That's Life: What Kind of Fakery Is This?
That's Life: What Kind of Fakery Is This?
One of the most troubling trends is the free substitution of products by laboratories, foreign and domestic, though in the case of pirated name brand products, China seems to be the most common offender. I have been talking to dentists who tell me they have tried BruxZir crowns and were not impressed by what they saw. This I find not just surprising, but startling, because in every case I've been involved in, the opposite is actually true.
By digging a little deeper, what I'm finding out is that labs are claiming to have something "Just like BruxZir" and then substituting regular isostatically pressed and bound zirconia, which is nothing like BruxZir. I have also been asked to make adjustments to e.max done elsewhere, only to have it ruined in the oven on a regular firing cycle indicating it was just some pressed ceramic material and not lithium disilicate e.max.
Not only is this fraud, but altering a doctors prescription is against the law. Another side effect is that the product failures cannot be accurately reported because there is no proof that the failed product was in fact the material requested. Manufacturers are starting to realize that mislabeled restorations and consumables is a serious epidemic. Just look at the material authentication programs in use today.
If you believe you have received counterfeit products, or to report any other problems with dental products, be aware the FDA has a reporting mechanism in place. They received $32 million dollars $100 million dollars this year to enforce these laws, and it's important you know how to address issues with product failures or substitution. Laboratories not in compliance with FDA GMPs and material disclosure laws take heed.
Here is the process:
Reporting Problems to FDA:
- Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with counterfeit materials, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program2. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements3 should follow the reporting procedures established by their facilities.
- To help us learn as much as possible about the adverse events associated with counterfeit materials, please include the following information in your reports, if available:
- Manufacturer's name
- Product name (brand name)
- Date product was manufactured
- Expiration date
- Catalog number
- Lot number
- Size
- Details of the adverse event and medical and/or surgical interventions (if required)
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.
