An estimated 30 million Americans wear dentures, and most use one denture cream or another containing zincwhich helps both to hold dentures in place and to eliminate odors. As it happens, zinc, in small amounts, is necessary for the human body to function. Scientists have known for decades that too much zinc, however, can cause copper deficiency, which in turn can lead to nerve damage. Over just the last few years, studies have connected the dots between the zinc in denture creams and nerve damage.
These findings became more widespread starting in 2008 with the publication of a study in the journal Neurology that showed a link between denture creams and severe neuropathy. Other such studies followed, further supporting the conclusion that denture creams can be dangerous. Soon, trial lawyers representing injured denture cream users began to file lawsuits against two of the major manufacturers of dangerous products, GlaxoSmithKline (maker of Poligrip) and Procter & Gamble (manufacturer of Fixodent). Both manufacturers maintained that when used properly (that is, not to excess) their products were safe. Still, GSK began including a slip of paper in boxes of Poligrip reading, For Best Results Start With a Small Amount, and eventually voluntarily replaced all denture creams containing zinc with zinc-free alternatives. P&G, however, did not act as decisively in the wake of the controversy, merely adding a warning to its Web site. Fixodent still includes zinc.
Denture creams are classified by the U.S. Food and Drug Administration as Class I medical devices, meaning that they are considered low-risk products. As with other Class I devices, denture creams were not required to have any specific label warnings. In fact, GSK and P&G did not even disclose the zinc in their dental adhesives until after the article in Neurology was published. Despite a lack of formal labeling requirements,lawyers representing injured denture cream users claim that the manufacturers did not provide adequate warning of the products potential dangers. The link between zinc and nerve damage might prompt the FDA eventually to require warning labels on denture creams containing zinc. In the meantime, the FDA has issued a statement that denture creams are indeed subject to FDA regulation and that Class 1 device manufacturers must comply with FDA requirements, which include: adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading. The FDA added, Manufacturers also must report malfunctions that could result in death or serious injury.
Without explicitly saying so, the FDA was most likely referring to the severe neurological side effects associated with zinc poisoning. When consumed in excess levels, zinc leads to copper depletion. Copper is necessary for the body to maintain normal brain and nervous system function. When excessive zinc causes the body to be purged of copper, neuropathy (a disorder of the peripheral nervous systemthe part of the nervous system outside of the brain and spinal cord) can result. This type of nerve damage, if left untreated, can lead to permanent disability and even death.
Zinc toxicity (hyperzincemia) and low copper levels (hypocupremia) can cause a number of neurological side effects, including:
* Numbness, tingling, buzzing, pinching, or electric shocks in the arms and legs
* Strange, unpleasant sensations when touching something
* The inability to move arms, legs, feet, or hands
* A lack of coordination when walking
* The perception of wearing stockings or gloves (gloves and stocking sensation)
* Reduced ability to perspire
* Abnormal blood pressure and heart rate
* Constipation
* Bladder dysfunction
With permanent disability and even death possibly resulting from zinc poisoning, if you are using or have used denture cream containing zinc and experience these or other unexplained symptoms, contact your doctor immediately. Normal copper and zinc levels can be restored when you stop using
denture cream, but early detection is critical for preventing severe harm.
A diagnosis of hyperzincemia, hypocupremia, or neuropathy could entitle you to compensation from a denture cream manufacturer. But proving your claim will require help from an attorney who has experience taking on big corporations. The Rottenstein Law Group has been defending the rights of individuals injured by consumer products for more than 25 years. We know that you need and deserve a sympathetic advocate who will represent your interests alone.
