More Questions Than Answers
Posted Apr 28, 2011, Published 2008-04-01
Commentary by Kelly Carr
Foreign Dental Work Put To Test, an investigative report about lead found in restorations made in China, has been the talk of the industry since it aired on February 27 on Columbus, Ohio's WBNS 10TV. Patient safety has always been a critical concern in our industry but when you throw in the controversial subject of offshore outsourcing and the recent coverage about contaminated pet food, tainted Heparin and toxic toys, the coverage has the potential to be especially inflammatory.
For those who haven't seen or heard about the report, here's a brief synopsis: Reporter Lindsey Seavert told of an Ohio woman who experienced pain and an infection in her jaw after her dentist placed an ill-fitting three-unit PFM bridge in her mouth last year. After learning the bridge was made in China and thinking about all the recent reports of lead contamination in imported goods, she had the bridge removed and tested for hazardous materials, and lead (160 ppm) was found in the restoration.
10TV conducted its own experiment and, working with a local dentist, ordered eight PFM crowns from four laboratories in China and sent them to NSL Analytics in Cleveland for testing. One of the eight crowns tested positive for lead (210 ppm). Several other TV stations, newspapers and blogs picked up the story, although the coverage was minimal compared to the extensive media reporting about other contaminated Chinese imports we've seen in the past year.
Seavert's report was fairly short and aimed at the general population. As an industry insider, I felt it had some holes so I contacted her to clarify some points. For instance, her report didn't specify whether the lead was found in the porcelain or the alloy. We had heard from several industry members that it was in the porcelain, which she confirmed. I also wondered if the station tested any crowns made in the U.S. for lead; it hadn't.
Seavert said she first learned about offshoring in our industry about six months ago when a laboratory owner contacted her to report she had laid off several employees because she couldn't compete with pricing from offshore laboratories. Seavert began researching the story and during that time, she learned about the Ohio patient through the NADL, which the patient had contacted.
As an editor, it's my nature to research and analyze situations from all angles. At press time, 10TV had aired three reports on this topic and, after watching them, I'm questioning exactly what's causing the Ohio patient's health problems. For instance, in the first report, the implication is that she is suffering from lead poisoning but it also shows the bridge on which certain areas of the porcelain are completely ground down to the metal. In a subsequent interview, the patient is quoted saying her bridge was, "one size fits all; large, uncomfortable and painful." Is the patient suffering from lead poisoning--which typically affects major organs in the central nervous, gastrointestinal and urinary systems after extended periods of exposure--or the effects of poor, ill-fitting dental work?
Lead is a natural element and many materials and foods contain trace amounts of lead that are considered acceptable by the FDA. For instance, no more than 0.5 ppm is considered an acceptable level of lead in candy and Congress is working on legislation to reduce the acceptable level of lead in toys to 90 ppm. Is a certain level of lead acceptable in a restoration? And if so, what is that level?
Initially, the ADA published an e-gram saying, "No dental prosthetic device should contain lead." However, its subsequent March 27 release incorporates subtler language, saying, "Lead should not be used as an ingredient in dental crowns. However, with sophisticated technology, it may be possible to detect lead in minute amounts in virtually everything, including air and water."
With this in mind, the ADA sent letters to the FDA and CDC asking for guidance: "...we ask that you provide some context for claims of possible health impacts of lead in dental prostheses in the amounts reported in the media. While recognizing that much remains to be learned about this issue, some general information from the FDA about the likelihood of harm would be of great interest to both dentists and patients and should come from the federal agency whose mission is to protect the public's health." At press time, neither agency had responded.
The ADA is also conducting independent tests to determine the degree to which lead may be present in crowns and in which material the lead is located. It's randomly testing approximately 100 restorations from both domestic and overseas laboratories.
The media coverage has created fresh debate on the age-old question: should there be mandatory certification and registration for all U.S. laboratories? It's also brought another issue to the forefront: a patient's right to know the point of origin of his restoration, just as he knows where his clothes, toys and most other products are made. Legally, laboratories must disclose where a restoration is made to their clients but dentists are under no legal obligation to pass that information onto their patients. However, in the past month, lawmakers in Alabama and New York have introduced legislation requiring dentists to disclose the origin of restorations to their patients.
Reaction among our readers has been mixed. Some are outraged and feel this could be the death-knell to offshoring while others, like me, are taking more of a wait-and-see approach as the story evolves. Will it simply be a blip on the radar or will the mainstream media attention initiate significant changes for our industry?
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