Denture Creams Super Poligrip and Fixodent May Cause Neurological Damage

Paul Napoli
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Posted by Paul NapoliOctober 13, 2009 4:34 PM

Thirty four million Americans have dentures and about one third utilize denture cream to secure dentures in the mouth. Users of denture creams are being warned that zinc in certain products has been linked to neurological damage.

Zinc is an essential mineral that is naturally present in some foods, added to others, and available as a dietary supplement. A wide variety of foods contain zinc, such as red meat, poultry, beans, nuts, certain types of seafood (such as crab, lobster and oysters), whole grains, fortified breakfast cereals, and dairy products. The National Institute of Health’s Recommended Dietary Allowance (RDA) of zinc for an adult over 19 years of age is 11mg for men and 8mg for women. Tolerable Upper Intake Level (UL), which is the maximum daily intake unlikely to cause adverse health effects, for an adult over 19 years of age is 40mg. Increased levels of zinc in the body can interfere with copper and iron absorption, which is known to increase the risk of significant neurological disease.

A 2008 study released by the American Academy of Neurology tested four patients with dentures who used excessive amounts of denture cream and the zinc concentrations in Fixodent and Poligrip. The study concluded that the denture creams contain zinc, and chronic excessive use may result in hypocupremia and serious neurologic disease. There have also been adverse events of neuropathy reported to the U.S. Food and Drug Administration (FDA) regarding both Proctor and Gamble Manufacturing Corp’s Fixodent and Super Poligrip made by GlaxoSmithKline PLC. Some researchers estimate that some people who use excessive amounts of denture adhesive to secure ill-fitting dentures may be exposed to 330 mg of zinc daily, far above the RDA and UL of National Institute of Health.

The FDA classifies denture adhesives as medical devices under the Food, Drug and Cosmetic Act. Moreover, the FDA has also classified this product as a low-risk device (Class I). The FDA does not require that manufacturers list the amount of zinc in these products, nor do they require a warning label.

Lawsuits have been filed against Proctor and Gamble Manufacturing Corp. and GlaxoSmithKline PLC on behalf of denture cream users who have experienced neurological side effects from Fixodent and Super Poligrip. The suits allege that the manufacturers failed to disclose the presence of zinc in the product or to warn consumers to risks associated with the product’s use.

If you or a loved one used Super Poligrip or Fixodent and experienced numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis, difficulty breathing or other neurological symptoms, your denture cream may have caused it. Doctors do not always attribute these symptoms to zinc poisoning, especially because most denture users are elderly. Certain tests are needed to understand if zinc poisoning has contributed to your medical condition.

When a product causes serious injury or death, it is important to contact a personal injury attorney who has experience in handling product liability cases. Products liability is the branch of law that deals with the liability of parties involved in the manufacturing of a product for any damages caused by the product. Call Napoli Bern Ripka LLP today at 888-529-4669 to discuss your case and determine if you are entitled to compensation for your injuries.


2 Comments

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JILL PAUL RN
Posted by JILL PAUL RN
October 13, 2009 6:42 PM

Paul, very informative article. Who would have guessed zinc poisoning? I do have a question for you. If the above products are classified as Medical Devices Class l, how can the users of such devices sue the manufacturers when pre-emption prevails? When Class l is the lowest class of Medical Devices, and when one cannot sue the manufacturer's of a faulty Class lll device, apparently I am missing something here. Could you please explain. By the way, I am a great proponent of the Medical Device Safety Act and am actively involved trying to get this important bill passed in Congress and The Senate. Thank you, Paul.

Joshua
Posted by Joshua
November 13, 2009 3:55 AM

If you wear dentures and are suffering from neuropathy, or know someone who wears dentures and have seen a steady decline in neurological function, it is likely the result of zinc poisoning from Fixodent denture adhesive.

This product is likely to be found in the medicine cabinet of any denture wearer. Please review this Web site for your options on upholding your rights as an important deadline approaches in this case: http://fixodent-lawsuit.com/about-the-firm.html

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