to prevent further damage. If a lead-contaminated crown is otherwise functioning also without symptoms, its poisoning could continue for years.
    It would be a signal public health service to have dentists identify which of their patients have received crowns imported from china. The patients would be empowered to evaluate the potential source of environmental pollution concealed inside their body. Early identification is a low-cost preventive-medicine step that could head off disaster before it occurs.
    It is overdue to issue a Recall of Crowns that were made overseas to determine which crowns are leaking poisonous lead contamination.
    Consumer protections have long mandated recalls of automobiles to prevent engine fires, failing brakes, and other defective parts. In the medical field recalls have been issued for failing cardiac defibrillators and mislabeled medicines.
    Lead poisoning does not present with the drama of an automobile fire or brake failure. Indeed, it takes a long time for the damage to become noticeable. But we all know we would want to know “yesterday” if we had a lead-contaminated crown in our mouths, (or a leak in our car’s brake system.) It is time for Dentistry’s first Nationwide Recall.
    In Dentistry the regulatory powers are diluted among the Several States. The issue of the safety of imported dental devices does not reside in any single agency or authority. The final arbiter of the safety of dental devices is an individual’s dentist.
    There may be solitary disasters occurring in afflicted individuals mouths and brains right now, in slow motion, as you are reading this. I feel that organized dentistry should not pass the buck on this issue merely because we have yet to codify the needed internal-environment protections in our Health-Law.

  7. AssociateQ said

    With all due respect, I disagree. The fact is that the NADL does not have neutral position on it; they do everything short of promoting it. Just pick up an issue of the rag they put out called the JDT.

    Plus, when you factor in that the NADL and NBC are one in the same, you have a much more complicated situation.

    What they say, what they believe and what Jim Glidewell thinks are three different things.

    Maybe if we all stopped being so damned PC about everything and pulled our heads out of the sand we could get somewhere. But a statement like “We don’t have to like it, but it’s a fact” sounds rather lethargic to me. I mean what if the colonists said “You know, like it or not England can levy all the taxes they want and that is a fact”? Or how about if people said “You know, like it or not only white men that own land can vote and that is a fact”.

    I am not talking about what IS, I am talking about what CAN BE. If we start to put our wallets and purses ahead of the safety, essentially the lives of our fellow man/woman, then what has this world come to?

    Wake up people.

    Q

  8. rt said

    i had a dental implant almost 1 year ago. The crown was on for 3 months. it hurt bad enough to make my dentist remove the crown, i was getting bad headaches also.
    with only the inplant left in, the symptons persist
    Mybe there is lead in my implant
    how do i check

  9. Dick McManus, DMD. said

    probably no lead in the implant. First off they are not made in China and the implant HAS to be a Titanium alloy or it will not hook onto the bone and stay. Lead does not osteointergrate with bone! Also if you read carefully you will see that they feel the lead was in the porcelain not the metal. How the lead got out of the porcelain is unknown but apparently it did.

  10. Dental Guy said

    I am just a lay person, but it sounds like your implant was not properly placed. Is your dentist just a general dentist? Another big problem with dentistry is that there is no assigned speciality for implants. If I was getting implants, I would want to make sure that the dentist is a member of the American Academy of Implant Dentistry http://www.aaid.com

    AAID does offer a credentialing program, and it’s unfortunate that so many dentists are placing implants without extensive training. The same problem can be said for orthodontics. More and more general dentists are trying to do orthodontic procedures as well as invisilign. Oh well, back to the lead saga…..

  11. AssociateQ said

    Amen to that Dental Guy. I have seen some cases that scream malpractice and the dentist just tells the patient “Well you did not have enough bone…….”.

    GP’s have no business doing implants unless they have done further training. Heck, half of the surgeons I have seen have no business doing implants.

    Q

  12. Oh this is a whole separate controversy!

  13. Labman said

    I have been a technician for 40 years and a one man lab owner for 32. Four years ago I let my CDT expire after 28 years. In all the years that I was a CDT the NBC and NADL did nothing for me except make me jump through hoops and pay them money. Now their efforts at forcing certification on us seems disingenuous since they are the ones to profit from any such regulation. Being a certified technician did not make me a better technician or a more honest person. Who is really going to profit from more regulations? Surely not an already struggling industry.

  14. AssociateQ said

    Teresa, this is true and I am sure you have some stories to tell!

    Q

  15. AssociateQ said

    Labman. I have heard your story hundreds, if not thousands of times. People are just saying “What the hell is this CDT thing gaining me?” and they are dumping it. And you are dead on in what you said. Now that techs are not renewing the NADL comes out and says “We think there should be a CDT in every lab”. Why is this the big push all of a sudden? Maybe because the CDT fees fund the whole dirty place? No I am sure that is not it.

    The problem is I don’t if anyone has any clue how it can be fixed. And nobody seems to want to work together. I mean the most logical answer is to have the state certify labs. But that comes with problems and the ADA will never let it happen because then they will have to pay higher fees to the labs.

    The NADL is corrupt and the sad thing is they are the only ones who don’t realize it. Simply put their ignorance corrupts them. Their lack of doing anything positive for the industry corrupts them. The fact that the NBC funds the NADL is corrupt. The NBC is corrupt. The whole thing should be torn apart and thrown away. Sometimes things are just too far gone for them to be fixed. Sometimes you do have to scrap the whole thing at start over. This is one of those times. I mean why did the NADL move from Virginia to Florida?

    Fact is the industry is run by a few. And those few are only looking out for themselves and for their friends. Sounds kind of like Washington politics doesn’t it?

    And the lead story is a bad situation and only getting worse. From what I hear a local station in New York is set to issue a report, not sure what or even if it is true but if this story keeps chugging along the way it has, with the press spreading MISINFORMATION then less and less people will trust their dentist. This is on top of an already large number of people who do not trust or want to go to the dentist.

    What does this equal? Less business for all of us. The industry may be recession proof, but it is not bad press proof.

    Q

  16. Labman said

    Q, What you said, “Fact is the industry is run by a few. And those few are only looking out for themselves and for their friends.” is right on. This is typical of most bureaucracy, they struggle to justify their existence. As far as taking care of their friends, that is one of the reasons I am no longer a CDT. Every year, year after year the same infection control requirement. I may be slow but eventually I get it. It seems that one of theirs has made a career out of this renewal requirement.

    I know I’m negative about this but that’s the way I see it. After forty years as a technician, I’m glad that I only have a few more years left in this industry. We one man labs are dinosaurs and will soon become extinct.

  17. AssociateQ said

    Labman, it sucks that you are syaing what you are saying, “I only have a few years….” but I understand and I think, no I know you are not alone.

    There are people who have put their heart and soul into this industry only to have it turn on them. I think it is the major reason why there will soon be a shortage of well trained technicians and then there will be even more problems. I don’t know any mother or father who is a lab tech and is saying to their kids, “Come be a dental technician like me”. Not this generation, that stopeed about 20 years ago.

    Now they are like “Get as far away as you can!”

    Really sucks that it has to go down like this.

    Q

  18. Labman said

    Q, I think our industry is reflecting a changing economy, away from small business to big box shopping. We can’t compete price wise with the Glidewells and the foreign labs. I shop at Costco and other big box stores but I also like to support smaller stores, that is what fuels our local economy. I see our industry moving toward the Harbor Freight model, some good products but mostly cheap inferior items made in China.

    I know that there is still a niche for high quality work. I personally have not suffered from this trend but I know it’s coming.

    You are right, I told both of my children to get a better education where they could make a good living without the long hours and relatively low pay. Thankfully they listen to dad.

    Oh by the way, going back to the CDT issue, When I told one of my dentist that I was paying for a non required certification he laughed and asked me, “why are you doing that? Another one of my accounts told me that me being a CDT wasn’t the reason he was sending me work. I guess at one time, just starting out, I felt that I needed validation as a technician and that was the only recognition out there. Now for good or bad the work speaks for itself.

    Labman

  19. I got an email today from NADL they have launched a new website to better educate the consumer. http://www.whatsinmymouth.us Hopefully this will help the issue out and better educate the consumer.

    From what I have seen in the industry it’s mainly the bigger labs that will have to combat this china issue. The smaller labs out there can finally go the doctors and present quality work. They do have dentists out there that want the best and will pay for it. It’s the same theory of why they have Rodeo drive you don’t see Walmart putting a hurt on those stores. It’s time to show the dentist what the high end labs can produce and why it’s better.

  20. Dick McManus, DMD. said

    Is this an issue where larger labs are shipping cases to China to do the work without the Dr. being aware this “China connection”. Or are there China Labs looking for business in the US and the Dr. knows the work is being done in China?
    I’ve been a dentist for 33 years and have had the chance to work with a lot of GREAT lab Techs, usually in smaller labs, and as the lab grows the quality changes and I’m off to find someone knew.
    Dick McManus

  21. Labtek said

    First of all let me say I agree with most of you here. Except Joyce, a little far fetched and too soon for such senseless hysteria. If you think the mercury in fillings fiasco was ridiculous, lets just implement this plan. This post is a little off topic but I want to take issue with the new website for concerned dental patients launched by the NADL. First, is it really the NADLs responsibility to inform the public or should I say create more panic within the public? I was floored when I read on this website that the NADL is telling the general public to contact a local CDT if they are concerned about dental work in their mouth so that the CDT can suggest a dentist that they can trust. How might they get this info? The NADL has posted a link that will take anyone to the Who’s Who directory. The very page it links to says in plain english This tool is for contacting your fellow NADL members, do not share with the general public. But wait, click on the link for NADL members, labs, etc. you must enter a user name and password. Click on the link for the NBC, all access, no passwords, CDT #’s nothing. There are people’s home addresses and e-mail addresses there for anyone to see. I don’t understand why the NADL respects the expectation of privacy of their paying members (fools) but not CDTs. This is just another example of how worthless the NADL is. I will support some moderate regulation with the states so long as there aren’t huge compliance cost that will run smaller labs out of business. This said, I think it is the responsibility of the Dentist and the ADA when it comes to the patients health. So if a patient is concerned about what’s in their mouth they should be directed to a dentist. We all know that alot of dentist aren’t worth a damn, many are, either way its their responsibility to care for their patients. In my lab we are all concerned about the patients health and well being but that concern is shown in our work and through our dentists. If we wanted recognition from patients we wouldn’t be dental technicians. The only recognition I need is the lab bill paid in full each month. Maybe one day I’ll have the guts to let my CDT expire and put that $180.00 to better use. If any of you are CDTs and this lack of privacy concerns you please join me in putting a stop to it. E-mail, phone, write the NADL and CDT people, I know there supposed to be connected but they’re so disorganized e-mail and/or call both.
    Thank you and lets not give up yet on our industry. Labtek

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