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Lead in Dental Products Continues to Worry Dentists

April 29, 2008 By Jim Du Molin

What’s Going on with the Lead Scare?

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…

Filed Under: Dental Editorials, Dental Safety Tagged With: ADA, dental lab, dentist, dentists, lead

Dentists and Dental Labs Subject of New Legislation

April 9, 2008 By Jim Du Molin

Proposed Laws Highlight Importance of Disclosure

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

Filed Under: Dental Editorials, Dental Safety, Legal Tagged With: Dental Crown, dental lab, dentists, foreign, law, lead, legislation

Dentists Speak Out on Foreign Dental Lab Work

April 2, 2008 By Jim Du Molin

Threat of Lead Contamination Highlights Importance of the Relationship Between Dentist and Dental Lab

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.)

Dental Survey Results 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

Filed Under: Dental Safety, Dental Surveys Tagged With: China, Dental Crown, dental lab, dentists, lead

Lead in Dental Crowns from China: Whose Fault Is It?

April 1, 2008 By Jim Du Molin

Protecting the Public from Tainted Dental Lab Work

Since news broke a few weeks ago of lead-tainted dental crowns from China, I’ve been giving you background information and sharing my opinions. This week, I’m going to take a back seat. Instead, let’s see what dentists had to say when responding to my survey. (Read the complete dental lead scare survey results.)

First, the numbers: When asked who should be responsible for protecting the public from tainted dental work, here’s how dentists replied:

31% said the FDA
25% said dental labs should police themselves
41% said dentists should take responsibility; and
3% said the burden should be on patients.

Two out of three dentists thinks this is likely to be nothing more than a tempest in a teapot, while the remainder expect it to be the next big health scandal. The scope of the threat is not clear, as further research has yet to be released. “We don’t know if this is a crisis,” a Washington dentist pointed out. “The labs and FDA need to test a large number of prosthetics that are produced in USA with foreign materials and in foreign countries.”

In Canada, dentists are required by law to have patients sign an informed consent form if their restoration has been manufactured in a foreign dental lab. In the US, dentists have no such notification requirement. “Patients have been systematically kept in the dark when it comes to dental procedures,” wrote a California dentist. “They should be given informed consent when choosing materials. Otherwise dentists will continue to do what they want to do.”

To many, the most important issue is that dentists take responsibility for the quality of their lab work. “Government oversight would not prevent an unscrupulous lab from farming out work,” a Pennsylvania dentist pointed out. “As with most business relationships, one of the best ways to really know what you getting is for the doctor to establish a personal relationship with the lab. This means meeting the owner/director, asking questions, and judging the lab’s honesty.”

Indeed, “judging a lab’s honesty” is one of a dentist’s most important responsibilities. Most dentists have nothing but criticism for colleagues who seem to value low prices over quality materials. “Too many dentists are accommodating low insurance payment schedules by buying their dental materials and laboratory fabrications that are too cheap,” seethed a Maryland dentist. “It doesn’t seem to matter that it compromises the health of the patient.”

To me, the critical question here is: Just what are a dentist’s responsibilities when it comes to evaluating if a dental lab is worthy of the doctor’s trust?

“My lab has assured me that their products are all manufactured in the US,” said a North Carolina dentist. “But so what? People don’t always tell the truth, but we must put trust in something. I trust my lab and I hope the system is not broken.” A Michigan dentist agreed, asking, “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?”

One comment really hit a nerve with me.

“I am certain the FDA will be monitoring all materials any US lab uses. It only stands to reason that overseas labs conform to our regulations.”

There’s some very dangerous logic going on in that statement! When it comes to ensuring the health and safety of your patients, you don’t get to just “take it on faith.” This isn’t just ethical guidance I’m giving you — this is legal guidance as well! If you don’t do your due diligence in checking out your dental lab, you could be legally liable. (The woman in Ohio who allegedly got lead poisoning from her Chinese crown? Word is, she’s planning to sue her dentist.)

So who should be in charge of making sure toxic materials aren’t used? The FDA seems the obvious choice. Indeed, the FDA does regulate dental products, but it’s an open secret that they do very little actual testing. In fact, the Nation Association of Dental Labs have been working with the FDA for several years to improve regulation. (Thanks to this scandal, I think we’ll finally start to see some progress on that front!)

I’ll leave you with the words of an Illinois dentist who concisely summed it up: “If you wouldn’t put it into your own mouth, you don’t put into a patient’s mouth.”