The Sickening News about Tainted Dental Lab Work
Chinese Dental Labs Turn Lead into Gold…?
When a 73-year-old Ohio woman fell ill, the news made national headlines. It wasn’t old age, or pneumonia, or cancer, or anything else you might expect. She had gotten lead poisoning from her new dental bridge.
Though she’d visited an American dentist, the bridge itself had been fabricated by a Chinese lab. Let me assure you that this is major news. I expect this health scandal will rock the world of dentistry.
| Lead: How Many Parts Per Million Is Okay? | |
| 210 | Discovered in one Chinese-made crown |
| 160 | Discovered in Ohio woman’s dental bridge |
| 600 | US legal limit in paint, toys, etc. |
| 90 | International standard for items such as toys (now being considered by US Congress) |
| 1 | Amount the UK permits in dental work |
| 0.5-3 | FDA guidelines for leachable lead in ceramic dishware |
| 0.1 | FDA limit in candy and food |
| 0.1 | Amount naturally in a healthy person’s blood |
The Ohio woman received this new dental bridge last year. However, the restoration site became inflamed, and chewing was unmanageably painful. The bridge was ultimately removed, and she’s had further surgeries since. She sent the bridge in question to a scientific testing laboratory, and its surface allegedly tested at 160 parts per million of lead. She has since retained a lawyer and is planning to sue her dentist. (Please note that she is planning to sue her dentist, not the dental lab!)
Chinese exports have received massive amounts of bad press after various health scandals. Do you remember the animals who died from eating tainted pet food? Then at least 21 Panamanians died after taking poison cough syrup. Danger made its way onto US shelves via toxic toothpaste. Most recently, children’s toys were pulled from the market after it was discovered that the paint contained high amounts of lead. All of these products were manufactured in China.
I know what many of you dentists are wondering: Is this for real? What evidence is there that Chinese labs are systematically producing lead-tainted dental restorations? Well, here’s the evidence that has so far come to light on this developing story:
- The Ohio woman’s partial bridge apparently tested at 160 parts per million of lead.
- Ohio TV station WBNS then conducted its own investigation, releasing the results on February 27. With the help of a local dentist, they ordered crowns from four different Chinese dental labs. One of the eight crowns tested positive for lead. The porcelain facing contained 210 parts per million.
- The ADA announced that it had begun its own investigation, and had recommended that the FDA and CDC do the same. (Read the ADA’s response and their talking points for dentists.)
Though most press focuses on work manufactured in China, it’s worth noting that products are imported from many other countries, including India and Mexico. Imported restorations are dramatically less expensive than work produced domestically; in some cases, a crown from China may cost as much as 90% less. Cost-saving measures have led to more and more international manufacturing.
In the US, about 15-20% of dental lab work is produced in China (primarily bridges and crowns); that’s 7 million foreign crowns each year. Many of these products are distributed by American labs. Three years ago, less that 1% of UK dental restorations were produced in China; that number is now up to 5%.
Theoretically, the FDA monitors all dental products, whether produced domestically or abroad. The FDA has the authority to inspect any dental lab, foreign or domestic, that makes products sold in the US. Dental labs with overseas operations must register with the FDA. But within the US, only three states (Texas, Kentucky and South Carolina) require dental labs to register with state health departments.
The National Association of Dental Labs (NADL) officially recommended that the FDA close some of these legal loopholes. Needless to say, the organization that represents 1400 US dental labs has grave concerns about the allegations of tainted dental products.
The lead appears to be in the porcelain surface of some restorations. But many foreign labs use porcelain and other materials made in the US or Europe. So where does the lead come from? Many suspect the lead is in the glaze used to stain and seal the porcelain.
Many pottery glazes contain lead. The lead itself is not particularly a problem until it comes into contact with acid. The acid is what allows the lead to leach out of the glaze. For pottery, this isn’t much of a problem. But since the human mouth is an acidic environment, lead might be transferred to the patient’s bloodstream.
Let’s be clear on this point: The FDA says there should not be detectable levels of lead in the surface material of a dental prosthetic device. Lead poisoning generally causes non-specific symptoms such as aches, abnormal bowels, or high blood pressure. As a result, proper diagnosis can take years.
Though labs are supposed to label outsourced work they provide to dentists, anecdotal evidence suggests that dentists do not in fact always know where their restorations were manufactured. Dentists: Do you know where your restorations are manufactured? Estimates suggest that 25% of US dentists are sending lab work to China - and what’s more, many of these dentists don’t even know it. You can’t just assume your dental lab does its own manufacturing. As a dentist, it’s your job to make sure you can stand behind the safety of any restorations you do.
Anyhow, folks, that’s just the tip of the iceberg! Check your inbox this Friday for a survey question on foreign dental labs. And you definitely won’t want to miss my next editorial. Do you know which of the major US dental labs import or manufacture foreign dental work? I do! And next week, I’ll start naming names.
Learn more - Plus, click here to post your comments on this story.
Stay updated by
subscribing
to our RSS feed.
You can leave a response or
trackback.





March 12th, 2008 at 7:11 am
It is an unfortunate situation for dentistry at the moment, and we dentists have to be flexible and move with the times. 2 years ago, I set up a website ( http://www.dentalholiday.co.uk ) so that we could maximise our influence on those seeking dental treatment abroad from the UK. Thankfully the strategy worked, and we are not suffering from a lack of patients, but have seen a 200% increase instead. I imagine that we must do a similar kind of thing with lab work coming from abroad. We won’t be able to stop it.
March 12th, 2008 at 10:52 am
How sad that we have forgotten our fiduciary responsibilities and now sate our avarice.
March 12th, 2008 at 12:52 pm
Has this woman been diagnosed clinically as having lead poisoning? Who is the dentist? Who is the foreign laboratory?
There is a difference between finding a trace of lead in a restoration and having lead poisoning.
What physician or toxicologist has stepped forward with this diagnosis? Or is this just a term applied by her attorney for her condition?
March 12th, 2008 at 12:56 pm
Gordon Christensen has been warning about a looming laboratory crisis created by cheap out of country dental labs… quality control being the greatest crisis because the good labs can’t compete with cheap off shore labs using recycled tin cans or rusty boat parts for metal inside the crowns let alone a good porcelin.
Those who advocate using a cheap lab for poor paying insurance covered patients and a better lab for a good paying insurance covered patient should be reprimanded for their unethical behavior.
I’ll bet the dentist doesn’t send the work for his own mouth overseas.
Dentists used to be one of the most trusted proffessions in the country but because of things like this we are soon to be below lawyers if we don’t start doing the right thing instead of the least-costly thing.
March 12th, 2008 at 4:44 pm
Andy,
Your questions are all the right ones. We are working on a follow-up set of editorials.
Jim Du Molin
March 12th, 2008 at 7:41 pm
This story may have the makings of a PR disaster, but it isn’t really so important as it may seem. Have you read “The World is Flat” by Thomas Friedman? If you truly believe that “recycled tin cans or rusty boat parts” are used, you are either an ignoramus or a bigot. I am writing this from LVI, where folks from the countries in question and many others are well represented. For years, US dentists have had to put up with schlocky, inadequate local lab work because the exigencies of meeting patients’ needs required the quick and convenient service only found locally, wherever we were. Often their work was only poor to fair, and their facilities dirty and dangerous (most escaped OSHA by employing only family members). Their prices, however have stayed on the cutting edge. With better transportation and communication, national labs have come into prominence, but they are either very expensive, or rely on outsourcing to keep their prices practical. In my experience, both these types of national labs provide lab work of much higher quality than the home town boys. We need to get some regs in place, and some regulating done. I don’t want to have to depend on the locals for my bread and butter cases, and I can’t always charge enough to justify the cost of boutique labs. Quality, like everything else in life, is where you find it. If you have it close to where you are, that’s real OK, too.
March 13th, 2008 at 6:47 am
My dental labs have now begun to send me letters stating that they do not, and never have outsourced to foreign countries. Unless the dental labs tell us that they do or do not outsource, how can we know?
March 18th, 2008 at 12:42 am
Ultimately, it is the dentist’s responsibility. Finding a trustworthy, high quality laboratory is required. If the dentist is primarily driven by price, they get what they deserve. Dentistry is largely about building relationships with patients, auxiliaries, reps, techs, and colleagues. People shouldn’t be disposable. On the other hand, the FDA needs to provide appropriate protection for the public to prohibit unhealthy medical devices or prosthesis. They are not living up to their responsibility.
March 30th, 2008 at 8:55 pm
I am really very sorry to hear that dental bridge which contains lead was made by Chinese dental labs. I am working for a outstanding China dental lab as sales representative now. I know nearly 93 percents American & European dental labs send their cases to fabricate in Asia since 1990’s. It has proved that all the dental products are very safe and reliable. I think the reason why this bridge contain lead is this Chinese dental lab which made the bridge is a small workshop and probably it doesn’t have the Medical Production Certification(approved by China Administration). Most outstanding dental labs, such as Modern dental lab and our Make-up Dental Lab use the materials which all are supplied by famous corporations(Dentsply, Bredent, Vita, Bego, Nobel Biocare, DeguDent, Wieland, Ivoclar Vivadent and so on.)So I think you can trust our pruducts. They are safe.
March 30th, 2008 at 9:00 pm
I agree with Jim Crummett’s opinion.
April 3rd, 2008 at 10:37 am
I am one of the partners who purchase a leading Prosthodontists lab in the US. We only worked with high-end dentists because they expected stellar work. Paying a quality technician, providing a clean lab, and staying up with new equipment and technology is expensive. Dentists want the cheapest restoration they can get. Quality technicians do not produce $89.00 restorations. Gold is about $1,000 per ounce. We only used High Noble until switching to all-ceramic and Quality High Noble restorations
were crawling upward to $300.00 per restoration. If anyone thinks they are getting High Noble for $89.00, it’s impossible. The labs in the US are constantly being asked to accept restorations from dentists and then they will outsource to other countries and return them to the US labs . . . Dentists and Patients none the wiser. We predicted two years ago that lead poisoning will reach epidemic proportions and cause illness in patients. We developed a mobile all-ceramic on-site at-your-door service because of these practices. See the video at http://www.vorofco.com These business will be popping up all over the US soon so dental patients and dentists can be assured they are receiving exactly what they order. Dentists may pay get what they pay for as stated above, but everyone has forgotten about the patient. Whether the dentist pays $89.00 or $200.00 for a restoration, the patient pays the same. As a dental patient, I know what I have to pay for a quality dentist’s crown, I surely don’t expect to receive a $60 or $90 Crown for the prices that are charged. Start with Insurance, dentists have to write-off so much, they are trying to save a buck. There are many facets to this, but the patient gets it in the end. I am a dental patient but I make my own restorations so I know I get quality.
April 17th, 2008 at 4:57 pm
Greetings,
Many domestic dental labs have been testing there own products produced here in the states and the results were unexpected. They contain lead.]
Also the ADA states that the limit for lead in dental devices is 300ppm. The material problem is not China’s it’s the manufactures, the FDA, the CDC, and the ADA.
Be a good reporter and investigate the facts for our industry. The patients deserve it.
Thank you,
John Collins CDT, MDT
Bio-Comp Dental Laboratory
Ivyland, PA
215-293-9760
April 20th, 2008 at 12:40 pm
Jimm Crummett I am a dental local technician, my work site is clean, I use Hospital grade Germicidal and UV-C air cleaner & have since the early 70’s. Although I am not a political CDT, I maintaining a good understanding of what I do. Doing the best I can without causing harm is very important to me. My charges are still very close to 1999 charges. I understand the first class at LVI is to improve the profit of any rate. I have customers who have gone to LVI, that Acculiner idea of LVI really is strange. I am glad to see you use the Stratus 100 now. I list my materials with ea case I do, Lot # brand of material. I have the CE, ADA, MSDS should the Dds need them. A Lab over seas might have some ADA material but I wonder if it just for their shelf & PR pictures as they just seem use what they want. As a removable lab I have had to try and repair some of their product. Jim DuMolin I know the article was pb contained materials but Mr. Crummett directed an insult against regulated good practice US labs, or maybe he has interest in a political prison lab, or slave labor sweat shop labs not in the USA.
April 25th, 2008 at 1:45 pm
Crowns made in the U.S. have now been found with traces of lead. The hype surrounding the China/lead issue that was championed by the NADL and others will now focus on the domestic product.
In an effort to demonize offshore product, some in the industry have now brought this undue scruitiny on their own heads.