Posted on 02/27/2008 5:42:59 PM PST by Patriotic Thunder
COLUMBUS, Ohio - Chris Collier has been a patient of Dr. Dave Rummel for 30 years.
When it comes to teeth, Collier is more concerned about his health than his smile.
"The reason I come here is because I know I can trust the dentist I have," Collier said. "I know I can get good workmanship."
SLIDESHOW: Images From Report
Rummel is one of the few dentists in central Ohio who makes his own crowns, bridges and dentures, but most other dentists rely on outside dental labs, 10 Investigates' Lindsey Seavert reported.
The labs can be down the street or even overseas, increasingly outsourcing work to India, Mexico and China. Chinese imports, like jewelry and toys, have been under heavy scrutiny for the last year because of lead concerns.
The dental community is concerned that unsafe metals have reached their industry, too.
"It's one thing if it's a toy a child plays with for 20 minutes. It's another thing if it is somebody's mouth for a lifetime," Rummel said. "There is an issue here."
10 Investigates obtained a letter from the National Association of Dental Laboratories that outlined the concerns. The organization told the Food and Drug Administration that outsourcing would increase because dental work created overseas is cheaper.
Even more of a concern is that dental labs or mostly "mom and pop" shops are unregulated in Ohio and 46 other states. Because of that, labs can outsource and no one may ever know, Seavert reported.
"Currently, laboratories that are outsourcing work overseas are required to disclose that to their dentist through existing FDA regulations but that is where it stops," said Bennett Napier of the NADL. "That disclosure does not have to pass on to the patient."
10 Investigates learned the deception goes one step further. Sometimes labs don't tell dentists, leaving them to unknowingly place foreign products in patient's mouths.
In the U.S., the materials in dental work are FDA approved. It is supposed to be that way in foreign countries but the FDA has no way to enforce it, Seavert reported.
The NADL said the FDA approached them first in 2004 and then in 2007, concerned about the increasing number of imported dental devices passing U.S. borders and acknowledged the need to better enforce dental lab regulations.
With millions of products and not enough manpower, the work crosses borders to places like Ravenna, Ohio. There, a 73-year-old woman hired a lawyer to sue her dentist. It began when she received a new dental bridge last year. The pain became so severe that she could not chew.
"She began to have some pretty significant complications and reactions and infection that stemmed from the restoration that ultimately had to be removed," Napier said.
The woman, who requested anonymity, told 10 Investigates that she later discovered her bridge was made in China. Worried, she had a lab test it for hazardous materials.
The lab determined that the porcelain filed away in her mouth contained lead. She has since undergone two surgeries, Seavert reported.
With 300 unregulated dental labs in Ohio and an estimated 7 million crowns coming into the country each year, 10 Investigates wondered how much a threat lead is in outsourced dental work.
We ordered eight crowns from four labs in China that advertise in industry magazines. With help from Rummel's lab, we received our product 10 days later.
Only one lab identified materials in the crowns. 10 Investigates first used a device that screens for lead. Of the eight, one crown came up positive.
We sent our sample to a Cleveland lab - NSL Analytics - to provide scientific proof. They specialize in testing metals and began by separating the porcelain from the metal.
The crown is diluted in a test tube that becomes a solution chemists test for lead. The machines give an instant reading of lead. 10 Investigates' results came back at 210 parts per million. The Ravenna woman's bridge measured 160 parts per million.
"We don't know what the FDA or the American Dental Association considers to be a risk as far as lead content," said Carm D'Agostino, a chemist.
With no known research on lead in dental work, the lab can only compare to toy standards.
Toys leaching lead over 90 parts per million are hazardous, so what about 210 parts per million in your mouth?
"I guess that tells me I need to be a little bit more concerned about other potential sources of lead," said Dr. Marcel Casavant, who runs central Ohio's lead program and poison control center. "I never would have guessed somebody would have put lead into a piece or a part installed into a human being."
Casavant said adults can live with lead poisoning for years and not know it.
"The symptoms are what we call non-specific - a little ache or a pain - abnormal bowel function," Casavant said.
Even high blood pressure and kidney trouble could be symptoms, according to Casavant.
He said he would never link lead poisoning to dental work but would have to add it to his list of questions when asking people what kind of dental work has occurred.
The NADL said that 10 Investigates' findings prove that the FDA needs to do more.
"It reinforces the concerns we have as an industry and concerns the FDA expressed to us that the potential is there," Napier said.
The NADL letter asks the FDA to track dental work from foreign labs to patient records. They want the FDA to register all labs, require them to disclose where they get their dental work and label what materials are in it.
The Ohio Dental Board admitted that is not sure what is happening in the state's roughly 300 labs and has no plans to regulate them. Lili Reitz, the director of Ohio's dental board, said the burden relies on the dentist.
"Ignorance is not a defense when you are ultimately responsible for what is going into the mouths of the patients that you serve," Reitz said.
Rummel said that 10 Investigates' lead findings only prove outsourcing comes with a risk.
"If a medical device is made out of a foreign country, I think the patient should know," Rummel said.
He recommends that people ask their dentist where their work is made.
"I think you can't really get something for nothing and I think (if) we start going down that road, we all suffer," Rummel said.
In response to our story, the Ohio Dental Board on Wednesday adopted a recommendation to the dentists they regulate.
They are asking dentists to give labs a form that would require the labs to disclose where their dental work is made.
On a federal level, 10 Investigates has asked the FDA for a response to our findings for the past two months.
On Wednesday, they told us that they are reviewing our report and developing a strategy to address our findings on all imported dental devices.
The Ohio Dental Association said that it would require their members to fill out the form in hopes of giving it a better idea of how many labs are outsourcing.
Thank you...we learn something every day—especially about china.
My dentist has a neat computer set up that really makes a great crown. Plus if you break a crown since he made it he makes you a new one FREE. I like getting my crown the same day and not having to wear a temporary crown that almost always comes off before the next visit to have the outside crow placed. He said he is one of only a few in Arkansas who make their own. I think the computer and set up was very expensive but he is already rich and likes the artistic aspect.
Where do most dentists get dental supplies for fillings these days? I’m wondering what might be in those.
everyone here is acting like a bunch of hysterical women. one crown has been “reported” to have contained lead amongst millions placed every year. i’m a dental lab tech and have been making crowns for twelve years and i’m very skeptical regarding this accusation. first of all getting porcelain to bond to metal is very tricky. you can’t just throw in some lead and expect everything to bond as usual. you have to work within certain coefficients of expansion for both porcelain and alloy to be able to bond . second there is only a couple of manufactures of porcelain in the entire world. from these few manufactures come all of the porcelains used worldwide. these porcelains will only fuse to certain formulated alloys. for example the porcelain i currently use must be applied to an alloy that has a coefficient of expansion between 14.2 - 14.9. lead just doesn’t just find its way into porcelains or dental alloys, it wouldn’t bond correctly. my belief on all this hysteria is based on the nadl trying to squeeze out small dental labs which account for more than half of all dental restorations made in the US. the nadl is run and backed by large corporate dental labs who are building and buying labs in china, mexico, costa rica, korea, etc. like its going out of style. some companies have formed that act as middlemen for smaller labs allowing them to outsource to foreign countries just like the big labs. other companies have formed domestically that allow small labs to utilize new technology such as zirconia core crowns as mentioned in an earlier post. the nadl is pushing the fda to mandate that all labs who outsource to foreign and domestic labs, for all or part of a crown, must register with the fda, which comes with huge compliance expenses. notice their not trying to stop foreign outsourcing. they’re pushing for this expense because they know most small labs will fold leaving most of the market for the corporate labs who can afford the compliance expenses. once this happens they can start sending their lab work to their company owned foreign labs and make money hand over fist. this may sound far fetched to an outsider but i’m in the industry, i read the journals, i see the advertisements from corp. labs for cheap outsourced crowns, i know who is on the nadl board, many of the ceo and presidents of the larg corp. labs. thankyou for letting me vent.
So me new toothies good r badz?
made in china or U.S.A. you probably are at greater risk of being struck by lightening on a clear day than finding lead in your mouth.
Glad you vented! Thanks for the info. : )
actually, the ohio lady is suing (that’s one case), the reporter in the story sampled 8 labs in china, and one of those came back with lead also (that’s two cases), then you have at least two other cases that are out there (now four cases) that haven’t gone mainstream. If your a dental lab technician, then you might want to head over to dentaltown and take a look for yourself. You’re spot on when it comes to the NADL, the current president(Joe Gerace) of NADL is/was a partner for the largest privately-owned dental lab corporation (Dental Services Group) in the United States and sends to china regularly.......makes you wonder doesn’t it?
ok two maybe four cases, it just seems way too convenient for the nadl. all of this couldn’t have come to light at a better time, right in the middle of their push for new fda regs. i’m still skeptical. when the lead paint in toys from china came to light, as awful as it is, i understand lead in paint. paint benefits from having lead in it just like gasoline. i know lead paint in kids toys is horrible i’m not ok w/ that. i’m just saying lead makes paint better. lead in no way benefits dental restorations. it just seems to me people are playing on the public fears. if you use the words china and lead along with any product in the same sentence you instantly create fear in uninformed people. i’m not saying lead wasn’t found in four crown i’m saying the only thing missing is the silver plater it was served on to the nadl.
There is a website where you can post questions and get them answered by dentists:
www.dentalanswerspro.com
there is also an article about lead and dental work
It is a public service website run by dentists.
-Z
That’s it, the lead found in one of the crowns (maybe more) was in the porcelain (glass color looking structure). They are using it to cover the metal substructure. If it isn’t right to be in kids toys, how can it be right to be in someone’s mouth? Just so you know......Kids toys were tested to have 91 ppm of lead content, one of these Chinese crowns had 212 ppm of lead content.....
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