Jim Du Molin offers dental marketing news and dental practice management advice for dentists.
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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:
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:
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.)
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…
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:
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.”
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.
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.
Jim Du Molin is a leading Internet marketing expert for dentists in North America. He has helped hundreds of doctors make more money in their practices using his proven Internet marketing techniques.
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