People quickly assumed the problem was with foreign dental labs, particularly those in China.

The Wealthy Dentist conducted a survey asking dentists a number of questions about foreign dental labs.

One dentist said,  “Patients have been systematically kept in the dark when it comes to dental procedures.  Patients should be given informed consent when choosing materials.”

Another dentist complained, “Too many dentists are accommodating low insurance payment schedules by buying materials and fabrications that are too cheap.  It doesn’t seem to matter that it compromises the health of the patient.”

Click on Play to hear more of what dentists have to say about foreign dental labs –

What has been your experience with dental labs?

So we asked dentists who should be responsible for the safety of dental products. One third said the FDA, one quarter said dental labs should police themselves, and 41% said dentists should take responsibility.

“My local lab is placing 'made in America' on all of the return cases for the patients to see,” mentioned one dentist.

“Too many dentists are accommodating low dental insurance payment schedules by buying their dental materials and laboratory fabrications that are too cheap," complained another. "It doesn't seem to matter that it compromises the health of the patient."

Read more: Lead found in dental crown from China: Dentist Survey Results

Two out of three dentists think that the current publicity is just a tempest in a teapot, while the remainder expect it to be the next big health scandal.

Read more: Dental Lab Safety Concerns

All sorts of products anufactured in China have recently been alleged to be contaminated. Reports have surfaced of lead being found in everything from dental crowns to children’s toys. Johnny Hart, creator of BC, has clearly taken notice…

See more BC comic strips…

In this survey, we asked dentists how concerned they are about various potential public health threats linked to dentistry. Dentists’ concerns, in order, are:

1. Lead in dental lab work
2. Mercury in amalgam
3. Bisphenol-A in composite, and
4. Fluoride in water supplies.

General dentists had higher levels of concern on all issues than specialists. However, specialists and generalists agreed on the relative dangers of the chemicals covered in this survey.

Dentists’ thoughts

• “I’d like to be doing all gold restorations.” (New Jersey dentist)
• “All four of these need to be totally nailed down as to their safety, or lack thereof.” (Arkansas dentist)
• “Two things that will bite dentistry in the butt are fluoride and amalgam if we don’t stop forcing them on the public.” (Idaho dentist)

Mercury

• “150 years have not proved Amalgam to be dangerous.” (Arkansas dentist)
• “Amalgams have saved billions of teeth!” (Washington dentist)
• “A known toxin, no safe levels, should be banned.” (Louisiana dentist)

Lead

• “Lead in dental casting alloy? Outrageous!” (Colorado dentist)
• “Recent articles have debunked the worry over the amount of lead in ‘farmed-out’ crowns. Still, we need to monitor that work.” (California dentist)

Bisphenol-A (BPA)

• “This stuff is everywhere. Composites without BPA just don’t hold up well.” (Wisconsin dentist)
• “It’s probably not too dangerous, but don’t cast stones, Mr. Composite: you live in a glass house!” (New Jersey dentist)
• “It’s ironic that many patients are removing long tested amalgam and replacing them with bisphenol composites of unproven safety.” (California dentist)

Fluoride

• “It’s been shown to be effective, but we shouldn’t be medicating the whole population.” (Colorado dentist)
• “The best public health measure ever instituted in this country for caries prevention.” (Texas dentist)
• “Known to be toxic.” (California dentist)

Post your thoughts or read the complete dental public health threats survey results

Dentists and dental labs have been in the spotlight recently due to the news of lead-tainted dental products like crowns and bridges. Right now, we don’t know if it’s a widespread problem, whose fault it might be, or whose job it is to resolve this whole mess.

Though the story broke a few months ago, there’s been precious little actual information released on the subject. So what’s going on behind the scenes? Let’s examine the paper trail… You have to read between the lines a little, but it’s frightening how no agency seems willing to take responsibility for this public health hazard.

The correspondence starts on March 6, when the American Dental Association (ADA) sent nearly identical letters to both the Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Does this circle of ineptitude remind you of anything?

Here’s what the ADA had to say to the CDC: (PDF)

“Staff members from the ADA… have been in contact with the CDC’s Oral Health Division. We are undertaking our own efforts to study the problem, including random, objective testing of prosthetics from both overseas and domestic labs and will be happy to share that information with the CDC. Of course, any such testing by the ADA is no substitute for the CDC and other government agencies performing their mandated functions to protect the health and safety of the public.

“Although we are not aware of any risk to health based on the small amount of information available, we and our patients are looking to CDC to affirm that this is true or, if it is not, take the appropriate steps to protect the public. Accordingly, we request that the CDC keep the ADA informed of its efforts to identify the extent of the potential contamination and the health effects of lead in dental prosthetics as well as any CDC plans for action.”

The ADA wrote the same thing to the FDA. (PDF)

“Staff members from the ADA divisions of Science and Government and Public Affairs already have been in contact with the FDA’s Center for Devices and Radiological Health Dental Devices Branch…. Of course, any testing by the ADA is no substitute for the FDA and other government agencies performing their mandated functions to protect the health and safety of the public.”

Let me translate: “”The ADA is doing our own research, but it’s really the FDA’s or CDC’s job to determine if this is a problem and what we should do next.”" The ADA’s point is legitimate; a professional organization should not be expected to provide the same public health services as the government.

On March 18, the ADA again wrote to virtually identical letters to both the FDA (PDF) and CDC (PDF).

“Media reports on ‘contaminated’ dental materials produced in foreign dental laboratories have become more frequent. The reports have an increasingly alarming tone and a sense of urgency since we first wrote to you on March 6. As a result, dentists are fielding more inquiries from concerned patients and there are disquieting reports of patients declining recommended treatment because of unsubstantiated fears.

“We are eager to understand the extent of any problems with dental materials, whether they are produced in foreign or domestic dental laboratories. In particular, we ask that you provide some context for claims of possible health impacts of lead in dental prosthesis in the amounts reported in the media. While recognizing that much remains to be learned about this issue, some general information from the CDC/FDA about the likelihood of harm would be of great interest to both dentists and patients and should come from the federal agency whose mission is to protect the public’s health.

“We also look to your agency to reassure patients that recommended dental treatment should not be ignored. The ADA is asking both the CDC and the FDA to consider providing a media update that will reassure the public that government agencies are taking appropriate steps to protect dental patients and that oral health care should not be postponed.”

Let’s translate that again: “Hey, guys, this goes beyond the scope of the ADA’s job… Can the government please offer some guidance?”

On April 14, the FDA responded to the ADA.

“The FDA is taking this report very seriously. FDA’s Center for Devices and Radiological Health (CDRH) is also working to obtain information on the presence of lead in dental prosthetics.

“At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence.”

Translation: “Sorry ADA, the FDA has nothing to say on the topic. Ask us again later.”

On April 17, the CDC replied to the ADA’s letters.

“Thank you for your correspondence regarding media reports about the lead content in a dental prosthesis made in a dental laboratory in China. The CDC became aware of this issue through conversations with staff at the ADA’s Divisions of Science and Government and Public Affairs and through media interest in this story.

“As you indicated, the FDA has regulatory authority over dental products, including dental prosthetic materials, and for the registration of foreign laboratories that import dental products into the United States. It is our understanding that the FDA is already acting on this information, At this time, CDC has had no formal request for any type of engagement from a state of local health authority.

“Although CDC has no specific information regarding the case to which you refer, we can provide you with some general information on lead exposure. Many consumer products contain lead in trace amounts, and federal regulations limit the amount of lead in consumer products… Certainly, CDC recommends against the unnecessary use of lead in consumer products, including dental crowns.

“The recent media reports of lead in dental porcelain/metal crowns suggest a level of approximately 200 parts per million. Such small amounts of lead as reported, however, are extremely unlikely to cause adverse health effects in adults because the dental products wear out slowly, so the lead would be released in tiny amounts over time. Even at an increased rate, it is highly unlikely that this amount would be a health risk to an adult.

“It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories. CDC would be happy to assist ADA in interpreting the health impact of the testing of dental porcelains/meals that is currently underway. CDC will also provide any support if requested from the FDA, as that agency conducts further testing of these products.”

Translation: “It’s the FDA’s job, not the CDC’s. Maybe it’s the ADA’s job, but definitely not the CDC’s. And the amount of lead in dental prostheses is probably safe.”

Are you as amazed by what you’re reading as me?!? Here are a few of the most bothersome points:

• “It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories,” writes the CDC, suggesting that it is the ADA’s responsibility to monitor the safety of dental products. The ADA is a private, voluntary professional organization funded by dues from member dentists. Testing and regulation is the government’s job, not the ADA’s.

  The ADA points this out in their initial letter, saying that “testing by the ADA is no substitute for the FDA, CDC and other government agencies performing their mandated functions to protect the health and safety of the public.”

• “The CDC became aware of this issue through conversations with staff at the ADA and through media interest in this story,” wrote the CDC.

  Really?!? Why was the ADA the one to bring this issue to the CDC’s attention? Does the CDC only investigate health threats that receive media attention?

• “At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence,” says the FDA.

  The FDA took over a month to respond to the ADA. The organization in charge of regulating dental materials (you know, making sure they’re safe and lead-free) hasn’t offered the public any guidance on this threat.

The CDC’s passing the buck to the FDA, and the FDA doesn’t appear to be doing much of anything. But dentists are worried, patients are panicking, and public is desperate to know more. As the public face of dentistry in the US, the ADA is now forced to stand in for do-nothing government agencies. Doctors, it’s time to put on your hip-high waders… it is going to get really deep before anyone in the government takes action or gives definitive guidance.

The relationship between dentists and their dental labs is a close one – but is it close enough?

The other shoe has dropped. The lead scandal, a story that The Wealthy Dentist has been covering for the last two months, has now gone national. ABC’s Good Morning America ran a segment about this potential crisis on May 8th. Doctor, you better have your story straight when you patients start asking you where your lab work in being done.

Dental labs have been in the spotlight due to the recent scare over lead apparently finding its way into dental restorations such as crowns and bridges. Dentists are realizing that they are ethically (and possibly legally) responsible for the quality of their dental lab’s work.

There are a number of holes in the current system. Allow me to point out just a few…

Start at the beginning

Once upon a time, would-be dentists studied alongside would-be dental technicians. The two professions are inextricably connected, and each would do well to understand the needs of the other. How better to foster this relationship than by educating students together?

Today, however, that is certainly not the case. At most schools, dental students and lab students have little to no exposure to each other. The communication gap that begins in school tends to continue into the working world.

“Most dentists don’t meet a technician until after they graduate and that’s criminal. The pre-clinical students and dental laboratory technology students are able to learn from each other, which helps them hone the skills they have and build new ones.”
- Bob Schneider, DDS, University of Iowa Hospitals and Clinics Professor (Journal of Dental Technology, June/July 2006)

Bridge the communication gap

One of the biggest complaints dental lab technicians have about dentists is that they often don’t give the lab all the information they’re supposed to. A proper prescription for a dental prosthesis includes detailed information about the materials to be used in its construction. When the dentist doesn’t provide all the details, it’s up to the technician to make these important decisions.

“Most dentists rely on the dental technician to choose the materials needed for the fabrication of the prosthesis. With lack of adequate information, all too often the design, fabrication, and completion of the case is left up to the technician. Therefore, our results indicate an apparent trend to which technicians are left to make crucial decisions for dentists.”
- Z. Afsharzand, DMD et al. (from the Journal of Prosthodontics, Vol 15. No 2 March-April 2006 pgs 123-28)

Know your partners

One dentist will have been working with the mom-and-pop dental lab down the street for thirty years. Another will use a major domestic lab after personally visiting the premises. Another will prefer the US-based chain with the lowest prices. Another will go online to find a Chinese lab that offers crowns for $39.95.

The dentist’s relationship with his or her lab isn’t something the patient can see. It’s not even something most patients would think to ask about. But even if it’s invisible to the patient, it’s likely to be the factor that best predicts the quality of the dental work they receive.

Patients deserve disclosure

In the US, dentists are not required to tell patients if their dental prosthetic was manufactured outside of the country. In fact, dental labs are not always required to tell dentists where the device was manufactured. (And since many US labs use partners overseas, a domestic return address is no guarantee.)

However, expect the laws to start changing soon. A number of states are already considering legislation mandating that labs inform dentists and/or dentists inform patients of work fabricated outside of the country. In Canada, for example, patients must sign an informed consent form before receiving any foreign dental work.

Keep on working

It may be as long as year before the ADA announces the results of their testing. Perhaps it’s a big fuss over nothing; perhaps we’re all slowly dying of lead poisoning. I can’t predict what the science will say. But I can definitely predict this: you, the dentist, are going to be held responsible for your dental lab work. Here’s hoping you can be proud to stand by your restorations.

Post your comments about dental labs

When last we spoke of the lead scandal, an Ohio TV station had reported finding the toxic metal in two dental crowns manufactured in Chinese dental labs. They launched their investigation after an elderly woman allegedly suffered lead poisoning from her dental bridge.

In two months since the story broke, a number of different organizations have begun their own testing of dental prosthetics. Unfortunately for those of us hungry for more data, few results have been publicly released.

However, the data that has come in so far suggests the lead scandal may be even bigger than we thought. Preliminary numbers suggest that a surprisingly high number of dental prostheses contain lead.

What’s more, the tainted dental work isn’t just coming from China. Lead has apparently been found in restorations made in the US as well as other countries.

Expanding upon their initial investigation, Ohio’s Channel 10 has released the results of further tests. What they found was not encouraging.

• China: 5 of 7 crowns tested contained 160-240 ppm lead.
• Thailand: 2 of 2 crowns tested at 130-140 ppm lead.
• USA: 2 of 4 crowns tested contained 110-130 ppm lead.

Since none of the components of a dental crown should contain lead, the million-dollar question (the one no one can answer right now) is where the lead is coming from. Is the lead in the glaze, the porcelain, or the metal? Are the dental labs responsible, or does the fault lie with those who manufacture the components?

Who’s doing what?

• The FDA is monitoring the situation, but is not currently planning to issue a Consumer Update.
• The CDC says it’s the FDA’s job, but suggests that even lead levels of 200 ppm are not dangerous.
• The ADA is conducting its own tests. Results have not been publicly released.

Read the report from 10 Investigates, or post your own comments on lead in dental products…

Even though there have only yet been official reports of two dental crowns (from Chinese dental labs) tainted with lead, that’s more than enough to make a lot of people very worried. And the relationships between American dental patients, dentists and dental labs are receiving more public attention than ever before.

The National Association of Dental Labs (NADL) has been campaigning the FDA for years to improve its regulation of dental laboratories. Of course the FDA already has regulations for foreign dental labs that export to the United States. But critics point out that inspections are minimal.

In addition, dental prostheses are in an import class of their own. Unlike virtually everything else, the FDA does not regulate the final products themselves, only the materials used in their fabrication. There’s no data on this point, but many worry that unethical labs may not be using the high-quality materials they report using, instead replacing them with less expensive alternatives. And China is already under the microscope for doing just that with other products such as pet food, toothpaste and cough syrup.

One of the issues this current scandal has highlighted is how little American consumers know about what’s in their mouths. Your shirt has a tag telling you it was made in China. The same message is imprinted on your dishes, stamped on your furniture, written on your user’s guide. But your dental crown that was made in China? No one ever tells you that.

Canadian dental patients have to sign an informed consent form before their dentists can give them a dental prosthetic manufactured outside of Canada. American dentists, on the other hand, aren’t even required to tell their patients where their dental bridge or crown was manufactured.

Now, a wave of new legislation has been proposed to help close that gap.

One such bill was recently introduced before the New York State Assembly. “Consumer protection is very important to me,” said Assemblyman Rob Walker, author of the bill. “If the bill is passed and signed by the governor, dentists will have to notify consumers where the actual prosthetic was made.” Dental patients would also be told what materials were used to make it. (Read more)

A similar bill was also introduced in Alabama. The synopsis of The Alabama Consumer Dental Act of 2008 reads as follows:

This bill would require dentists to provide prior written disclosure to their patients if any fixed and/or removable dental prosthetic device or appliance, whether fabricated in part or completely, including, but not limited to, a complete or partial denture, veneer, inlay, onlay, crown, or bridge, is manufactured outside of the United States and to provide that failure to make such a disclosure would be grounds for disciplinary actions.

South Carolina first introduced dental lab legislation a year ago. It focuses not on doctor-to-patient disclosure, but rather lab-to-dentist disclosure. The bill, which is still in committee and has yet to be approved, would:

• …require a dental laboratory that performs dental technological work outside of this state to employ a person who is registered by the state board of dentistry to authorize such work based on the prescription of a dentist licensed in this state,
• …require the laboratory to provide information on where the work was performed, and
• …require the laboratory to provide a list of the materials used in the work.

Similar legislation has been proposed in Florida in response to the lead scare. “This legislation is proactive and helps the state of Florida protect its citizens in light of recent documented cases of lead contamination in dental work coming into the U.S. from foreign countries.” The bill would:

• …require dental laboratories that operate in Florida to disclose to dentists where a product was manufactured and what materials were used in each restoration, and provide certificates of authenticity if available. (Although, the bill does not address this information going to the patient, under existing patient rights, a patient may request a copy of this information for their records from their dentist.)
• …require dental labs in Florida have a full-time technician who maintains 18 hours of approved continuing education in dental technology every two years.

Within the next month, we should hear the results of more tests, so we’ll have a better handle on the scope of this potential problem. But regardless of what the research reveals, you can bet that more states will be introducing similar legislation. (It’s already in the works in Michigan, Mississippi, Minnesota, Kansas, and California.)

Post your own comments to this story

Unless you’ve been living under a rock, you’ve heard that there’s early evidence that some dental lab work from China may contain lead. So The Wealthy Dentist conducted a survey on the topic. Read the full foreign dental lab survey results or Jim Du Molin’s most recent editorial.)

When we asked whose responsibility it should be to protect the public from tainted dental work, the most common answer was “dentists.” However, some feel the FDA should enforce regulations, while others think the dental labs should police themselves. Very few respondents suggested that patients who are concerned should be responsible for checking with their dentists.

We also asked respondents if the current fuss about possible lead contamination in dental crowns from China is the next big scandal or just a tempest in a teapot. One-third of dentists feels this will be the next big scandal, while the remaining two-thirds see it as nothing more than a tempest in a teapot.

Finally, we asked dentists if they know where their lab work comes from. Sixty percent are certain that all restorations are manufactured within the USA, and another 20% believe that to be the case. Only 10% acknowledge that they know they use products made overseas.

Here are just a few of the comments dentists had on the topic of alleged lead contamination…

• “My local lab is placing ‘made in America’ on all of the return cases for the patients to see.” (California dentist)
• “I expect that my US labs are not sending my work off shore and using the quality of material I specify, but how do I know for sure?” (Michigan dentist)
• “We don’t know if this is a crisis. The labs and FDA need to test a large number of prosthetics that are produced in USA with foreign materials and in foreign countries.” (Washington dentist)
• “The FDA should bear the responsibility, because the labs won’t and the dentists can’t.” (North Carolina dentist)
• “The last thing we need is more regulation. Let the labs police themselves.” (Pennsylvania dentist)
• “If dentists are communicating with their labs and specifying which type of metals to be used, they should be confident the lab is giving them that. If the lab is trying to cut costs by using metals that may contain hazardous materials and are not making dentists aware, the lab should be held responsible.” (Kentucky dentist)
• “I say the FDA should be in charge, but a big part of me does not like the idea of federal regulation, which already does not work particularly well.” (North Carolina dentist)
• “I don’t use labs that outsource to foreign countries. Those that choose to do so owe it to their patients to inform them of the practice.” (Arizona dentist)

Post your own comments or read the complete tainted dental lab work survey results