Dental Labs: Lead Content a Prescription for Disaster

Chinese Labs in Hot Water After Dental Crowns Found to Contain Lead

“Yeah doc, my lab uses nothing but the best materials.”

Indulge me for a moment in listening in on an imaginary conversation between a dentist and dental lab manager.

“I’ve heard some scary news about dental crowns made in China that are contaminated with lead. Since your dental lab is located in the US, I can just assume the crowns are made in the US, right?” asks the uncertain dentist.

“Yeah doc, I use nothing but the best materials!” the dental lab replies. “You’ve always trusted me to give you true art, I’m an artist, right?”

“Yeah, you’re a great artist,” agrees the dentist. “But are you sure your products are safe?”

“Just trust me,” insists the dental lab. “And trust me, I have that insurance thing you asked for, what did you say it was, an insurance binder? Oh, plus products liability insurance? And I’ll get that 510k FDA filing to you right away. You’ve got nothing to worry about, I’m the best.”

After a week without receiving documentation, the doctor follows up.

“No, I’m not sending you insurance thing,” scoffs the dental lab. “That would be an invasion of my privacy. Besides, you’re the doctor! You put the crown in, so you own it. Anyhow, I don’t have the time to document my processes and I’m not sure how to do a manufacturing map, but who needs it? What I do is ART!”

Trust me: If you go with Joe’s Super-Quality Basement Dental Lab, this is what you’ll get.

Which dental labs send work to foreign countries?

The answer? A lot more than you might think!

Fifteen to 20% of crowns in the US are manufactured elsewhere. I estimate 25% of American dentists may be using products made in Chinese dental labs – and many of them do not know it.

That’s why it’s no longer good enough to take your dental lab’s word for it. As a dentist, you should foster a strong relationship with your dental lab. Know the people, know the facilities, know the products – and know the right questions to ask. (As in, “Are all your products manufactured in the US? What safety precautions do you have in place?”)

The first thing you need to know is that many US dental labs outsource work to China and other countries. Even if you got a product through a US-based dental lab, you cannot just assume it was manufactured in the USA.

Secondly, large dental lab chains are particularly likely to send work to Chinese labs. Manufacturing costs can be as little as one-tenth as those at US labs, and big companies can save a tremendous amount of money via this lower-cost production. Some dental labs do their own manufacturing, while others are are simply brokers or aggregators who offer sales and distribution.

Name some names already!

DENTSPLY opened an FDA registered dental laboratory—Prident—in China in 2006. The dental laboratory materials used there are the same materials cleared by the FDA, supplied by DENTSPLY and sold to its US laboratory customers.

Dent-USA, despite what the name may suggest, is in fact the largest dental laboratory in China. Needless to say, its products are sold and marketed in the US. Their website stresses that they provide products that are FDA-approved. (In Germany, the company goes by German-Dent.)

Trident Dental Laboratories is one of the top dental labs in the US. Though the company is based in California, I have it on good authority that they also own a lab in China. This fact is not mentioned on their website.

Let me be clear: None of these labs are accused of any wrongdoing. In fact, only two dental crowns (actually, one was a bridge) have tested positive for lead. More testing is needed to determine the scope of this problem. But there are two things we can be sure of:

  1. Any lead in dental prostheses is too much lead.
  2. The vast majority of dental prostheses manufactured in China are perfectly safe.

Oh, and don’t let me forget the most important thing! When it comes to dental labs, due diligence is the dentist’s responsibility.

Whose responsibility is it to protect the public from tainted dental lab work?

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Dental Labs in China: How Much Do You Really Know?

Dentists: How Much Do You Really Know about Dental Labs?

When lead was found in dental crowns made in China, the National Association of Dental Laboratories – the public face of America’s dental labs – was thrust into the spotlight. They have launched a website, http://www.whatsinyourmouth.us, providing consumers with information on the current lead scare.Dentists and dental labs

The typical NADL lab has 10-25 employees, but of course American dental labs come in all shapes and sizes. Single-technician labs still exist, but more are closing every year. Larger labs are becoming more common, as are corporations that operate multiple labs.

Chinese dental labs manufacturing for export to the US are not basement operations. While a large American dental lab might employ a hundred technicians, one in China might have a thousand. Bennett Napier, co-executive director of the NADL, traveled to China to visit laboratories and speak with lab representatives.

Located in south China, Veden Dental Labs has 400 employees who manufacture 4,000 units a day for US and European customers. “It’s a campus environment because they’re working 24-hour shifts,” explained Napier, describing the lab’s golf course and employee housing. “It makes it easier to have employees right there and if there are peak times, the people are right there on site and they can walk 20 feet from housing and go to work.” (Take a look inside a Chinese lab.)

Not all Chinese labs have on-site employee housing. However, the three-shift workday is typical. Operating 24 hours a day, these labs are able to churn out large volumes of work in short periods of time. A crown, for example, takes about four days.

In fact, sending work to China for manufacturing can actually save time. Even including shipping, the turnaround time for Chinese work tends to be a week. Some American labs take 10 days or longer.

And at as little as $29 a unit, the price of a Chinese-fabricated crown is impossible to beat. Foreign dental labs are changing the economic reality of lab work. In 2007 alone, the number of dental implants imported to the US from China increased by 35%.

What will this mean for American dental labs? Well, things are only going to get more difficult for small mom-and-pop operations. Some theorize that US dental labs will become increasingly divided into two categories: mega-labs run with with brutal efficiency, and an upper echelon of boutique labs catering to higher-end dental practices.

Some American dental “labs” don’t actually have their own laboratories or do their own manufacturing. They would more properly be called brokers. They accept orders from dentists, then send the work to actual dental labs (sometimes domestically, sometimes internationally) for manufacturing.

All dental labs are required to label products along the lines of “Manufactured by X Dental Lab, Shanghai, China” or “Distributed by X Dental Laboratory, New York, NY, USA.” But keep in mind that a product distributed by an American company may still have been manufactured in another country.

Dentists are not required to pass this information on to their patients. This is in stark contrast to Canada, where patients must sign a consent form if their dental work is manufactured outside of the country.

Of course the FDA does have regulations for importing dental prostheses into the US, but enforcement is limited. Each and every single manufactured crown or bridge is supposed to be accompanied by a 510k form filed with the FDA. (See a sample 510k form.)

In the case of the dental industry, the FDA does not regulate the final products per se; rather, they regulate the materials. Even if a dental crown was manufactured in China, it was likely produced using materials made in the US or Europe.

Or at least, that’s what the Chinese dental labs say. But how can a dentist be absolutely certain the lab uses the materials they say they do? That’s why a trusted dental lab is one of a dentist’s most valuable resources. If a dentist has not done his or her due diligence in selecting a lab, that dentist could be held liable.

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Lead in Chinese Products Even a Problem in Comics…

Lead Scandal Makes the Funny Pages

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

ADA Left Holding the Bag in Dental Lab Controversy

When Scandal Strikes, Some Bury Their Heads in the Sand

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.

 

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Dentists: Do You Trust Your Dental Lab?

The Hidden Costs of a $40 Dental Crown

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.

How much do you really know about dental labs?

The following information was provided by the National Association of Dental Labs (NADL). All numbers apply to the US.

  • $80 billion: Annual revenue generated by dentistry
  • $7 billion: Annual dental lab sales
  • 12,000: Total number of dental laboratories
  • 5,000: Number of those that are single-technician labs
  • 48,000: Number of full and part-time dental technicians
  • 11,000: Number of dental technicians predicted to leave the profession by 2014
  • 68%: Percent of surveyed NADL labs outsourcing at least some work to domestic labs
  • 5%: Percent of surveyed labs outsourcing overseas

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.

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