From the ADA:
An Ohio CBS-TV affiliate is airing today an investigative report about outsourcing dental lab work offshore—and the story's hook is that one of the crowns received from a Chinese lab contained lead.
The reporter worked with a local dentist to order eight dental crowns (porcelain and full metal) from several labs in China, which were then sent to NSL Analytics in Cleveland for testing. One of the crowns tested positive for lead at 210 ppm. The story also will include information about a woman from Kent, Ohio, with a partial bridge that apparently tested positive for lead at 160 ppm. The woman apparently filed or will be filing a lawsuit, alleging that the bridge caused infection and swelling, which she attributes to the lead.
Product danger and contamination stories are big in the media these days—witness the recent pet food and toy stories from 2007—so it's important for you to be armed with the facts.
Here's what we know:
* No dental prosthetic device should contain lead.
* It's the quality of work and safety of materials that matter most to dentists and patients, not where the dental lab work is done. The underlying concern should not be where dental lab work is done (because there are offshore labs that do great work) but rather how you, the dentist, and your patients can be assured of the quality of the work and safety of the materials used. That said, we suspect that the China angle will be played up, especially after the scare over lead paint in toys. You may need information on what to ask your dental lab supplier(s) to be assured that the products you are purchasing from them are safe. View our tip sheet on questions to ask your labs. This will help you talk with your patients, too.
* Some of your patients will ask where you send your lab work and whether their own crowns or bridges might contain lead. To help you prepare for these questions, view these talking points. Of course, you will want to customize these to fit your needs, but these are basic points you can start with.
* Rather than waiting for the FDA or state legislatures to take some action, we are going to have our own labs do some random, objective testing of prosthetic devices, some from U.S. labs and others from offshore labs. This will take some time (we're still evaluating and don't know how long) to prepare for and execute, but we believe it is important that the ADA do this type of objective testing to gather additional intelligence on whether the Ohio testing was an isolated incident or cause for greater concern. As always, we're going to let science show the way. We'll keep you informed of what we learn and the next steps that result from the testing.
* The tip sheet refers to ISO or ANSI compliance. The standards for dental prostheses address the safety and quality of the metal-ceramic dental restorative system (ANSI/ADA Specification No. 38) and include a requirement for the manufacturer to test for the metal alloy composition and concentrations of the materials. There also are standards for noble metals.
* Some state legislatures (for example, Florida and South Carolina) are considering legislation to tighten up the regulation of dental laboratories. Provisions under consideration include requirements that dental labs disclose information such as where devices are made and the materials used. Be on the lookout for future legislative alerts from your state dental society on this topic.
* We made a strong statement to the press that we do not believe any lead should be in dental prosthetic devices. We have been advised by industry experts that there are no FDA-approved materials used in dental prosthetic devices that contain lead, which again points to the importance of your lab adequately assuring you that they use only FDA-approved materials.
* Labs fill the order that you give them based on what you request. The more detailed your request is in terms of what materials you expect them to use (or not use), the more assurance you will have about what they are providing. It is important to specify the exact materials that you want used in the prosthesis.
Here's what we don't know:
* We don't know whether this is an isolated incident or indicates a larger problem. We were surprised to learn that any dental prosthetic device might have lead in it.
* We understand that the lead was found in the surface of the crown, so our scientists suspect (but do not know for sure) that it could have come from the pigment. It's also theoretically possible that the lead could have come through a soldering process or as a contaminant from the lab environment. Again, as noted above, lead should not be in any FDA-approved materials.
We would like to hear from you if you have already experienced a problem with a dental prosthetic device containing lead. We also want to know of any other questions that we may not have outlined in this eGRAM or in the linked documents. Please send your comments and inquiries to: [email protected]. We will continue to share information with you as we continue to understand this better, so watch ada.org and be on the lookout for possible follow-up eGRAMs.
Needless to say, this is a very delicate issue. No one is more concerned about the possibility of lead contamination of dental products than dentists. On the other hand, we don't want to overreact to what could be an isolated incident. For now, be armed with the facts, communicate with your patients and stay tuned, because this story has the potential to evolve rapidly.
Finally, we hope this information helps you understand why it's very important for us to have your most current e-mail information. Please share this information with your colleagues, and ask them to let us know ([email protected]) their current e-mail address if they did not receive this eGRAM directly from us.
As always, thank you for your support of the work of the American Dental Association. It's through the strength of our membership that we are able to be helpful and responsive on critical issues like this one.
For more information, go to ADA.
To read more about dental labs and outsourcing, go to dental labs and outsourcing.
To read more about this topic from OSAP, go to OSAP.