The Sickening News about Tainted Dental Lab Work

Chinese Dental Labs Turn Lead into Gold…?

When a 73-year-old Ohio woman fell ill, the news made national headlines. It wasn’t old age, or pneumonia, or cancer, or anything else you might expect. She had gotten lead poisoning from her new dental bridge.

Though she’d visited an American dentist, the bridge itself had been fabricated by a Chinese lab. Let me assure you that this is major news. I expect this health scandal will rock the world of dentistry.

Lead: How Many Parts Per Million Is Okay?
210 Discovered in one Chinese-made crown
160 Discovered in Ohio woman’s dental bridge
600 US legal limit in paint, toys, etc.
90 International standard for items such as toys (now being considered by US Congress)
1 Amount the UK permits in dental work
0.5-3 FDA guidelines for leachable lead in ceramic dishware
0.1 FDA limit in candy and food
0.1 Amount naturally in a healthy person’s blood

The Ohio woman received this new dental bridge last year. However, the restoration site became inflamed, and chewing was unmanageably painful. The bridge was ultimately removed, and she’s had further surgeries since. She sent the bridge in question to a scientific testing laboratory, and its surface allegedly tested at 160 parts per million of lead. She has since retained a lawyer and is planning to sue her dentist. (Please note that she is planning to sue her dentist, not the dental lab!)

Chinese exports have received massive amounts of bad press after various health scandals. Do you remember the animals who died from eating tainted pet food? Then at least 21 Panamanians died after taking poison cough syrup. Danger made its way onto US shelves via toxic toothpaste. Most recently, children’s toys were pulled from the market after it was discovered that the paint contained high amounts of lead. All of these products were manufactured in China.

I know what many of you dentists are wondering: Is this for real? What evidence is there that Chinese labs are systematically producing lead-tainted dental restorations? Well, here’s the evidence that has so far come to light on this developing story:

  1. The Ohio woman’s partial bridge apparently tested at 160 parts per million of lead.
  2. Ohio TV station WBNS then conducted its own investigation, releasing the results on February 27. With the help of a local dentist, they ordered crowns from four different Chinese dental labs. One of the eight crowns tested positive for lead. The porcelain facing contained 210 parts per million.
  3. The ADA announced that it had begun its own investigation, and had recommended that the FDA and CDC do the same. (Read the ADA’s response and their talking points for dentists.)

Though most press focuses on work manufactured in China, it’s worth noting that products are imported from many other countries, including India and Mexico. Imported restorations are dramatically less expensive than work produced domestically; in some cases, a crown from China may cost as much as 90% less. Cost-saving measures have led to more and more international manufacturing.

In the US, about 15-20% of dental lab work is produced in China (primarily bridges and crowns); that’s 7 million foreign crowns each year. Many of these products are distributed by American labs. Three years ago, less that 1% of UK dental restorations were produced in China; that number is now up to 5%.

Theoretically, the FDA monitors all dental products, whether produced domestically or abroad. The FDA has the authority to inspect any dental lab, foreign or domestic, that makes products sold in the US. Dental labs with overseas operations must register with the FDA. But within the US, only three states (Texas, Kentucky and South Carolina) require dental labs to register with state health departments.

The National Association of Dental Labs (NADL) officially recommended that the FDA close some of these legal loopholes. Needless to say, the organization that represents 1400 US dental labs has grave concerns about the allegations of tainted dental products.

The lead appears to be in the porcelain surface of some restorations. But many foreign labs use porcelain and other materials made in the US or Europe. So where does the lead come from? Many suspect the lead is in the glaze used to stain and seal the porcelain.

Many pottery glazes contain lead. The lead itself is not particularly a problem until it comes into contact with acid. The acid is what allows the lead to leach out of the glaze. For pottery, this isn’t much of a problem. But since the human mouth is an acidic environment, lead might be transferred to the patient’s bloodstream.

Let’s be clear on this point: The FDA says there should not be detectable levels of lead in the surface material of a dental prosthetic device. Lead poisoning generally causes non-specific symptoms such as aches, abnormal bowels, or high blood pressure. As a result, proper diagnosis can take years.

Though labs are supposed to label outsourced work they provide to dentists, anecdotal evidence suggests that dentists do not in fact always know where their restorations were manufactured. Dentists: Do you know where your restorations are manufactured? Estimates suggest that 25% of US dentists are sending lab work to China – and what’s more, many of these dentists don’t even know it. You can’t just assume your dental lab does its own manufacturing. As a dentist, it’s your job to make sure you can stand behind the safety of any restorations you do.

Anyhow, folks, that’s just the tip of the iceberg! Check your inbox this Friday for a survey question on foreign dental labs. And you definitely won’t want to miss my next editorial. Do you know which of the major US dental labs import or manufacture foreign dental work? I do! And next week, I’ll start naming names.

Learn more – Plus, click here to post your comments on this story.

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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Are Dentists Liable for Lead in Dental Products?

Dentists Must Do Their Due Diligence

With recent news that some dental prostheses may be contaminated with lead, a lot of dentists are wondering if they’re legally liable for the quality of their dental lab work.

Unfortunately, there’s no simple answer to that question. However, one thing is clear: if you, the dentist, haven’t done your due diligence in selecting a reputable dental lab, you could be held responsible for the quality of their products.

“The liability situation is the same as it has always been, each party, the dentist and the dental laboratory must do their due diligence to comply with existing laws and regulations,” said Bennett Napier of the National Association of Dental Labs (NADL). “The liability exposure is different in each case specific scenario depending on a number of factors.”

But what exactly does “due diligence” mean? Well, it definitely means that you’re not choosing a dental lab on the internet because they have the cheapest crowns available. It does mean that you’ve researched your lab. Ideally, you’ve talked to the owner, visited the premises, and heard good reviews from other customers. If not… well, just be prepared for the possible consequences.

We at The Wealthy Dentist have been investigating what dentists may be able to do to protect themselves.

1. Make your dental lab tell you where the work is coming from and what it’s made of. Remarkably, most dental labs are NOT required to pass this information on to the prescribing dentist.

Florida and South Carolina have recently passed legislation that would require such disclosure, and other states are likely to follow suit soon. The NADL is working on a universal form for dental laboratories. Ohio has a similar form; the state’s dental board recommends but does not currently mandate use of these forms.

Highlights from the Ohio State Dental Board Laboratory Prescription & Point of Origin Form

Type of Restoration: _______

Materials:
– Porcelain to High Noble
– Porcelain to Noble
– Porcelain to Base Metal (NP)
– Full Metal High Noble
– Full Metal Noble
– Full Metal Base (NP)

This case will be:
– Fabricated by technicians at our own dental laboratory.
– Sent to another laboratory in the U.S. to be fabricated (Lab Name & Location)
– Sent to an overseas/foreign laboratory to be fabricated (Lab Name & Location)

See the full Ohio dental lab form

2. Make sure you’re giving your dental lab a full prescription.

An alarming number of dentists don’t actually give their dental labs all the information a technician needs to formulate a dental prosthesis. When information is missing (for example, what specific metals should be used), the technician is left to make an educated guess.

A checklist form can help ensure that dentists are giving their labs all the necessary information.

The Ohio State Dental Board has also released prescription guidelines. This form outlines the minimal information that should be included in a dentist’s prescription.

  1. Form must include basic information on patient, dentist and dental lab, as well as type of prosthesis.
  2. Crowns and bridges: Shade prescription, shade mapping, and material prescription.
  3. Partial and complete dentures: Shade prescription. tooth material prescription, tooth mold (shape) prescription, design of partial denture framework.
  4. Orthodontics or occlusal splints: explicit definition of type of prosthesis and instructions.
  5. Any additional explicit instructions from the dentist.
  6. Point of origin information should be included.

See the full dental lab prescription guidelines

3. Check your lab’s credentials.

The NADL’s Napier offers the following advice to dentists: “Dentists as part of minimizing their liability risk exposure can look at working with dental laboratories that are Certified Dental Laboratories or DAMAS accredited dental laboratories where third party validation occurs to ensure the lab’s quality system includes material traceability of lot and batch numbers of materials used for a specific dental restoration.”

The National Board for Certification in Dental Laboratory Technology (NBC) has developed a form for use by Certified Dental Technicians (CDTs).

Dental Restoration Disclosure Form
This case was manufactured by:
CDT Name: ___________________
CDT Number: ___________________
at ___________________(Dental Laboratory),
in ___________________(City, State, Country)
using the following FDA registered materials in the final restoration:
____________________________
____________________________
[Place Identalloy/IdentCERAM Sticker Here]

See the complete CDT dental restoration form

4. Stay current. It’s quite possible your state is considering new legislation for dentists and dental labs. You might consider setting up a Google News Alert to keep you informed of the latest news; just use “dental lab” and your state as keywords.

Can you suggest any additional resources? We’d love to see what forms you’re using with your dental lab. Just send us an email at DrWeeklyNewsUpdate@TheWealthyDentist.com!

Foreign Dental Labs Cause a Stir Among Dentists (video)

Foreign dental lab safetyIn light of reports of dental crowns manufactured in Chinese dental labs that may be contaminated with lead, we conducted a survey of dentists on the topic of foreign dental laboratories.

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

Dental Materials Safety Concerns (video)

Dental materials safety: who's responsible?The safety of dental materials has been in the news due to concerns about BPA in sealants and composite and reports of dental crowns manufactured in foreign dental labs that may be contaminated with lead.

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

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