The FDA's Inadequate Response to Denture Adhesive Zinc Poisoning

 

Millions of Americans wear dentures and use popular over the counter denture adhesives to put the dentures in their mouths.

Denture adhesives are considered to be medical devices and are, therefore, under the control of the U.S. Food and Drug Administration (FDA).

How Does the FDA Classify Fixodent and Poligrip?

The FDA classifies denture adhesives as Class I Medical Devices. Class I devices present minimal potential for harm and are simpler in design that higher classes of medical devices. Typically a Class I device, such as denture adhesives, is not life sustaining, is not life supporting and does not present a reasonable source of injury from normal usage.

As Class 1 devices, denture adhesives such as Fixodent, Poligrip and Super Poligrip are only subject to general controls. GlaxoSmithKline, as the manufacturer of Poligrip and Super Poligrip and Proctor and Gamble, as the manufacturer of Fixodent, must register their products with the FDA and notify the FDA before marketing the device. They must also use good manufacturing techniques and properly brand and label their products.

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What Has Been the FDA's Response to the Link between Zinc Poisoning and Denture Adhesives?

Many years have passed since the FDA first classified Fixodent, Poligrip and Super Poligrip as Class I Medical Devices. Since then, adverse event reports linking these denture adhesives to zinc poisoning have been received and reviewed by the FDA. Additionally, there have been lawsuits filed by patients who have allegedly suffered zinc poisoning from their denture adhesives.

Yet, the FDA has not taken any action to inform the public of the risk of zinc poisoning nor has the FDA required the manufacturers of these products to take steps to remove zinc from their products or put warning labels on their packaging.

In the absence of FDA action, the American public remains vulnerable to zinc poisoning. Many denture adhesive users do not know that Fixodent and Super Poligrip contain zinc or that zinc poisoning is a threat to them. Those who are aware of the danger often learned about the danger from media coverage of zinc poisoning lawsuits brought by other denture adhesive users. Therefore, since the FDA has refused to act on this matter, private lawsuits are even more important to raise awareness about this important issue and to help victims collect monetary damages.

Do You Have A Fixodent or Poligrip Case? »

If you or a loved one have suffered from zinc poisoning after using Fixodent, Poligrip or Super Poligrip, please contact a products liability attorney today so that you can learn how to protect your own financial future and potentially the health of other denture adhesive users.

Fill out the online form or call us toll free at 866-761-1385 for your FREE case review.