In the News

As reported by the New London Day, April 28, 2008.

Lead In Dental Work Prompts Fears About Chinese-Made Crowns, Bridges

Laws Passed After Problems Are Detected In Several States

By Lee Howard

Not many people think about what goes into their mouth when a dentist starts working to repair their smile.

But more and more patients have started asking about their crowns and bridges - the metal and ceramic inserts that are formed to replace missing or cracked teeth - ever since a February report in Ohio that found some dental work made in China contained high lead levels.

An Ohio television station reported on the case of a 73-year-old woman who had a bad reaction to a multi-unit bridge made in China that turned out to contain lead in the ceramic. The TV station subsequently tested eight crowns purchased from four Chinese dental laboratories and found that one of them contained 210 parts per million of lead.

The American Dental Association has said that dental restorations are not supposed to be made with lead, which has been linked to kidney damage and disorders of the central nervous and reproductive systems in humans. The United States recently set the acceptable lead level in toys at 90 parts per million, reduced from a previous limit of 600 parts per million.

“This is an incredibly dangerous situation,” said state Rep. Elizabeth Ritter, D-Waterford, a member of the state legislature's Public Health Committee.

The issue came to light too late for the Connecticut legislature, currently toward the end of its biennial short session, to take any action. But at least a dozen other states across the country have proposed laws requiring dentists to inform patients where their dental crowns were made and what types of materials are used in them.

The situation has caused such an uproar in some parts of the country that the American Dental Association last month asked the federal Centers for Disease Control and the U.S. Food and Drug Administration to weigh in on the health risks.

“In spite of no new information on the possible extent of this problem, media reports on 'contaminated' dental materials produced in foreign dental laboratories have become frequent,” the ADA's president, Mark J. Feldman, stated in letters to the two agencies. “There are disquieting reports of patients declining recommended treatment because of unsubstantiated fears.”

The dental association, which wants the two agencies to quiet fears, currently is conducting tests on 100 randomly obtained dental crowns from both foreign and domestic sources. It hopes to determine the extent to which lead may be present in dental crowns and to share the results with the public.

Meanwhile, another report in Ohio just last week revealed that all of the 12 dental crowns a TV station ordered from both foreign and domestic labs had at least traces of lead. More troubling, in over half the cases the amount of lead was regarded by some experts as potentially dangerous.

The U.S. Food and Drug Administration said in a statement, however, that it didn't believe the crowns pose a significant public health risk.

Dr. Robert Kelly, a professor at the University of Connecticut dental school in Farmington, said federal agencies and patients who have had crowns placed in their mouths shouldn't worry. The way crowns are made makes it difficult for lead to escape into the mouth, according to tests conducted in the past few weeks by the two major manufacturers of the ceramic portion of the dental work, Vipa in Germany and Ivoclar in Lichtenstein, he said.

“It's locked up tight; it's not coming out,” said Kelly, who has scoured the manufacturers' data. “It's not a health issue.”

Linda Orgain, a health communications specialist with the Centers for Disease Control in Atlanta, agreed that any lead released by a crown would be a minimal amount and would not cause a health problem.

“We don't want people to get overly anxious about a crown in that they think they need to remove or replace it,” she said.

The uproar over health risks has resulted in at least one positive, according to Bennett Napier, co-executive director of the National Association of Dental Laboratories, based in Florida. It has brought to light what some see as a disturbing trend: the outsourcing of dental work to areas of the world with cheap labor and no regulatory oversight.

Napier estimates that 15 to 20 percent of all crowns, bridges and dentures in the United States are now manufactured offshore -- and the percentage is rising every year. Offshore dental labs accounted for up to $1.6 billion of the $8 billion spent on dental-lab work in the United States last year.

To give an idea of the size of some of these labs, a new facility in China owned by a leading U.S. company is expected to employ 1,500 technicians and will be manufacturing 100,000 dental works a month within the next four years, according to an article this month in the Journal of Dental Technology.

“Large labs are getting larger,” Napier said in a phone interview. “But the number of labs is constricting. Over a recent 24-month period, the number of labs in the United States was down by 2,000, the majority of them sole-proprietor operations.”

At last count, the United States had a little more than 12,000 dental labs. While many patients are under the impression that their dentists create the crowns and bridges that go in their mouths, the vast majority of dentists these days pay labs to do the work.

But even some of these domestic labs outsource crown and bridge work to other countries.

“It's a global market,” Napier said. “Many dentists are not aware of this, the patients are not aware of this, but they have a right to know, and should be assured that it's safe.”

Though the dental labs Napier's organization represents have been affected by outsourcing, “Our association isn't anti-offshore,” Napier said.

The question, he added, is whether offshore work is safe; whether it complies with U.S. regulatory standards; whether it has the same standards of workmanship and materials as domestic labs provide, and whether dentists (and dental labs themselves) reveal if a crown is produced offshore.

Connecticut, like most states, does not regulate dental laboratories. The FDA is supposed to have oversight, but it has few inspectors to do the work-and, in many countries, it wouldn't be allowed to do inspections.

“From the FDA's standpoint, we are concerned about enforcement,” said Napier. “They don't have enough funding, and they don't have enough manpower to ensure the safety of all materials.”

As troubling as outsourcing has proven for some small mom-and-pop dental labs in southeastern Connecticut, several of which have gone out of business or downsized their operations in recent years, the opportunity to tap into cheap labor has been a boon for other, often larger, labs. These labs can charge their usual rates for crowns, essentially acting as a middle man and pocketing a profit of perhaps $100 on each dental insert while performing little or none of the work themselves.

“If the saving were being sent on to the patient, you could absolutely say nothing,” said Stephen Danna, owner of Willimantic Dental Lab. “But that's not the case. The profit is increasing for the middle men.”

Small dental labs have survived the outsourcing wars by specializing in certain procedures, such as dental implants, or by improving their turn-around times on crowns and bridges. While foreign labs often guarantee turn-arounds of 10 days, local companies can complete the work in half the time - a huge step up from the two- to three-week turnaround that had been traditional before overseas competition.

About half a dozen local dental lab owners contacted by The Day, many of whom did not want to be named, said they receive phone calls and mail inquiries all the time to get them to outsource their work to places like China, Vietnam, Thailand, India, Mexico, Costa Rica and the Philippines.

“Relax...outsource to Pacific Edge and enjoy more free time,” reads one post card sent to a local lab from Pacific Edge Dental Laboratories in Tijuana, Mexico. The card superimposes dental work over a picture of a beach on which two chaise lounges sit in the shade under a palm tree.

Michael Malinski of Mystic is a dental technician who saw the effects of outsourcing first-hand. While an employee at a dental lab in New Haven, he was the sole employee out of nine technicians retained after the company's owners decided to outsource most of their work.

“They were doing it to increase the bottom line,” said Malinski, now retired. “I don't know if it's dangerous or not, but I saw the quality, and the quality wasn't there.”

Malinski said he saw good work from overseas as well as bad, but he detected more problems with the overseas products. Some of the work didn't look like teeth, and the color matching wasn't as good as with domestic products, he said.

In addition, the fit wasn't quite right in many cases, he said, causing seepage after a couple years, potentially leading to various periodontal problems, including gum disease.

The problem, said Danna, the Willimantic dental lab owner, is that foreign companies don't play by the same rules as domestic labs.

“Imports are not checked or required to reach ADA specifications,” Danna said. “It's an unfair playing field.”

Danna and others said offshore labs often use inferior materials, including metals that have not been certified. Lab owners, citing scientific studies, said precious metals, including gold, silver and palladium, are the best products for oral applications; nonprecious metals tend to corrode more quickly in the mouth.

Safety has become particularly important in light of a predicted doubling of demand for dental services in the period from 2005 to 2015, a time when baby boomers will be exponentially increasing demand for bridges, crowns and dentures.

So what's a consumer to do?

Valerie Logan, owner of Natural Profiles, a one-woman lab in Stonington, said consumers should ask their dentists what materials are being used in their crowns. Consumers should make sure the products have Identalloy and IdentCeram labels, proving they have been accepted by the ADA, she said.

“Everyone has the right to ask their doctor who is making their crowns and where they are being made,” she said.

Dentists, for their part, need to stay on top of the type of material being used in the dental work they put in patients' mouths, according to the ADA. Dentists or companies that outsource their work directly to a foreign lab need to ask tough questions about ownership and quality control and may want to visit the facility, suggest officials with the National Association of Dental Laboratories.

Members of the local dental lab community, including Malinski, the retired technician from Mystic, said there are good dentists and bad dentists, as in any field, and the best dental practices are sticklers for quality control. They make sure to order high-quality materials and contract with reputable labs.

“It all boils down to if you get a good dentist, you get a good product,” Malinski said.