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Were your dentures, crowns made in China? Law would require disclosure

You know where your clothes are made. The country name is stitched on the tag. But do you know where the crowns, bridges and dentures in your mouth come from?

The Erie County Legislature thinks maybe you should.

Legislators are weighing a proposed local law that would require local dentists to disclose where the prosthetics they are cementing into your mouth were originally made.

Andy Jakson, owner of the Evolution Dental Science lab in Cheektowaga, has pushed the law after his firsthand experience working with a lab in China that purported to make crowns and other permanent dental fixtures for patients out of FDA-approved materials. In reality, the company was selling the FDA-approved materials on the black market and shipping back dental products made with inferior products.

"It's silly that we've got to know where shoes are made because they're going to be touching your skin, but something that is permanently placed in your mouth has no disclosure at all," said Jakson, whose lab annually makes dental prosthetics worth $3 million. "It's a medical device. I can't even fathom why it's not a law yet."

The Food and Drug Administration requires that dental prosthetics like crowns and bridges last seven years. But many of these dental fixtures last patients 20 years or more. And if those fixtures aren't being made to the proper health and safety standard, critics say, the possibility exists that they could absorb bacteria or leech contaminants into a person's body.

Groups like the American Dental Association and the Centers for Disease Control and Prevention have not found sufficient evidence that the general public is at much risk by having dental work made by overseas companies. But an investigative report from 2008 tested multiple crowns made in China and found they had unacceptable levels of lead.

Legislature Majority Leader Joseph Lorigo, who has an appointment to receive his first dental crown later this month, said patients have the right to know where their dental work is made. Area labs may partner with overseas companies to produce dental prosthetics that reduce costs, but rarely is that information voluntarily passed to patients.

Lorigo said he was shocked to learn that federal law requires the textile industry to list the fiber content, country of origin and care instructions for their fabrics, but the health community has no requirement to inform patients where medical devices implanted in their bodies are made.

He submitted a proposed law on Monday that likely will be sent to the Legislature's Health and Human Services Committee for discussion on Monday. He said he anticipates it will receive bipartisan support, though he remains interested in receiving feedback on the proposal.

"The law, in my opinion, is a perfect example of the legislative process working the exact way it's supposed to," said Lorigo, C-West Seneca. "I'm going to hope we can have it passed in the fall."

His broader hope is that the legislation gains steam at higher levels of government.

Jakson brought the issue to the Legislature's attention several months ago, recounting how his dental lab had partnered with a lab in China about a decade ago. To ensure the lab met FDA requirements, Jakson said he spent three weeks in Shenzhen, China, touring five different dental labs to assess their ability to meet U.S. standards. He picked one of the pricier labs that seemed trustworthy.

To ensure the lab used FDA-grade materials, he said, his company shipped U.S. materials to the Chinese lab. But the quality of the products he was getting in return made him suspicious, he said, so he ceased shipping one particularly popular shade of dental-grade porcelain.

That didn't stop the overseas lab from continuing to ship back finished products supposedly made with the porcelain that Jakson was no longer sending. So he had the products tested by the U.S. manufacturer that made the raw materials. That company confirmed the dental products shipped back to Jakson were not made from the same materials Jakson sent over.

The Chinese company gave dishonest explanations for what happened, he said, and a liaison later informed him the materials he sent over had been sold on the black market. In addition, he said, one box of finished prosthetics that had been held up at the border finally arrived with mold growing on the dental models, suggesting the use of unclean water.

He also pointed out that overseas labs in places like China typically can't be sued, leaving U.S. labs, dentists and patients with little recourse if a dental prosthetic turns out to be made under false pretenses.

The law under consideration by the Legislature would require two types of disclosure regarding the origin of the custom crowns, bridges, dentures and veneers: Dental labs must disclose the origin of their prosthetics to dentists, and dentists must disclose the origin of their prosthetics to patients.

Failure to do so would result in fines starting at $1,000 and increasing to $5,000 and misdemeanor charges for repeat offenders.

In response to the possibility that the proposed law may be imposing unwanted regulations on businesses or narrow profit margins, Jakson said, "This is not about increasing or decreasing somebody's business. This is about the safety of the patient."

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